Download CCR Template - Colorado Secretary of State

Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
1
DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT
2
Hazardous Materials and Waste Management Division
3
6 CCR 1007-1
4
STATE BOARD OF HEALTH
5
RULES AND REGULATIONS PERTAINING TO RADIATION CONTROL
6
PART 6:
7
X-RAYS IMAGING IN THE HEALING ARTS
8
RH 6.1 Purpose and Scope.
9
6.1.1
10
11
12
6.1.1.1 RULES AND REGULATIONS SET FORTH HEREIN ARE ADOPTED PURSUANT TO
THE PROVISIONS OF SECTIONS 25-1-108, 25-1.5-101(1)(L), AND 25-11-104, CRS.
6.1.2
13
14
15
16
BASIS AND PURPOSE.
6.1.2.1 A STATEMENT OF BASIS AND PURPOSE OF THESE REGULATIONS
ACCOMPANIES THIS PART AND CHANGES TO THIS PART. A COPY MAY BE
OBTAINED FROM THE DEPARTMENT.
6.1.3
17
18
19
20
21
AUTHORITY.
SCOPE.
6.1.3.1 This Part 6 establishes requirements, for which a registrant is responsible, for use of xray equipment IMAGING SYSTEMS by or under the supervision of an individual
authorized by and licensed in accordance with State OF COLORADO statutes to engage
in the healing arts or veterinary medicine.
6.1.4
APPLICABILITY
22
23
6.1.4.1 The provisions of this Ppart are in addition to, and not in substitution for, other applicable
provisions IN PART 1, 2, 4, 7, 10 OR OTHER PARTS of these Rregulations.
24
25
6.1.4.2 PART 9 AND PART 24 SPECIFICALLY APPLY TO SOME PARTICULAR HEALING
ARTS X-RAY IMAGING REGISTRANTS.
26
27
28
6.1.4.3 THE REQUIREMENTS AND PROVISIONS OF THIS PART APPLY TO EACH
REGISTRANT OR APPLICANT FOR REGISTRATION SUBJECT TO THIS PART
UNLESS SPECIFICALLY EXEMPTED.
29
30
31
6.1.5
PUBLISHED MATERIAL INCORPORATED BY REFERENCE.
6.1.5.1 PUBLISHED MATERIAL INCORPORATED IN PART 6 BY REFERENCE IS
AVAILABLE IN ACCORD WITH 1.4.
6-1
Colorado Radiation Regulations, Proposed Revised Part 6
32
May 12, 2017
RH 6.2 Definitions.
33
AS USED IN PART 6, THESE TERMS HAVE THE DEFINITIONS SET FORTH AS FOLLOWS.
34
35
36
“AAPM ONLINE REPORT 03” MEANS “ASSESSMENT OF DISPLAY PERFORMANCE FOR
MEDICAL IMAGING SYSTEMS”, AAPM ONLINE REPORT NO. 03 BY TASK GROUP 18 OF
THE AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE (APRIL 2003).
37
38
39
40
“AAPM REPORT 4” MEANS “BASIC QUALITY CONTROL IN DIAGNOSTIC RADIOLOGY”,
AAPM REPORT NO. 4 BY THE DIAGNOSTIC RADIOLOGY COMMITTEE, TASK FORCE ON
QUALITY ASSURANCE PROTOCOL OF THE AMERICAN ASSOCIATION OF PHYSICISTS
IN MEDICINE (NOVEMBER 1977).
41
42
43
“AAPM REPORT 74” MEANS “QUALITY CONTROL IN DIAGNOSTIC RADIOLOGY”, AAPM
REPORT NO. 74 BY TASK GROUP 12 OF THE DIAGNOSTIC X-RAY IMAGING COMMITTEE
OF THE AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE (JULY 2002).
44
45
46
47
48
“AAPM REPORT 93” MEANS “ACCEPTANCE TESTING AND QUALITY CONTROL OF
PHOTOSTIMULABLE STORAGE PHOSPHOR IMAGING SYSTEMS”, AAPM REPORT NO. 93
BY TASK GROUP 10 OF THE RADIOGRAPHY AND FLUOROSCOPY SUBCOMMITTEE OF
THE DIAGNOSTIC IMAGING COUNCIL CT COMMITTEE OF THE AMERICAN ASSOCIATION
OF PHYSICISTS IN MEDICINE (OCTOBER 2006).
49
50
51
52
53
“AAPM REPORT 96” MEANS “THE MEASUREMENT, REPORTING, AND MANAGEMENT OF
RADIATION DOSE IN CT”, AAPM REPORT NO. 96 BY TASK GROUP 23 (CT DOSIMETRY)
OF THE RADIOGRAPHY AND FLUOROSCOPY SUBCOMMITTEE OF THE DIAGNOSTIC
IMAGING COUNCIL CT COMMITTEE OF THE AMERICAN ASSOCIATION OF PHYSICISTS IN
MEDICINE (JANUARY 2008).
54
55
“Accessible surface” means the external surface of the enclosure or housing provided by the
manufacturer.
56
“Added filtration” means any filtration which is in addition OF A FILTER to the inherent filtration.
57
58
59
60
“Aluminum equivalent” means the thickness of ALUMINUM (type 1100 aluminum alloy1 WITH A
NOMINAL CHEMICAL COMPOSITION OF ALUMINUM 99.00 PERCENT MINIMUM AND
COPPER 0.12 PERCENT MAXIMUM) affording the same attenuation, under specified conditions,
as the material in question.
61
62
1
63
64
65
66
67
“Attenuation block” means a block or stack, having THAT HAS A THICKNESS OF dimensions 20
centimeters by 20 centimeters by 3.8 cmentimeters, IS MADE of ALUMINUM (type 1100
aluminum alloy1 WITH A NOMINAL CHEMICAL COMPOSITION OF ALUMINUM 99.00
PERCENT MINIMUM AND COPPER 0.12 PERCENT MAXIMUM), or other material(s) having
equivalent attenuation, AND IS LARGE ENOUGH TO INTERCEPT THE ENTIRE X-RAY BEAM.
68
69
70
“Automatic exposure control” (AEC) means a device which THAT automatically controls one or
more technique factors SETTINGS in order to obtain at a THE pre-selected location a required
quantity of radiation. (See also “Pphototimer”).
The nominal chemical composition of type 1100 aluminum alloy is 99.00 percent
minimum aluminum, 0.12 percent copper.
6-2
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
71
72
73
74
“AUTOMATIC EXPOSURE RATE CONTROL” (AERC) MEANS A DEVICE THAT
AUTOMATICALLY CONTROLS ONE OR MORE EXPOSURE SETTINGS IN ORDER TO
OBTAIN AT THE PRE-SELECTED LOCATION(S) A REQUIRED QUANTITY OF RADIATION
PER UNIT TIME.
75
76
“AUTOMATIC FILM PROCESSOR” MEANS A DEVICE THAT PRODUCES AN IMAGE FROM
A FILM-SCREEN SYSTEM IN MECHANICAL STEPS WITH LIMITED HUMAN INTERVENTION.
77
“Barrier”. (See “Pprotective barrier”).
78
79
“Beam axis” means, FOR PURPOSES OF PART 6, a line from the source through the centers of
the x-ray field.
80
81
“Beam-limiting device” means a device which THAT provides a means to restrict the dimensions
of the x-ray field.
82
83
84
“BONE DENSITOMETRY SYSTEM” MEANS A DEVICE THAT USES ELECTRONICALLYPRODUCED IONIZING RADIATION FOR THE SOLE OR PRIMARY PURPOSE OF
DETERMINING THE DENSITY OF BONE STRUCTURES IN HUMAN PATIENTS.
85
86
87
88
“C-arm x-ray system” means an x-ray system in which the image receptor and x-ray tube housing
assembly are connected by a common mechanical support system OR COORDINATED in order
to maintain a desired spatial relationship. This system is designed to allow a change in the
projection of the beam through the patient without a change in the position of the patient.
89
90
“Cephalometric device” means a device intended for the radiographic visualization and
measurement of the dimensions of the human head.
91
92
93
“Certified components” means components of AN x-ray IMAGING systems COMPONENT THAT
IS which are subject to regulations promulgated under Public Law 90-602, the Radiation Control
for Health and Safety Act of 1968.
94
95
“Certified system” means any x-ray system which THAT has one or more ANY certified
component(s).
96
97
98
“Changeable filters” means any filter, exclusive of inherent filtration, which THAT can be removed
from the useful beam through any electronic, mechanical, or physical process under operator
control.
6-3
Colorado Radiation Regulations, Proposed Revised Part 6
99
100
May 12, 2017
“Coefficient of variation” (or “C”) means the ratio of the standard deviation to the mean value of a
population of observations. It is estimated using the following equation:
x  x
101

s 1n
C   
x x  i 1

102
where
103
s = Estimated standard deviation of the population
104
x = Mean value of observations in sample
105
xi = ith observation in sample
106
n = Number of observations in sampleD
i
n 1
2
 1/ 2




107
108
“COMPUTED RADIOGRAPHY” (CR). SEE “PHOTOSTIMULABLE STORAGE PHOSPHOR
SYSTEM”.
109
110
“Computed tomography” (CT) means the production of a tomogram by the acquisition and
computer processing of x-ray transmission data.
111
112
“CONTRAST-TO-NOISE RATIO” (CNR) RELATES THE CONTRAST OF AN OBJECT IN AN
ACQUIRED IMAGE TO THE INHERENT NOISE IN THE IMAGE.
113
114
115
“Control panel” means that part of the x-ray control upon which are mounted the switches, knobs,
pushbuttons, and other hardware necessary for the operator's use for TO manually SELECT
EXPOSURE setting the technique factors.
116
“Cooling curve” means the graphical relationship between heat units stored and cooling time.
117
“CT”. (See “Ccomputed tomography”).
118
119
120
121
“CT CONDITIONS OF OPERATION” MEANS ALL SELECTABLE PARAMETERS
GOVERNING THE OPERATION OF A CT X-RAY SYSTEM INCLUDING, BUT NOT LIMITED
TO, NOMINAL TOMOGRAPHIC SECTION THICKNESS, FILTRATION, AND THE EXPOSURE
SETTINGS.
122
123
124
“CT GANTRY” MEANS THE TUBE HOUSING ASSEMBLIES, BEAM-LIMITING DEVICES,
DETECTORS, AND THE SUPPORTING STRUCTURES AND FRAMES THAT HOLD THESE
COMPONENTS.
125
126
“Dead-man switch” means a switch so constructed that a circuit-closing contact can be
maintained only by continuous pressure on the switch by the operator.
127
“Detector”. (See “Radiation detector”).
128
129
“Diagnostic source assembly” means the tube housing assembly with a beam-limiting device
attached.
6-4
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
130
131
132
133
134
135
“Diagnostic x-ray imaging system” (ALSO “DIAGNOSTIC X-RAY IMAGING SYSTEM” OR
“DIAGNOSTIC X-RAY SYSTEM”) means an assemblage of components for the generation,
emission, and reception of x-rays and the transformation, storage and visual display of the
resultant x-ray image,.“Diagnostic x-ray system” means an x-ray system WITH THE
ASSEMBLED SYSTEM designed and used for irradiation of any part of the human or animal
body for the purpose of diagnosis or visualization.
136
137
138
“DIGITAL RADIOGRAPHY” MEANS USE OF AN X-RAY IMAGING PROCESSING SYSTEM
TO PRODUCE A RADIOGRAPHIC IMAGE DISPLAYED ON A VIDEO MONITOR AFTER
MATHEMATICAL TRANSFORMATION.
139
140
“Direct scattered radiation” means that scattered radiation which THAT has been deviated in
direction only by materials irradiated by the useful beam. (See “Sscattered radiation”).
141
“DOSE PROFILE” MEANS THE DOSE AS A FUNCTION OF POSITION ALONG A LINE.
142
143
144
“ELEMENTAL AREA” MEANS THE SMALLEST AREA WITHIN A DIGITALLY ACQUIRED
IMAGE FOR WHICH THE X-RAY ATTENUATION PROPERTIES OF A BODY ARE DEPICTED.
SEE ALSO “PICTURE ELEMENT”.
145
146
“Entrance exposure rate” means the exposure per unit time at the point where the center of the
useful beam enters the patient.
147
“Equipment”. (See “x-ray equipment”).
148
149
150
“ESTABLISHED OPERATING LEVEL” MEANS THE VALUE OF A PARTICULAR QUALITY
ASSURANCE PARAMETER THAT HAS BEEN ESTABLISHED AS AN ACCEPTABLE
NORMAL LEVEL BY THE FACILITY'S QUALITY ASSURANCE PROGRAM.
151
152
153
154
155
156
“FACILITY”, FOR MAMMOGRAPHY (TO SUPPLEMENT THE PART 1 MEANING OF
“FACILITY”), MEANS A HOSPITAL, OUTPATIENT DEPARTMENT, CLINIC, RADIOLOGY
PRACTICE, MOBILE UNIT, OFFICE OF A PHYSICIAN, OR OTHER FACILITY THAT
CONDUCTS MAMMOGRAPHY ACTIVITIES, INCLUDING THE FOLLOWING: OPERATION OF
EQUIPMENT TO PRODUCE A MAMMOGRAM, INITIAL INTERPRETATION OF THE
MAMMOGRAM, AND MAINTAINING VIEWING CONDITIONS FOR THAT INTERPRETATION.
157
158
“Field emission equipment” means equipment which THAT uses an x-ray tube in that electron
emission from the cathode is due solely to the action of an electric field.
159
“Filter” means material placed in the useful beam to preferentially absorb selected radiations.
160
161
162
“FLOOR PLAN” MEANS, FOR PURPOSES OF PART 6, A PLAN VIEW OF THE OVERALL
LAYOUT TO SCALE OF A ROOM OR GROUP OF ROOMS, INCLUDING THE LOCATION
AND CONFIGURATION OF ANY RADIATION PRODUCING MACHINE IN EACH ROOM.
163
164
165
166
“FLUOROSCOPIC AIR KERMA DISPLAY DEVICE” MEANS A DEVICE, SUBSYSTEM, OR
COMPONENT THAT PROVIDES THE DISPLAY OF AIR KERMA RATE AND CUMULATIVE
AIR KERMA. IT INCLUDES RADIATION DETECTORS (IF ANY), ELECTRONIC AND
COMPUTER COMPONENTS, ASSOCIATED SOFTWARE, AND DATA DISPLAYS.
167
168
169
170
“Fluoroscopic imaging assembly” means a subsystem in which x-ray photons produce a SET OF
visible imageS. It includes the image receptor(s) such as the image intensifier and spot-film
device, electrical interlocks, if any, and structural material providing linkage between the image
receptor and diagnostic source assembly.
6-5
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
171
172
173
“FLUOROSCOPIC IRRADIATION TIME” MEANS THE CUMULATIVE DURATION DURING AN
EXAMINATION OR PROCEDURE OF OPERATOR-ENABLED X-RAY TUBE ACTIVATION IN
ANY FLUOROSCOPIC MODE OF OPERATION.
174
175
“FLUOROSCOPY” MEANS A TECHNIQUE FOR GENERATING X-RAY IMAGES AND
PRESENTING THEM SIMULTANEOUSLY AND CONTINUOUSLY AS VISIBLE IMAGES.
176
177
“Focal spot (actual)” means the area projected on the anode of the x-ray tube bombarded by the
electrons accelerated from the cathode and from which the useful beam originates.
178
179
“General purpose radiographic x-ray system” means any radiographic x-ray system which THAT,
by design, is not limited to radiographic examination of specific anatomical regions.
180
“Gonad shield” means a protective barrier for the testes or ovaries.
181
182
183
184
185
“Half-value layer” (HVL)” means the thickness of specified material that attenuates the beam of
radiation to an extent such that the exposure rate is NEEDED TO reduced A RADIATION BEAM
TO by one-half of its original valueINTENSITY. In tThis definition EXCLUDES, the contribution of
all scattered radiation, other than any that might be present initially in the beam, is deemed to be
excluded.
186
187
“HAND-HELD X-RAY EQUIPMENT”. SEE “X-RAY EQUIPMENT”, UNDER “PORTABLE XRAY EQUIPMENT”.
188
189
“HARD COPY PROCESSOR” MEANS A DEVICE THAT PRODUCES A PRINTED IMAGE
FROM DIGITAL IMAGE DATA.
190
191
192
193
194
195
“Healing arts screening” means, FOR PURPOSES OF THESE REGULATIONS, the testing of
EXPOSURE OF ANY human beings using AN x-ray IMAGING machines for the detection or
evaluation of health indications when such A tests are IS not specifically and individually ordered
by a licensed practitioner of the healing arts PHYSICIAN, CHIROPRACTOR, DENTIST OR
PODIATRIST legally authorized to prescribe such x-ray A test for the purpose of diagnosis or
treatment.
196
197
"Heat unit" means a unit of energy equal to the product of the peak kilovoltage, milliamperes, and
seconds (, that is, kVp x• mA x• second).
198
“HVL”. SEE “HALF-VALUE LAYER”.
199
200
201
“Image intensifier” means a device, installed in its housing, which THAT instantaneously converts
an x-ray pattern into a corresponding visible light image and electronically amplifies the
brightness of that visible image.
202
203
204
205
206
“Image receptor” means any device, such as a fluorescent screen or radiographic film, X-RAY
IMAGE INTENSIFIER TUBE, PHOTOSTIMULABLE PHOSPHOR, OR SOLID-STATE OR
GASEOUS DETECTOR, which THAT transforms incident x-ray photons either into a visible
image or into another form which THAT can be made into a visible image by further
transformations.
207
208
209
“Image receptor support DEVICE” means, for mammographic systems, that part of the system
designed to support the image receptor perpendicular to the beam axis during a mammographic
examination AND ALSO DESIGNED TO PROVIDE A PRIMARY PROTECTIVE BARRIER.
210
211
“Inherent filtration” means the filtration of the useful beam provided by the permanently installed
components of the tube housing assembly.
6-6
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
212
“Irradiation” means the exposure of matter to ionizing radiation.
213
“Kilovolts peak”. (See “Ppeak tube potential”).
214
“kV” means kilovolts.
215
“kVp”. (See “Ppeak tube potential”).
216
“kWs” means kilowatt-second.
217
218
219
220
221
222
"LAST IMAGE HOLD RADIOGRAPH" (LIH) MEANS AN IMAGE OBTAINED EITHER BY
RETAINING ONE OR MORE FLUOROSCOPIC IMAGES, WHICH MAY BE TEMPORARILY
INTEGRATED, AT THE END OF A FLUOROSCOPIC EXPOSURE OR BY INITIATING A
SEPARATE AND DISTINCT RADIOGRAPHIC EXPOSURE AUTOMATICALLY AND
IMMEDIATELY IN CONJUNCTION WITH TERMINATION OF THE FLUOROSCOPIC
EXPOSURE.
223
224
“LATERALITY”, IN MAMMOGRAPHY, MEANS THE DESIGNATION OF EITHER THE LEFT
OR RIGHT BREAST.
225
226
“Lead equivalent” means the thickness of lead affording the same attenuation, under specified
conditions, as the material in question.
227
228
“Leakage radiation” means radiation emanating from the diagnostic source assembly except for
the useful beam.
229
230
231
“Leakage technique factors CONTROL SETTINGS” means the technique factors EXPOSURE
SETTINGS associated with the diagnostic source assembly which THAT are used in measuring
leakage radiation,. They are defined as follows:
232
233
234
235
236
237
(1)
For diagnostic source assemblies intended for capacitor energy storage
equipment, the maximum-rated peak tube potential and the maximum-rated
number of exposures in an hour for operation at the maximum-rated peak tube
potential with the quantity of charge per exposure being 10 millicoulombs,
i.e.THAT IS, 10 mAilliampere second, or the minimum obtainable from the unit,
whichever is larger;
238
239
240
241
(2)
For diagnostic source assemblies intended for field emission equipment rated for
pulsed operation, the maximum-rated peak tube potential and the
maximum-rated number of x-ray pulses in an hour for operation at the maximumrated peak tube potential.
242
243
244
(3)
For all other diagnostic source assemblies, the maximum-rated peak tube
potential and the maximum-rated continuous tube current for that MAXIMUMRATED PEAK TUBE potential.
245
246
247
“LEAKAGE RADIATION” MEANS THE PORTION OF IONIZING RADIATION ORIGINATING
FROM THE X-RAY IMAGING SYSTEM THAT IS NOT PART OF THE USEFUL BEAM. SEE
“USEFUL BEAM”.
248
249
250
251
“Light field” means that area of the intersection of the light beam from the beam-limiting device,
and one of the set of planes parallel to, and including, the plane of the image receptor, whose
perimeter is the locus of points, at which the illumination is one-fourth of the maximum in the
intersection.
6-7
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
252
253
254
255
“Line-voltage regulation” means the difference between the no-load and the load line potentials
expressed as a percent of the load line potential. It is calculated using the following equation:
Percent line-voltage regulation = 100 (Vn-Vl)/Vl , where: Vn = Nno-load line potential and Vl = Lload
line potential.
256
257
“LUMINANCE” MEANS THE AMOUNT OF LIGHT THAT PASSES THROUGH OR IS EMITTED
FROM A PARTICULAR AREA AND FALLS WITHIN A GIVEN SOLID ANGLE.
258
“mA” means milliampere.
259
260
“MAMMOGRAM” MEANS A RADIOGRAPHIC IMAGE PRODUCED THROUGH
MAMMOGRAPHY.
261
“MAMMOGRAPHY” MEANS RADIOGRAPHY OF THE BREAST. SEE ALSO 6.10.1.1.
262
263
264
265
“MAMMOGRAPHY PHANTOM” MEANS A TEST OBJECT USED TO SIMULATE
RADIOGRAPHIC CHARACTERISTICS OF COMPRESSED BREAST TISSUE AND
CONTAINING COMPONENTS THAT RADIOGRAPHICALLY MODEL ASPECTS OF BREAST
DISEASE AND CANCER.
266
267
268
“MAMMOGRAPHY MEDICAL OUTCOMES AUDIT” MEANS A SYSTEMATIC COMPARISON
OF POSITIVE MAMMOGRAM ASSESSMENT DATA TO CORRESPONDING PATHOLOGY
RESULTS.
269
270
“MAMMOGRAPHY MODALITY” MEANS A TECHNOLOGY FOR RADIOGRAPHY OF THE
BREAST.
271
272
“MANUAL FILM PROCESS” MEANS A WAY TO PRODUCE AN IMAGE THAT REQUIRES
HUMAN INTERVENTION TO MOVE THE FILM FROM DEVELOPER TO FIXER TO WASH.
273
“mAs” means milliampere second.
274
275
“Maximum line current” means the root-mean-square current in the supply line of an x-ray
machine operating at its maximum rating.
276
“Mini-c-arm x-ray system(s)” means a system that meets the following criteria:
277
(1)
Ssource-image receptor distance less than or equal to 450 cm (18 INCHES);
278
(2)
Ffield of view less than or equal to 15 cm six (6) inches);
279
(3)
MAXIMUM kVp less than or equal to 7580 kVp; AND
280
281
(4)
MAXIMUM mA less than or equal to 0.25 mA; and entrance exposure rate less
than or equal to 10 roentgen (1.29 mC/kg) per minute at the exit port.
282
“Mobile x-ray equipment”. (See “x-ray equipment”).
6-8
Colorado Radiation Regulations, Proposed Revised Part 6
283
284
285
286
May 12, 2017
“MODE OF OPERATION” MEANS A DISTINCT METHOD OF FLUOROSCOPY,
MAMMOGRAPHY OR RADIOGRAPHY PROVIDED BY THE MANUFACTURER AND
SELECTED WITH A SET OF SEVERAL EXPOSURE CONTROL SETTINGS UNIQUELY
ASSOCIATED WITH THE MODE.
287
288
(1)
THE SET OF DISTINCT SETTINGS FOR THE MODE MAY BE SELECTED BY
THE OPERATION OF A SINGLE CONTROL.
289
290
291
292
293
294
(2)
EXAMPLES OF DISTINCT MODES OF OPERATION INCLUDE NORMAL
FLUOROSCOPY (ANALOG OR DIGITAL), HIGH-LEVEL CONTROL
FLUOROSCOPY, CINERADIOGRAPHY (ANALOG OR DIGITAL), DIGITAL
SUBTRACTION ANGIOGRAPHY, ELECTRONIC RADIOGRAPHY USING THE
FLUOROSCOPIC IMAGE RECEPTOR, MAMMOGRAPHY AND PHOTOSPOT
RECORDING.
295
296
297
298
299
300
301
(3)
IN A SPECIFIC MODE OF OPERATION, CERTAIN SYSTEM VARIABLES
AFFECTING AIR KERMA, AKR, OR IMAGE QUALITY, SUCH AS IMAGE
MAGNIFICATION, X-RAY FIELD SIZE, PULSE RATE, PULSE DURATION,
NUMBER OF PULSES, SOURCE-IMAGE RECEPTOR DISTANCE (SID), OR
OPTICAL APERTURE, MAY BE ADJUSTABLE OR MAY VARY; THEIR
VARIATION PER SE DOES NOT COMPRISE A MODE OF OPERATION
DIFFERENT FROM THE ONE THAT HAS BEEN SELECTED.
302
303
304
“NCRP REPORT 147” MEANS NATIONAL COUNCIL ON RADIATION PROTECTION AND
MEASUREMENTS REPORT NO. 147, “STRUCTURAL SHIELDING DESIGN FOR MEDICAL
IMAGING FACILITIES” (NOVEMBER 2004).
305
306
307
“NOISE” MEANS THE FLUCTUATION OF A SIGNAL WITHIN A MEASURED REGION OF
INTEREST, FOR EXAMPLE, AS A RESULT OF STATISTICAL FLUCTUATION OF THE
SIGNAL AND ELECTRONIC NOISE IN THE DETECTOR.
308
309
“Optical Density” (OD) =EQUALS Llog(1/Ttransmittance), where the transmittance of the film is
the fraction of incident light transmitted by the film.
310
311
312
313
314
315
“Patient” means an individual HUMAN BEING or AN animal subjected to WHOM RADIOACTIVE
MATERIALS OR MACHINE-PRODUCED RADIATION IS DELIVERED FOR healing arts
examination, diagnosis, or treatment. IN ADDITION, FOR MAMMOGRAPHY, PATIENT MEANS
ANY INDIVIDUAL WHO UNDERGOES A MAMMOGRAPHY EVALUATION IN A FACILITY,
REGARDLESS OF WHETHER THE PERSON IS REFERRED BY A PHYSICIAN OR IS
SELF-REFERRED.
316
“PBL”. SEE “POSITIVE BEAM LIMITATION”.
317
318
“Peak tube potential” means the maximum value of the potential difference across the x-ray tube
during an exposure.
319
320
321
“Phantom” means an object designed such that the interaction of ionizing radiation with the object
is suitable for the evaluation of the particular characteristics of the x-ray system or anatomic
region under consideration.
322
323
324
325
“PHOTOSTIMULABLE STORAGE PHOSPHOR IMAGING” (PSP) MEANS AN X-RAY IMAGE
PROCESSING SYSTEM THAT EMPLOYS REUSABLE IMAGING PLATES AND ASSOCIATED
HARDWARE AND SOFTWARE TO ACQUIRE AND DISPLAY DIGITAL PROJECTION
RADIOGRAPHS.
6-9
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
326
327
328
329
“Phototimer” means a method for controlling radiation exposure to image receptors by the amount
of radiation which THAT reaches a radiation monitoring device(s). The radiation monitoring
device(s) iAs part of an electronic circuit which THAT controls the duration of time the tube is
activated. (See “Aautomatic exposure control”).
330
331
“PICTURE ELEMENT” (PIXEL) MEANS AN ELEMENTAL AREA OF A DIGITALLY
ACQUIRED IMAGE.
332
“PID”. SEE “POSITION INDICATING DEVICE”.
333
“PIXEL”. SEE “PICTURE ELEMENT”.
334
“PORTABLE X-RAY EQUIPMENT”. SEE “X-RAY EQUIPMENT”.
335
336
337
“Position indicating device” (PID)” means a device on dental x-ray equipment used to indicate the
beam position and to establish a definite source-surface (skin) distance. It may or may not
incorporate or serve as a beam-limiting device.
338
339
340
“Positive beam limitation” (PBL)” means the automatic or semi-automatic adjustment of an x-ray
beam to the size of the selected image receptor, whereby exposures cannot be made without
such adjustment.
341
342
“PRIMARY PROTECTIVE BARRIER” MEANS THE MATERIAL, EXCLUDING FILTERS,
PLACED TO ATTENUATE THE USEFUL BEAM FOR RADIATION PROTECTION PURPOSES.
343
344
“Protective apron” means an apron GARMENT made of radiation-absorbing materials used to
reduce radiation exposure to the TORSO OF THE wearer.
345
346
347
348
349
“Protective barrier” means a barrier of radiation absorbing material(s) used to reduce radiation
exposure. The types of protective barriers are as follows:(1)
SEE “Pprimary protective
barrier” AND , means the material, excluding filters, placed in the direct useful beam, for
protection purposes, to reduce the radiation exposure; (2)
“Ssecondary protective barrier”,
means the material which attenuates stray radiation.
350
351
“Protective glove” means a glove made of radiation-absorbing materials used to reduce radiation
exposure to the wearer.
352
353
354
"PULSED MODE" MEANS OPERATION OF A FLUOROSCOPIC X-RAY SYSTEM SUCH
THAT THE X-RAY TUBE CURRENT IS PULSED BY THE X-RAY CONTROL TO PRODUCE
ONE OR MORE EXPOSURE INTERVALS OF DURATION LESS THAN ONE-HALF SECOND.
355
356
“Radiation detector” means a device which in the presence of radiation provides a signal or other
indication suitable for use in measuring one or more quantities of incident radiation.
357
358
359
“Radiation therapy simulation system” means a radiographic/or fluoroscopic x-ray system OR A
COMPUTED TOMOGRAPHY SYSTEM intended for localizing the volume to be exposed during
radiation therapy and confirming the position and size of the therapeutic irradiation field.
360
361
“Radiograph” means an image receptor on which the image is created directly or indirectly by an
x-ray pattern and results in a permanent record.
362
363
“Radiographic imaging system” means any system whereby a permanent or semipermanent
image is recorded on an image receptor by the action of ionizing radiation.
6 - 10
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
364
365
366
“RADIOGRAPHY” MEANS A TECHNIQUE FOR GENERATING AND RECORDING AN X-RAY
PATTERN FOR THE PURPOSE OF PROVIDING THE USER WITH THE IMAGE(S) AFTER
TERMINATION OF THE EXPOSURE.
367
“Rating” means the operating limits as specified by the component manufacturer.
368
369
“Recording” means producing a permanent RETRIEVABLE form of an image resulting from x-ray
photons.
370
371
“REFERENCE PLANE” MEANS A PLANE THAT IS DISPLACED FROM AND PARALLEL TO
THE TOMOGRAPHIC PLANE.
372
373
374
“Response time” means the time required for an instrument system to reach 90 percent of its final
reading when the radiation-sensitive volume of the instrument system is exposed to a step
change in radiation flux from zero sufficient to provide a steady state midscale reading.
375
376
377
378
“SCAN” MEANS THE COMPLETE PROCESS OF COLLECTING X-RAY TRANSMISSION
DATA FOR THE PRODUCTION OF A TOMOGRAM. DATA CAN BE COLLECTED
SIMULTANEOUSLY DURING A SINGLE SCAN FOR THE PRODUCTION OF ONE OR MORE
TOMOGRAMS.
379
380
381
382
“Scattered radiation” means IONIZING radiation that, during passage through matter, has been
deviated in EMITTED BY INTERACTION OF IONIZING RADIATION WITH MATTER, THE
INTERACTION BEING ACCOMPANIED BY A CHANGE IN direction OF THE RADIATION. (See
ALSO “Ddirect scattered radiation”).
383
384
“SECONDARY PROTECTIVE BARRIER” MEANS A BARRIER SUFFICIENT TO ATTENUATE
SCATTERED AND LEAKAGE RADIATION FOR RADIATION PROTECTION PURPOSES.
385
386
387
“Shutter” means a device attached to the tube housing assembly which THAT can intercept the
entire cross sectional area of the useful beam and which THAT has a lead equivalency not less
than that of the tube housing assembly.
388
“SID”. SEE “SOURCE-IMAGE RECEPTOR DISTANCE”.
389
390
391
“SIGNAL-TO-NOISE RATIO” (SNR) MEANS THE MAGNITUDE OF THE SIGNAL OF
INTEREST COMPARED TO THE MAGNITUDE OF THE NOISE OF THE BACKGROUND OF
THAT SIGNAL.
392
393
394
395
396
“Single-occupancy room” means a room which has walls on all sides (excluding the room
entrance) of a minimum of seven (7) feet high that has an x-ray attenuation (for the x-ray beam in
use at the facility) equivalent to at least two (2) thicknesses of one-half inches of gypsum
wallboard which is occupied by one individual at a time. This only applies to rooms with dental
intraoral or panoramic machines.
397
398
399
400
“SOLID STATE X-RAY IMAGING DEVICE” MEANS AN ASSEMBLY CONFIGURATION THAT
INTERCEPTS X-RAY PHOTONS AND CONVERTS THE PHOTON ENERGY INTO A
MODULATED ELECTRONIC SIGNAL REPRESENTATIVE OF THE X-RAY INTENSITY OVER
THE AREA OF THE IMAGING DEVICE.
401
“Source”, FOR AN X-RAY MACHINE, means the focal spot of the x-ray tube.
402
403
“Source-image receptor distance” (SID)” means the distance from the source to the center of the
input surface of the image receptor.
6 - 11
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
404
405
“SOURCE-SKIN DISTANCE” (SSD) MEANS THE DISTANCE BETWEEN THE SOURCE AND
THE SKIN OF THE PATIENT.
406
407
“Spot check” means a procedure which THAT is performed to assure that a previous calibration
continues to be valid.
408
409
“Spot film IMAGE” means a radiograph which THAT is made during a fluoroscopic examination to
permanently record conditions which THAT exist during that fluoroscopic procedure.
410
411
412
413
414
“Spot-film IMAGE device” means a device intended to transport and/or position a radiographic
image receptor (FOR EXAMPLE, A FILM-SCREEN CASSETTE OR A CR CASSETTE) between
the x-ray source and fluoroscopic image receptor. It includes a device intended to hold a cassette
over the input end of an THE FLUOROSCOPIC image RECEPTOR intensifier for the purpose of
makPRODUCing a radiograph.
415
416
“Source-to-skin distance (SSD)” means the distance between the source and the skin of the
patient.
417
“SSD”. SEE “SOURCE-SKIN DISTANCE”.
418
419
“STANDARD BREAST” MEANS A 4.2-CM-THICK COMPRESSED BREAST CONSISTING OF
FIFTY (50) PERCENT GLANDULAR AND FIFTY (50) PERCENT ADIPOSE TISSUE.
420
“STATIONARY X-RAY EQUIPMENT”. SEE “X-RAY EQUIPMENT”.
421
“Stray radiation” means the sum of leakage and scattered radiation.
422
423
“Technique chart” means a chart which specifies, for common examinations performed with a
specific system, the following information:
424
(1)
technique factors to be utilized versus patient's anatomical size;
425
(2)
type and size of the film or film-screen combination to be used;
426
(3)
type and focal distance of the grid to be used, if any; and
427
(4)
source to image receptor distance to be used.
6 - 12
Colorado Radiation Regulations, Proposed Revised Part 6
428
429
May 12, 2017
“Technique factors” means AN EXPOSURE CONTROL SETTING the following conditions of
operation THAT SPECIFIES THE PEAK TUBE POTENTIAL IN kV AND:
430
431
(1)
EITHER TUBE CURRENT IN mA AND EXPOSURE TIME IN SECONDS, OR
THE PRODUCT OF TUBE CURRENT AND EXPOSURE TIME IN mAs; OR
432
433
(12)
For capacitor energy storage equipment, peak tube potential in kV and
quantity of charge in mAs; OR
434
435
(23)
For field emission equipment rated for pulsed operation, peak tube potential in
kV, and number of x-ray pulses; OR
436
(34)
For CT x-ray systems, EITHER:
437
(a)
TUBE CURRENT IN mA AND SCAN TIME IN SECONDS; OR
438
439
(b)
THE PRODUCT OF TUBE CURRENT AND ROTATION TIME IN mAs,
AS MODIFIED TO ACCOUNT FOR HELICAL PITCH.
440
441
442
443
designed for pulsed operation, peak tube potential in kV, scan time in seconds,
and either tube current in mA, x-ray pulse width in seconds, and the
number of x-ray pulses per scan, or the product of tube current, x-ray
pulse width, and the number of x-ray pulses in mAs;
444
445
446
447
(4)
For CT x-ray systems not designed for pulsed operation, peak tube potential in
kV, and either tube current in mA and scan time in seconds, or the product of
tube current and exposure time in mAs and the scan time when the scan time
and exposure time are equivalent; and
448
449
450
(5)
For all other equipment, peak tube potential in kV, and either tube current in mA
and exposure time in seconds, or the product of tube current and exposure time
in mAs.
451
452
“Termination of irradiation” means the stopping of irradiation in a fashion which THAT will not
permit continuance of irradiation without the resetting of operating conditions at the control panel.
453
454
“Tomogram” means the depiction of the x-ray attenuation properties of a section through the
body.
455
456
“TOMOGRAPHIC PLANE” MEANS THE GEOMETRIC PLANE THAT IS IDENTIFIED AS
CORRESPONDING TO THE OUTPUT TOMOGRAM.
457
458
“TOMOGRAPHIC SECTION” MEANS THE VOLUME OF AN OBJECT WHOSE X-RAY
ATTENUATION PROPERTIES ARE IMAGED IN A TOMOGRAM.
459
460
“TOMOSYNTHESIS” MEANS TO MATHEMATICALLY RECONSTRUCT A PLANAR IMAGE
USING VIEWS ACQUIRED FROM MULTIPLE X-RAY BEAM PROJECTION ANGLES.
6 - 13
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
461
“Tube” means an x-ray tube, unless otherwise specified.
462
463
464
“Tube housing assembly” means the tube housing with tube installed,. It includesING
high-voltage and/or filament transformers and other appropriate elements when such are
contained within the tube housing.
465
466
467
“Tube rating chart” means the set of curves which TYPICALLY DISPLAYED ON A GRAPH,
THAT specify the rated limits of operation of the tube in terms of the technique factors
EXPOSURE SETTINGS. These curves are typically displayed on a graph.
468
469
470
“Useful beam” means the radiation emanating from the tube housing port or the radiation head
and passing through the aperture of the beam limiting device when the exposure controls are in a
mode to cause the system to produce radiation.
471
472
“Variable-aperture beam-limiting device” means a beam-limiting device which THAT has capacity
for stepless adjustment of the x-ray field size at a given SID.
473
474
“Visible area” means that portion of the input surface of the image receptor over which incident
x-ray photons are producing a visible image.
475
476
477
478
479
480
“VOLUMETRIC DENTAL IMAGING SYSTEM” MEANS AN X-RAY MACHINE THAT
PRODUCES, FOR ORAL AND MAXILLOFACIAL STRUCTURES, A THREE-DIMENSIONAL
TOMOGRAPHIC DATA SET OR A TIME SEQUENCE OF THREE-DIMENSIONAL
TOMOGRAPHIC DATA SETS. A DENTAL X-RAY MACHINE ONLY CAPABLE OF
PRODUCING A TWO-DIMENSIONAL IMAGE IS NOT CONSIDERED TO BE A VOLUMETRIC
DENTAL IMAGING SYSTEM.
481
482
“Wedge filter” means an added filter THAT effectSing continuous progressive attenuation
CHANGE IN TRANSMISSION OVER on all or A part of the useful beam.
483
484
485
“X-ray exposure control” means a device, switch, button or other similar means by which an
operator initiates and/or terminates the radiation exposure. The x-ray exposure control may
include such associated equipment as timers and back-up timers.
486
487
“X-ray equipment” means an x-ray system, subsystem, or component thereof, INCLUDING:
. Types of x-ray equipment are as follows:
488
489
490
491
492
493
494
(1)
“Mobile OR PORTABLE x-ray equipment” means x-ray equipment THAT IS
DESIGNED TO BE TRANSPORTED FROM PLACE TO PLACE. MOBILE
EQUIPMENT IS OFTEN mounted on a permanent base with wheels and/or
casters for moving while completely assembled. MOBILE X-RAY EQUIPMENT
INCLUDES EQUIPMENT TRANSPORTED IN A VEHICLE. (2) “Portable x-ray
equipment” means x-ray INCLUDES equipment designed to be hand-carried
AND HAND-HELD DURING USE.
495
496
(32)
“Stationary x-ray equipment” means x-ray equipment which THAT is installed in a
fixed location.
6 - 14
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
497
498
499
“X-ray field” means that area of the intersection of the useful beam and any one of the set of
planes parallel to and including the plane of the image receptor, whose perimeter is the locus of
points at which the exposure AIR KERMA rate is one-fourth of the maximum in the intersection.
500
501
502
503
504
“X-ray high-voltage generator” means a device which THAT transforms electrical energy from the
potential supplied by the x-ray EXPOSURE control to the tube operating potential. The device
may also include means for transforming alternating current to direct current, filament
transformers for the x-ray tube(s), high-voltage switches, electrical protective devices, and other
appropriate elements.
505
506
“X-RAY IMAGE PROCESSING SYSTEM” MEANS AN ASSEMBLAGE OF COMPONENTS
FOR CREATING A VISIBLE OR VIEWABLE IMAGE.
507
508
“X-ray IMAGING subsystem” means any combination of two or more components of an x-ray
IMAGING system.
509
510
“X-RAY IMAGING SYSTEM” OR “X-RAY SYSTEM” MEANS AN ASSEMBLAGE OF
COMPONENTS FOR THE CONTROLLED PRODUCTION OF X-RAYS.
511
512
513
514
(1)
AT A MINIMUM, AN X-RAY IMAGING SYSTEM INCLUDES AN X-RAY
HIGH-VOLTAGE GENERATOR, AN X-RAY EXPOSURE CONTROL,
A TUBE HOUSING ASSEMBLY, A BEAM-LIMITING DEVICE, AND
NECESSARY SUPPORTING STRUCTURES.
515
516
517
(2)
ADDITIONAL COMPONENTS SUCH AS THE IMAGE RECEPTOR(S) THAT
FUNCTION WITH THE SYSTEM ARE CONSIDERED INTEGRAL PARTS OF
THE SYSTEM.
518
519
520
521
522
“X-ray table” means a patient support device with its patient support structure (tabletop)
interposed between the patient and the image receptor during radiography and/or above table
fluoroscopy. This includes, but is not limited to, any stretcher equipped with a radiolucent panel
and any table equipped with a cassette tray (or bucky), cassette tunnel, FLUOROSCOPIC image
intensifierRECEPTOR, or spot-film device beneath the tabletop.
523
524
“X-ray tube” means any electron tube which THAT is designed to be used primarily for the
production of x-rays.
525
“X-RAY SYSTEM”. SEE “X-RAY IMAGING SYSTEM”.
6 - 15
Colorado Radiation Regulations, Proposed Revised Part 6
526
GENERAL REGULATORY PROVISIONS
527
RH 6.3 General Requirements.
528
529
530
531
532
533
May 12, 2017
Effective July 1, 1995, all human use radiation machines used in Colorado shall meet the Federal
Performance Standards, Subchapter J - Radiological Health, 21 CFR 1020.30 through 1020.33,
effective April 1, 1997. The Department may grant exemptions to machines manufactured prior to
August 4, 1974, provided the registrant can demonstrate that the exemption will not result in
undue risk from excessive exposure and will benefit the patient.
6.3.1
Administrative Controls.
534
535
536
6.3.1.1 Registrant.EACH RADIATION MACHINE USED IN THE HEALING ARTS IN THE
STATE OF COLORADO SHALL BE REGISTERED WITH THE DEPARTMENT AS
REQUIRED BY 2.4 AND INSPECTED AS PRESCRIBED IN 2.5.
537
538
539
6.3.1.2 EACH RADIATION MACHINE USED ON HUMANS SHALL MEET THE FEDERAL
PERFORMANCE STANDARDS, SUBCHAPTER J - RADIOLOGICAL HEALTH,
21 CFR 1020.30 THROUGH 1020.33 (JULY 1, 2009).
540
541
542
543
(1)
X-RAY IMAGING SYSTEMS AND THEIR ASSOCIATED COMPONENTS
CERTIFIED PURSUANT TO 21 CFR 1020.30 THROUGH 1020.33 (JULY 1,
2009) SHALL BE MAINTAINED IN COMPLIANCE WITH APPLICABLE
REQUIREMENTS OF 21 CFR 1020.30 THROUGH 1020.33 (JULY 1, 2009).
544
545
546
547
(2)
DIAGNOSTIC X-RAY COMPONENTS AND SYSTEMS CERTIFIED IN
ACCORDANCE WITH 21 CFR PART 1020 SHALL NOT BE MODIFIED SUCH
THAT THE COMPONENT OR SYSTEM FAILS TO COMPLY WITH ANY
APPLICABLE REQUIREMENT OF 21 CFR PART 1020 OR PART 6.
548
549
(3)
THE OWNER SHALL KEEP A RECORD OF THE DATE, SERVICE PROVIDER
AND DETAILS OF EACH COMPONENT OR SYSTEM MODIFICATION .
550
551
552
553
(4)
LIMITED EXEMPTION FROM THIS REQUIREMENT MAY BE GRANTED BY
THE DEPARTMENT FOR A RADIATION MACHINE MANUFACTURED PRIOR
TO AUGUST 4, 1974, PROVIDED THE REGISTRANT DEMONSTRATES THAT
SUCH EXEMPTION WILL NOT RESULT IN UNDUE RISK.
554
555
6.3.1.3 The registrant shall be responsible for directing the operation of the x-ray IMAGING
system(s) under his THE REGISTRANT’S administrative control.
556
557
558
6.3.1.4 The registrant or the registrant's agent shall assure that the ALL APPLICABLE
requirements of RH 6.3.1 PARTS 1, 2, 4, 6 AND 10 are met in the operation of the x-ray
IMAGING system(s).
559
560
561
562
563
564
6.3.1.5 THE REGISTRANT OR THE REGISTRANT'S AGENT SHALL, including the use of
licensed/certified/registered persons or companies (APPROVED providers) to provide OF
services, CONSISTENT WITH 2.6.1, to the facility. Such services includeING BUT NOT
LIMITED TO the operation of x-ray equipment, interpretation of exams, inspection of xray RADIATION machines and facilities, AND ASSEMBLY, installation, service and/or
calibration of x-ray RADIATION machines.
6 - 16
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
565
566
567
568
569
6.3.1.6 AN X-RAY IMAGING SYSTEM THAT CONTINUES TO BE IN NONCOMPLIANCE
WITH A REQUIREMENT OF THESE REGULATIONS SHALL NOT BE USED FOR ANY
PURPOSE UNLESS SUCH USE OR OPERATION IS EXPLICITLY AUTHORIZED BY
THE DEPARTMENT, FOR EXAMPLE, BY CORRECTION IN ACCORDANCE WITH
2.6.3 AND/OR FORM 59-1.
570
571
572
6.3.1.71.1
An x-ray IMAGING system which THAT does not meet the provisions of these
Rregulations, and is determined AS PROVIDED IN APPENDIX 6D to be unsafe for
human use, shall not be operated for diagnostic or therapeutic purposes.
573
574
575
576
6.3.1.8 USE OF A RADIATION MACHINE IN THE HEALING ARTS SHALL BE BY OR UNDER
THE GENERAL SUPERVISION OF A PHYSICIAN, CHIROPRACTOR, DENTIST,
PODIATRIST, OR VETERINARIAN WHO HAS A CURRENT ACTIVE STATE OF
COLORADO LICENSE TO PRACTICE THE HEALING ARTS.
577
578
6.3.1.9 ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE FOR A RADIATION
MACHINE OPERATOR.
579
580
6.3.(1).1.2
shall:
EACH Iindividuals who will be operating the AN x-ray IMAGING systems
581
(a)
Bbe adequately instructed in the safe operating procedures;
582
(b)
and Bbe competent in the safe use of the equipment.; AND
583
584
(c)
MEET EACH APPLICABLE REGISTRATION REQUIREMENT OF
2.6.1.
585
586
587
6.3.1.1.2.1
In addition to RH 6.3.1.1.2, operators, except for the licensed
practitioners, shall meet the training requirements, if any, of the
appropriate licensing board.;
588
589
590
6.3.1.1.2.2
In addition to RH 6.3.1.1.2 and 6.3.1.1.2.1, operators of x-ray
machine systems in mammography facilities shall meet the requirements
in RH 6.10.2.1.1.
591
592
593
6.3.1.10
IF RADIOACTIVE MATERIALS ARE ALSO PRESENT AT THE FACILITY, THE
FACILITY REGISTRANT SHALL COORDINATE AS APPROPRIATE REQUIREMENTS
UNDER PART 6 WITH ANY RELATED REQUIREMENT OF THE LICENSE.
6 - 17
Colorado Radiation Regulations, Proposed Revised Part 6
594
595
596
597
6.3.2
May 12, 2017
GENERAL SPECIFICATIONS FOR FACILITY AND EQUIPMENT DESIGN, CONFIGURATION
AND PREPARATION.
6.3.2.1 EVALUATION OF SHIELDING DESIGN PRIOR TO COMMENCEMENT OF
OPERATION.
598
599
600
601
602
(1)
THE FLOOR PLAN AND EQUIPMENT CONFIGURATION OF A RADIATION
MACHINE FACILITY SHALL BE DESIGNED TO MEET ALL APPLICABLE
REQUIREMENTS OF THESE REGULATIONS AND IN PARTICULAR TO
PRECLUDE AN INDIVIDUAL FROM RECEIVING A DOSE IN EXCESS OF THE
LIMITS IN 4.6, 4.12, 4.13, 4.14 AND 4.15.
603
604
605
606
(2)
THE FLOOR PLAN AND EQUIPMENT CONFIGURATION OF EACH
RADIATION MACHINE FACILITY SHALL BE SUBMITTED TO A QUALIFIED
EXPERT FOR DETERMINATION OF SHIELDING REQUIREMENTS IN
ACCORDANCE WITH APPENDICES 6A, 6B AND 6C.
607
608
(3)
THE QUALIFIED EXPERT SHIELDING DESIGN REQUIRED BY 6.3.2.1(2)
SHALL BE COMPLETED PRIOR TO:
609
(a)
CONSTRUCTION OF A NEW FACILITY;
610
611
612
(b)
ANY RENOVATION OR MODIFICATION OF AN EXISTING FACILITY
THAT HAS A POTENTIAL TO REDUCE THE EFFECTIVENESS OF
EXISTING SHIELDING FROM X-RAY RADIATION; OR
613
614
(c)
INSTALLATION OF A NEW RADIATION MACHINE IN AN EXISTING
FACILITY.
615
616
617
618
(4)
A QUALIFIED EXPERT WHO COMPLETES THE SHIELDING DESIGN
REQUIRED BY 6.3.2.1(2) SHALL PROVIDE THE SHIELDING DESIGN TO THE
FACILITY REGISTRANT, INCLUDING THE ANNOTATED DIMENSIONAL
DRAWING SPECIFIED IN 6.3.2.3.
619
620
621
622
(5)
THE FACILITY REGISTRANT SHALL CONSTRUCT THE SHIELDING AND
CONFIGURE THE EQUIPMENT IN ACCORDANCE WITH THE
RECOMMENDATION(S) PROVIDED BY THE QUALIFIED EXPERT
PURSUANT TO 6.3.2.1(4).
6 - 18
Colorado Radiation Regulations, Proposed Revised Part 6
623
624
625
626
May 12, 2017
6.3.2.2 EVALUATION OF SHIELDING DESIGN AFTER COMMENCEMENT OF OPERATIONS.
(1)
A QUALIFIED EXPERT SHALL REVIEW AND MODIFY THE SHIELDING
DESIGN, CONSISTENT WITH 6.3.2.1 AND APPENDICES 6A, 6B AND 6C,
WHENEVER:
627
628
629
(a)
A CERTIFICATION EVALUATION OR A SURVEY DURING
OPERATION SHOWS THAT A DOSE IN EXCESS OF A LIMIT IN
PART 4 IS POSSIBLE;
630
631
(b)
AN EXISTING FACILITY IS TO BE MODIFIED SUCH THAT EXISTING
SHIELDING MIGHT BE INADEQUATE;
632
(c)
THE PRIMARY BEAM ORIENTATION IS CHANGED;
633
634
(d)
THE PRIMARY SHIELDING IS ALTERED DUE TO THE
MODIFICATION OR RENOVATION OF A FACILITY;
635
636
(e)
MOBILE OR NON-HANDHELD PORTABLE X-RAY EQUIPMENT IS
USED REGULARLY IN THE SAME LOCATION;
637
638
639
640
(f)
RADIATION MACHINE WORKLOAD (FOR EXAMPLE, mA-MINUTE
PER WEEK WORKLOAD) HAS INCREASED OR IS PROJECTED TO
INCREASE ABOVE THAT WHICH WAS THE BASIS FOR THE
ORIGINAL SHIELDING DESIGN; OR
641
642
643
(g)
THE REGISTRANT IS UNABLE TO PRODUCE FOR INSPECTION A
WRITTEN SHIELDING DESIGN COMPLETED IN ACCORDANCE
WITH 6.3.2.1 AND/OR 6.3.2.2.
644
645
646
647
648
649
650
651
652
(2)
IF QUALIFIED EXPERT ANALYSIS OF OPERATING CONDITIONS
REQUIRED BY 6.3.2.2(1) INDICATES THAT AN INDIVIDUAL MIGHT
RECEIVE A DOSE IN EXCESS OF THE LIMITS IN 4.6, 4.12, 4.13, 4.14 OR
4.15, THEN THE FACILITY REGISTRANT SHALL MODIFY THE SHIELDING
AND/OR EQUIPMENT CONFIGURATION IN ACCORDANCE WITH THE
RECOMMENDATION(S) OF THE QUALIFIED EXPERT.
6.3.2.3 THE REGISTRANT SHALL RETAIN, FOR EACH ROOM IN WHICH A STATIONARY
X-RAY IMAGING SYSTEM IS LOCATED, A CURRENT DIMENSIONAL DRAWING
THAT INCLUDES INDICATION OF THE:
653
654
(1)
USE OF EACH AREA ADJACENT TO THE ROOM AND AN ESTIMATION OF
THE EXTENT OF OCCUPANCY IN EACH SUCH AREA; AND
655
656
657
(2)
RESULTS BY A QUALIFIED EXPERT FROM CALCULATION(S) FOR THE
TYPE AND THICKNESS OF MATERIAL(S) IN EACH PROTECTIVE BARRIER
(FOR EXAMPLE, LEAD EQUIVALENCY):
658
659
660
(a)
AFTER INSTALLATION AND, IF POSSIBLE, PRIOR TO
COMMENCEMENT OF OPERATION, CONSISTENT WITH 6.3.2.1;
AND
661
662
(b)
WHENEVER SHIELDING IS MODIFIED, CONSISTENT WITH 6.3.2.2;
AND/OR
6 - 19
Colorado Radiation Regulations, Proposed Revised Part 6
663
664
665
666
667
668
669
670
(3)
May 12, 2017
IF THE REGISTRANT IS UNABLE TO PRODUCE FOR INSPECTION THE
CALCULATION(S) REQUIRED BY 6.3.2.3(2), RESULTS FROM SURVEY(S)
CONDUCTED BY A QUALIFIED EXPERT TO DETERMINE RADIATION
LEVELS PRESENT UNDER SPECIFIED TEST CONDITIONS AT THE
OPERATOR'S POSITION AND AT COGNIZABLE POINTS OUTSIDE THE
ROOM.
6.3.2.4 A FACILITY AREA IS EXEMPT FROM THE REQUIREMENTS OF 6.3.2.1 (AND
CONSEQUENTLY EXEMPT FROM 6.3.2.2 AND 6.3.2.3) IF:
671
672
(1)
ONLY DENTAL INTRAORAL, DENTAL PANORAMIC, MINI-C-ARM OR BONE
DENSITOMETRY EQUIPMENT IS USED IN THE AREA;
673
674
(2)
MOBILE OR PORTABLE X-RAY EQUIPMENT IS USED INFREQUENTLY NOT
ROUTINELY IN THE SAME LOCATION; OR
675
676
(3)
EXEMPTION FOR A PARTICULAR AREA OR LOCATION HAS BEEN
APPLIED FOR IN WRITING AND GRANTED BY THE DEPARTMENT.
677
678
679
680
681
682
683
6.3.2.5 THE REGISTRANT SHALL MAINTAIN FOR INSPECTION, FOR EACH X-RAY
IMAGING SYSTEM, THE MODEL AND SERIAL NUMBER OF EACH TUBE HOUSING
ASSEMBLY AND CONTROL PANEL:
(1)
684
685
686
687
688
689
(a)
(2)
690
691
692
693
694
695
696
697
698
699
700
701
ONE UNIQUE IDENTIFICATION NUMBER THAT DESIGNATES THE ENTIRE
RADIATION MACHINE SHALL BE PERMANENTLY ASSIGNED BY THE
FACILITY REGISTRANT TO EACH RADIATION MACHINE AND PROVIDED
IN ALL CORRESPONDENCE WITH THE DEPARTMENT.
IF AVAILABLE, THE SERIAL NUMBER(S) FROM THE MANUFACTURER
SHALL BE CLEARLY VISIBLE AS A LABEL OR STENCIL ON THE
CONTROL PANEL AND THE TUBE HOUSING ASSEMBLY.
(a)
(3)
IF FEASIBLE, THE SERIAL NUMBER(S) SHALL BE THE “CONTROL
SERIAL NUMBER” IN ITEM 4 ON FDA FORM 2579, OR
EQUIVALENT.
EACH SERIAL NUMBER SHALL BE THE SAME AS THE
CORRESPONDING NUMBER FOUND ON FDA FORM 2579, UNLESS
PRIOR WRITTEN APPROVAL IS OBTAINED FROM THE
DEPARTMENT.
IF EITHER THE CONTROL PANEL OR THE TUBE HOUSING ASSEMBLY
SERIAL NUMBER FROM THE MANUFACTURER IS USED AS THE ONE
UNIQUE IDENTIFICATION NUMBER THAT DESIGNATES THE ENTIRE
RADIATION MACHINE, AND THEN SUBSEQUENTLY THE DESIGNATED
CONTROL PANEL OR THE TUBE HOUSING ASSEMBLY IS REPLACED,
THE REGISTRANT SHALL ASSIGN A NEW UNIQUE IDENTIFICATION
NUMBER FOR THE ENTIRE RADIATION MACHINE AND IMMEDIATELY
PROVIDE THAT NEW NUMBER TO THE DEPARTMENT.
6 - 20
Colorado Radiation Regulations, Proposed Revised Part 6
702
703
May 12, 2017
6.3.2.6 THE REGISTRANT SHALL MAINTAIN FOR INSPECTION, FOR EACH X-RAY
IMAGING SYSTEM FOR WHICH A SHIELDING DESIGN IS REQUIRED:
704
(1)
THE INSTALLATION AS-BUILT DRAWING(S); AND
705
706
707
708
709
(2)
THE SIGNED STATEMENT REQUIRED BY 2.7.1.1 (WITHOUT EXCEPTION
AFTER JUNE 30, 2010) AND RETAINED IN ACCORD WITH 2.4.1.1(4), THAT
ALL FLOOR PLAN AND EQUIPMENT CONFIGURATION SPECIFICATIONS
IN ANY APPLICABLE WRITTEN SHIELDING DESIGNS REQUIRED BY 6.3.2
WERE EXPLICITLY FOLLOWED.
710
711
712
6.3.1.1.3
A technique chart shall be provided in the vicinity of the diagnostic x-ray
system's control panel which specifies, for all examinations performed with that
system, the following information:
713
714
6.3.1.1.3.1
Patient's body part and anatomical size, or body part thickness, or age
(for pediatrics), versus technique factors to be utilized;
715
6.3.1.1.3.2
Type and size of the film or film-screen combination to be used;
716
6.3.1.1.3.3
Type and focal distance of the grid to be used, if any;
717
718
6.3.1.1.3.4
Source to image receptor distance to be used, (except for dental intraoral
radiography;
719
720
6.3.1.1.3.5
Type and location of placement of patient shielding (i.e. gonad , etc.) to
be used; and
721
6.3.1.1.3.6
For mammography, indication of kVp/target/filter combination.
6 - 21
Colorado Radiation Regulations, Proposed Revised Part 6
722
723
724
6.3.3
May 12, 2017
GENERAL RADIATION SAFETY AND CONTROL OF RADIATION EXPOSURE.
6.3.3.1.1.4
Written safety procedures shall be DEVELOPED AND PROVIDED FOR SAFE
OPERATION OF EACH X-RAY IMAGING SYSTEM.
725
726
727
728
729
(1)
THE WRITTEN SAFETY PROCEDURES SHALL BE READILY AVAILABLE
provided to each individual RADIATION MACHINE OPERATOR PRIOR TO
operating x-ray IMAGING equipment. These procedures shall include any
restrictions of the operating technique required for the safe operation of the
particular x-ray system.
730
731
(2)
The operator shall be able to demonstrate familiarity with these procedures
APPLICABLE TO SAFE USE OF THE SYSTEM BEING OPERATED.
732
(3)
THE PROCEDURES SHALL INCLUDE:
733
734
(a)
ANY RESTRICTION ON TECHNIQUE PARTICULAR TO THE
SYSTEM, CONSISTENT WITH 6.3.3.2;
735
736
737
(b)
LIMITATIONS ON BEAM SIZE, TO THE SMALLEST AREA THAT IS
CLINICALLY NECESSARY, INCLUDING APPROPRIATE
COLLIMATION:
738
739
740
741
(i)
FOR EACH TUBE WITH VARIABLE COLLIMATION, THE
COLLIMATION PROCEDURE SHALL SPECIFY WHETHER
POSITIVE BEAM LIMITATION (PBL) OR MANUAL
COLLIMATION SHALL BE USED;
742
743
744
745
(ii)
FOR TUBES COLLIMATED MANUALLY, ALL IMAGES
SHALL PROVIDE A POSITIVE INDICATION OF
COLLIMATION, EXCEPT AS PROVIDED BY 6.10.2.3 OR
WHEN DIAGNOSIS MIGHT BE COMPROMISED;
746
(c)
PATIENT HOLDING INSTRUCTIONS CONSISTENT WITH 6.3.3.8.
6 - 22
Colorado Radiation Regulations, Proposed Revised Part 6
747
748
749
750
751
752
May 12, 2017
6.3.3.2 TO REDUCE RADIATION EXPOSURE TO THE MINIMUM THAT IS NECESSARY,
THE REGISTRANT SHALL MAINTAIN A DOCUMENTED PROTOCOL FOR
TECHNIQUE SELECTION FOR EACH TYPE OF EXAMINATION PERFORMED BY
EACH X-RAY IMAGING SYSTEM.
(1)
753
754
755
756
A CHART BASED ON THE PROTOCOL(S) SHALL BE LOCATED NEAR
EACH SYSTEM’S CONTROL PANEL.
(a)
THE CHART SHALL STATE THE EXPOSURE SETTINGS TO BE
USED CORRESPONDING TO THE PATIENT’S BODY PART AND
ANATOMICAL SIZE, OR BODY PART THICKNESS, OR AGE (FOR
PEDIATRICS), INCLUDING BUT NOT LIMITED TO:
757
(i)
TYPE OF IMAGE RECEPTOR TO BE USED;
758
759
(ii)
TYPE AND FOCAL DISTANCE OF THE GRID TO BE USED, IF
ANY AND IF VARIABLE;
760
761
762
(iii)
SOURCE TO IMAGE RECEPTOR DISTANCE TO BE USED,
EXCEPT FOR INTRAORAL RADIOGRAPHY IN
ACCORDANCE WITH 6.7.2.2(1);
763
(iv)
kVp;
764
(v)
MODE OF OPERATION; AND
765
(vi)
mAs, IF MANUAL MODE IS USED; AND
766
767
(b)
TYPE AND LOCATION OF PLACEMENT OF PATIENT SHIELDING
(FOR EXAMPLE, GONAD OR THYROID SHIELDING) TO BE USED.
768
769
(2)
THE REQUIREMENT OF 6.3.3.2(1)(a) IS CONSIDERED MET IF
ANATOMICALLY PROGRAMMABLE CONTROLS ARE USED.
770
771
(3)
FOR COMPUTED AND DIGITAL RADIOGRAPHY, THE CHART REQUIRED
BY 6.3.3.2(1) SHALL:
772
773
(a)
PORTRAY HOW TO DETERMINE APPLICABLE EXPOSURE
SETTINGS IN ACCORD WITH DOCUMENTED PROTOCOL;
774
775
776
(b)
SPECIFY A CONTROL RANGE FOR THE EXPOSURE INDICATOR IN
ACCORDANCE WITH THE MANUFACTURER’S
RECOMMENDATION; AND
777
778
(c)
SPECIFY PEDIATRIC PROTOCOL FOR EACH UNIT THAT IMAGES
PEDIATRIC PATIENTS.
6 - 23
Colorado Radiation Regulations, Proposed Revised Part 6
779
780
(4)
May 12, 2017
THE SETTINGS TO BE USED DURING AN EXPOSURE SHALL BE
INDICATED BEFORE THE EXPOSURE BEGINS.
781
782
783
(a)
IF AUTOMATIC EXPOSURE CONTROLS ARE USED, THE
EXPOSURE SETTINGS THAT ARE SET PRIOR TO THE EXPOSURE
SHALL BE INDICATED.
784
785
(b)
THE REQUIREMENT OF 6.3.3.2(4) MAY BE MET BY PERMANENT
MARKINGS ON EQUIPMENT HAVING FIXED EXPOSURE SETTINGS.
786
787
788
789
790
791
792
793
(5)
THE CHART SHALL BE REVISED AS NECESSARY WHENEVER A
CERTIFIED COMPONENT IS REPLACED OR ADDED.
6.3.3.3 EXPOSURE UNDER PART 6 OF ANY HUMAN BEING TO THE USEFUL BEAM
SHALL BE SOLELY FOR HEALING ARTS PURPOSES AND ONLY AFTER SUCH
EXPOSURE HAS BEEN AUTHORIZED BY A LICENSED PHYSICIAN,
CHIROPRACTOR, DENTIST OR PODIATRIST WHO HAS A CURRENT ACTIVE
STATE OF COLORADO LICENSE AND HAS MET ALL APPLICABLE
REQUIREMENTS OF PART 2.
794
795
796
(1)
DELIBERATE EXPOSURE OF A HUMAN BEING FOR TRAINING,
DEMONSTRATION OR OTHER NON-HEALING-ARTS PURPOSES IS
STRICTLY PROHIBITED; AND
797
798
799
(2)
AUTHORIZATION FOR HEALING ARTS SCREENING MAY BE GRANTED BY
THE DEPARTMENT PROVIDED THE REGISTRANT DEMONSTRATES THAT
SUCH HEALING ARTS SCREENING WILL NOT RESULT IN UNDUE RISK.
800
801
(a)
EACH HEALING ARTS SCREENING PROGRAM SHALL OBTAIN
PRIOR WRITTEN APPROVAL BY THE DEPARTMENT.
802
803
804
805
806
807
808
(b)
EACH APPLICANT FOR DEPARTMENT APPROVAL OF A HEALING
ARTS SCREENING PROGRAM SHALL SUBMIT TO THE
DEPARTMENT A COMPLETED FORM R-300, “APPLICATION FOR
REGISTRATION – HEALING ARTS SCREENING,” INCLUDING AS
PROVIDED IN 2.4.1.2 ALL OF THE INFORMATION REQUIRED BY
APPENDIX 6F AND/OR BY FORM R-300 AND ANY ACCOMPANYING
INSTRUCTIONS, TOGETHER WITH THE REQUIRED FEE(S).
809
810
811
(c)
THE DEPARTMENT SHALL BE NOTIFIED IMMEDIATELY IF ANY
INFORMATION SUBMITTED TO THE DEPARTMENT BECOMES
INVALID OR OUTDATED.
812
813
814
815
816
817
818
819
(3)
FDA/MQSA-CERTIFIED FACILITIES THAT ARE REGISTERED WITH THE
DEPARTMENT FOR THE USE OF DEDICATED MAMMOGRAPHIC
EQUIPMENT FOR MAMMOGRAPHY SCREENING ARE APPROVED FOR
MAMMOGRAPHY SCREENING ONLY AND ARE CONSIDERED TO HAVE
MET 6.3.3.3(2).
6.3.3.41.1.5
Except for patients who cannot be moved out of the room, only the staff and
ancillary personnel required for the medical procedure or training shall be in the room
during the A radiographic or fluoroscopic exposure.
6 - 24
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
820
821
822
823
6.3.3.5 EACH FACILITY SHALL HAVE PROTECTIVE APRONS AND GLOVES AVAILABLE
IN SUFFICIENT NUMBERS TO PROVIDE PROTECTION TO ALL INDIVIDUALS WHO
ARE INVOLVED WITH X-RAY IMAGING OPERATIONS AND WHO ARE OTHERWISE
NOT SHIELDED.
824
825
826
827
6.3.3.6 TO REDUCE DIRECT RADIATION EXPOSURE, INDIVIDUAL SHIELDING SHALL BE
PROVIDED FOR ALL MODALITIES (EXCEPT FOR A CASE IN WHICH SHIELDING
WOULD INTERFERE WITH THE GONAD, THYROID, DENTAL OR OTHER
DIAGNOSTIC PROCEDURE).
828
829
830
831
(1)
FOR A HUMAN PATIENT WHO HAS NOT PASSED BEYOND THE
REPRODUCTIVE AGE, DURING RADIOGRAPHIC PROCEDURES IN WHICH
THE GONADS ARE IN THE USEFUL BEAM, GONAD SHIELDING OF NOT
LESS THAN 0.5 MILLIMETER LEAD EQUIVALENT SHALL BE USED.
832
833
834
(2)
FOR A HUMAN PATIENT DURING ALL RADIOGRAPHIC PROCEDURES IN
WHICH THE THYROID IS IN THE USEFUL BEAM, THYROID SHIELDING OF
NOT LESS THAN 0.25 MILLIMETER LEAD EQUIVALENT SHALL BE USED.
835
836
837
838
(3)
IN A CASE WHERE THE PATIENT MUST HOLD THE IMAGE RECEPTOR,
ANY PORTION OF THE BODY OTHER THAN THE AREA OF CLINICAL
INTEREST STRUCK BY THE USEFUL BEAM SHALL BE PROTECTED BY
NOT LESS THAN 0.5 MILLIMETER LEAD EQUIVALENT MATERIAL.
839
840
841
(4)
EACH INDIVIDUAL Oother than the patient being examined:6.3.1.1.5.1All
individuals shall be positioned such that no part of the body will be struck by the
useful beam unless protected by a minimum of 0.5 millimeter lead equivalent.
842
843
844
845
846
847
6.3.3.7 TO REDUCE SCATTER RADIATION EXPOSURE, INDIVIDUAL SHIELDING SHALL
BE PROVIDED AS FOLLOWS:
(1)6.3.1.1.5.2 THE OPERATOR, OTHER sStaff and ancillary personnel, AND EACH
OTHER INDIVIDUAL REQUIRED FOR THE MEDICAL PROCEDURE OR WHO
CANNOT BE REMOVED FROM THE ROOM shall be protected from the direct
scatter radiation:
848
849
(a)
bBy A protective aprons or whole body protective barriers of not less
than 0.25 millimeter lead equivalent;, AND/or
850
851
(b)
sShall be so positioned that the nearest portion of the body is at least A
DISTANCE OF 1.832 meters (MORE THAN 6 feet) from both the:
852
(i)
tTube head; and the
853
(ii)
nNearest edge of the image receptor; AND
854
(iii)
PATIENT;
855
856
857
858
(c)
EXCEPT THAT PROTECTIVE POSITIONING SHALL BE AS
DETERMINED BY THE OPERATOR OF A MINI-C-ARM X-RAY
SYSTEM OR A PORTABLE HAND-HELD X-RAY DEVICE (AS
PROVIDED IN APPENDIX 6E).
6 - 25
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
859
860
861
862
863
6.3.1.1.5.3
Human patients who cannot be removed from the room shall be
protected from the direct scatter radiation whole body protective barriers
of 0.25 millimeter lead equivalent or shall be so positioned that the
nearest portion of the body is at least 1.83 meters (6 feet) from both the
tube head; and the nearest edge of the image receptor
864
865
866
867
6.3.1.1.6
Gonad shielding of not less than 0.25 millimeter lead equivalent shall be used for
human patients, who have not passed beyond the reproductive age, during radiographic
procedures in which the gonads are in the useful beam, except for cases in which this
would interfere with the diagnostic procedure.
868
869
870
871
6.3.1.1.7
Individuals shall not be exposed to the useful beam except for healing arts
purposes and unless such exposure has been authorized by a licensed practitioner of the
healing arts. This provision specifically prohibits deliberate exposure for the following
purposes:
872
873
6.3.1.1.7.1
exposure of an individual for training, demonstration or other non-healing
arts purposes; and
874
875
6.3.1.1.7.2
exposure of an individual for the purpose of healing arts screening
except as authorized by RH 6.3.1.1.11 .
876
877
6.3.31.1.8
When a patient or film IMAGE RECEPTOR must be provided with auxiliary
support during a radiation exposure:
878
879
6.3.1.1.8.(1)
AND
mMechanical holding devices shall be used when the technique permits.;
880
881
(2)
882
6.3.1.1.8.2
883
884
(a)
Indicate the requirements for selecting a holder and the procedure the
holder shall follow; AND
885
886
887
888
(b)
EXPRESSLY LIMIT ROUTINE USE OF PERSONNEL WHO ARE
SUBJECT TO THE OCCUPATIONAL DOSE LIMITS IN 4.6 FOR
HOLDING A PATIENT SOLELY TO IMMOBILIZE THE PATIENT
DURING RADIOGRAPHIC EXAMINATIONS; AND
The written safety procedures, required by RH 6.3.3.1.1.4, shall: list individual
projections where holding devices cannot be utilized;
written safety procedures, as required by RH 6.31.1.4, shall i
889
890
6.3.1.1.8.(3)
tThe human holder shall be INSTRUCTED IN PERSONAL RADIATION
SAFETY AND protected as required by RH 6.3.31.1.5.1;
891
892
6.3.1.1.8.(4)
nNo individual shall be used routinely to hold film IMAGE RECEPTORS
or patients.; and
893
894
895
896
6.3.1.1.8.5 in those cases where the patient must hold the film , except during intraoral
examinations, any portion of the body other than the area of clinical interest
struck by the useful beam shall be protected by not less than 0.5 millimeter lead
equivalent material.
897
898
899
6.3.1.1.8.6
each facility shall have leaded aprons and gloves available in sufficient
numbers to provide protection to all personnel who are involved with x-ray
operations and who are otherwise not shielded.
6 - 26
Colorado Radiation Regulations, Proposed Revised Part 6
900
901
902
903
904
905
906
May 12, 2017
6.3.31.1.9
IMAGE PROCESSING procedures and auxiliary equipment designed to
minimize patient and personnel exposure commensurate with the needed diagnostic
information shall be utilized.
6.3.1.1.9.(1)
The speed of film, or FILM-screen and film combinations, IMAGING
PLATE OR RECEPTOR AND IMAGE PROCESSING, shall be the fastest speed
OR SPEED EQUIVALENT consistent with the diagnostic objective of the
examinations.
907
908
6.3.1.1.9.1.1
The radiation exposure to the patient shall be the minimum
exposure required to produce images of acceptable diagnostic quality.
909
910
911
6.3.1.1.9.(2)
Portable or mobile x-ray equipment shall be used only for examinations
where it is impractical to transfer the patient(s) to a stationary x-ray installation, or
when portable or mobile equipment is most suitable for the diagnostic procedure.
912
913
914
6.3.1.1.9.3
X-ray systems subject to RH 6.6 shall not be utilized in procedures
where the source to patient distance is less than 30 cmentimeters, except for
veterinary systems.
915
916
917
6.3.1.1.9.4(3) If anti-scatter grids are used between the patient and the image receptor
to decrease scattered radiation to the film and improve contrast, the grid shall
BE:
918
919
6.3.1.1.9.4.1(a) be pPositioned properly, i.e., WITH THE tube side facing the
correct direction, and grid centered to the central ray; AND
920
6.3.1.1.9.4.2(b) be oOf the proper focal distance for the SID being used.
921
922
923
6.3.31.1.10
All EACH individuals who areIS associated with the operation of an x-ray
IMAGING system are subject to SHALL MEET the requirements of RH 4.6, 4.10, 4.12,
4.13, 4.14, and 4.18 of these Regulations. In addition:
924
925
926
927
6.3.1.1.10.(1) When protective clothing or devices are worn, personnel DOSIMETRIC
monitoring devices ARE REQUIRED, THEY shall be worn, such that the
requirements of 4.6, 4.10, 4.12, 4.13, 4.14, and 4.18 shall be met IN
ACCORDANCE WITH 4.6.3.
928
929
930
6.3.1.1.10.(2) EACH OPERATOR OF PORTABLE HAND-HELD X-RAY EQUIPMENT
SHALL WEAR WHOLE BODY AND EXTREMITY PERSONNEL DOSIMETRIC
MONITORING DEVICES.
931
932
(3)
DELIBERATE Eexposure of a personnel DOSIMETRIC monitoring device to
deceptively indicate a dose delivered to an individual is STRICTLY prohibited.
933
934
935
936
937
938
6.3.1.1.11
Healing Arts Screening. With the exception of FDA/MQSA-approved facilities which are
registered with the Department for the use of dedicated mammographic equipment, any person
proposing to conduct a healing arts screening program shall not initiate such a program without
prior approval of the Department. When requesting such approval, that person shall submit the
information outlined in Appendix C of this Part. If any information submitted to the Department
becomes invalid or outdated, the Department shall be immediately notified.
939
940
6.3.1.1.12
Information and Maintenance Record and Associated Information. The registrant shall
maintain the following information for each x-ray system for inspection by the Department:
6 - 27
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
941
6.3.1.1.12.1
942
943
6.3.1.1.12.2
model and serial numbers of each tube housing assembly and control
panel;
944
945
946
947
948
6.3.1.1.12.2.1 The facility registrant shall assign a unique identification number to each
tube housing assembly and/or control panel which lacks a clearly visible serial
number from the manufacturer. The tube housing assembly and/or control panel
shall be labeled or stenciled with this number. This number shall be used by the
registrant to identify this machine in all correspondence with the Department.
949
6.3.1.1.12.3
950
6.3.4
maximum technique factors for which the machine has been rated;
Tube rating charts and cooling curves;
MEASUREMENTS, MAINTENANCE AND RECORDS.
951
952
953
954
955
956
6.3.4.1 The registrant shall maintain the following information for each x-ray system for
inspection by the Department:6.3.1.1.12.4 records for the previous three (3) years of
surveys, measurements, calibrations, maintenance, and modifications, CERTIFICATION
EVALUATIONS PURSUANT TO 2.5, DEPARTMENT FORMS 59-1 AND 59-2, AND
CORRECTIVE ACTIONS FOR EACH performed on the x-ray IMAGING system(s) with
the names of persons who performed such services;.
957
958
959
960
961
962
963
964
965
966
6.3.4.21.1.12.5 Except for single occupancy rooms using only dental intraoral or panoramic
machines, THE REGISTRANT SHALL RETAIN a dimensional drawing AND
ACCOMPANYING CALCULATION(S) AND/OR SURVEY(S) AS PROVIDED IN 6.3.2.3
of the EACH room in which a stationary x-ray system is located, EXCEPT AS
EXEMPTED UNDER 6.3.2.4.with such drawing indicatIng the use of areas adjacent to
the room and an estimation of the extent of occupancy by an individual in such areas. In
addition, the drawing shall include:6.3.1.1.12.5.1the results of a survey for radiation levels
present at the operator's position and at pertinent points outside the room at specified
test conditions, or 6.3.1.1.12.5.2the type and thickness of materials, or lead equivalency,
of each protective barrier; and
967
968
969
6.3.4.3 CONSISTENT WITH 2.4.1 AND 6.3.2, THE REGISTRANT SHALL RETAIN ON FILE AT
THE FACILITY FOR THE LIFE OF THE FACILITY EACH SHIELDING DESIGN ALONG
WITH INSTALLER AS-BUILT DRAWINGS.
970
971
972
6.3.4.4 EACH FACILITY SHALL HAVE AVAILABLE A PRINTED OR ELECTRONIC RECORD
CONTAINING EACH PATIENT’S NAME, THE TYPE OF EXAMINATION(S), AND THE
DATE(S) THE EXAMINATION(S) WERE PERFORMED.
973
6.3.1.1.12.6
974
975
976
977
978
979
980
981
6.3.1.1.13
Collimation. The registrant shall provide safety training to all operators on
radiation safety procedures including collimation. The collimation procedure shall specify
for each tube with variable collimation whether positive beam limitation (PBL) or manual
collimation shall be used. 6.3.1.1.13.1 If manual collimation is used, then there shall be
positive indication of collimation on all films except as provided in RH 6.10.2.6.7, or when
contraindicated and diagnosis could be compromised. Tubes collimated manually need
not comply with PBL requirements. 6.3.1.1.13.2 Regardless of the method of collimation,
the beam size shall be limited to the smallest area which is clinically necessary.
982
6.3.51.1.14
a copy of all correspondence with this Department regarding that x-ray system.
Film Processing QUALITY ASSURANCE (QA) Program.
6 - 28
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
983
984
985
986
987
988
989
6.3.5.1 TO AVOID UNNECESSARY OR DUPLICATIVE RADIATION EXPOSURES, Every
EACH human use facility which is required to be inspected on an annual basis shall have
an active filmIMAGE processing QUALITY CONTROL AND QUALITY ASSURANCE
(QA) program which includes THAT FOLLOWS MANUFACTURERS’ SPECIFICATIONS
AND/OR THE STANDARDS OF AN APPROPRIATE NATIONALLY RECOGNIZED
ORGANIZATION, FOR EXAMPLE, THE AMERICAN COLLEGE OF RADIOLOGY OR
AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE.
990
991
992
993
994
995
6.3.5.2 EACH REGISTRANT THAT USES A HARD COPY IMAGING SYSTEM WITH
TRANSMISSION VIEWING, WHETHER WITH OR WITHOUT LIQUID CHEMISTRY,
SHALL DOCUMENT THAT QUALITY CONTROL AND QUALITY ASSURANCE HAVE
BEEN PERFORMED ACCORDING TO SPECIFICATIONS OF THE MANUFACTURER
OR A REGISTERED MEDICAL PHYSICIST AND/OR A NATIONALLY RECOGNIZED
ORGANIZATION, INCLUDING:
996
(1)
PERIODIC PRINTING OF A SENSITOMETRIC STRIP OR PATTERN;
997
998
999
1000
(2)
DOCUMENTATION OF LOW, MEDIUM AND HIGH DENSITY CALIBRATION
AND THAT ANY CALIBRATION WHICH FAILED TO MEET A
MANUFACTURER’S SPECIFICATION WAS CORRECTED BEFORE THE
IMAGE PRINTER WAS USED TO PRINT ANOTHER IMAGE; AND
1001
(3)
ANNUAL REVIEW OF ALL QUALITY CONTROL TESTS.
1002
1003
6.3.5.3 EACH REGISTRANT THAT USES AN AUTOMATIC FILM PROCESSOR SHALL
ADOPT AN ACCEPTABLE SENSITOMETRIC QUALITY CONTROL PROGRAM.
1004
1005
1006
(1)
FILM PROCESSORS USED TO DEVELOP RADIOGRAPHS SHALL BE
ADJUSTED AND MAINTAINED TO MEET THE TECHNICAL DEVELOPMENT
SPECIFICATIONS FOR THE RADIOGRAPHY FILM IN USE.
1007
1008
1009
1010
1011
1012
(2)
FOR ALL X-RAY IMAGING SYSTEMS, A CONTINUOUS AND DOCUMENTED
SENSITOMETRIC QUALITY CONTROL PROGRAM SHALL BE , INCLUDING
QUALITY CONTROL TESTS FOR SPEED, CONTRAST AND FOG, SHALL BE
PERFORMED ACCORDING TO SPECIFICATIONS OF THE MANUFACTURER
AND/OR A REGISTERED MEDICAL PHYSICIST AND/OR A NATIONALLY
RECOGNIZED ORGANIZATION.
6 - 29
Colorado Radiation Regulations, Proposed Revised Part 6
1013
1014
1015
1016
1017
1018
May 12, 2017
6.3.5.41.1.14.1 The x-ray film must be developed following the specifications of the film
manufacturer for development time and temperatureEACH REGISTRANT THAT USES
A MANUAL FILM PROCESS SHALL:
(1)
1019
1020
Those FOLLOW APPLICABLE manufacturer’s recommendations
DEVELOPMENT TIME AND TEMPERATURE SPECIFICATIONS, WHICH
SHALL must be available for review.;
6.3.1.1.14.1.1In lieu of the requirements of RH 6.3.1.1.14.1, the facility may
adopt a continuous, documented sensitometric quality control program.
1021
1022
1023
(2)
1024
1025
6.3.1.1.14.3If an automatic film processor is used then its developer temperature must be
monitored and logged at least once per week.
1026
1027
6.3.1.1.14.4For both manual and automated processing there must be an adequate
method used to monitor and/or determine processing time.
1028
1029
6.3.1.1.14.5An adequate developer replenishment system must be functional to meet the
manufacturer's recommendations for automated film processors.
1030
1031
1032
(3)
1033
6.3.1.1.14.2If manual processing of films is done the temperature of the
developer must be mMeasured and logged DEVELOPMENT TEMPERATURE
each day OF USE; AND the processing system is used.
For manual developing procedures the DOCUMENT IN A WRITTEN LOG THE
CHANGE OF developer chemicals must be changed at least every month. and
documented in a written log.
6.3.5.51.1.14.6 The REGISTRANT SHALL CONTROL darkroom lighting must be such that:
1034
1035
1036
1037
(1)
eExposure of a film to the darkroom safelight for one minute does not increase
the optical density of that film by more than 0.1 optical density units when the test
film has a latent image sufficient to produce a density between 1.0 and 2.0
optical density units prior to safe light exposure.;
1038
(2)
If used, daylight film handling boxes shall preclude fogging of the film.; AND
1039
1040
1041
6.3.1.1.14.7(3) The base plus fog of an unexposed film must DOES not exceed
0.25 optical density units when developed by the routine procedure used by the
facility.
1042
1043
1044
1045
6.3.5.61.1.14.7.1
All film storage, including pass boxes, if provided, shall be so constructed
as to exclude light from the darkroom when cassettes are placed in or removed from the
boxes, and shall incorporate adequate shielding from stray radiation to prevent exposure
of undeveloped film.
1046
1047
1048
6.3.1.1.15
Every human use facility which is required to be inspected on a
three-year basis shall have their film(s) developed according to the film
manufacturer's recommendation for development time and temperature.
6 - 30
Colorado Radiation Regulations, Proposed Revised Part 6
1049
1050
1051
1052
1053
May 12, 2017
6.3.5.7 THE REGISTRANT SHALL ENSURE THAT EACH MONITOR USED FOR PRIMARY
IMAGE INTERPRETATION IS EVALUATED ACCORDING TO SPECIFICATIONS OF
THE MANUFACTURER OR A REGISTERED MEDICAL PHYSICIST AND/OR A
NATIONALLY RECOGNIZED ORGANIZATION, FOR EXAMPLE, IN AAPM ONLINE
REPORT OR-03 (APRIL 2005), INCLUDING BUT NOT LIMITED TO:
1054
1055
1056
(1)
FREQUENT CAREFUL CLEANING OF EACH PRIMARY IMAGE
INTERPRETATION WORKSTATION AND DATA ACQUISITION
WORKSTATION MONITOR;
1057
1058
1059
(2)
PERIODIC VISUAL ASSESSMENT OF SOCIETY OF MOTION PICTURE AND
TELEVISION ENGINEERS (SMPTE) PATTERN OR EQUIVALENT TEST
PATTERN;
1060
1061
1062
1063
(3)
INITIAL AND ANNUAL VERIFICATION THAT MONITOR CALIBRATION
CONFORMS WITH THE DICOM PART 14 GRAYSCALE STANDARD
DISPLAY FUNCTION (SEE AAPM ONLINE REPORT OR-03), OR
EQUIVALENT:
1064
(a)
VISUALIZATION OF LOW CONTRAST PATCHES;
1065
(b)
VISUALIZATION OF SPATIAL RESOLUTION TARGETS;
1066
(c)
MEASUREMENT OF AMBIENT LIGHT LEVELS;
1067
1068
(d)
MEASUREMENT OF THE LUMINANCE FROM A SUFFICIENT
NUMBER OF DRIVING LEVELS;
1069
1070
1071
1072
(e)
MEASUREMENTS TO ASSURE THAT THE LUMINANCE FOR
MULTIPLE MONITORS ARE WITHIN 5% OF EACH OTHER WHEN
MORE THAN ONE MONITOR IS BEING UTILIZED AT A PRIMARY
IMAGE INTERPRETATION WORKSTATION.
1073
1074
1075
1076
1077
1078
1079
6.3.5.8 THE REGISTRANT SHALL ENSURE THAT COMPUTED RADIOGRAPHY
CASSETTES AND CASSETTE READERS USED FOR PRIMARY IMAGE
INTERPRETATION ARE EVALUATED PERIODICALLY ACCORDING TO
SPECIFICATIONS OF THE MANUFACTURER AND/OR A REGISTERED MEDICAL
PHYSICIST AND/OR A NATIONALLY RECOGNIZED ORGANIZATION, FOR
EXAMPLE, IN AAPM REPORT 93, IN A PROGRAM REVIEWED ANNUALLY BY A
REGISTERED MEDICAL PHYSICIST.
1080
6.3.5.9 SPECIAL REQUIREMENT FOR VIEWBOXES AND LIGHTING IN MAMMOGRAPHY.
1081
1082
1083
(1)
A VIEWBOX USED FOR CLINICAL QUALITY REVIEW AND INTERPRETING
MAMMOGRAMS SHALL BE CAPABLE OF PRODUCING A LUMINANCE OF
AT LEAST 3,000 CANDELA PER SQUARE METER (CD-M-2).
1084
1085
1086
1087
(2)
THE REGISTRANT SHALL MAKE SPECIAL LIGHTS FOR FILM
ILLUMINATION (THAT IS, HOT LIGHTS), CAPABLE OF PRODUCING LIGHT
LEVELS GREATER THAN THAT PROVIDED BY THE VIEW BOX,
AVAILABLE TO THE INTERPRETING PHYSICIAN.
6 - 31
Colorado Radiation Regulations, Proposed Revised Part 6
1088
6.3.2
May 12, 2017
Plan Review and Shielding Design.
1089
1090
1091
1092
1093
1094
1095
1096
1097
1098
1099
6.3.2.1 Prior to the construction of a new x-ray facility, the floor plans and equipment
arrangement shall be submitted to a qualified expert for the determination of shielding
requirements. Prior to the modification or renovation of an existing x-ray facility, or
installation of a new x-ray machine in an existing x-ray facility, the plans and equipment
arrangements shall be submitted to a qualified expert for determination of shielding
requirements when there is a change in primary beam orientation, or a change in primary
shielding due to the modification or renovation of a facility, or there is a projected
increase in the x-ray workload from that which was used for the original x-ray shielding
design. In such cases shielding shall meet the criteria in Appendix B and the
recommendations of the qualified expert. The required information is denoted in
Appendices A and B of this Part.
1100
1101
1102
1103
1104
6.3.2.1.1
Facilities using only dental intraoral machines in an open bay area are exempt
from the requirement of RH 6.3.2.1, provided that there is a distance of at least 1.83
meters (6 feet) between two (2) adjacent chairs. Facilities using only bone densitometry
machines, mini-c-arms, dental intraoral or panoramic machines in single occupancy
rooms are exempt from the requirements of RH 6.3.2.1.
1105
1106
1107
1108
6.3.2.2 The review of such plans, and determination of shielding requirements, shall not preclude
the requirement of additional modifications should a subsequent analysis of operating
conditions indicate the possibility of an individual receiving a dose in excess of the limits
prescribed in RH 4.6, 4.12, 4.13, and 4.14 of these Regulations.
6 - 32
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
1109
1110
RH 6.4 General Requirements for SAFE USE OF All Diagnostic X-Ray IMAGING Systems OF ANY
KIND.
1111
6.4.1
ADMINISTRATIVE CONTROLS.
1112
1113
1114
1115
6.4.1.1 IN ADDITION TO THE GENERAL REQUIREMENTS OF 6.3, THE REQUIREMENTS OF
6.4 APPLY TO ALL DIAGNOSTIC X-RAY IMAGING EQUIPMENT AND ASSOCIATED
FACILITIES, EXCEPT AS PROVIDED BY 6.7.5.1 FOR DENTAL USES AND 6.8.5.1
FOR VETERINARY USES.
1116
1117
1118
6.4.1.2 EACH INDIVIDUAL WHO OPERATES AN X-RAY IMAGING SYSTEM USED ON
LIVING HUMANS SHALL MEET THE APPLICABLE RADIATION SAFETY TRAINING
AND EXPERIENCE REQUIREMENTS OF 2.6.1.
1119
1120
1121
1122
1123
6.4.2
In addition to other requirements of this Part, all EACH diagnostic x-ray IMAGING systems shall
meet the following EQUIPMENT DESIGN AND CONFIGURATION requirements:.
6.4.2.1 Warning Label.
(1)
“WARNING: This x-ray unit may be dangerous to patient and operator unless
safe exposure factors and operating instructions are observed.”
1124
1125
1126
1127
1128
1129
1130
The control panel containing the main power switch shall bear this or an
equivalent warning statement, legible and accessible to view:
6.4.2.2 Battery Charge Indicator.
(1)
On battery-powered x-ray generators, visual means shall be provided on the
control panel to indicate whether the battery is in a state of charge adequate for
proper operation.
6.4.2.3 Leakage Radiation from the Diagnostic Source Assembly.
1131
1132
1133
1134
(1)
The leakage radiation from the diagnostic source assembly measured at a
distance of 1 meter in any direction from the source shall not exceed 25.8 μC/kg
0.88 mGy (100 mR) per minute in one ANY 1 hour when the x-ray tube is
operated at its leakage exposure settings.
1135
1136
(2)
Compliance shall be determined by measurements averaged over an area of 100
square cmentimeters with no linear dimension greater than 20 cmentimeters.
1137
6.4.2.4 Radiation from Components Other Than the Diagnostic Source Assembly.
1138
1139
1140
1141
1142
1143
(1)
The radiation emitted by a component other than the diagnostic source assembly
shall not exceed 0.516 μC/kg 18 μGy per minute (2 mR) in ANY one hour at
5 cmentimeters from any accessible surface (THAT CAN BE EASILY OR
ACCIDENTALLY TOUCHED BY AN INDIVIDUAL WITHOUT THE USE OF A
TOOL) of the component when it is operated in an assembled x-ray system
under any conditions for which it was designed.
1144
1145
1146
(2)
Compliance shall be determined by measurements averaged over an area of
100 square cmentimeters with no linear dimension greater than 20
cmentimeters.
6 - 33
Colorado Radiation Regulations, Proposed Revised Part 6
1147
May 12, 2017
6.4.2.5 Beam Quality. 6.4.5.1: Half-Vvalue Layer.
1148
1149
1150
1151
6.4.5.1.(1)
The half-value layer of the useful beam for a given x-ray tube potential
shall not be less than the values shown in Table I6-1. If it is necessary to
determine such half-value layer at an x-ray tube potential which is not listed in
Table I, linear interpolation or extrapolation may be made.
Table 6-1
Design operating
range (kVp)
Below 50
50 to 70
Above 70
Measured
potential (kVp)
Half-value layer (mm of aluminum)
Other Systems
Dental Systems
30
0.3
1.5
40
0.4
1.5
49
0.5
1.5
50
1.2
1.5
60
1.3
1.5
70
1.5
1.5
71
2.1
2.1
80
2.3
2.3
90
2.5
2.5
100
2.7
2.7
110
3.0
3.0
120
3.2
3.2
140
3.8
3.8
150
4.1
4.1
6 - 34
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
TABLE 6-1
X-RAY TUBE VOLTAGE
MINIMUM HVL
(KILOVOLT PEAK)
(MM OF ALUMINUM)
DENTAL X-RAY SYSTEMS
WITH INTRAORAL IMAGE
RECEPTORS
ALL X-RAY SYSTEMS OTHER
THAN DENTAL X-RAY
SYSTEMS
DESIGNED MEASURED
MADE BEFORE, ON OR
MADE BEFORE MADE ON OR
OPERATING OPERATING AFTER DECEMBER 1, 1980 JUNE 10, 2006 AFTER JUNE
RANGE
POTENTIAL
10, 2006
BELOW 51
51 TO 70
ABOVE 70
1152
1153
1154
(2)
30
1.5
0.3
0.3
40
1.5
0.4
0.4
50
1.5
0.5
0.5
51
1.5
1.2
1.3
60
1.5
1.3
1.5
70
1.5
1.5
1.8
71
2.1
2.1
2.1
2.5
80
2.3
2.3
2.3
2.9
90
2.5
2.5
2.5
3.2
100
2.7
2.7
2.7
3.6
110
3.0
3.0
3.0
3.9
120
3.2
3.2
3.2
4.3
130
3.5
3.5
3.5
4.7
140
3.8
3.8
3.8
5.0
150
4.1
4.1
4.1
5.4
IF IT IS NECESSARY TO DETERMINE SUCH HALF-VALUE LAYER AT AN
X-RAY TUBE POTENTIAL THAT IS NOT LISTED IN TABLE 6-1, LINEAR
INTERPOLATION OR EXTRAPOLATION IS ACCEPTABLE.
6 - 35
Colorado Radiation Regulations, Proposed Revised Part 6
1155
1156
1157
May 12, 2017
6.4.5.1.2
The requirements of RH 6.4.5.1.1 will be considered to have been met if
it can be demonstrated that the aluminum equivalent of the total filtration in the
primary beam is not less than that shown in Table II.
Table II6-2
Filtration Required vs. Operating Voltage
Operating Voltage (kVp)
1158
Total Filtration (inherent plus added)
(mm aluminum equivalent)
Other Systems
Dental Systems
Below 50
0.5
1.5
50 - 70
1.5
1.5
Above 70
2.5
2.5
6.4.2.6 BEAM QUALITY: ADDITIONAL SPECIAL REQUIREMENTS.
1159
1160
1161
6.4.5.1.3(1)
Beryllium window tubes, except those used for mammography, shall
have a minimum of 0.5 millimeter aluminum equivalent filtration permanently
installed in the useful beam.
1162
1163
1164
1165
6.4.5.1.4(2)
For capacitor energy storage equipment, compliance with the
requirements of RH 6.4.2.5 shall be determined with the system fully charged
AND FOR THE HIGHEST CLINCIALLY USED and a minimum setting of 10 mAs
for each exposure.
1166
1167
1168
6.4.5.1.5(3)
The required minimal aluminum equivalent filtration shall include the
filtration contributed by all materials which THAT are always present between the
source and the patient.
1169
1170
6.4.5.2 Filtration Controls.(4) For x-ray systems which THAT have variable kVp and variable
filtration for the useful beam, a FILTRATION CONTROL device shall:
1171
(a)
lLink the kVp selector with the filter(s); and
1172
1173
1174
(b)
shall pPrevent an exposure unless the minimum amount of filtration
required by RH 6.4.2.5.(1) is in the useful beam for the given kVp which
THAT has been selected.
6 - 36
Colorado Radiation Regulations, Proposed Revised Part 6
1175
6.4.2.67
May 12, 2017
Multiple Tube HEADs.
1176
1177
1178
1179
(1)
THE TUBE HOUSING ASSEMBLY SUPPORTS SHALL BE ADJUSTED SUCH
THAT THE TUBE HOUSING ASSEMBLY WILL REMAIN STABLE DURING AN
EXPOSURE UNLESS TUBE HOUSING MOVEMENT IS A DESIGNED
FUNCTION OF THE X-RAY SYSTEM.
1180
1181
1182
(2)
Where two or more radiographic tubes are controlled by one exposure switch,
the tube or tubes which THAT have been selected shall be clearly indicated prior
to initiation of the exposure.
1183
1184
(a)
1185
1186
(3)
1187
1188
1189
6.4.7
1190
6.4.2.87.1
1191
1192
1193
This indication shall be both on the x-ray control and at or near the tube
housing assembly which THAT has been selected.
ANY INFORMATION DISPLAYED AT THE TUBE HEAD SHALL MEET
MANUFACTURER’S SPECIFICATIONS.
Mechanical Support of Tube Head. The tube housing assembly supports shall be
adjusted such that the tube housing assembly will remain stable during an exposure
unless tube housing movement is a designed function of the x-ray system.
(1)
Locks.
All position locking, holding, and centering devices on THE x-ray systems
AND/OR components and system shall function as designed.
6.4.2.9 THE X-RAY CONTROL SHALL PROVIDE:
1194
1195
(1)
VISUAL INDICATION OBSERVABLE AT OR FROM THE OPERATOR'S
PROTECTED POSITION WHENEVER X-RAYS ARE PRODUCED; AND
1196
1197
(2)
A SIGNAL AUDIBLE TO THE OPERATOR TO INDICATE THAT THE
EXPOSURE HAS TERMINATED.
1198
6.4.8
Technique Indicators.
1199
1200
1201
6.4.8.1 The technique factors to be used during an exposure shall be indicated before
the exposure begins. If automatic exposure controls are used, the technique
factors which are set prior to the exposure shall be indicated.
1202
1203
6.4.8.2 The requirement of RH 6.4.8.1may be met by permanent markings on equipment
having fixed technique factors.
6 - 37
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
1204
1205
RH 6.5 SPECIAL REQUIREMENTS FOR SAFE USE OF FluoroscopYic X-Ray Systems Except for
Computed Tomography X-Ray Systems.
1206
6.5.1
ADMINISTRATIVE CONTROLS.
1207
1208
6.5.1.1 IN ADDITION TO THE PROVISIONS OF 6.3 AND 6.4, THE REQUIREMENTS OF 6.5
APPLY TO ALL FLUOROSCOPIC X-RAY IMAGING EQUIPMENT AND FACILITIES.
1209
1210
1211
1212
6.5.1.2 SUPERVISION AND USE OF A FLUOROSCOPIC X-RAY SYSTEM FOR THE
PURPOSE OF LOCALIZATION TO OBTAIN IMAGES FOR DIAGNOSTIC PURPOSES
SHALL BE BY AN INDIVIDUAL WHO HAS ADEQUATE RADIATION SAFETY
TRAINING AND EXPERIENCE.
1213
1214
1215
1216
(1)
A PHYSICIAN, CHIROPRACTOR, PODIATRIST OR VETERINARIAN WHO
HAS A CURRENT ACTIVE STATE OF COLORADO LICENSE TO PRACTICE
THE HEALING ARTS SHALL DIRECTLY SUPERVISE USE OF A
FLUOROSCOPIC X-RAY SYSTEM.
1217
1218
1219
(2)
TRAINING AND EXPERIENCE SHALL BE AS REQUIRED IN 2.6.1, IN
PARTICULAR 2.6.1.5 AND ANY APPLICABLE APPENDIX TO PART 2, AND
6.3.1.9.
1220
1221
1222
1223
(3)
INTERPRETATION OF BOTH REAL TIME AND STORED IMAGES SHALL BE
BY A PHYSICIAN, CHIROPRACTOR, PODIATRIST OR VETERINARIAN WHO
HAS A CURRENT ACTIVE STATE OF COLORADO LICENSE TO PRACTICE
THE HEALING ARTS.
1224
1225
6.5.2
All EACH fluoroscopic x-ray systems shall meet the following EQUIPMENT DESIGN AND
CONFIGURATION requirements:.
1226
6.5.1
Limitation of Useful Beam.
1227
1228
6.5.12.1
ONLY IMAGE-INTENSIFIED OR DIRECT-DIGITAL-RECEPTOR
FLUOROSCOPIC EQUIPMENT SHALL BE USED.
1229
6.5.2.2 LIMITATION OF THE USEFUL BEAM.
1230
(1)
1231
1232
1233
6.5.1.1.1(a)
The fluoroscopic imaging assembly shall be provided with a primary
protective barrier which THAT intercepts the entire cross section of the useful
beam at any SID.
1234
1235
6.5.1.1.2(b)
The x-ray tube used for fluoroscopy shall not produce x rays unless the
PRIMARY PROTECTIVE barrier is in position to intercept the entire useful beam.
1236
1237
Primary PROTECTIVE Barrier TO LIMIT THE USEFUL BEAM.
6.5.1.2 X-Ray Field .6.5.1.2.1 Non-Intensified Fluoroscopic Equipment.6.5.1.2.1.1
image-intensified fluoroscopic equipment shall be used.
6 - 38
Only
Colorado Radiation Regulations, Proposed Revised Part 6
1238
1239
1240
1241
(2)
May 12, 2017
LIMITATION OF THE X-RAY FIELD.
(a)
FOR FLUOROSCOPIC EQUIPMENT MANUFACTURED BEFORE
JUNE 10, 2006, OTHER THAN RADIATION THERAPY SIMULATION
SYSTEMS, THE FOLLOWING APPLY:
1242
1243
1244
1245
(i)
6.5.1.2.1.2For fluoroscopic equipment, nNeither the length nor
the width of the x-ray field in the plane of the image receptor
shall exceed that of the visible area of the image receptor by
more than three (3) percent of the SID.
1246
1247
(ii)
The sum of the excess length and the excess width shall be no
greater than four (4) percent of the SID. In addition:
1248
1249
1250
1251
(iii)
THE ERROR IN ALIGNMENT SHALL BE DETERMINED
ALONG THE LENGTH AND WIDTH DIMENSIONS OF THE
X-RAY FIELD THAT PASS THROUGH THE CENTER OF THE
VISIBLE AREA OF THE IMAGE RECEPTOR.
1252
1253
(3)6.5.1.2.1.3 means shall be provided tTo permit further limitation of the field, THE
FOLLOWING SPECIFICATIONS SHALL ALSO BE MET.
1254
1255
1256
1257
(a)
Beam-limiting devices manufactured after May 22, 1979, and
incorporated in equipment with a variable SID and/or a visible area of
greater than 300 square cmentimeters shall be provided with means for
stepless adjustment of the x-ray field.;
1258
1259
1260
1261
(b)6.5.1.2.1.4 aAll equipment with a fixed SID and a visible area of 300 square
cmentimeters or less shall be provided with either stepless adjustment of
the x-ray field or with means to further limit the x-ray field size at the
plane of the image receptor to 125 square cmentimeters or less.
1262
1263
1264
(c)
1265
1266
(d)6.5.1.2.1.5 fFor equipment manufactured after February 25, 1978, when the
angle between the image receptor and beam axis is variable:, m
If provided, stepless adjustment shall, at the greatest SID, provide
continuous field sizes from the maximum obtainable to a field size of
5 cmentimeters by 5 cmentimeters or less.;
1267
1268
(i)
Means shall be provided to indicate when the axis of the x-ray
beam is perpendicular to the plane of the image receptor; and
1269
1270
(ii)
tThe entire cross section of the useful beam shall be intercepted
by the primary protective barrier at any SID.
6 - 39
Colorado Radiation Regulations, Proposed Revised Part 6
1271
1272
May 12, 2017
(e)6.5.1.2.1.6 Compliance shall be determined with the beam axis indicated to
be perpendicular to the plane of the image receptor.
1273
1274
1275
(i)
Measurement shall be made in perpendicular directions
corresponding to the vertical and horizontal directions on the
video/tv monitor image.
1276
1277
1278
1279
(ii)
For collimating systems which THAT are not circular,
measurement shall be made along the directions closest to the
vertical and horizontal direction on the video monitor image
yielding the smallest dimension in each direction.
1280
1281
1282
1283
1284
1285
(4)6.5.1.2.2
ADDITIONAL X-RAY FIELD SPECIFICATIONS FOR Spot-film dDevices
shall meet the following additional requirements:
(a)6.5.1.2.2.1 mMeans shall be provided between the source and the patient
for adjustment of the x-ray field size in the plane of the film IMAGE
RECEPTOR to the size of that portion of the film IMAGE RECEPTOR
that has been selected on the spot film selector.
1286
1287
1288
1289
1290
1291
1292
(i)
Such adjustment shall be automatically accomplished except
when the x-ray field size in the plane of the film IMAGE
RECEPTOR is smaller than that of the selected portion of the
film IMAGE RECEPTOR. For spot film devices manufactured
after June 21, 1979, if the x-ray field size is less than the size of
the selected portion of the film , the means for adjustment of the
field size shall be only at the operator's option.
1293
1294
1295
1296
1297
1298
(ii)
IF THE X-RAY FIELD SIZE IS LESS THAN THE SIZE OF THE
SELECTED PORTION OF THE IMAGE RECEPTOR, THE
FIELD SIZE SHALL NOT OPEN AUTOMATICALLY TO THE
SIZE OF THE SELECTED PORTION OF THE IMAGE
RECEPTOR UNLESS THE OPERATOR HAS SELECTED
THAT MODE OF OPERATION.
1299
1300
1301
1302
1303
1304
1305
1306
1307
1308
1309
1310
1311
(b)6.5.1.2.2.2 Neither the length nor the width of the x-ray field in the plane of
the image receptor shall differ from the corresponding dimensions of the
selected portion of the image receptor by more than three (3) percent of
the SID when adjusted for full coverage of the selected portion of the
image receptor.
(i)
The sum, without regard to sign, of the length and width
differences shall not exceed four (4) percent of the SID. On
spot-film devices manufactured after February 25, 1978, if the
angle between the plane of the image receptor and beam axis is
variable, means shall be provided to indicate when the axis of
the x-ray beam is perpendicular to the plane of the image
receptor, and compliance shall be determined with the beam axis
indicated to be perpendicular to the plane of the image receptor.
6 - 40
Colorado Radiation Regulations, Proposed Revised Part 6
1312
1313
1314
May 12, 2017
(c)6.5.1.2.2.3 iIt shall be possible to adjust the x-ray field size in the plane of
the film IMAGE RECEPTOR to a size smaller than the selected portion
of the film IMAGE RECEPTOR.
1315
1316
1317
(i)
The minimum field size at the greatest SID shall be equal to, or
less than, 5 cmentimeters by 5 cmentimeters, OR 125 CM2 FOR
A FIXED SID.
1318
1319
1320
(d)6.5.1.2.2.4 tThe center of the x-ray field in the plane of the film IMAGE
RECEPTOR shall be aligned with the center of the selected portion of
the film IMAGE RECEPTOR to within two (2) percent of the SID.; and
1321
1322
1323
1324
1325
1326
(e)6.5.1.2.2.5 oOn spot-film devices manufactured after February 25, 1978, if
the angle between the plane of the image receptor and beam axis is
variable, means shall be provided to indicate when the axis of the x-ray
beam is perpendicular to the plane of the image receptor, and
compliance shall be determined with the beam axis indicated to be
perpendicular to the plane of the image receptor.
1327
(5)6.5.1.2.3
1328
1329
(a)
Override.
If a means exists to override any of the automatic x-ray field size
adjustments required in RH 6.5.12.2, that means SHALL:
1330
1331
6.5.1.2.3.1(i)
shall bBe designed for use only in the event of system
failure AND NOT AS A SUBSTITUTE FOR PROMPT REPAIR;
1332
1333
1334
6.5.1.2.3.2(ii) shall iIncorporate a signal visible at the operator's
position which THAT will indicate whenever the automatic field
size adjustment is overridden; and
1335
6.5.1.2.3.3(iii) shall bBe clearly and durably labeled as follows:
1336
“FOR X-RAY FIELD LIMITATION SYSTEM FAILURE”
1337
6.5.2.3 Activation of the Fluoroscopic Tube.
1338
1339
1340
1341
(1)
X-ray production in the fluoroscopic mode shall be controlled by a device which
THAT requires continuous pressure by the operator for the entire time of any
exposure, BUT MEANS MAY BE PROVIDED TO PERMIT COMPLETION OF
ANY SINGLE EXPOSURE OF A SERIES IN PROCESS.
1342
1343
(2)
When recording serial fluoroscopic images, the operator shall be able to
terminate the x-ray exposure(s) at any time.
6 - 41
Colorado Radiation Regulations, Proposed Revised Part 6
1344
May 12, 2017
6.5.2.4 FLUOROSCOPIC TIMER FOR UNITS MADE BEFORE JUNE 10, 2006.
1345
1346
(1)
MEANS SHALL BE PROVIDED TO PRESET THE CUMULATIVE
IRRADIATION TIME OF THE FLUOROSCOPIC X-RAY TUBE.
1347
1348
(2)
THE MAXIMUM CUMULATIVE TIME OF THE TIMING DEVICE SHALL NOT
EXCEED FIVE (5) MINUTES WITHOUT RESETTING.
1349
1350
1351
1352
(3)
A SIGNAL AUDIBLE TO THE OPERATOR SHALL INDICATE THE
COMPLETION OF ANY PRESET CUMULATIVE IRRADIATION TIME AND
SHALL CONTINUE TO SOUND WHILE X-RAYS ARE PRODUCED UNTIL THE
TIMING DEVICE IS RESET.
1353
1354
1355
1356
(4)
FLUOROSCOPIC EQUIPMENT MAY BE MODIFIED IN ACCORDANCE WITH
1020.30(q) TO COMPLY WITH THE REQUIREMENTS OF 1020.32(h)(2) AND,
IF MODIFIED, SHALL BEAR A LABEL INDICATING THE STATEMENT:
“MODIFIED TO COMPLY WITH 21 CFR 1020.32(h)(2).”
1357
1358
1359
1360
1361
1362
1363
6.5.2.5 FOR X-RAY CONTROLS MANUFACTURED ON OR AFTER JUNE 10, 2006, EACH
FLUOROSCOPIC TUBE SHALL BE PROVIDED WITH BOTH A DISPLAY AND
AUDIBLE SIGNAL:
(1)
THE DISPLAY, WHICH SHALL SHOW THE FLUOROSCOPIC IRRADIATION
TIME IN MINUTES AND TENTHS OF MINUTES AT THE FLUOROSCOPIST'S
WORKING POSITION INDEPENDENTLY OF THE AUDIBLE SIGNAL
REQUIRED BY 6.5.2.5(2), SHALL:
1364
1365
1366
(a)
DISPLAY CONTINUOUSLY WHEN THE X-RAY TUBE IS ACTIVATED
AND BE UPDATED AT LEAST ONCE EVERY 6 SECONDS
(0.1 MINUTE);
1367
1368
(b)
DISPLAY WITHIN 6 SECONDS (0.1 MINUTE) OF TERMINATION OF
AN EXPOSURE AND REMAIN DISPLAYED UNTIL RESET; AND
1369
1370
1371
(c)
BE PROVIDED WITH MEANS TO RESET THE DISPLAY TO ZERO
PRIOR TO THE BEGINNING OF A NEW EXAMINATION OR
PROCEDURE.
1372
(2)
A SIGNAL AUDIBLE TO THE FLUOROSCOPIST SHALL SOUND:
1373
1374
1375
(a)
FOR EACH PASSAGE OF 5 MINUTES OF FLUOROSCOPIC
IRRADIATION TIME DURING AN EXAMINATION OR PROCEDURE;
AND
1376
1377
(b)
UNTIL MANUALLY RESET OR, IF AUTOMATICALLY RESET, FOR
AT LEAST 2 SECONDS.
1378
1379
1380
6.5.2.6 INDICATION OF POTENTIAL AND CURRENT IS REQUIRED.
(1)
DURING FLUOROSCOPY AND CINEFLUOROGRAPHY THE KV AND THE
MA SHALL BE CONTINUOUSLY INDICATED.
6 - 42
Colorado Radiation Regulations, Proposed Revised Part 6
1381
May 12, 2017
6.5.2.7 LAST-IMAGE-HOLD (LIH) DISPLAY.
1382
1383
1384
1385
1386
(1)
FOR AN LIH IMAGE OBTAINED BY RETAINING PRE-TERMINATION
FLUOROSCOPIC IMAGES, IF THE NUMBER OF IMAGES AND METHOD OF
COMBINING IMAGES ARE SELECTABLE BY THE USER, THE SELECTION
SHALL BE INDICATED PRIOR TO INITIATION OF THE FLUOROSCOPIC
EXPOSURE.
1387
1388
1389
1390
1391
1392
(2)
FOR AN LIH IMAGE OBTAINED BY INITIATING A SEPARATE
RADIOGRAPHIC-LIKE EXPOSURE AT THE TERMINATION OF
FLUOROSCOPIC IMAGING, THE EXPOSURE SETTINGS FOR THE LIH
IMAGE SHALL BE SELECTABLE PRIOR TO THE FLUOROSCOPIC
EXPOSURE, AND THE COMBINATION SELECTED SHALL BE INDICATED
PRIOR TO INITIATION OF THE FLUOROSCOPIC EXPOSURE.
1393
1394
1395
1396
1397
1398
1399
(3)
MEANS SHALL BE PROVIDED TO CLEARLY INDICATE TO THE USER
WHETHER A DISPLAYED IMAGE IS THE LIH RADIOGRAPH OR
FLUOROSCOPY. DISPLAY OF THE LIH RADIOGRAPH SHALL BE
REPLACED BY THE FLUOROSCOPIC IMAGE CONCURRENTLY WITH REINITIATION OF FLUOROSCOPIC EXPOSURE, UNLESS SEPARATE
DISPLAYS ARE PROVIDED FOR THE LIH RADIOGRAPH AND
FLUOROSCOPIC IMAGES.
1400
1401
1402
1403
1404
(4)
THE PREDETERMINED OR SELECTABLE OPTIONS FOR PRODUCING THE
LIH RADIOGRAPH SHALL INCLUDE A DESCRIPTION OF ANY EXPOSURE
SETTINGS APPLICABLE FOR THE SELECTED OPTION AND THE IMPACT
OF THE SELECTABLE OPTIONS ON IMAGE CHARACTERISTICS AND THE
MAGNITUDE OF RADIATION EMISSIONS.
1405
1406
1407
6.5.2.8 THE FOLLOWING REQUIREMENTS APPLY TO DISPLAYS OF THE VALUES OF
AKR AND CUMULATIVE AIR KERMA FOR EACH X-RAY TUBE USED DURING AN
EXAMINATION OR PROCEDURE:
1408
1409
1410
(1)
FLUOROSCOPIC EQUIPMENT MANUFACTURED ON OR AFTER JUNE 10,
2006, SHALL DISPLAY AT THE FLUOROSCOPIST'S WORKING POSITION
THE AKR AND CUMULATIVE AIR KERMA.
1411
1412
1413
1414
(2)
WHEN THE X-RAY TUBE IS ACTIVATED AND THE NUMBER OF IMAGES
PRODUCED PER UNIT TIME IS GREATER THAN SIX IMAGES PER
SECOND, THE AKR IN mGy/MIN SHALL BE CONTINUOUSLY DISPLAYED
AND UPDATED AT LEAST ONCE EVERY SECOND.
1415
1416
1417
1418
(3)
THE CUMULATIVE AIR KERMA IN UNITS OF MGY SHALL BE DISPLAYED
EITHER WITHIN 5 SECONDS OF TERMINATION OF AN EXPOSURE OR
DISPLAYED CONTINUOUSLY AND UPDATED AT LEAST ONCE EVERY 5
SECONDS.
1419
1420
(4)
THE DISPLAY OF THE AKR SHALL BE CLEARLY DISTINGUISHABLE FROM
THE DISPLAY OF THE CUMULATIVE AIR KERMA.
6 - 43
Colorado Radiation Regulations, Proposed Revised Part 6
1421
1422
1423
1424
1425
1426
(5)
May 12, 2017
THE AKR AND CUMULATIVE AIR KERMA SHALL REPRESENT THE VALUE
FOR CONDITIONS OF FREE-IN-AIR IRRADIATION AT ONE OF THE
FOLLOWING REFERENCE LOCATIONS SPECIFIED ACCORDING TO THE
TYPE OF FLUOROSCOPE. THE REFERENCE LOCATION SHALL BE
IDENTIFIED AND DESCRIBED SPECIFICALLY IN THE INFORMATION
PROVIDED TO USERS AS REQUIRED BY 2.7.1.3.
1427
1428
1429
1430
1431
(a)
FOR FLUOROSCOPES WITH X-RAY SOURCE BELOW THE X-RAY
TABLE, X-RAY SOURCE ABOVE THE TABLE, OR OF LATERAL
TYPE, THE REFERENCE LOCATIONS SHALL BE THE RESPECTIVE
LOCATIONS SPECIFIED IN 6.5.4.1 (1), 6.5.4.1 (2), OR 6.5.4.1 (4) FOR
MEASURING COMPLIANCE WITH AIR-KERMA RATE LIMITS.
1432
1433
1434
1435
1436
1437
(b)
FOR C-ARM FLUOROSCOPES, THE REFERENCE LOCATION
SHALL BE 15 CM FROM THE ISOCENTER TOWARD THE X-RAY
SOURCE ALONG THE BEAM AXIS. ALTERNATIVELY, THE
REFERENCE LOCATION SHALL BE AT A POINT SPECIFIED BY THE
MANUFACTURER TO REPRESENT THE LOCATION OF THE
INTERSECTION OF THE X-RAY BEAM WITH THE PATIENT'S SKIN.
1438
1439
1440
(6)
CONSISTENT WITH 6.5.2.8(1), A METHOD SHALL BE PROVIDED TO RESET
TO ZERO THE DISPLAY OF CUMULATIVE AIR KERMA PRIOR TO THE
COMMENCEMENT OF A NEW EXAMINATION OR PROCEDURE.
1441
1442
1443
1444
1445
1446
(7)
THE DISPLAYED AKR AND CUMULATIVE AIR KERMA SHALL NOT
DEVIATE FROM THE ACTUAL VALUES BY MORE THAN +/-35 PERCENT
OVER THE RANGE OF 6 mGy/MIN AND 100 mGy TO THE MAXIMUM
INDICATION OF AKR AND CUMULATIVE AIR KERMA, RESPECTIVELY.
COMPLIANCE SHALL BE DETERMINED WITH AN IRRADIATION TIME
GREATER THAN 3 SECONDS.
1447
1448
(8)
AKR AND AIR KERMA DISPLAY CALIBRATION SHALL BE VERIFIED
ANNUALLY BY A REGISTERED MEDICAL PHYSICIST.
1449
1450
1451
1452
1453
1454
1455
1456
1457
1458
6.5.2.9 SPOT IMAGER EXPOSURE REPRODUCIBILITY.
(1)
FLUOROSCOPIC SYSTEMS EQUIPPED WITH SPOT IMAGE MODE SHALL
MEET THE FOLLOWING EXPOSURE REPRODUCIBILITY REQUIREMENTS
WHEN OPERATING IN THE SPOT IMAGE MODE:
(a)
WHEN ALL EXPOSURE SETTINGS ARE HELD CONSTANT,
INCLUDING CONTROL PANEL SELECTIONS ASSOCIATED WITH
AN AUTOMATIC EXPOSURE CONTROL SYSTEM, THE
COEFFICIENT OF VARIATION OF AIR KERMA FOR BOTH MANUAL
AND AUTOMATIC EXPOSURE CONTROL SYSTEMS SHALL NOT
EXCEED 0.05.
6 - 44
Colorado Radiation Regulations, Proposed Revised Part 6
1459
6.5.2.10
1460
1461
1462
1463
1464
1465
1466
1467
1468
1469
1470
1471
(1)
6.5.3
May 12, 2017
BARRIER TRANSMITTED RADIATION RATE LIMITS.
THE AKR DUE TO TRANSMISSION THROUGH THE PRIMARY PROTECTIVE
BARRIER WITH THE ATTENUATION BLOCK IN THE USEFUL BEAM,
COMBINED WITH RADIATION FROM THE IMAGE INTENSIFIER, IF
PROVIDED, SHALL NOT EXCEED 0.334*10-6 OF THE ENTRANCE AKR
(ONE-THIRD OF ONE MILLIONTH OF THE ENTRANCE AKR) AT 10 CM
FROM ANY ACCESSIBLE SURFACE (THAT CAN BE EASILY OR
ACCIDENTALLY TOUCHED BY AN INDIVIDUAL WITHOUT THE USE OF A
TOOL) OF THE FLUOROSCOPIC IMAGING ASSEMBLY BEYOND THE
PLANE OF THE IMAGE RECEPTOR.
Exposure Rate Limits.RADIATION EXPOSURE CONTROL DEVICES AND OPERATION.
6.5.3.1 Entrance Exposure Rate AIR KERMA RATE (AKR) Limits for Fluoroscopic Equipment
Manufactured Before May 19, 1995.
1472
(1)
EQUIPMENT WITHOUT AERC IS NOT PERMITTED.
1473
1474
1475
1476
1477
1478
(2)6.5.3.1.1
Equipment with Automatic Exposure Rate Control (AERC). Fluoroscopic
equipment that is provided with AERC shall not be operable at any combination
of tube potential and current that will result in an exposure rate in excess of 2.58
× 10-3 coulomb per kilogram (C/kg) 88 mGy per minute [10 roentgens per minute
(10 R/min)] at the point where the center of the useful beam enters the patient
MEASURED PER 6.5.4:
1479
1480
1481
1482
1483
1484
(a)
E, except:6.5.3.1.1.1Dduring recording of fluoroscopic images WHEN
THE RECORDED IMAGES ARE INTENDED FOR SUBSEQUENT
INTERPRETATION BY A PHYSICIAN, CHIROPRACTOR,
PODIATRIST OR VETERINARIAN WHO HAS A CURRENT ACTIVE
STATE OF COLORADO LICENSE TO PRACTICE THE HEALING
ARTS. or;6.5.3.1.1.2
1485
(b)
EXCEPT wWhen an optional high-level control is provided.
1486
1487
1488
1489
1490
1491
(i)
When so provided,UNLESS THE HIGH-LEVEL CONTROL IS
ACTIVATED, the equipment shall not be operable at any
combination of tube potential and current that will result in an
exposure rate in excess of 1.29 m-3 C/kg 44 mGy per minute
(5 R/min) at the point where the center of the useful beam enters
the patient, unless the high-level control is activated.
1492
1493
1494
(ii)
Special means of activation of high-level controls shall be
operable only when continuous manual activation is provided by
the operator.
1495
1496
(iii)
A continuous signal audible to the operator shall indicate that the
high-level control is being employed.
1497
1498
1499
1500
1501
6.5.3.1.2Equipment Without AERC (Manual Mode).
Fluoroscopic equipment that is not provided with AERC shall not be operable at
any combination of tube potential and current that will result in an exposure rate
in excess of 2.58 × 10-3 coulomb per kilogram (C/kg) per minute (10 R/min) at the
point where the center of the useful beam enters the patient, except:
6 - 45
Colorado Radiation Regulations, Proposed Revised Part 6
1502
1503
1504
1505
1506
1507
May 12, 2017
6.5.3.1.2.1during recording of fluoroscopic images, or; 6.5.3.1.2.1 when an
optional high-level control is activated. Special means of activation of high-level
controls shall be required. The high-level control shall be operable only when
continuous manual activation is provided by the operator. A continuous signal
audible to the operator shall indicate that the high-level control is being
employed.
1508
6.5.3.1.3 Equipment with Both an AERC Mode and a Manual Mode.
1509
1510
1511
1512
1513
(3)
Fluoroscopic equipment that is provided with both an AERC mode and a manual
mode shall not be operable at any combination of tube potential and current that
will result in an exposure rate in excess of 2.58 × 10-3 coulomb per kilogram
(C/kg) 88 mGy per minute (10 R/min) at the point where the center of the useful
beam enters the patient MEASURED PER 6.5.4, except:
1514
1515
1516
1517
1518
1519
6.5.3.1.3.1(a) EXCEPT Dduring recording of fluoroscopic images WHEN THE
RECORDED IMAGES ARE INTENDED FOR SUBSEQUENT
INTERPRETATION BY A PHYSICIAN, CHIROPRACTOR,
PODIATRIST OR VETERINARIAN WHO HAS A CURRENT ACTIVE
STATE OF COLORADO LICENSE TO PRACTICE THE HEALING
ARTS; or
1520
1521
6.5.3.1.3.1(b) EXCEPT Wwhen the mode or modes have an optional high-level
control.
1522
1523
1524
1525
1526
1527
1528
1529
(i)
UNLESS THE HIGH-LEVEL CONTROL IS ACTIVATED, in
which case that mode or modes shall not be operable at any
combination of tube potential and current that will result in an
entrance exposure rate AKR in excess of 1.293 m × 10-3 C/kg
per minute (5 R/min) at the point where the center of the useful
beam enters the patient, unless the high-level control is
activated6.5.3.1(1)(a). 6.5.3.1(2)(a), or 6.5.3.1(3)(a) as
measured per 6.5.4.
1530
1531
(ii)
Special means of activation of high-level controls shall be
required.
1532
1533
(iii)
The high-level control shall be operable only when continuous
manual activation is provided by the operator.
1534
1535
(iv)
A continuous signal audible to the operator shall indicate that the
high-level is being employed.
1536
1537
1538
1539
6.5.3.1.3.1(4) Fluoroscopic units which THAT have the high-level control activated and
an entrance AKR exposure rate exceeding 5.16 × 10-3 C/kg 0.1 Gy per minute
(2011 R/min) shall be posted with the measured maximum entrance AKR
exposure rate, ON A SIGN THAT:
1540
(a)
IS visible at the operator's position.;
1541
1542
1543
1544
1545
(b)
STATES THAT “THE SYSTEM MAY EXCEED AN ENTRANCE AKR
EXCEEDING 0.1 GY PER MINUTE (MORE THAN 10 R/MIN)”.Such sign
will note that the entrance exposure rate of fluoroscopic equipment
manufactured after May 19, 1995, which have the high level control
activated, are limited to 5.16 × 10-3 C/kg per minute (20 R/min).
6 - 46
Colorado Radiation Regulations, Proposed Revised Part 6
1546
1547
1548
1549
1550
1551
May 12, 2017
6.5.3.2 Entrance Exposure Rate AKR Limits For Fluoroscopic Equipment Manufactured On and
After May 19, 1995.
6.5.3.2.(1)
Fluoroscopic equipment operable at any combination of tube potential
and current that results in an AKR greater than 1.29 m× 10-3 C/kg 44 mGy per
minute (5 R/min) at the point where the center of the useful beam enters the
patient shall be equipped with AERC.
1552
1553
(a)
Provision for mManual selection of technique factorsEXPOSURE
SETTINGS may ALSO be provided.
1554
1555
1556
1557
6.5.3.2.(2)
Fluoroscopic equipment shall not be operable at any combination of tube
potential and current that will result in an AKR in excess of 2.586 × 10-3 C/kg
88 mGy per minute (10 R/min) at the point where the center of the useful beam
enters the patient MEASURED PER 6.5.4.
1558
1559
1560
1561
1562
1563
1564
1565
(3)
FOR EQUIPMENT MANUFACTURED PRIOR TO JUNE 10, 2006, except:ION
TO 6.5.3.2(2) IS ALLOWED .2.1Dduring the recording of images from an x-ray
image-intensifier tube using photographic film or a video camera when the x-ray
source is operated in a pulsed mode WHEN THE RECORDED IMAGES ARE
INTENDED FOR SUBSEQUENT INTERPRETATION BY A PHYSICIAN,
CHIROPRACTOR, PODIATRIST OR VETERINARIAN WHO HAS A CURRENT
ACTIVE STATE OF COLORADO LICENSE TO PRACTICE THE HEALING
ARTS; or 6.5.3.2.2.2
1566
1567
1568
1569
1570
(4)
FOR EQUIPMENT MANUFACTURED ON OR AFTER JUNE 10, 2006,
EXCEPTION TO 6.5.3.2(2) IS ALLOWED DURING THE RECORDING OF
IMAGES FROM THE FLUOROSCOPIC IMAGE RECEPTOR FOR THE
PURPOSE OF PROVIDING THE USER WITH A RECORDED IMAGE(S)
AFTER TERMINATION OF THE EXPOSURE.
1571
1572
1573
1574
1575
(a)
(5)
SUCH RECORDING DOES NOT INCLUDE IMAGES RESULTING
FROM A LAST-IMAGE-HOLD FEATURE THAT ARE NOT
RECORDED.
EXCEPTION TO 6.5.3.2(2) IS ALLOWED wWhen the high-level control is
activated.
1576
1577
1578
1579
(a)
, tThe equipment shall not be operable at any combination of tube
potential and current that will result in an exposure rate in excess of 5.16
× 10-3 C/kg 176 mGy per minute (20 R/min) at the point where the center
of the useful beam enters the patient.
1580
1581
1582
(b)
Special means of activation of high-level controls shall be required. The
high-level control shall only be operable when continuous manual
activation is provided by the operator.
1583
1584
(c)
A continuous signal audible to the operator shall indicate that the
high-level control is being employed.
1585
1586
6.5.3.3 A mini-c-arm x-ray system shall have an exposure rate less than or equal to
1.29 × 10-3 C/kg 88 mGy (10 R) per minute at the exit port.
6 - 47
Colorado Radiation Regulations, Proposed Revised Part 6
1587
May 12, 2017
6.5.3.4 CONTROL OF SCATTERED RADIATION.
1588
1589
1590
1591
1592
(1)
1593
1594
CONVENTIONAL FLUOROSCOPIC TABLE DESIGNS WHEN COMBINED
WITH PROCEDURES UTILIZED SHALL BE SUCH THAT NO UNPROTECTED
PART OF ANY STAFF OR ANCILLARY INDIVIDUAL'S BODY SHALL BE
EXPOSED TO UNATTENUATED SCATTERED RADIATION THAT
ORIGINATES FROM UNDER THE TABLE.
(a)
1595
1596
1597
1598
1599
(2)
THE ATTENUATION REQUIRED SHALL BE NOT LESS THAN
0.25 MILLIMETER LEAD EQUIVALENT.
EQUIPMENT CONFIGURATION WHEN COMBINED WITH PROCEDURES
SHALL BE SUCH THAT NO PORTION OF ANY STAFF OR ANCILLARY
INDIVIDUAL'S BODY, EXCEPT THE EXTREMITIES OR HEAD, SHALL BE
EXPOSED TO UNATTENUATED SCATTERED RADIATION UNLESS THAT
INDIVIDUAL:
1600
1601
(a)
IS AT LEAST 2M (MORE THAN 6 FEET) FROM THE CENTER OF THE
USEFUL BEAM, OR
1602
1603
1604
1605
1606
(b)
THE RADIATION HAS PASSED THROUGH NOT LESS THAN
0.25 MILLIMETER LEAD EQUIVALENT MATERIAL INCLUDING, BUT
NOT LIMITED TO, DRAPES, OR SELF-SUPPORTING CURTAINS, IN
ADDITION TO ANY LEAD EQUIVALENCY PROVIDED BY THE
PROTECTIVE APRON REFERRED TO IN 6.3.3.5.
1607
1608
1609
1610
1611
1612
1613
(3)
1614
1615
1616
1617
1618
EXCEPTION TO 6.5.3.4(2) IS ALLOWED IF THE FACILITY HAS A WRITTEN
POLICY THAT APPLIES TO WHEN THE USE OF DRAPES OR
SELF-SUPPORTING CURTAINS IS CONTRA-INDICATED AND THE
DIAGNOSIS MIGHT BE COMPROMISED, SUCH AS WHERE A STERILE
FIELD WILL NOT PERMIT THE USE OF THE NORMAL PROTECTIVE
BARRIERS. IF THE USE OF PRE-FITTED STERILIZED COVERS FOR THE
BARRIERS IS PRACTICAL, EXEMPTION IS NOT APPROPRIATE.
6.5.3.5 OVERHEAD FLUOROSCOPY SHALL NOT BE USED AS A POSITIONING TOOL FOR
GENERAL PURPOSE RADIOGRAPHIC EXAMINATIONS.
6.5.4
EACH FLUOROSCOPIC X-RAY SYSTEM SHALL FULFILL THE FOLLOWING
MEASUREMENT AND MAINTENANCE REQUIREMENTS.
6.5.4.13.3
Compliance with the requirements of RH 6.5.3 shall be determined as follows:
1619
1620
6.5.3.3.(1)
If the source is below the table, exposure rate AKR shall be measured
one centimeter above the tabletop or cradle.
1621
1622
1623
1624
6.5.3.3.(2)
If the source is above the table, the exposure rate AKR shall be
measured at 30 cmentimeters above the tabletop with the end of the beamlimiting device or spacer positioned as closely as possible to the point of
measurement.
6 - 48
Colorado Radiation Regulations, Proposed Revised Part 6
1625
1626
1627
1628
1629
1630
1631
6.5.3.3.(3)
All CFOR A c-arm TYPE OF fluoroscopes, both stationary and mobile,
shall meet the entrance exposure rate limits in RH 6.5.3.1.1, 6.5.3.1.2, and
6.5.3.1.3, THE AKR SHALL BE MEASURED AT 30 cmentimeters from the input
surface of the fluoroscopic imaging assembly, with the source positioned at any
available SID, provided that the end of the spacer assembly or beam-limiting
device is not closer than 30 cmentimeters from the input surface of the
fluoroscopic imaging assembly.
1632
1633
1634
1635
1636
1637
1638
1639
1640
1641
(a)
FOR A C-ARM TYPE OF FLUOROSCOPE HAVING AN SID LESS
THAN 45 CM, THE AKR SHALL BE MEASURED AT THE MINIMUM
SSD, OR CORRECTED TO THE MINIMUM SSD USING THE INVERSE
SQUARE LAW.
6.5.3.3.(4)
All EACH lateral-type fluoroscopes, both EITHER stationary and OR
mobile, AKR shall meet the entrance exposure rate limits in RH 6.5.3.1.(1),
6.5.3.1.(2), and 6.5.3.1.(3), BE measured at a point 15 cmentimeters from the
centerline of the table (ISOCENTER) and in the direction of the x-ray source with
the end of the beam-limiting device or spacer positioned as closely as possible to
the point of measurement.
1642
1643
1644
1645
1646
May 12, 2017
(a)
If the tabletop is movable, it shall be positioned as closely as possible to
the lateral x-ray source, with the end of the beam-limiting device or
spacer no closer than 15 cmentimeters to the centerline of the table.
6.5.3.3.(5)
Periodic measurement of entrance exposure rateAKR shall be
performed as follows:
1647
1648
6.5.3.3.5.1(a) Such measurements shall be made annually or after any
maintenance of the system which THAT might affect the exposure rate.
1649
1650
6.5.3.3.5.1(b) Conditions of periodic measurement of entrance exposure rate
AKR are as follows:
1651
1652
6.5.3.3.5.2.1(i) The measurement shall be made under the conditions
that satisfy the requirements of RH 6.5.4.13.3;
1653
1654
6.5.3.3.5.2.2(ii) The kVp shall be the maximum kVp which THAT can be
produced by the x-ray system;
1655
1656
1657
1658
1659
6.5.3.3.5.2.3(iii) The x-ray system(s) that incorporates automatic
exposure rate control shall have the beam collimated to the size
of the detector and have sufficient material placed in the useful
beam to intercept the entire beam so that output of the machine
is a maximum for the x-ray system; and
1660
1661
1662
6.5.3.3.5.2.4(iv) X-ray system(s) that do not incorporate an automatic
exposure rate control shall utilize the maximum milliamperage
typical of the clinical use of the x-ray system.2
1663
1664
1665
1666
1667
2
Materials should be placed in the useful beam when
conducting these periodic measurements to protect the imaging system.
(6)
FOR OTHER FLUOROSCOPIC SYSTEMS NOT DESCRIBED ABOVE, THE
AKR SHALL BE MEASURED AT THE REFERENCE POINT SPECIFIED BY
THE MANUFACTURER FOR MAXIMUM DOSE RATE MEASUREMENTS.
6 - 49
Colorado Radiation Regulations, Proposed Revised Part 6
1668
1669
1670
1671
1672
1673
1674
1675
6.5.4
May 12, 2017
Barrier Transmitted Radiation Rate Limits.
6.5.4.1 The exposure rate due to transmission through the primary protective barrier with
the attenuation block in the useful beam, combined with radiation from the image
intensifier, if provided, shall not exceed 0.516 μC/kg per hour (2 milliroentgen) at
10 centimeters from any accessible surface of the fluoroscopic imaging assembly
beyond the plane of the image receptor for each roentgen per minute of entrance
exposure rate.
6.5.4.2 SOURCE-SKIN DISTANCE (SSD) SHALL NOT BE LESS THAN:
1676
(1)
38 CM ON STATIONARY FLUOROSCOPES;
1677
1678
1679
1680
(2)
30 CM ON ALL MOBILE AND PORTABLE FLUOROSCOPES, INCLUDING
C-ARM FLUOROSCOPES HAVING A MAXIMUM SOURCE-IMAGE
RECEPTOR DISTANCE OF GREATER THAN OR EQUAL TO 45 CM AND OARM FLUOROSCOPES;
1681
1682
(3)
20 CM FOR MOBILE FLUOROSCOPES USED FOR SPECIFIC SURGICAL
APPLICATION;
1683
1684
1685
1686
1687
1688
1689
(a)
(4)
THE WRITTEN SAFETY PROCEDURES MUST PROVIDE
PRECAUTIONARY MEASURES TO BE ADHERED TO DURING THE
USE OF THESE SYSTEMS;
19 CM FOR STATIONARY, MOBILE, OR PORTABLE MINI-C-ARM
FLUOROSCOPIC SYSTEMS HAVING A MAXIMUM SOURCE-IMAGE
RECEPTOR DISTANCE OF LESS THAN 45 CM MANUFACTURED ON OR
AFTER JUNE 10, 2006;
1690
(a)
SUCH SYSTEMS SHALL BE LABELED FOR EXTREMITY USE ONLY;
1691
1692
1693
1694
1695
1696
(b)
IN ADDITION, FOR THOSE SYSTEMS INTENDED FOR SPECIFIC
SURGICAL APPLICATION THAT WOULD BE PROHIBITED AT THE
SOURCE-SKIN DISTANCES SPECIFIED IN THIS PARAGRAPH,
PROVISIONS MAY BE MADE FOR OPERATION AT SHORTER
SOURCE-SKIN DISTANCES BUT IN NO CASE LESS THAN 10 CM;
AND
1697
1698
1699
(c)
THE WRITTEN SAFETY PROCEDURES MUST PROVIDE
PRECAUTIONARY MEASURES TO BE ADHERED TO DURING THE
USE OF THESE SYSTEMS; AND
1700
1701
(5)
THE DISTANCE IN CM RECOMMENDED BY THE MANUFACTURER FOR
EQUIPMENT NOT SPECIFIED IN 6.5.4.2(1) THROUGH 6.5.4.2(4).
6 - 50
Colorado Radiation Regulations, Proposed Revised Part 6
1702
6.5.4.23
May 12, 2017
Measuring Compliance of Barrier Transmission.
1703
1704
1705
1706
6.5.4.2.(1)
The exposure rate due to transmission through the primary protective
barrier combined with radiation from the image intensifier shall be determined by
measurements averaged over an area of 100 square cmentimeters with no linear
dimension greater than 20 cmentimeters.
1707
1708
1709
6.5.4.2.(2)
If the source is below the tabletop, the measurement shall be made with
the input surface of the fluoroscopic imaging assembly positioned 30
cmentimeters above the tabletop.
1710
1711
1712
1713
6.5.4.2.(3)
If the source is above the tabletop and the SID is variable, the
measurement shall be made with the end of the beam-limiting device or spacer
as close to the tabletop as it can be placed, provided that it shall not be closer
than 30 cmentimeters.
1714
1715
6.5.4.2.(4)
Movable grids and compression devices shall be removed from the
useful beam during the measurement.
1716
1717
1718
1719
6.5.4.2.(5)
The attenuation block shall be positioned in the useful beam
10 cmentimeters from the point of measurement of entrance exposure rate AKR
and between this point and the input surface of the fluoroscopic imaging
assembly.
1720
6.5.4.4 EACH REGISTERED FACILITY SHALL MAINTAIN RECORDS OF:
1721
1722
(1)
CUMULATIVE FLUOROSCOPIC EXPOSURE TIME AND/OR OTHER PATIENT
DOSE ESTIMATION DATA (FOR EXAMPLE, KERMA-AREA-PRODUCT); AND
1723
1724
(2)
THE TYPE AND DATE OF EACH EXAMINATION, PATIENT IDENTIFICATION,
SYSTEM USED, AND OPERATOR'S NAME.
1725
1726
6.5.5
Indication of Potential and Current. During fluoroscopy and cinefluorography the kV and the mA
shall be continuously indicated on certified units.
1727
6.5.6
Source-to-Skin Distance.
1728
The SSD shall not be less than:
1729
6.5.6.1 38 centimeters on stationary fluoroscopes installed after September 1, 1992,
1730
1731
6.5.6.2 35.5 centimeters on stationary fluoroscopes which were in operation on or before
September 1, 1992,
1732
6.5.6.3 30 centimeters on all mobile fluoroscopes;
1733
1734
1735
6.5.6.4 20 centimeters for fluoroscopes used for specific surgical application. The written safety
procedures must provide precautionary measures to be adhered to during the use of
these systems; and
1736
6.5.6.5 9 centimeters for mini c-arms.
6 - 51
Colorado Radiation Regulations, Proposed Revised Part 6
1737
6.5.7
May 12, 2017
Fluoroscopic Timer.
1738
1739
1740
6.5.7.1 Means shall be provided to preset the cumulative on-time of the fluoroscopic x-ray tube.
The maximum cumulative time of the timing device shall not exceed five (5) minutes
without resetting.
1741
1742
1743
6.5.7.2 A signal to the operator shall indicate the completion of any preset cumulative on-time.
Such signal shall continue to sound while x-rays are produced until the timing device is
reset
1744
6.5.8
Control of Scattered Radiation.
1745
1746
1747
1748
6.5.8.1 Conventional fluoroscopic table designs when combined with procedures utilized shall be
such that no unprotected part of any staff or ancillary individual's body shall be exposed
to unattenuated scattered radiation which originates from under the table. The
attenuation required shall be not less than 0.25 millimeter lead equivalent.
1749
1750
1751
1752
6.5.8.2 Equipment configuration when combined with procedures shall be such that no portion of
any staff or ancillary individual's body, except the extremities or head, shall be exposed
to the unattenuated scattered radiation emanating from above the tabletop unless that
individual:
1753
6.5.8.2.1
is at least 120 centimeters from the center of the useful beam, or
1754
1755
1756
1757
6.5.8.2.2
the radiation has passed through not less than 0.25 millimeter lead
equivalent material including, but not limited to, drapes, or self-supporting
curtains, in addition to any lead equivalency provided by the protective apron
referred to in RH 6.3.1.1.5.1.
1758
1759
1760
6.5.8.3 The Department may grant exemptions to RH 6.5.8.2 where a sterile field will not permit
the use of the normal protective barriers. Where the use of pre-fitted sterilized covers for
the barriers is practical, the Department shall not permit such exemption.
1761
1762
6.5.8.4 The Department may grant exemptions to RH 6.5.8.2 when the use of drapes or
self-supporting curtains are contra indicated and the diagnosis could be compromised.
6 - 52
Colorado Radiation Regulations, Proposed Revised Part 6
1763
1764
6.5.5
1765
1766
May 12, 2017
EACH FLUOROSCOPIC X-RAY SYSTEM SHALL HAVE WRITTEN QUALITY CONTROL AND
QUALITY ASSURANCE PROCEDURES.
6.6.5.1 THE QUALITY CONTROL AND QUALITY ASSURANCE PROCEDURES SHALL BE
CONSISTENT WITH 6.3.5 AND SHALL FOLLOW:
1767
(1)
SPECIFICATIONS OF THE MANUFACTURER; AND
1768
(2)
SPECIFICATIONS OF A REGISTERED MEDICAL PHYSICIST; AND/OR
1769
1770
(3)
STANDARDS OF AN APPROPRIATE NATIONALLY RECOGNIZED
ORGANIZATION.
1771
1772
1773
1774
1775
1776
1777
1778
1779
1780
6.5.5.2 SYSTEM QUALITY ASSURANCE SHALL BE EVALUATED PERIODICALLY BY A
REGISTERED MEDICAL PHYSICIST, IN ACCORDANCE WITH STANDARDS AND
PROTOCOLS PUBLISHED BY NATIONALLY RECOGNIZED ORGANIZATIONS
(FOR EXAMPLE, AAPM REPORT 4 AND AAPM REPORT 74), UNLESS THE
REGISTERED MEDICAL PHYSICIST DETERMINES THAT A PARTICULAR
RECOMMENDATION OF SUCH REPORT IS NOT WARRANTED FOR THE CLINICAL
TASKS FOR WHICH THE EQUIPMENT WILL BE USED.
6.5.6
Radiation Therapy Simulation Systems.
6.5.6.1 Radiation therapy simulation systems shall be exempt from all the requirements of
RH 6.5.2.21, 6.5.3, 6.5.2.4, and 6.5.2.57, 6.5.2.10, 6.5.3.1 and 6.5.3.2, provided that:
1781
1782
1783
1784
6.5.9.(1)
suEAch system Is are designed and used in such a manner that no
individual other than the patient, required staff and ancillary personnel are IS in
the x-ray room during ANY periods of time when the system is producing x-rays;
and
1785
1786
1787
1788
6.5.9.(2)
SEACH systems which THAT doES not meet the requirements of RH
6.5.2.4 OR 6.5.2.57 are IS provided with a means of indicating the cumulative
time that an individual patient has been exposed to x-rays. Procedures shall
require in such cases that the timer be reset between examinations.
1789
1790
(3)
STAFF AND ANCILLARY PERSONNEL SHALL BE PROTECTED IN
ACCORDANCE WITH 6.3.3.5, 6.3.3.6, 6.3.3.7 AND 6.3.3.8.
6 - 53
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
1791
1792
SPECIAL REQUIREMENTS FOR OTHER GENERAL PURPOSE DIAGNOSTIC X-RAY IMAGING
SYSTEMS
1793
1794
1795
RH 6.6 Radiographic SAFE USE OF A GENERAL PURPOSE X-RAY IMAGING SYSTEM
(Other Than DENTAL, Fluoroscopic, Dental Intraoral, Veterinary, Computed Tomography, or
Mammography) X-Ray Systems.
1796
6.6.1
1797
1798
1799
ADMINISTRATIVE CONTROLS.
6.6.1.1 IN ADDITION TO THE PROVISIONS OF 6.3 AND 6.4, THE SPECIAL REQUIREMENTS
OF 6.6 APPLY TO ALL X-RAY IMAGING EQUIPMENT AND ASSOCIATED
FACILITIES OTHER THAN:
1800
(1)
FLUOROSCOPY (IN 6.5);
1801
1802
(2)
DENTAL (IN 6.7, WITH CROSS-REFERENCE IN 6.7.2.1 TO 6.6.2 AND IN
6.7.3.1 TO 6.6.3);
1803
(3)
VETERINARY (IN 6.8);
1804
(4)
COMPUTED TOMOGRAPHY (IN 6.9);
1805
(5)
MAMMOGRAPHY (IN 6.10).
1806
1807
1808
1809
1810
1811
1812
1813
1814
1815
1816
1817
1818
1819
6.6.1.2 EACH INDIVIDUAL WHO OPERATES AN X-RAY IMAGING SYSTEM SUBJECT TO
6.6 SHALL MEET THE APPLICABLE ADEQUATE RADIATION SAFETY TRAINING
AND EXPERIENCE REQUIREMENTS OF 2.6.1.
6.6.2
FOR EACH STATIONARY, MOBILE AND/OR PORTABLE X-RAY IMAGING SYSTEM
SUBJECT TO 6.6, Beam Limitation.Tthe useful beam shall be limited to the area of clinical
interest.
6.6.21.1.1
General Purpose Stationary and Mobile X-Ray Systems.6.6.1.1.1There shall be
provided aA means for stepless adjustment of the size of the x-ray field SHALL BE
PROVIDED.
(1)
6.6.21.1.2
FOR CERTIFIED SYSTEMS, STEPLESS ADJUSTMENT OF THE SIZE OF
THE X-RAY FIELD SHALL BE PROVIDED SUCH THAT THE MINIMUM FIELD
SIZE AT AN SID OF 100 CM SHALL BE EQUAL TO OR LESS THAN 5 CM BY
5 CM.
A method shall be provided for visually defining the perimeter of the x-ray field.
1820
1821
1822
1823
1824
(1)
The total misalignment of the edges of the visually defined field with the
respective edges of the x-ray field along either the length or width of the visually
defined field shall not exceed two (2) percent of the distance from the source to
the center of the visually defined field when the surface upon which THAT it
appears is perpendicular to the axis of the x-ray beam.
1825
1826
1827
1828
(2)
A LIGHT LOCALIZER USED TO DEFINE THE X-RAY FIELD OF A CERTIFIED
SYSTEM SHALL PROVIDE ILLUMINATION SUFFICIENT TO PERMIT VISUAL
DETERMINATION OF THE X-RAY FIELD UNDER AMBIENT LIGHT
CONDITIONS OF UP TO 500 LUX (46 FOOT CANDLES).
6 - 54
Colorado Radiation Regulations, Proposed Revised Part 6
1829
1830
1831
May 12, 2017
6.6.21.1.3
The Department may grant an exemption on non-certified x-ray systems to RH
6.6.2.1.1.1 and 6.6.21.1.2 provided the registrant makes a written application for such
exemption and in that application DEMONSTRATES THAT:
1832
1833
6.6.1.1.3.1(a) demonstrates iIt is impractical to comply with RH 6.6.2.1.1.1 and
6.6.21.1.2 ; and
1834
1835
6.6.1.1.3.2(b) tThe purpose of RH 6.6.2.1.1.1 and 6.6.21.1.2 will be met by
other methods.
1836
1837
1838
6.6.2.41.2
Additional BEAM LIMITATION Requirements for EACH Stationary General
Purpose X-rRay Systems. In addition to the requirements of RH 6.6.1.1, stationary
general purpose x-ray systems, shall meet the following requirements:
1839
6.6.1.2.(1)
A method shall be provided to:
1840
1841
(a)
iIndicate when the axis of the x-ray beam is perpendicular to the plane of
the image receptor;, to a
1842
1843
(b)
Align the center of the x-ray field with respect to the center of the image
receptor to within two (2) percent of the SID;, and to i
1844
(c)
Indicate the SID to within two (2) percent;
1845
1846
6.6.1.2.(2)
The beam-limiting device shall indicate numerically the field size in the
plane of the image receptor to which it is adjusted; and
1847
1848
1849
1850
1851
1852
6.6.1.2.(3)
Indication of field size dimensions and SID's shall be specified in inches
and/or centimeters, and shall be such that aperture adjustments result in x-ray
field dimensions in the plane of the image receptor which THAT correspond to
those indicated by the beam-limiting device to within two (2) percent of the SID
when the beam axis is indicated to be perpendicular to the plane of the image
receptor.
1853
1854
6.6.2.51.3
BEAM LIMITATION REQUIREMENTS FOR EACH X-Ray Systems Designed for
One Image Receptor Size.
1855
1856
1857
1858
1859
(1)
Radiographic equipment designed for only one image receptor size at a fixed SID
shall be provided with means to limit the field at the plane of the image receptor
to dimensions no greater than those of the image receptor, and to align the
center of the x-ray field with the center of the image receptor to within two (2)
percent of the SID;, or
1860
1861
1862
1863
(2)
RADIOGRAPHIC EQUIPMENT DESIGNED FOR ONLY ONE IMAGE
RECEPTOR SIZE AT A FIXED SID shall be provided with means to both size
and align the x-ray field such that the x-ray field at the plane of the image
receptor does not extend beyond any edge of the image receptor.
6 - 55
Colorado Radiation Regulations, Proposed Revised Part 6
1864
1865
May 12, 2017
6.6.2.61.4
BEAM LIMITATION REQUIREMENTS FOR EACH X-Ray Systems Other Than
Those Described in RH Governed by 6.6.21.1, 6.6.1.2 and 6.6.1.3 THROUGH 6.2.2.5.
1866
1867
1868
1869
6.6.1.4.(1)
Means shall be provided to limit the x-ray field in the plane of the image
receptor so that such field does not exceed each dimension of the image
receptor by more than two (2) percent of the SID when the axis of the x-ray beam
is perpendicular to the plane of the image receptor.
1870
1871
1872
1873
1874
6.6.1.4.(2)
Means shall be provided to align the center of the x-ray field with the
center of the image receptor to within two (2) percent of the SID, or means shall
be provided to both size and align the x-ray field such that the x-ray field at the
plane of the image receptor does not extend beyond any edge of the image
receptor.
1875
1876
1877
1878
6.6.1.4.(3)
RH 6.6.2.61.4.1 and 6.6.2.64.2 may be met with a system that meets the
requirements for a general purpose x-ray system as specified in RH 6.6.12.1
AND 6.6.2.2 or, when alignment means are also provided, may be met with
either:
1879
1880
1881
1882
1883
6.6.1.4.3.1(a) aAn assortment of removable, fixed-aperture, beam-limiting
devices sufficient to meet the requirement for each combination of image
receptor size and SID for which the unit is designed with each such
device having clear and permanent markings to indicate the image
receptor size and SID for which it is designed; or
1884
1885
1886
1887
1888
6.6.1.4.3.2(b) aA beam-limiting device having multiple fixed apertures sufficient
to meet the requirement for each combination of image receptor size and
SID for which the unit is designed. Permanent, clearly legible markings
shall indicate the image receptor size and SID for which each aperture is
designed and shall indicate which aperture is in position for use.
1889
1890
1891
1892
6.6.2.7 POSITIVE BEAM LIMITATION (PBL) FOR A DIAGNOSTIC X-RAY SYSTEM WITH
ANY CERTIFIED COMPONENT.
(1)
WHEN A PBL SYSTEM IS PROVIDED, IT SHALL PREVENT X-RAY
PRODUCTION WHEN:
1893
1894
1895
1896
(a)
EITHER THE LENGTH OR WIDTH OF THE X-RAY FIELD IN THE
PLANE OF THE IMAGE RECEPTOR DIFFERS FROM THE
CORRESPONDING IMAGE RECEPTOR DIMENSION BY MORE THAN
THREE (3) PERCENT OF THE SID; OR
1897
1898
1899
(b)
THE SUM OF THE LENGTH AND WIDTH DIFFERENCES AS STATED
IN 6.6.2.7(1)(a) WITHOUT REGARD TO SIGN EXCEEDS FOUR (4)
PERCENT OF THE SID.
1900
1901
(c)
THE BEAM-LIMITING DEVICE IS AT A SID FOR WHICH PBL IS NOT
DESIGNED FOR SIZING.
6 - 56
Colorado Radiation Regulations, Proposed Revised Part 6
1902
1903
(2)
May 12, 2017
WHEN PROVIDED, THE PBL SYSTEM SHALL FUNCTION AS DESCRIBED IN
6.6.2.7(1) WHENEVER ALL THE FOLLOWING CONDITIONS ARE MET:
1904
1905
(a)
THE IMAGE RECEPTOR IS INSERTED INTO A PERMANENTLY
MOUNTED CASSETTE HOLDER;
1906
1907
(b)
THE IMAGE RECEPTOR LENGTH AND WIDTH ARE LESS THAN
50 CM;
1908
1909
1910
1911
(c)
THE X-RAY BEAM AXIS IS WITHIN ± THREE (3) DEGREES OF
VERTICAL AND THE SID IS 90 CM TO 130 CM INCLUSIVE; OR THE
X-RAY BEAM AXIS IS WITHIN ± THREE (3) DEGREES OF
HORIZONTAL AND THE SID IS 90 CM TO 205 CM INCLUSIVE;
1912
1913
(d)
THE X-RAY BEAM AXIS IS PERPENDICULAR TO THE PLANE OF
THE IMAGE RECEPTOR TO WITHIN ± THREE (3) DEGREES;
1914
1915
(e)
NEITHER TOMOGRAPHIC NOR STEREOSCOPIC RADIOGRAPHY IS
BEING PERFORMED;
1916
(f)
MANUAL COLLIMATION IS NOT USED;
1917
1918
(g)
THE MACHINE IS USED FOR PROCEDURES OTHER THAN
THERAPY SIMULATION; AND
1919
(h)
THE PBL SYSTEM HAS NOT BEEN INTENTIONALLY OVERRIDDEN.
1920
1921
(3)
IF A MEANS OF OVERRIDING THE PBL SYSTEM EXISTS, THAT MEANS
SHALL:
1922
1923
(a)
BE DESIGNED FOR USE ONLY IN THE EVENT OF PBL SYSTEM
FAILURE, OR IF THE SYSTEM IS BEING SERVICED; AND
1924
1925
1926
1927
(b)
REQUIRE, IF IN A POSITION THAT THE OPERATOR WOULD
CONSIDER IT PART OF THE OPERATIONAL CONTROLS, OR IF IT
IS REFERENCED IN THE OPERATOR'S MANUAL, OR IN OTHER
MATERIALS INTENDED FOR THE OPERATOR, THAT:
1928
(i)
A KEY BE UTILIZED TO DEFEAT THE PBL;
1929
1930
(ii)
THE KEY REMAIN IN PLACE DURING THE ENTIRE TIME
THE PBL SYSTEM IS OVERRIDDEN; AND
1931
1932
1933
(iii)
THE KEY OR KEY SWITCH BE CLEARLY AND DURABLY
LABELED AS FOLLOWS: “FOR X-RAY FIELD LIMITATION
SYSTEM FAILURE”; AND
1934
(c)
NOT BE USED AS A SUBSTITUTE FOR PROMPT REPAIR.
6 - 57
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
1935
1936
1937
1938
(4)
COMPLIANCE WITH 6.6.2.7 SHALL BE DETERMINED WHEN THE
EQUIPMENT INDICATES THAT THE BEAM AXIS IS PERPENDICULAR TO
THE PLANE OF THE IMAGE RECEPTOR AND THE PROVISIONS OF
6.6.2.7(2) ARE MET.
1939
1940
(5)
COMPLIANCE SHALL BE DETERMINED NO SOONER THAN FIVE (5)
SECONDS AFTER INSERTION OF THE IMAGE RECEPTOR.
1941
1942
1943
1944
(6)
THE PBL SYSTEM SHALL BE CAPABLE OF OPERATION, AT THE
DISCRETION OF THE OPERATOR, SUCH THAT THE SIZE OF THE FIELD
MAY BE MADE SMALLER THAN THE SIZE OF THE IMAGE RECEPTOR
THROUGH STEPLESS ADJUSTMENT OF THE FIELD SIZE.
1945
1946
(7)
THE MINIMUM FIELD SIZE AT AN SID OF 100 CM SHALL BE EQUAL TO OR
LESS THAN 5 CM BY 5 CM.
1947
1948
1949
1950
(8)
THE PBL SYSTEM SHALL BE DESIGNED SUCH THAT IF A CHANGE IN
IMAGE RECEPTOR DOES NOT CAUSE AN AUTOMATIC RETURN TO PBL
FUNCTION AS DESCRIBED IN 6.6.2.7, THEN ANY CHANGE OF IMAGE
RECEPTOR SIZE OR SID MUST CAUSE THE AUTOMATIC RETURN.
1951
1952
6.6.32 Radiation Exposure Control Devices.
6.6.32.1
Timers.
1953
1954
1955
(1)
Means shall be provided to terminate the exposure at a preset time interval,
preset product of current and time, a preset number of pulses, or a preset
radiation exposure to the image receptor.
1956
1957
(2)
In addition, it shall not be possible to make an exposure when the timer is set to
a “zero” or “off” position if either position is provided.
1958
1959
(3)
TERMINATION OF EXPOSURE SHALL CAUSE AUTOMATIC RESETTING OF
THE TIMER TO ITS INITIAL SETTING OR TO “ZERO”.
1960
1961
1962
6.6.32.2
X-Ray Control.
6.6.2.2.(1)
An x-ray control shall be incorporated into each x-ray system such that
an exposure can be terminated by the operator at any time except for:
1963
6.6.2.2.1.1(a)
1964
1965
6.6.2.2.1.2(b) dDuring serial radiography when a means shall be provided to
permit completion of any single exposure of the series in process.
1966
1967
6.6.2.2.(2)
Except for bone mineral densitometry devices, each x-ray control shall
be located in such a way as to meet the following requirements:
1968
1969
1970
1971
1972
1973
eExposure of one-half (0.5) second or less, or
6.6.2.2.2.1(a) FOR stationary x-ray systems, and mobile or portable systems
used routinely in one location, shall be required to have the x-ray control
permanently mounted in a protected SEPARATED area BEHIND A
WHOLE BODY PROTECTIVE BARRIER (OF NOT LESS THAN 0.25
MILLIMETER LEAD EQUIVALENT) WHERE so that the operator is
required to remain in that protected area during the entire exposure.
6 - 58
Colorado Radiation Regulations, Proposed Revised Part 6
1974
1975
1976
1977
May 12, 2017
6.6.2.2.2.2(b) mMobile and portable x-ray systems not routinely used in one
location shall be required to have an exposure switch so arranged that
the operator can stand at least 21.83 meters (MORE THAN 6 feet) from
the patient, the x-ray tube and the useful beam.
1978
1979
(i)
Mobile and portable x-ray systems used in surgery are
considered to be not routinely used in one location.
1980
1981
1982
(ii)
A SEPARATE EXPOSURE SWITCH IS NOT REQUIRED FOR
PORTABLE HAND-HELD X-RAY EQUIPMENT THAT HAS
THE CONTROL ON THE DEVICE.
1983
1984
1985
6.6.2.2.2.3
The x-ray control shall provide visual indication observable at or from the
operator's protected position whenever x-rays are produced. In addition, a signal
audible to the operator shall indicate that the exposure has terminated.
1986
1987
(3)
THE SETTINGS TO BE USED DURING AN EXPOSURE SHALL BE
INDICATED BEFORE THE EXPOSURE BEGINS.
1988
1989
1990
(a)
WHEN AUTOMATIC EXPOSURE CONTROLS ARE USED, THE
EXPOSURE SETTINGS THAT ARE SET PRIOR TO THE EXPOSURE
SHALL BE INDICATED.
1991
1992
1993
(b)
ON EQUIPMENT HAVING FIXED EXPOSURE SETTINGS,
PERMANENT MARKINGS VISIBLE FROM THE OPERATOR’S
POSITION ARE ACCEPTABLE.
1994
6.6.32.3
Automatic Exposure Controls.
1995
1996
(1)
When an automatic exposure control is provided, :6.6.2.3.1indication shall be
made on the control panel when this mode of operation is selected;
1997
1998
1999
6.6.2.3.(2)
iIf the x-ray tube potential is equal to or greater than 50 kVp, the
minimum exposure time for field emission equipment rated for pulsed operation
shall be equal to or less than a time interval equivalent to two (2) pulses;
2000
2001
2002
6.6.2.3.(3)
tThe minimum exposure time for all equipment other than that specified
in RH 6.6.32.3.(2) shall be equal to or less than one-sixtieth (1/60) second or a
time interval required to deliver 5 mAs, whichever is greater;
2003
2004
2005
2006
2007
2008
6.6.2.3.(4)
eEither the product of peak x-ray tube potential, current, and exposure
time shall be limited to not more than 60 kWs per exposure, or the product of xray tube current and exposure time shall be limited to not more than 600 mAs per
exposure except that, when the x-ray tube potential is less than 50 kVp, the
product of x-ray tube current and exposure time shall be limited to not more than
2000 mAs per exposure; and
2009
2010
2011
6.6.2.3.(5)
aA visible signal shall indicate when an exposure has been terminated at
the limits required by RH 6.6.32.3.(4), and manual resetting shall be required
before further automatically timed exposures can be made.
6 - 59
Colorado Radiation Regulations, Proposed Revised Part 6
2012
6.6.32.4
May 12, 2017
Timer Reproducibility.
2013
2014
2015
2016
2017
2018
2019
(1)
With a timer setting of 0.5 seconds or less, the average exposure period (T avg)
shall be greater than or equal to five (5) times the maximum exposure period
(Tmax) minus the minimum exposure period (T min) when four (4) timer tests
exposures are performed: Tavg ≥ 5(Tmax - Tmin). FOR ANY SPECIFIC
COMBINATION OF SELECTED TECHNIQUE FACTORS, THE ESTIMATED
COEFFICIENT OF VARIATION OF THE AIR KERMA SHALL BE NO
GREATER THAN 0.05.
2020
2021
(2)
MEASURING COMPLIANCE FOR LINEARITY SHALL BE IN ACCORD WITH
21 CFR 1020.31.
2022
2023
2024
2025
2026
6.6.3.5 Source-to-Skin Distance.
(1)
6.6.3.64
All Each mobile or portable radiographic X-RAY IMAGING systems shall be
provided with means to limit the source-to-skin distance to equal to or greater
than 30 cmentimeters.
Exposure Reproducibility.
2027
2028
2029
2030
(1)
When all technique factors EXPOSURE SETTINGS are held constant, including
control panel selections associated with automatic exposure control systems, the
coefficient of variation of exposure AIR KERMA for both manual and automatic
exposure control systems shall not exceed 0.05.
2031
2032
2033
2034
(2)
The facility registrant may request an exemption for any machines manufactured
prior to 1974, which THAT cannot meet this requirement. The exemption request
must verify that this exposure reproducibility variation will not result in
unnecessary patient radiation exposure due to the need for repeat examinations.
2035
2036
2037
2038
2039
2040
2041
2042
2043
6.6.3.75
(1)
Radiation from Capacitor Energy Storage Equipment in Standby Status.
Radiation emitted from the x-ray tube when the exposure switch or timer is not
activated shall not exceed a rate of 0.516 μC/kg 17.6 μGy (2 mR) per hour at
5 cmentimeters from any accessible surface (THAT CAN BE EASILY OR
ACCIDENTALLY TOUCHED BY AN INDIVIDUAL WITHOUT THE USE OF A
TOOL) of the diagnostic source assembly, with the beam-limiting device fully
open.
6.6.3.8 LINEARITY FOR A DIAGNOSTIC X-RAY SYSTEM WITH ANY CERTIFIED
COMPONENT.SHALL BE IN ACCORD WITH 21 CFR 1020.31(c)(3).
6 - 60
Colorado Radiation Regulations, Proposed Revised Part 6
2044
2045
May 12, 2017
6.6.3.9 ACCURACY FOR A DIAGNOSTIC X-RAY SYSTEM WITH ANY CERTIFIED
COMPONENT.
2046
2047
2048
(1)
DEVIATION OF EXPOSURE SETTINGS FROM INDICATED VALUES SHALL
NOT EXCEED THE LIMITS SPECIFIED FOR THAT SYSTEM BY ITS
MANUFACTURER.
2049
2050
(2)
IF MANUFACTURER SPECIFICATIONS ARE NOT AVAILABLE, THE
FOLLOWING CRITERIA SHALL BE USED:
2051
2052
(a)
THE KVP SHALL NOT DEVIATE FROM INDICATED VALUES BY
MORE THAN TEN (10) PERCENT.
2053
2054
(b)
THE TIMER ACCURACY SHALL NOT DEVIATE FROM INDICATED
VALUES BY MORE THAN:
2055
2056
(i)
TEN (10) PERCENT FOR AN INDICATED TIME OF GREATER
THAN 20 MS; OR
2057
2058
(ii)
FIFTY (50) PERCENT FOR AN INDICATED TIME OF 20 MS
OR LESS, OR 1 PULSE, WHICHEVER IS GREATER.
2059
2060
6.6.4
FOR EACH GENERAL PURPOSE X-RAY IMAGING SYSTEM, THE REGISTRANT SHALL
ENSURE THAT MANUFACTURER MAINTENANCE SPECIFICATIONS ARE FOLLOWED.
2061
2062
2063
6.6.6
Additional Requirements Applicable to Certified Systems Only.Diagnostic x-ray systems
incorporating one or more certified component(s) shall be required to comply with the following
additional requirement(s) which relate to that certified component(s).
2064
2065
2066
2067
2068
2069
2070
2071
6.6.6.1 Linearity. When the equipment allows a choice of x-ray tube current or mAs settings for
any fixed x-ray tube potential within the range of 40 to 100 percent of the maximum
rating, the average ratio of exposure to the indicated milliampere-seconds product
obtained at any two (2) consecutive tube current or mAs settings shall not differ by more
than 0.10 times their sum: |Т1 - Т2| ≤ 0.10(Т1+Т2), where Т1 and Т2 are the average
mR/mAs (microcoulomb/kilogram per mAs) values obtained at each of two (2)
consecutive tube current settings or at two settings differing by no more than a factor of
two (2) when the mAs selector provides continuous selection.
2072
2073
2074
6.6.6.2 Accuracy. Deviation of technique factors from indicated values shall not exceed the limits
specified for that system by its manufacturer. If manufacturer specifications are not
available, the following criteria shall be used:
2075
2076
6.6.6.2.1
The kVp shall not deviate from indicated values by more than ten (10)
percent.
2077
6.6.6.2.2
The timer accuracy shall not deviate from indicated values by more than:
2078
6.6.6.2.2.1
ten (10) percent for an indicated time of greater than 20 ms; or
2079
6.6.6.2.2.2
fifty (50) percent for an indicated time of 20 ms or less.
2080
6.6.6.3 Beam Limitation for Stationary and Mobile General Purpose X-Ray Systems.
6 - 61
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
2081
2082
2083
6.6.6.3.1
There shall be provided a means of stepless adjustment of the size of
the x-ray field. The minimum field size at an SID of 100 centimeters shall be
equal to or less than 5 centimeters by 5 centimeters.
2084
2085
2086
2087
2088
2089
6.6.6.3.2
When a light localizer is used to define the x-ray field, it shall provide an
average illumination of not less than 160 lux (15 foot candles) at 100 centimeters
or at the maximum SID, whichever is less. The average illumination shall be
based upon measurements made in the approximate center of each quadrant of
the light field. Radiation therapy simulation systems are exempt from this
requirement.
2090
2091
2092
6.6.6.3.3
For collimators manufactured prior to August 1, 1974, average net
illuminance measurement made in the approximate center of each quadrant of
the light field shall not be less than the values indicated below:
Column 1
Column 2
Ambient Light Illuminance
2093
2094
2095
2096
2097
2098
2099
Net Minimum Light
Illuminance Above Ambient
5 to 25 lux
25 lux
26 to 50 lux
50 lux
51 to 75 lux
75 lux
76 to 100 lux
100 lux
101 to 159 lux
100 lux
6.6.6.3.3.1
If the ambient light was reduced to achieve a net light localizer
illuminance of any value in column 2, operating procedures shall be
written, describing steps which must be taken for reducing the ambient
light to allow enhancement of the light field during positioning. All x-ray
machine operators shall be trained in these procedures. The operating
procedures shall be filed in the written safety procedures manual and
maintained on the premises of the registered facility.
2100
2101
6.6.6.4 Beam Limitation for Portable X-Ray Systems. Beam limitation for portable x-ray systems
shall meet the beam limitation requirements of RH 6.6.1.1 and 6.6.6.3.
2102
6.6.6.5 Positive Beam Limitation (PBL).
2103
6.6.6.5.1
When a PBL system is provided, it shall prevent x-ray production when:
2104
2105
2106
6.6.6.5.1.1
either the length or width of the x-ray field in the plane of the
image receptor differs from the corresponding image receptor dimension
by more than three (3) percent of the SID; or
2107
2108
2109
6.6.6.5.1.2
The sum of the length and width differences as stated in RH
6.6.6.5.1.1 of this section without regard to sign exceeds four (4) percent
of the SID.
6 - 62
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
2110
2111
6.6.6.5.1.3
The beam limiting device is at a SID for which PBL is not
designed for sizing.
2112
2113
2114
6.6.6.5.2
Conditions for PBL.When provided, the PBL system shall function as
described in RH 6.6.6.5.1 of this section whenever all the following conditions are
met:
2115
2116
6.6.6.5.2.1
The image receptor is inserted into a permanently mounted
cassette holder;
2117
2118
6.6.6.5.2.2
The image receptor length and width are less than
50 centimeters;
2119
2120
2121
2122
6.6.6.5.2.3
The x-ray beam axis is within ±three (3) degrees of vertical and
the SID is 90 centimeters to 130 centimeters inclusive; or the x-ray beam
axis is within ±three (3) degrees of horizontal and the SID is
90 centimeters to 205 centimeters inclusive;
2123
2124
6.6.6.5.2.4
The x-ray beam axis is perpendicular to the plane of the image
receptor to within ±three (3) degrees;
2125
2126
6.6.6.5.2.5
Neither tomographic nor stereoscopic radiography is being
performed;
2127
6.6.6.5.2.6
2128
2129
6.6.6.5.2.7
The machine is used for procedures other than therapy
simulation; and
2130
6.6.6.5.2.8
Manual collimation is not used;
The PBL system has not been intentionally overridden.
2131
2132
2133
2134
2135
6.6.6.5.3
If a means of overriding the PBL system exists, that means:
6.6.6.5.3.1Shall be designed for use only in the event of PBL system failure, or if
the system is being serviced; and 6.6.6.5.3.2If in a position that the operator
would consider it part of the operational controls, or if it is referenced in the
operator's manual, or in other materials intended for the operator,
2136
6.6.6.5.3.2.1
2137
2138
2139
2140
6.6.6.5.3.2.2
shall require that the key remain in place during the entire time the PBL
system is overridden; and 6.6.6.5.3.2.3 shall require that the key or key switch
be clearly and durably labeled as follows: “FOR X-RAY FIELD LIMITATION
SYSTEM FAILURE”
2141
2142
2143
2144
6.6.6.5.4
Compliance with RH 6.6.6.5 shall be determined when the equipment
indicates that the beam axis is perpendicular to the plane of the image receptor
and the provisions of RH 6.6.6.5.2 are met. Compliance shall be determined no
sooner than five (5) seconds after insertion of the image receptor.
2145
2146
2147
2148
2149
6.6.6.5.5
The PBL system shall be capable of operation, at the discretion of the
operator, such that the size of the field may be made smaller than the size of the
image receptor through stepless adjustment of the field size. The minimum field
size at an SID of 100 centimeters shall be equal to or less than 5 centimeters by
5 centimeters.
shall require that a key be utilized to defeat the PBL;
6 - 63
Colorado Radiation Regulations, Proposed Revised Part 6
2150
2151
2152
2153
6.6.6.5.6
The PBL system shall be designed such that if a change in image
receptor does not cause an automatic return to PBL function as described in
RH 6.6.6.5 then any change of image receptor size or SID must cause the
automatic return.
2154
2155
2156
2157
2158
2159
2160
2161
May 12, 2017
6.6.6.6 Timers. Except for dental panoramic systems, termination of exposure shall cause
automatic resetting of the timer to its initial setting or to “zero”.
6.6.5
FOR EACH GENERAL-USE DIAGNOSTIC RADIOGRAPHIC X-RAY SYSTEM, THE
REGISTRANT SHALL ENSURE THAT WRITTEN QUALITY CONTROL AND QUALITY
ASSURANCE PROCEDURES ARE AVAILABLE AND IN USE, INCLUDING FOR FACILITY
OPERATIONS AND EMERGENCIES.
6.6.5.1 THE QUALITY CONTROL AND QUALITY ASSURANCE PROCEDURES SHALL BE
CONSISTENT WITH 6.3.5 AND SHALL FOLLOW:
2162
(1)
SPECIFICATIONS OF THE MANUFACTURER; AND
2163
(2)
SPECIFICATIONS OF A REGISTERED MEDICAL PHYSICIST; AND/OR
2164
2165
(3)
STANDARDS OF AN APPROPRIATE NATIONALLY RECOGNIZED
ORGANIZATION.
2166
2167
6.6.5.2 ROUTINE PERIODIC QUALITY CONTROL SHALL BE COMPARABLE TO THE
FOLLOWING:
2168
2169
(1)
CASSETTE MAINTENANCE (FOR EXAMPLE, ERASURE AND/OR SCREEN
CLEANING);
2170
2171
2172
2173
(2)
IMAGES INSPECTED FOR EVIDENCE OF CLINICALLY RELEVANT
ARTIFACTS (FOR EXAMPLE, DUST AND NON-UNIFORMITIES) WITH
APPROPRIATE CORRECTIVE ACTION (FOR EXAMPLE, CLEANING OF
SCREENS) TAKEN AS NEEDED AND DOCUMENTED;
2174
(3)
ANALYSIS OF REPEATED AND/OR REJECTED IMAGES; AND
2175
(4)
INVESTIGATION OF ERRORS OUTSIDE A CONTROL RANGE;
2176
2177
(5)
MEASUREMENTS USING PHANTOMS, IF REQUIRED (FOR EXAMPLE, IN
BONE DENSITOMETRY); AND
2178
2179
(6)
MEASUREMENTS OF SCATTERED RADIATION AT THE OPERATOR’S
POSITION, IF REQUIRED (FOR EXAMPLE, IN BONE DENSITOMETRY).
2180
6.6.5.3 ANNUAL QUALITY ASSURANCE SHALL BE COMPARABLE TO THE FOLLOWING:
2181
(1)
ALL QUALITY CONTROL TESTS SHALL BE REVIEWED ANNUALLY;
2182
2183
2184
(2)
IMAGING SYSTEMS SHALL BE TESTED IN ACCORDANCE WITH
STANDARDS AND PROTOCOLS PUBLISHED BY A NATIONALLY
RECOGNIZED ORGANIZATION; AND
2185
2186
(3)
THE FREQUENCY OF QUALITY CONTROL TESTING AND CORRECTIVE
ACTIONS TAKEN AS A RESULT ARE FOLLOWED AND DOCUMENTED
6 - 64
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
2187
RH 6.7 SAFE USE OF A Intraoral Dental Radiographic X-RAY IMAGING Systems.
2188
6.7.1
ADMINISTRATIVE CONTROLS.
2189
2190
2191
6.7.1.1 In addition to the provisions of RH 6.3 and 6.4, the requirements of RH 6.7 apply to x-ray
equipment and associated facilities used for dental radiographyX-RAY IMAGING.
Requirements for extra-oral dental radiographic systems are covered in RH 6.6.
2192
2193
2194
6.7.1.2 EACH INDIVIDUAL WHO OPERATES A DENTAL X-RAY IMAGING SYSTEM SHALL
MEET THE APPLICABLE ADEQUATE RADIATION SAFETY TRAINING AND
EXPERIENCE REQUIREMENTS OF PART 2.6.1, IN PARTICULAR 2.6.1.10.
2195
2196
2197
2198
2199
6.7.2
EACH DENTAL X-RAY IMAGING SYSTEM SHALL MEET THE FOLLOWING EQUIPMENT
DESIGN AND CONFIGURATION REQUIREMENTS.
6.7.2.1 CEPHALOMETRIC AND VOLUMETRIC DENTAL X-RAY SYSTEMS SHALL MEET
THE EQUIPMENT DESIGN AND CONFIGURATION REQUIREMENTS OF 6.3.2 AND
6.6.2, EXCEPT THAT:
2200
2201
2202
(1)
THE SHIELDING DESIGN DESCRIBED IN 6.3.2 IS REQUIRED FOR THE
ROOM(S) OF ANY FACILITY HAVING A CEPHALOMETRIC AND/OR
VOLUMETRIC DENTAL X-RAY SYSTEM REGARDLESS OF OCCUPANCY.
2203
2204
2205
(2)
A DENTAL FACILITY MAY APPLY IN WRITING AND BE GRANTED
EXEMPTION BY THE DEPARTMENT FOR A PARTICULAR ROOM AND
X-RAY EQUIPMENT CONFIGURATION.
2206
2207
2208
2209
2210
2211
2212
2213
2214
2215
2216
6.7.2.2 INTRAORAL AND PANORAMIC DENTAL X-RAY SYSTEMS SHALL MEET THE
FOLLOWING REQUIREMENTS:
6.7.(1) Source-to-Skin Distance (SSD) FOR INTRAORAL DENTAL X-RAY SYSTEMS.
(a)
EACH Xx-ray IMAGING systems designed for use with an intraoral
image receptor shall be provided with means to limit SSD, to not less
than :6.7.1.1 18 cmentimeters if operable above 50 kVp, or 6.7.1.210
centimeters if not operable above 50 kVp.
6.7.(2) Field Limitation FOR INTRAORAL DENTAL X-RAY SYSTEMS.
(a)
EACH Radiographic X-RAY IMAGING systems designed for use with an
intraoral image receptor shall be provided with means to limit the x-ray
beam such that:
2217
2218
2219
6.7.2.1(i)
iIf the minimum SSD is 18 cmentimeters or more, the
x-ray field, at the minimum SSD, shall be containable in a circle
having a diameter of no more than 7 cmentimeters; and
2220
2221
2222
6.7.2.2(ii)
iIf the minimum SSD is less than 18 cmentimeters, the
x-ray field, at the minimum SSD, shall be containable in a circle
having a diameter of no more than 6 cmentimeters.
6 - 65
Colorado Radiation Regulations, Proposed Revised Part 6
2223
2224
2225
2226
2227
2228
(3)
6.7.3
May 12, 2017
AS PROVIDED IN 6.3.2.4, NEITHER THE SHIELDING DESIGN DESCRIBED
IN 6.3.2 NOR THE DIMENSIONAL DRAWING, CALCULATION OR SURVEY
DESCRIBED IN 6.3.2.3 ARE REQUIRED FOR INTRAORAL OR PANORAMIC
DENTAL EQUIPMENT.
EACH DENTAL X-RAY IMAGING SYSTEM SHALL MEET THE FOLLOWING RADIATION
EXPOSURE OPERATIONAL CONTROL REQUIREMENTS.
2229
2230
6.7.3.1 CEPHALOMETRIC AND VOLUMETRIC DENTAL X-RAY SYSTEMS SHALL MEET
THE RADIATION EXPOSURE CONTROL REQUIREMENTS OF 6.6.3:
2231
2232
2233
6.7.3.2 INTRAORAL AND PANORAMIC DENTAL X-RAY SYSTEMS SHALL MEET THE
FOLLOWING RADIATION EXPOSURE CONTROL REQUIREMENTS INSTEAD OF
THE REQUIREMENTS IN 6.6.3:
2234
6.7.3(1) Timers.
2235
2236
2237
6.7.4.1(a)
Means shall be provided to terminate the exposure at a preset
time interval, preset product of current and time, a preset number of
pulses, or a preset radiation exposure to the image receptor.
2238
2239
(b)
In addition: 6.7.3.1It shall not be possible to make an exposure when the
timer is set to a “zero” or “off” position if either position is provided.
2240
2241
(c)
6.7.3.2Termination of exposure shall cause automatic resetting of the
timer to its initial setting or to “zero”.
2242
6.7.3.3(d)
2243
2244
2245
2246
2247
(i)
2248
2249
2250
2251
2252
Timer Reproducibility.
With a timer setting of 0.5 seconds or less, the average exposure
period (Tavg) shall be greater than or equal to five (5) times the
maximum exposure period (T max) minus the minimum exposure
period (Tmin) when four (4) timer tests are performed:
Tavg ≥ 5(Tmax - Tmin).
6.7.4(2) X-Ray Control FOR INTRAORAL OR PANORAMIC DENTAL X-RAY
SYSTEMS.
6.7.4.1(a)
An x-ray control shall be incorporated into each x-ray IMAGING
system such that an exposure can be terminated by the operator at any
time, except for exposures of one-half (0.5) second or less.
6 - 66
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
2253
2254
6.7.4.2(b)
Each x-ray control shall be located in such a way as to meet the
following requirements:
2255
2256
2257
2258
2259
2260
2261
2262
2263
2264
6.7.4.2.1(i)
FOR stationary x-ray systems, and mobile or
NON-HAND-HELD portable systems used routinely in one
location, shall be required to have the x-ray control permanently
mounted in a protected SEPARATED area, so that the BEHIND
A WHOLE BODY PROTECTIVE BARRIER (OF NOT LESS
THAN 0.25 MILLIMETER LEAD EQUIVALENT) WHERE
operator is required to remain in that protected area during the
entire exposure, or the exposure control shall be such that the
operator can stand at least 21.83 meters (MORE THAN 6 feet)
from the patient, the x-ray tube and the useful beam;
2265
2266
2267
2268
2269
6.7.4.2.2(ii)
mMobile and NON-HAND-HELD portable x-ray systems
not routinely used in one location shall be required to have an
exposure switch so arranged that the operator can stand at least
21.83 meters (MORE THAN 6 feet) from the patient, the x-ray
tube and the useful beam.; OR
2270
2271
(iii)
2272
2273
2274
2275
2276
2277
2278
2279
2280
2281
2282
2283
2284
2285
2286
2287
2288
2289
PORTABLE HAND-HELD X-RAY EQUIPMENT SHALL MEET
APPENDIX 6E.
6.7.4.3 The x-ray control shall provide visual indication observable at or from the
operator's protected position whenever x-rays are produced.
6.7.5(3) Exposure reproducibility.
6.7.5.1(a)
The estimated coefficient of variation of radiation exposure shall
be no greater than 0.05, for any specific combination of selected
technique factors EXPOSURE SETTINGS.
6.7.6(4) Linearity SHALL BE IN ACCORD WITH 21 CFR 1020.31(C)(3).
6.7.6.1 When the equipment allows a choice of x-ray tube current settings and is
operated on a power supply as specified by the manufacturer in
accordance with the requirements of applicable Federal standards, for
any fixed x-ray tube potential within the range of 40 to 100 percent of the
maximum rating, the average ratios of exposure to the indicated
milliampere-seconds product obtained at any two (2) consecutive tube
current or mAs settings shall not differ by more than 0.10 times their
sum: |Т1 - Т2| ≤ 0.10(Т1+Т2), where Т1 and Т2 are the average mR/mAs
values obtained at each of two (2) consecutive tube current or mAs
settings.
6.7.7(5) Accuracy.
2290
2291
2292
6.7.7.1(a)
Deviation of technique factors EXPOSURE SETTINGS from
indicated values shall not exceed the limits specified for that system by
its manufacturer.
2293
2294
2295
(b)
If those MANUFACTURER SPECIFICATIONS are not available,
accuracy of all exposure factors shall be within ten (10) percent of the
selected factor(s).
6 - 67
Colorado Radiation Regulations, Proposed Revised Part 6
2296
May 12, 2017
6.7.8(6) Beam Quality.
2297
2298
2299
6.7.8.1(a)
All certified dental x-ray systems manufactured on and after
December 1, 1980, shall have a minimum half-value layer not less than
1.5 millimeters aluminum equivalent.
2300
2301
(b)
2302
6.7.9
Systems operating above 70 kVp are subject to the filtration
requirements of RH 6.4.2.5.(1).
Administrative Controls.
2303
2304
6.7.9.1(7)
Patient and film IMAGE RECEPTOR holding devices shall be used when
the techniques permit.
2305
2306
2307
6.7.9.2(8)
The tube housing and the PID shall not be hand-held during an
exposure, EXCEPT AS PROVIDED IN APPENDIX 6E FOR PORTABLE
HAND-HELD X-RAY EQUIPMENT.
2308
2309
6.7.9.3(9)
The x-ray system shall be operated in such a manner that the area of the
useful beam at the patient's skin is minimized.
2310
2311
6.7.9.4(10)
Dental fluoroscopy without image intensification OR DIRECT DIGITAL
RECEPTORS shall not be used.
2312
6.7.3.3 THE X-RAY CONTROL SHALL PROVIDE:
2313
2314
(1)
VISUAL INDICATION OBSERVABLE AT THE OPERATOR'S PROTECTED
POSITION WHENEVER X-RAYS ARE PRODUCED; AND
2315
2316
(2)
A SIGNAL AUDIBLE TO THE OPERATOR SHALL INDICATE THAT THE
EXPOSURE HAS TERMINATED.
2317
2318
6.7.3.4 A THYROID SHIELD SHALL BE USED TO REDUCE PATIENT EXPOSURE TO
SCATTERED RADIATION.
2319
2320
2321
2322
6.7.3.5 ABSENT STRUCTURAL PROTECTION AGAINST SCATTER RADIATION, DURING
RADIATION MACHINE OPERATION AT LEAST A 2-METER DISTANCE (MORE
THAN 6 FEET) SHALL BE MAINTAINED FROM ANY BYSTANDER LOCATION AND
BETWEEN PATIENT OPERATING CHAIRS.
2323
2324
6.7.4
FOR EACH DENTAL X-RAY IMAGING SYSTEM, MANUFACTURER MAINTENANCE
SPECIFICATIONS SHALL BE FOLLOWED.
6 - 68
Colorado Radiation Regulations, Proposed Revised Part 6
2325
2326
6.7.5
2327
May 12, 2017
FOR EACH DENTAL X-RAY IMAGING SYSTEM, WRITTEN QUALITY CONTROL AND
QUALITY ASSURANCE PROCEDURES SHALL INCLUDE:
6.7.5.1 FOR PROCESSING OF INTRAORAL FILMS, PERFORMANCE OF THE FOLLOWING:
2328
2329
(1)
FOLLOW APPLICABLE MANUFACTURER’S TIME AND TEMPERATURE
SPECIFICATIONS, WHICH SHALL BE AVAILABLE FOR REVIEW;
2330
(2)
MEASURE AND LOG TEMPERATURE EACH DAY OF USE; AND
2331
2332
(3)
DOCUMENT IN A WRITTEN LOG THE CHANGE OF DEVELOPER
CHEMICALS AT LEAST EVERY MONTH.
2333
2334
2335
2336
2337
6.7.5.2 FOR VOLUMETRIC DENTAL SYSTEMS, CONDUCT PERIODIC CALIBRATIONS AND
ANNUAL QUALITY CONTROL TESTS ACCORDING TO THE MANUFACTURER’S
SPECIFICATIONS, INCLUDING ANY ADDITIONAL OR MORE FREQUENT TESTING
NECESSARY AT THE RECOMMENDATION OF THE REGISTERED MEDICAL
PHYSICIST.
2338
6.7.5.3 ANNUAL REVIEW OF ALL QUALITY CONTROL TESTS.
2339
Other Diagnostic X-ray Systems
2340
RH 6.8 SAFE USE OF A Veterinary Medicine IMAGING SYSTEM Radiographic Installations.
2341
6.8.1
ADMINISTRATIVE CONTROLS.
2342
2343
2344
6.8.1.1 IN ADDITION TO THE PROVISIONS OF 6.3 AND 6.4, THE REQUIREMENTS OF THIS
6.8, AND AS APPROPRIATE ALSO 6.5 AND 6.9, APPLY TO EQUIPMENT AND
ASSOCIATED FACILITIES USED FOR VETERINARY X-RAY IMAGING.
2345
2346
2347
6.8.1.2 EACH INDIVIDUAL WHO OPERATES A VETERINARY X-RAY IMAGING SYSTEM
SHALL MEET THE APPLICABLE ADEQUATE RADIATION SAFETY TRAINING AND
EXPERIENCE REQUIREMENTS OF 2.6.1, IN PARTICULAR 2.6.1.12.
2348
2349
2350
6.8.2
EACH VETERINARY MEDICINE INSTALLATION SHALL MEET THE FOLLOWING
EQUIPMENT DESIGN AND CONFIGURATION REQUIREMENTS.
6.8.2.1 Equipment.
2351
2352
6.8.1.(1)
The protective tube housing shall be equivalent to the requirements of
RH 6.4.2.3.
2353
2354
2355
6.8.1.(2)
Diaphragms or cones shall be provided for collimating the useful beam to
the area of clinical interest and shall provide the same degree of protection as is
required of the housing.
2356
2357
6.8.1.(3)
The total filtration permanently in the useful beam shall meet the
requirement of RH 6.4.2.5.(1).
2358
2359
6.8.1.4 Exposure Reproducibility. The coefficient of variation of exposure shall not
exceed 0.10 when all technique factors are held constant.
6 - 69
Colorado Radiation Regulations, Proposed Revised Part 6
2360
6.8.2.21.5
May 12, 2017
A method shall be provided for visually defining the perimeter of the x-ray field.
2361
2362
2363
2364
2365
(1)
2366
2367
6.8.1.6 A device shall be provided to terminate the exposure after a preset time or
exposure.
2368
2369
6.8.1.7 A dead-man type of exposure switch shall be provided, together with an electrical
cord of sufficient length, so that the operator can stand out of the useful beam.
2370
The total misalignment of the edges of the visually defined field with the
respective edges of the x-ray field along either the length or width of the visually
defined field shall not exceed 52 (fiveTWO) percent of the distance from the
source to the center of the visually defined field when the surface upon which it
appears is perpendicular to the axis of the x-ray beam.
6.8.2.3 Structural Shielding.
2371
2372
2373
(1)
All wall, ceiling, and floor areas shall be equivalent to or provided with applicable
protective barriers to assure compliance with RH 4.6, 4.12, 4.13, and 4.14 of
these Regulations.
2374
2375
2376
(2)
A VETERINARY INSTALLATION SHALL MEET THE REQUIREMENTS OF
6.3.2 IN ORDER TO MINIMIZE RADIATION EXPOSURE TO PERSONNEL
AND INDIVIDUAL MEMBERS OF THE PUBLIC.
2377
2378
2379
(3)6.8.2.1
Veterinary facilities are exempt from the requirements of Appendix 6B,
provided that SO LONG AS the REQUIREMENTS OF 6.8.3 ARE MET.operator
is adequately protected by distance and/or shielding
2380
6.8.2.4 LINEARITY SHALL BE IN ACCORD WITH 21 CFR 1020.31(c)(3).
2381
6.8.2.5 ACCURACY.
2382
2383
2384
(1)
DEVIATION OF EXPOSURE SETTINGS FROM INDICATED VALUES SHALL
NOT EXCEED THE LIMITS SPECIFIED FOR THAT SYSTEM BY ITS
MANUFACTURER.
2385
2386
(2)
IF MANUFACTURER SPECIFICATIONS ARE NOT AVAILABLE, THE
FOLLOWING CRITERIA SHALL BE USED:
2387
2388
(a)
THE KVP SHALL NOT DEVIATE FROM INDICATED VALUES BY
MORE THAN TEN (10) PERCENT.
2389
2390
(b)
THE TIMER ACCURACY SHALL NOT DEVIATE FROM INDICATED
VALUES BY MORE THAN:
2391
2392
(i)
TEN (10) PERCENT FOR AN INDICATED TIME OF GREATER
THAN 20 MS; OR
2393
2394
(ii)
FIFTY (50) PERCENT FOR AN INDICATED TIME OF 20 MS
OR LESS, OR 1 PULSE, WHICHEVER IS GREATER.
6 - 70
Colorado Radiation Regulations, Proposed Revised Part 6
2395
May 12, 2017
6.8.2.6 TIMERS.
2396
2397
2398
2399
(1)
MEANS SHALL BE PROVIDED TO TERMINATE THE EXPOSURE AT A
PRESET TIME INTERVAL, PRESET PRODUCT OF CURRENT AND TIME, A
PRESET NUMBER OF PULSES, OR A PRESET RADIATION EXPOSURE TO
THE IMAGE RECEPTOR.
2400
2401
2402
(2)
IT SHALL NOT BE POSSIBLE TO MAKE AN EXPOSURE WHEN THE TIMER
IS SET TO A “ZERO” OR “OFF” POSITION IF EITHER POSITION IS
PROVIDED.
2403
2404
(3)
TERMINATION OF EXPOSURE SHALL CAUSE AUTOMATIC RESETTING OF
THE TIMER TO ITS INITIAL SETTING OR TO “ZERO”.
2405
6.8.2.7 EXPOSURE REPRODUCIBILITY.
2406
2407
(1)
2408
2409
2410
2411
THE COEFFICIENT OF VARIATION OF EXPOSURE SHALL NOT EXCEED
0.05 WHEN ALL EXPOSURE SETTINGS ARE HELD CONSTANT.
6.8.2.8 A DEAD-MAN TYPE OF EXPOSURE SWITCH OR EQUIVALENT REMOTE DEVICE
SHALL ENABLE THE OPERATOR TO STAND OUT OF THE USEFUL BEAM.
6.8.3
EACH VETERINARY MEDICINE INSTALLATION SHALL HAVE THE FOLLOWING Ooperating
AND EXPOSURE CONTROL Pprocedures.
2412
2413
2414
2415
6.8.3.1 Whenever possible, the operator shall stand well away from the useful beam and the
animal BE POSITIONED during radiographic exposures SO THAT THE NEAREST
PORTION OF THE BODY IS AT LEAST 2 METERS (MORE THAN 6 FEET) FROM
BOTH THE TUBE HEAD AND THE NEAREST EDGE OF THE IMAGE RECEPTOR.
2416
2417
2418
6.8.3.2 No individual, other than the operator, shall be in the x-ray room while exposures are
being made, unless such individual's assistance is required and the person is adequately
protected by shielding and/or distance.
2419
2420
2421
2422
(1)
ALL OTHER STAFF AND ANCILLARY PERSONNEL REQUIRED FOR THE
PROCEDURE SHALL BE PROTECTED FROM DIRECT SCATTER
RADIATION BY PROTECTIVE APRONS OR WHOLE BODY PROTECTIVE
BARRIERS OF NOT LESS THAN 0.25 MILLIMETER LEAD EQUIVALENT.
6 - 71
Colorado Radiation Regulations, Proposed Revised Part 6
2423
2424
May 12, 2017
6.8.3.3 When an animal must be held in position during radiography, mechanical supporting or
restraining devices should be used.
2425
2426
2427
2428
(1)
EACH INDIVIDUAL OTHER THAN THE ANIMAL BEING EXAMINED SHALL
BE POSITIONED SUCH THAT NO PART OF THE BODY WILL BE STRUCK
BY THE USEFUL BEAM UNLESS PROTECTED BY A MINIMUM OF 0.5
MILLIMETER LEAD EQUIVALENT.
2429
2430
2431
2432
(12)
If the animal must be held by an individual, that individual shall be protected with
appropriate shielding devices, such as protective gloves and apron, and THE
INDIVIDUAL shall be so positioned that no part of his/her THE INDIVIDUAL’S
body will be struck by the useful beam.
2433
2434
(23)
The exposure of any individual used for this purpose shall be maintained below
the limits specified in RH 4.6, 4.12, and 4.13.
2435
2436
2437
2438
6.8.3.4 No human shall hold the image receptor during radiography unless that individual is
protected with appropriate shielding devices, such as protective gloves and apron, and
that any part of his/her THE INDIVIDUAL’S body struck by the useful beam shall be
monitored.
2439
2440
(1)
2441
2442
The exposure of any individual used for this purpose shall be maintained below
the limits specified in RH 4.6, 4.12, and 4.13.
6.8.3.5 USE OF PORTABLE HAND-HELD X-RAY EQUIPMENT SHALL BE CONSISTENT
WITH APPENDIX 6E.
2443
2444
6.8.4
EACH VETERINARY X-RAY IMAGING SYSTEM SHALL FOLLOW MANUFACTURER
MAINTENANCE SPECIFICATIONS.
2445
2446
6.8.5
EACH VETERINARY X-RAY IMAGING SYSTEM SHALL HAVE WRITTEN QUALITY
CONTROL AND QUALITY ASSURANCE PROCEDURES THAT INCLUDE:
2447
2448
6.8.5.1 FOR PROCESSING OF VETERINARY FILMS, PERFORMANCE OF THE
FOLLOWING:
2449
2450
(1)
FOLLOW APPLICABLE MANUFACTURER’S TIME AND TEMPERATURE
SPECIFICATIONS, WHICH SHALL BE AVAILABLE FOR REVIEW;
2451
(2)
MEASURE AND LOG TEMPERATURE EACH DAY OF USE; AND
2452
2453
(3)
DOCUMENT IN A WRITTEN LOG THE CHANGE OF DEVELOPER
CHEMICALS AT LEAST EVERY MONTH.
2454
6.8.5.2 ANNUAL REVIEW OF ALL QUALITY CONTROL TESTS.
6 - 72
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
2455
SPECIAL REQUIREMENTS FOR COMPUTED TOMOGRAPHY
2456
RH 6.9 SAFE USE OF A Computed Tomography X-Ray Systems.
2457
6.9.1
ADMINISTRATIVE CONTROLS.
2458
2459
2460
6.9.1.1 IN ADDITION TO THE PROVISIONS OF 6.3 AND 6.4, THE REQUIREMENTS OF THIS
6.9 APPLY TO EQUIPMENT AND ASSOCIATED FACILITIES USED FOR COMPUTED
TOMOGRAPHY.
2461
2462
2463
6.9.1.2 SUPERVISION AND OPERATION OF A COMPUTED TOMOGRAPHY SYSTEM USED
ON LIVING HUMANS SHALL BE BY AN INDIVIDUAL WHO HAS ADEQUATE
RADIATION SAFETY TRAINING AND EXPERIENCE.
2464
(1)
SUPERVISION SHALL BE CONSISTENT WITH 6.3.1.7.
2465
2466
(2)
TRAINING AND EXPERIENCE SHALL BE AS PROVIDED IN 2.6.1, IN
PARTICULAR 2.6.1.9 AND APPENDIX 2E, AND 6.3.1.8.
2467
Definitions.
2468
2469
In addition to the definitions provided in RH 1.4 and 6.2 of these Regulations, the following
definitions shall be applicable to RH 6.9:
2470
2471
2472
“Computed tomography dose index (CTDI)” means the integral from -7T to +7T of the dose profile
along a line perpendicular to the tomographic plane divided by the product of the nominal
tomographic section thickness and the number of tomograms produced in a single scan, that is:
-7T
1
∫
CTDI =
nT
D(z) dz
+7T
2473
where:
2474
z = Position along a line perpendicular to the tomographic plane.
2475
D(z) = Dose at position z.
2476
T = Nominal tomographic section thickness.
2477
n = Number of tomograms produced in a single scan.
2478
2479
This definition assumes that the dose profile is centered around z=0 and that, for a multiple
tomogram system, the scan increment between adjacent scans is nT.
2480
2481
“Contrast scale (CS)” means the change in the linear attenuation coefficient per CTN relative to
water, that is:
μx - μw
CS =
(CTN)x - (CTN)w
2482
where:
6 - 73
Colorado Radiation Regulations, Proposed Revised Part 6
2483
μx = Linear attenuation coefficient of the material of interest.
2484
μw = Linear attenuation coefficient of water.
2485
(CTN)x = CTN of the material of interest.
2486
(CTN)w = CTN of water.
May 12, 2017
2487
2488
2489
“CT conditions of operation” means all selectable parameters governing the operation of a CT xray system including, but not limited to, nominal tomographic section thickness, filtration, and the
technique factors as defined in RH 6.2.
2490
2491
“CT gantry” means the tube housing assemblies, beam-limiting devices, detectors, and the
supporting structures and frames which hold these components.
2492
2493
“CT number (CTN)” means the number used to represent the x-ray attenuation associated with
each elemental area of the CT image.
k (μx - μw)
CTN =
μw
2494
where:
2495
k = A constant3
2496
3
The constant has a normal value of 1,000 when the Houndsfield scale of CTN is used.
2497
μx = Linear attenuation coefficient of the material of interest.
2498
μw = Linear attenuation coefficient of water.
2499
2500
2501
“Dose profile” means the dose as a function of position along a line. “Elemental area” means the
smallest area within a tomogram for which the x-ray attenuation properties of a body are
depicted. (Ssee also “Ppicture element”).
2502
2503
“Multiple tomogram system” means a computed tomography x-ray system which obtains x-ray
transmission data simultaneously during a single scan to produce more than one tomogram.
2504
2505
“Noise” means the standard deviation of the fluctuations in CTN expressed as a percentage of
the attenuation coefficient of water. Its estimate (S n) is calculated using the following expression:
100 × CS × s
Sn =
μw
2506
where:
2507
CS = Contrast scale
2508
μw = Linear attenuation coefficient of water.
2509
2510
s = Estimated standard deviation of the CTN of picture elements in a specified area of the
CT image.
6 - 74
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
2511
2512
2513
“Nominal tomographic section thickness” means the full width at half-maximum of the sensitivity
profile taken at the center of the cross-sectional volume over which x-ray transmission data are
collected.
2514
“Picture element” means an elemental area of a tomogram.
2515
“Reference plane” means a plane which is displaced from and parallel to the tomographic plane.
2516
2517
2518
“Scan” means the complete process of collecting x-ray transmission data for the production of a
tomogram. Data can be collected simultaneously during a single scan for the production of one or
more tomograms.
2519
2520
“Scan increment” means the amount of relative displacement of the patient with respect to the CT
x-ray system between successive scans measured along the direction of such displacement.
2521
2522
“Scan sequence” means a pre-selected set of two or more scans performed consecutively under
pre-selected CT conditions of operation.
2523
2524
“Scan time” means the period of time between the beginning and end of x-ray transmission data
accumulation for a single scan.
2525
2526
“Single tomogram system” means a CT x-ray system which obtains x-ray transmission data
during a scan to produce a single tomogram.
2527
2528
“Tomographic plane” means that geometric plane which is identified as corresponding to the
output tomogram.
2529
2530
“Tomographic section” means the volume of an object whose x-ray attenuation properties are
imaged in a tomogram.
2531
2532
2533
2534
2535
2536
2537
2538
2539
2540
6.9.2
Requirements for Equipment.EACH COMPUTED TOMOGRAPHY FACILITY SHALL MEET THE
FOLLOWING EQUIPMENT DESIGN AND CONFIGURATION REQUIREMENTS.
6.9.2.1 Termination of Exposure.
6.9.2.1.(1)
Means shall be provided to terminate the x-ray exposure automatically
by either de-energizing the x-ray source or shuttering the x-ray beam in the event
of equipment failure affecting data collection.
(a)
Such termination shall occur within an interval that limits the total scan
time to no more than 110 percent of its preset value through the use of
either a backup timer or devices which THAT monitor equipment
function.
2541
2542
6.9.2.1.(2)
A visible signal shall indicate when the x-ray exposure has been
terminated through the means required by RH 6.9.2.1.(1).
2543
2544
2545
6.9.2.1.(3)
The operator shall be able to terminate the x-ray exposure at any time
during a scan, or series of scans under CT x-ray system control, of greater than
one-half second duration.
6 - 75
Colorado Radiation Regulations, Proposed Revised Part 6
2546
May 12, 2017
6.9.2.2 Tomographic Plane Indication and Alignment.
2547
2548
2549
6.9.2.2.(1)
For any single tomogram system, means shall be provided to permit
visual determination of the tomographic plane or a reference plane offset from
the tomographic plane.
2550
2551
2552
6.9.2.2.2
For any multiple tomogram system, mMeans shall be provided to permit
visual determination of the location of a reference TOMOGRAPHIC plane. This
reference plane can be offset from the location of the tomographic planes.
2553
2554
2555
2556
6.9.(2).2.3
If a device using a light source is used to satisfy RH 6.9.2.1.(1) or
6.9.2.2.2, the light source shall provide illumination levels sufficient to permit
visual determination of the location of the tomographic plane or reference plane
under ambient light conditions of up to 500 lux (46 foot candles).
2557
6.9.2.3 Beam-On and Shutter Status Indicators and Control Switches.
2558
2559
6.9.2.3.(1)
The CT x-ray control and gantry shall provide visual indication whenever
x-rays are produced and, if applicable, whether the shutter is open or closed.
2560
2561
6.9.2.3.(2)
Each emergency button or switch shall be clearly labeled as to its
function.
2562
6.9.2.4 PATIENT COMMUNICATION.
2563
2564
(1)
PROVISION SHALL BE MADE FOR TWO-WAY AURAL COMMUNICATION
BETWEEN THE PATIENT AND THE OPERATOR AT THE CONTROL PANEL.
2565
2566
2567
2568
2569
(2)
WINDOWS, MIRRORS, CLOSED-CIRCUIT TELEVISION, OR AN
EQUIVALENT SHALL BE PROVIDED TO PERMIT CONTINUOUS
OBSERVATION OF THE PATIENT DURING IRRADIATION AND SHALL BE
SO LOCATED THAT THE OPERATOR CAN OBSERVE THE PATIENT FROM
THE CONTROL PANEL.
2570
2571
(3)
PATIENT SCANNING SHALL BE ALLOWED ONLY WHEN A VIEWING
SYSTEM IS AVAILABLE AND IN USE.
6 - 76
Colorado Radiation Regulations, Proposed Revised Part 6
2572
2573
2574
6.9.3
May 12, 2017
EACH COMPUTED TOMOGRAPHY FACILITY SHALL HAVE THE FOLLOWING OPERATING
PROCEDURES AND RADIATION EXPOSURE CONTROLS.
6.9.3.1 CONSOLE PERFORMANCE.
2575
2576
(1)
THE CT X-RAY SYSTEM SHALL NOT BE OPERATED EXCEPT BY AN
INDIVIDUAL WHO HAS BEEN SPECIFICALLY TRAINED IN ITS OPERATION.
2577
2578
(2)
INFORMATION SHALL BE READILY AVAILABLE REGARDING THE
OPERATION OF THE SYSTEM.
2579
2580
(3)
INFORMATION REGARDING CALIBRATION OF THE SYSTEM SHALL BE
READILY AVAILABLE, INCLUDING:
2581
2582
2583
(a)
DATES OF THE LATEST CALIBRATION AND SPOT CHECKS AND
THE LOCATION WITHIN THE FACILITY WHERE THE RESULTS OF
THOSE TESTS MAY BE OBTAINED;
2584
2585
2586
2587
2588
2589
(b)
INSTRUCTIONS ON THE USE OF THE CT PERFORMANCE
PHANTOM(S) INCLUDING A SCHEDULE OF SPOT CHECKS
APPROPRIATE FOR THE SYSTEM, ALLOWABLE VARIATIONS FOR
THE INDICATED PARAMETERS, AND THE RESULTS OF AT LEAST
THE MOST RECENT SPOT CHECKS CONDUCTED ON THE
SYSTEM;
2590
2591
2592
2593
2594
2595
(c)
WHEN OPERATORS MUST SELECT EXPOSURE SETTINGS, A
CURRENT PROTOCOL SHALL BE AVAILABLE AT THE CONTROL
PANEL THAT SPECIFIES FOR EACH ROUTINE EXAMINATION THE
CT CONDITIONS OF OPERATION AND THE TYPICAL NUMBER OF
SCANS PER EXAMINATION, INCLUDING GUIDANCE FOR AGEAPPROPRIATE SCANNING.
2596
6.9.3.2.4
Indication of CT Conditions of Operation.
2597
2598
2599
(1)
The CT x-ray system shall be designed such that the CT conditions of operation
to be used during a scan or a scan sequence shall be indicated prior to the
initiation of a scan or a scan sequence.
2600
2601
(2)
On equipment having all or some of these conditions of operation at fixed values,
this requirement may be met by permanent markings.
2602
2603
(3)
Indication of CT conditions of operation shall be visible from any position from
which scan initiation is possible.
2604
2605
2606
6.9.3.32.5
(1)
Extraneous Radiation.
When data are not being collected for image production, the radiation adjacent to
the tube port shall not exceed that permitted by RH 6.4.2.3.
6 - 77
Colorado Radiation Regulations, Proposed Revised Part 6
2607
2608
May 12, 2017
6.9.3.42.6
Additional Requirements Applicable to CT X-Ray Systems Containing a Gantry
Manufactured After September 2, 1992.
2609
2610
6.9.2.6.(1)
The total error in the indicated location of the tomographic plane or
reference plane shall not exceed 5 millimeters.
2611
2612
2613
2614
6.9.2.6.(2)
If the x-ray production period is less than one-half second, the indication
of x-ray production shall be actuated for at least one-half second. Indicators at or
near the gantry shall be discernible from any point external to the patient opening
where insertion of any part of the human body into the primary beam is possible.
2615
2616
2617
6.9.2.6.(3)
The deviation of indicated scan increment versus actual increment shall
not exceed plus or minus 1 millimeter with any mass from 0 to 100 kilograms
resting on the support device.
2618
2619
2620
2621
(a)
The patient support device shall be incremented from a typical starting
position to the maximum incremented distance, THE
MANUFACTURER’S SPECIFIED DISTANCE, or 30 cmentimeters,
whichever is less, and then returned to the starting position.
2622
2623
(b)
Measurement of actual versus indicated scan increment may be taken
anywhere along this travel.
2624
2625
2626
2627
2628
(c)
For multi-slice scanners whereWHEN table increment is not the primary
means of slice position location, the qualified expert REGISTERED
MEDICAL PHYSICIST may provide for prior written Department review
and approval alternative measurement procedures to determine the
accuracy of slice position.
2629
2630
2631
2632
2633
2634
2635
2636
6.9.2.6.(4)
Premature termination of the x-ray exposure by the operator shall
necessitate resetting of the CT conditions of operation prior to the initiation of
another scan.
6.9.3
Facility Design Requirements.
6.9.3.1 Aural Communication.
Provision shall be made for two-way aural communication between the patient and the
operator at the control panel.
6.9.3.2 Viewing Systems.
2637
2638
2639
2640
6.9.3.2.(1)
Windows, mirrors, closed-circuit television, or an equivalent shall be
provided to permit continuous observation of the patient during irradiation and
shall be so located that the operator can observe the patient from the control
panel.
2641
2642
6.9.3.2.(2)
Patient scanning shall be allowed only when a viewing system is
available and in use.
2643
2644
2645
(3)
C-arm-based CT systems utilizing image intensifier or flat panel detection
systems with cone beam geometry are exempt from the requirements of
6.9.3.2(1) and 6.9.3.2(2).
6 - 78
Colorado Radiation Regulations, Proposed Revised Part 6
2646
2647
2648
2649
2650
2651
2652
2653
6.9.4
May 12, 2017
EACH COMPUTED TOMOGRAPHY FACILITY SHALL CONDUCT REQUIRED Ssurveys,
Eevaluations, Ccalibrations, AND Sspot Cchecks, and Operating Procedures.
6.9.4.1 Radiation Surveys and Evaluations.
6.9.4.1.(1)
All CT x-ray systems installed after September 1, 1992 and those
systems not previously surveyed shall have a shielding A RADIATION survey
SHALL BE made by, or under the direction SUPERVISION of, a qualified
expertREGISTERED MEDICAL PHYSICIST, TO VERIFY AND DOCUMENT
COMPLIANCE WITH 4.14 AND 4.15 FOR:.
2654
2655
2656
(a)
In addition, such surveys shall be done after aAny change in the facility
or equipment which THAT might cause a significant increase in radiation
hazard;.
2657
2658
2659
(b)
ANY INITIAL OR NEW LOCATION FOR A CT IMAGING SYSTEM
THAT IS DESIGNED TO BE TRANSPORTED FROM PLACE TO
PLACE.
2660
2661
2662
6.9.4.1.2
The registrant shall obtain a written report of the survey from the
qualified expert, and a copy of the report shall be made available to the
Department upon request.
2663
2664
2665
2666
2667
6.9.4.1.3(2)
Notwithstanding the provisions of RH 2.5.1.2, CT x-ray systems (OTHER
THAN C-ARM-BASED CT SYSTEMS UTILIZING IMAGE INTENSIFIER OR
FLAT PANEL DETECTION SYSTEMS) that have undergone aN X-RAY tube
change within 12 months of the last annual evaluation do not require a complete
calibration AT THE TIME OF THE X-RAY TUBE CHANGE, provided that:
2668
2669
2670
(a)
tThe CT x-ray system operation after the tube change meets the criteria
established by the qualified expertREGISTERED MEDICAL
PHYSICIST.; AND
2671
2672
2673
2674
(b)
The certification evaluation (CE) need not be performed each time an
x-ray tube is replaced. However, eEach CT system shall receive a
CERTIFICATION EVALUATION (CE) at least within one year of the
previous CE.
6 - 79
Colorado Radiation Regulations, Proposed Revised Part 6
2675
2676
2677
2678
2679
May 12, 2017
6.9.4.2 Radiation CalibrationsDOSIMETRY.
6.9.4.2.(1)
The calibration of the radiation output of the CT x-ray system shall be
performMEASURed by, or under the direction PERSONAL SUPERVISION of, a
qualified expertREGISTERED MEDICAL PHYSICIST: who is physically present
at the facility during such calibration.
2680
2681
2682
6.9.4.2.2(a)
The calibration of a CT x-ray system shall be performed aAt
intervals, (not exceeding one year), specified by a qualified
expertREGISTERED MEDICAL PHYSICIST;
2683
2684
2685
2686
2687
2688
2689
6.9.4.2.3(b)
IN ACCORDANCE WITH PROTOCOLS PUBLISHED BY
NATIONALLY RECOGNIZED ORGANIZATIONS (FOR EXAMPLE,
AAPM REPORT 96), UNLESS THE REGISTERED MEDICAL
PHYSICIST DETERMINES THAT A PARTICULAR
RECOMMENDATION OF SUCH REPORT IS NOT WARRANTED FOR
THE CLINICAL TASKS FOR WHICH THE EQUIPMENT WILL BE
USED;
2690
2691
(c)
The calibration of the radiation output of a CT x-ray system shall be
performed wWith a calibrated dosimetry system.
2692
2693
(i)
The calibration of such system shall be tTraceable to a national
standard.; AND
2694
2695
(ii)
The dosimetry system shall have been cCalibrated within the
preceding two (2) years.
2696
2697
2698
(2)
CT DOSIMETRY SHALL BE EVALUATED BY A REGISTERED MEDICAL
PHYSICIST IN ACCORDANCE WITH PROTOCOLS PUBLISHED BY A
NATIONALLY RECOGNIZED ORGANIZATION.
2699
2700
2701
6.9.4.2.(4)
CT dosimetry phantom(s) shall be used in determining the radiation
output of a CT x-ray system. Such phantom(s) shall meet the following
specifications and conditions of use:
2702
2703
2704
2705
2706
2707
6.9.4.2.4.1
CT dosimetry phantom(s) shall be right circular cylinders of water
or polymethyl methacrylate. The phantom(s) shall be at least
14 centimeters in length and shall have diameters of 32 centimeters for
testing CT x-ray systems designed to image any section of the body and
centimeters16 centimeters for systems designed to image the head or for
whole body scanners operated in the head scanning mode.
2708
2709
2710
2711
2712
6.9.4.2.4.2
CT dosimetry phantom(s) shall provide means for the placement
of a dosimeter(s) along the axis of rotation and along a line parallel to the
axis of rotation 1 centimeter from the outer surface and within the
phantom. Means for the placement of dosimeters or alignment devices at
other locations may be provided.
2713
2714
2715
2716
2717
6.9.4.2.4.3
Any effects on the doses measured due to the removal of
phantom material to accommodate dosimeters shall be accounted for
through appropriate corrections to the reported data or included in the
statement of maximum deviation for the values obtained using the
phantom.
6 - 80
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
2718
2719
2720
6.9.4.2.4.4
All dose measurements shall be performed with the CT
dosimetry phantom placed on the patient couch or support device
without additional attenuation materials present.
2721
2722
6.9.4.2.5.
The calibration shall be required for each common type of head, body, or
whole-body scan performed at the facility.
2723
6.9.4.2.6
Calibration shall meet the following requirements:
6.9.4.2.6.1
The CTDI 4 along the two axes specified in 6.9.4.2.4.2 shall be
measured.
2724
2725
2726
2727
2728
2729
(i)
The CT dosimetry phantom shall be oriented so that the
measurement point 1 centimeter from the outer surface and
within the phantom is in the same angular position within the
gantry as the point of maximum surface CTDI identified.
2730
2731
(ii)
The CT conditions of operation shall correspond to typical values
used by the registrant. 4
2732
2733
2734
(iii)
For the purpose of determining the CTDI, the manufacturer's
statement as to the nominal tomographic section thickness for
that particular system may be utilized.
2735
6.9.4.2.6.2
2736
6.9.4.2.7
2737
2738
(3)
2739
The spot checks specified in RH 6.9.4.3 shall be made.
Calibration procedures shall be in writing.
Records of calibrationMEASUREMENTs performed shall be maintained for a
period of three (3) years for inspection by the Department.
6.9.4.3 Spot Checks.
2740
2741
6.9.4.3.(1)
The spot-check procedures shall be in writing and shall have been
developed by a qualified expertREGISTERED MEDICAL PHYSICIST.
2742
2743
2744
2745
2746
6.9.4.3.(2)
The spot-check procedures shall incorporate the use of a
COMMENSURATE CT performance phantoms which has a capability of
providing an indication of contrast scale, noise, nominal tomographic section
thickness, the resolution capability of the system for low and high contrast
objects, and measuring the mean CTN for water or other reference material.
2747
2748
2749
6.9.4.3.(3)
All spot checks shall be included in the calibration required by RH 6.9.4.2
and PERFORMED at time intervals and under system conditions specified by a
qualified expertREGISTERED MEDICAL PHYSICIST.
6 - 81
Colorado Radiation Regulations, Proposed Revised Part 6
2750
2751
2752
2753
2754
May 12, 2017
6.9.4.3.(4)
Spot checks shall include acquisition of images obtained with the CT
performance phantom(s) using the same processing mode and CT conditions of
operation as are used to perform calibrations required by RH 6.9.4.2. The
iImages OF THE SPOT CHECKS shall be retained, AT LEAST until a new
calibration is performed, as follows:
2755
2756
6.9.4.3.4.1(a) pPhotographic copies of the images obtained from the image
recording device; or
2757
2758
6.9.4.3.4.2(b) iImages stored in digital form on a storage medium compatible
with the CT x-ray system.
2759
2760
2761
6.9.4.3.(5)
Written OR ELECTRONIC records of the spot checks performed shall be
maintained for inspection by the Department.
6.9.4.4 Operating Procedures.
2762
2763
6.9.4.4.1
The CT x-ray system shall not be operated except by an individual who
has been specifically trained in its operation.
2764
2765
2766
6.9.4.4.2
Information shall be available at the control panel regarding the operation
of the system. Information regarding calibration of the system shall be readily
available. Such information shall include the following:
2767
2768
6.9.4.4.2.1
dates of the latest calibration and spot checks and the location within
the facility where the results of those tests may be obtained;
2769
2770
2771
2772
6.9.4.4.2.2
instructions on the use of the CT performance phantom(s) including
a schedule of spot checks appropriate for the system, allowable
variations for the indicated parameters, and the results of at least the
most recent spot checks conducted on the system;
2773
2774
6.9.4.4.2.3
the distance in millimeters between the tomographic plane and the
reference plane if a reference plane is utilized; and
2775
2776
2777
2778
6.9.4.4.2.4
when operators must select technique factors, a current technique
chart shall be available at the control panel which specifies for each
routine examination the CT conditions of operation and the typical
number of scans per examination.
2779
2780
2781
2782
6.9.4.4.3
If the calibration or spot check of the CT x-ray system identifies that a
system operating parameter has exceeded a tolerance established by the
qualified expert, use of the CT x-ray system on patients shall be limited to those
uses permitted by established written instructions of the qualified expert.
6 - 82
Colorado Radiation Regulations, Proposed Revised Part 6
2783
2784
2785
2786
2787
6.9.5
May 12, 2017
EACH COMPUTED TOMOGRAPHY SYSTEM SHALL HAVE WRITTEN QUALITY CONTROL
AND QUALITY ASSURANCE PROCEDURES CONSISTENT WITH 6.3.5, INCLUDING:
6.9.5.1 IF A CALIBRATION REQUIRED BY 6.9.4.2 OR A SPOT CHECK REQUIRED BY
6.9.4.3 IDENTIFIES THAT A SYSTEM OPERATING PARAMETER IS OUTSIDE A
SPECIFIED OR RECOMMENDED TOLERANCE OR RANGE:
2788
2789
2790
(1)
THE CT X-RAY SYSTEM SHALL NOT BE USED ON A PATIENT EXCEPT AS
PERMITTED BY DOCUMENTED INSTRUCTIONS OF A REGISTERED
MEDICAL PHYSICIST; AND
2791
2792
(2)
CORRECTION OR MODIFICATION SHALL BE MADE WITHIN 30 DAYS OF
THE DATE OF THE TEST IDENTIFYING THE PROBLEM.
2793
2794
2795
2796
6.9.5.2 THE COMPUTED TOMOGRAPHY SYSTEM SHALL MEET THE SPECIFICATIONS
AND/OR SPECIFICATIONS OF THE MANUFACTURER OR REGISTERED MEDICAL
PHYSICIST AND/OR APPROPRIATE NATIONALLY RECOGNIZED ORGANIZATION,
OR EQUIVALENT APPROVED BY THE DEPARTMENT, FOR:
2797
(1)
ALIGNMENT LIGHT ACCURACY;
2798
(2)
SLICE THICKNESS;
2799
(3)
IMAGE QUALITY; AND
2800
(4)
CT NUMBER ACCURACY.
2801
2802
6.9.5.3 ALL QUALITY CONTROL TESTS SHALL BE REVIEWED BY A REGISTERED
MEDICAL PHYSICIST AT LEAST ANNUALLY.
6 - 83
Colorado Radiation Regulations, Proposed Revised Part 6
2803
SPECIAL REQUIREMENTS FOR MAMMOGRAPHY
2804
RH 6.10
2805
6.10.1 ADMINISTRATIVE CONTROLS.
May 12, 2017
SAFE USE AT A Mammography FACILITY.
2806
2807
2808
6.10.1.1
IN ADDITION TO THE PROVISIONS OF 6.3 AND 6.4, THE REQUIREMENTS
OF 6.10 APPLY TO EQUIPMENT AND ASSOCIATED FACILITIES USED FOR
MAMMOGRAPHY.
2809
6.10.1.2
Each facility performing mammography shall:
2810
(1)
Meet the requirements of 21 CFR 900;
2811
2812
2813
(2)
Have a valid certificate issued by the U.S. Department of Health and Human
Services pursuant to the Mammography Quality Standards Reauthorization Act
of 1998, Public Law 105-248, and 21 CFR 900;
2814
2815
(3)
Ensure that 210 CFR 900 quality control and quality assurance standards for
maintaining viewing conditions and interpretation of an image are met.
2816
Definitions.
2817
2818
“Continuing education unit (CEU)” means one contact hour of training or education, which is
documentable.
2819
2820
“Established operating level” means the value of a particular quality assurance parameter that
has been established as an acceptable normal level by the facility's quality assurance program.
2821
2822
2823
2824
“Facility” means a hospital, outpatient Department, clinic, radiology practice, mobile unit, office of
a physician, or other facility that conducts mammography activities, including the following:
operation of equipment to produce a mammogram, initial interpretation of the mammogram, and
maintaining viewing conditions for that interpretation.
2825
“Laterality” means the designation of either the right or left breast.
2826
“Mammogram” means a radiographic image produced through mammography.
2827
2828
2829
2830
“Mammography” means radiography of the breast, but for the purposes of this part, does not
include: radiography of the breast performed during invasive interventions for localization or
biopsy procedures; or radiography of the breast performed with an investigational mammography
device as part of a scientific study conducted.
2831
2832
2833
2834
“Mammography phantom” means a test object used to simulate radiographic characteristics of
compressed breast tissue and containing components that radiographically model aspects of
breast disease and cancer. For the purpose of this section, phantom means mammography
phantom.
2835
2836
“Mammography medical outcomes audit” means a systematic collection of mammography results
and the comparison of those results with outcomes data.
2837
2838
“Patient” means any individual who undergoes a mammography evaluation in a facility,
regardless of whether the person is referred by a physician or is self-referred.
6 - 84
Colorado Radiation Regulations, Proposed Revised Part 6
2839
2840
2841
2842
2843
May 12, 2017
“Standard breast” means a 4.2 centimeter (cm) thick compressed breast consisting of fifty (50)
percent glandular and fifty (50) percent adipose tissue.
6.10.2 Quality Standards.
6.10.2.1
Personnel.
6.10.2.1.1
Radiologic Technologists.
2844
2845
All mammographic examinations shall be performed by a person who meets the
following requirements.
2846
6.10.2.1.1.1
2847
2848
2849
2850
2851
2852
2853
2854
2855
2856
2857
2858
2859
2860
2861
2862
2863
General Requirements.
Be approved by the Department as a mammographer, as defined in RH
2.2 and has met the requirement of RH 2.4.4.1.1.1; or as a provisional
mammographer, as specified under RH 2.4.4; or as a student
radiographer working under the provision of RH 2.4.4.1.3; and
6.10.2.1.1.1
Continuing Education.
The mammographer shall document fifteen (15) hours of continuing
education which are no more than 36 months old. Mammographers who
fail to meet this continuing education requirement shall obtain a sufficient
number of continuing education units (CEU) in mammography to bring
their total up to at least fifteen (15) CEU.
6.10.2.1.1.1
Continuing Experience.
The mammographer shall have performed a minimum of 200
mammography examinations every 24 months. Mammographers who fail
to meet the continuing experience requirement of RH 6.10.2.1.1.3 shall
perform a minimum of 25 mammography examinations under the direct
supervision of a qualified mammographer, before resuming the
performance of unsupervised mammography examinations.
2864
2865
2866
6.10.1.32.1.2 Qualified Inspectors.All EACH qualified inspectors WHO conductingS A
mammography facility and x-ray machine CERTIFICATION evaluations shall meet the
requirements of Appendix 2IB.1.c. of Part 2.
2867
2868
2869
6.10.1.4
EACH INDIVIDUAL WHO PERFORMS A MAMMOGRAPHY EXAMINATION
SHALL MEET THE APPLICABLE ADEQUATE RADIATION SAFETY TRAINING AND
EXPERIENCE REQUIREMENTS OF 2.4.5.4, 2.6.1.6 AND APPENDIX 2M.
6 - 85
Colorado Radiation Regulations, Proposed Revised Part 6
2870
2871
2872
May 12, 2017
6.10.1.5
IN THE STATE OF COLORADO, THE REGULATORY REQUIREMENTS OF
PART 6 SHALL ALSO APPLY AS APPROPRIATE TO RADIOGRAPHY OF THE
BREAST PERFORMED:
2873
2874
(1)
DURING INVASIVE INTERVENTIONS FOR LOCALIZATION OR BIOPSY (FOR
EXAMPLE, STEREOTACTIC BIOPSY PROCEDURES); OR
2875
2876
2877
(2)
WITH AN INVESTIGATIONAL DEVICE AS PART OF A SCIENTIFIC STUDY
CONDUCTED IN ACCORDANCE WITH FDA INVESTIGATIONAL DEVICE
EXEMPTION REGULATIONS; OR
2878
2879
(3)
DURING ANY OTHER PROCEDURE FOR RADIOGRAPHY OF THE BREAST
THAT THE DEPARTMENT DETERMINES AND DESIGNATES.
2880
2881
2882
2883
6.10.1.6
THE REGISTRANT SHALL ESTABLISH AND MAINTAIN A QUALITY
ASSURANCE PROGRAM TO ENSURE THE SAFETY, RELIABILITY, CLARITY, AND
ACCURACY OF MAMMOGRAPHY SERVICES PERFORMED AT THE FACILITY,
WHICH PROGRAM SHALL:
2884
2885
2886
2887
(1)
FOLLOW MANUFACTURERS’ SPECIFICATIONS AND/OR THE STANDARDS
OF AN APPROPRIATE NATIONALLY RECOGNIZED ORGANIZATION, FOR
EXAMPLE, THE AMERICAN COLLEGE OF RADIOLOGY OR AMERICAN
ASSOCIATION OF PHYSICISTS IN MEDICINE; AND
2888
2889
(2)
APPLY TO AND BE ADHERED TO FOR EACH PROCEDURE SUBJECT TO
6.10.1.
2890
2891
2892
2893
2894
2895
2896
2897
2898
2899
2900
6.10.2.2
Equipment.Only x-ray systems meeting the following standards shall be used:
6.10.2.2.1
(1)
6.10.2.2.2
(1)
6.10.2.2.3
System Design.
The x-ray system shall be specifically designed for mammography.; and
Image Receptor Sizes.
Systems using screen-film image receptors shall provide, at a minimum, for
operation with image receptors of 18 × 24 centimeters (cm) and 24 × 30 cm. The
image receptors shall be equipped with moving grids matched to all image
receptor sizes provided. Systems used for magnification procedures shall be
capable of operation with the grid removed from between the source and image
receptor;.
Beam Limitation and Light Fields.
2901
2902
2903
(1)
All systems shall have beam-limiting devices that allow the useful beam to
extend to or beyond the chest wall edge of the image receptor and shall meet the
requirement of RH 6.10.2.6.8.
2904
2905
(2)
When a light localizer is used to define the x-ray field, it shall meet the
requirement of RH 6.6.6.3.2.
2906
2907
2908
6.10.2.2.4
(1)
Magnification.
Systems used to perform non-interventional problem-solving procedures shall
have radiographic magnification capability available for use by the operator.
6 - 86
Colorado Radiation Regulations, Proposed Revised Part 6
2909
2910
2911
(2)
6.10.2.2.5
May 12, 2017
Systems used for magnification procedures shall provide, as a minimum, at least
one magnification value within the range of 1.4 to 2.0.
Focal Spot Selection.
2912
2913
(1)
When more than one focal spot is provided, the system shall indicate, prior to the
exposure, which focal spot is selected.
2914
2915
(2)
When more than one target material is provided, the system shall indicate, prior
to the exposure, the preselected target material.
2916
2917
2918
(3)
When the target material and/or focal spot is automatically selected by the
machine, the system shall display, after the exposure, the used target material
and/or focal spot.
2919
6.10.2.2.6
Compression.
2920
(1)
All mammography systems shall incorporate a compression device.
2921
2922
2923
2924
6.10.2.2.6.1
Application of Compression. Effective October 28, 2002, each system
shall provide an initial power driven compression activated by hands-free controls
and fine adjustment compression controls operable from both sides of the
patient.
2925
2926
2927
6.10.2.2.6.2
Compression Paddle. Systems shall be equipped with different sized
compression paddles that match the sizes of all full-field image receptors
provided for the system.
2928
2929
2930
2931
6.10.2.2.6.2.1 The compression paddle shall be flat and parallel to the breast
support table and shall not deflect from parallel by more than 1 cm at any
point on the surface of the compression paddle when compression is
applied.
2932
2933
2934
2935
6.10.2.2.6.2.2 Equipment intended by the manufacturer's design to not be flat
and parallel to the breast support table during compression shall meet
the manufacturer's design specifications and maintenance requirements.
Such equipment is exempt from the requirement of RH 6.10.2.2.6.2.1.
2936
2937
6.10.2.2.6.2.3 The chest wall edge of the compression paddle shall be straight
and parallel to the edge of the image receptor.
2938
2939
6.10.2.2.6.2.4 The chest wall edge may be bent upward to allow for patient
comfort but shall not appear on the image.
2940
6.10.2.2.7
Technique Factor Selection and Display.
2941
2942
(1)
Manual selection of milliampere seconds (mAs) or at least one of its component
parts [milliampere (mA) and time] shall be available.
2943
2944
2945
2946
6.10.2.2.7.1
The technique factors (kVp, mA and time in second or milliseconds, or
mAs) to be used during an exposure shall be indicated prior to the exposure,
except when the automatic exposure controls (AEC) are used, in which case the
technique factors that are set prior to the exposure shall be indicated.
6 - 87
Colorado Radiation Regulations, Proposed Revised Part 6
2947
2948
2949
2950
2951
May 12, 2017
6.10.2.2.7.2
Following AEC mode use, the system shall indicate the actual kVp and
mAs used during the exposure. The mAs may be displayed as mA and time.
6.10.3.2.2.8
Automatic Exposure Control. All systems shall provide an AEC mode that is
operable in all combinations of equipment configuration, i.e., grid, non-grid, magnification,
non-magnification, and various target-filter combinations.
2952
2953
6.10.2.2.8.1 The size and available positions of the detector shall be clearly indicated on
the compression paddle.
2954
2955
2956
6.10.2.2.8.2 The system shall provide means for the operator to vary the selected optical
density (OD) from the normal or zero setting to the positive and/or negative
values of density settings.
2957
2958
2959
6.10.2.2.9
X-ray Film and Intensifying Screens. The registrant shall use x-ray film, and
intensifying screens, that have been designated by the manufacturers as appropriate and
screen/film compatible for mammography.
2960
6.10.2.2.10
2961
2962
2963
(1)
2964
6.10.2.2.11
2965
2966
(1)
2967
6.10.2.2.12
2968
2969
2970
(1)
Film Processing Solutions.
The registrant shall use chemical solutions that are capable of developing the
mammography films in a manner equivalent to the minimum requirements
specified by the film manufacturer.
Lighting.
Hot lights), capable of producing light levels greater than that provided by the
view box, shall be available for use to the interpreting physician.
Film Masking Devices.
The registrant shall ensure that film masking devices that can limit the illuminated
area to a region equal to or smaller than the exposed portion of the film are
available and used.
2971
2972
2973
6.10.2.2.13
Viewboxes used for interpreting mammograms and clinical quality review by the
technologist shall be capable of producing a luminance of at least 3,000 candela per
square meter (cd/-m-2).
2974
2975
6.10.2.3.1
Medical Records And Mammography Reports.6.10.2.3.1 Contents and
Terminology.
2976
2977
(1)
The registrant shall prepare a written report of the results of each mammography
examination performed.
2978
(2)
The report shall include:
2979
(a)
the name of the patient and an additional patient identifier;
2980
(b)
the date of the examination;
2981
2982
(c)
the name of the interpreting physician who interpreted the mammogram;
and
2983
(d)
the overall final assessment of findings.
6 - 88
Colorado Radiation Regulations, Proposed Revised Part 6
2984
6.10.2.3.2
May 12, 2017
Communication of Mammography Results to the Patient.
2985
2986
(1)
2987
2988
2989
2990
6.10.2.3.2.1
The registrant shall send the mammography report, as described in RH
6.10.2.3(1), in addition to a written notification of results in lay terms, within thirty
(30) days from the date of the mammography examination, to all patients who do
not name a health care provider to receive the report.
2991
2992
2993
6.10.2.3.2.2
Registrants that accept patients who do not have a primary care provider
shall maintain a system for referring such patients to a health care provider when
clinically needed.
2994
6.10.2.3.3
The registrant shall maintain a system to ensure that the results of each
mammography examination are communicated to the patient in a timely manner.
Communication of Mammography Results to Health Care Providers.
2995
2996
2997
When the patient has named a referring health care provider, the registrants shall
provide a written report of the mammography examination, within thirty (30) days
from the date of the exam, to that provider.
2998
2999
3000
3001
6.10.2.3.4
Record Keeping. The registrant shall maintain mammography films and reports in
a permanent medical record of the patient for a period of not less than five (5) years, or
not less than ten (10) years if no additional mammograms of the patient are performed at
the facility.
3002
3003
3004
6.10.2.3.4.1
The registrant shall upon request or on behalf of, by the patient,
permanently or temporarily transfer the original mammograms and copies of the
patient's reports as directed by the patients or their representatives.
3005
3006
3007
6.10.2.3.4.2
Any fee charged to the patients for providing the services described in
RH 6.10.2.3.4.1 shall not exceed the documented costs associated with this
service.
3008
3009
3010
3011
6.10.2.3.5
Mammographic Image Identification. Each mammography image shall clearly
indicate the patient's name and an additional patient identifier; the date of the
examination; the view and laterality; the facility name and location; the technologist
identification; the cassette/screen identification; and the mammography unit.
3012
3013
3014
6.10.2.4
Quality Assurance - General Rrequirements. The registrant shall establish and
maintain a quality assurance program to ensure the safety, reliability, clarity, and accuracy of
mammography services performed at the facility.
3015
3016
3017
3018
3019
3020
3021
3022
6.10.2.5
Quality Assurance - Quality Control of Mammography
Operations.
6.10.2.5.1All tests specified in RH 6.10.2.5 shall be performed by a
qualified mammographer or provisional mammographer.
6.10.2.2
(1)
Daily Quality Control Tests.
Film processors used to develop mammograms shall be adjusted and maintained
to meet the technical development specifications for the mammography film in
use.
6 - 89
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
3023
3024
(2)
A processor performance test shall be done on each day that examinations are
provided prior to clinical films being developed.
3025
(3)
The test shall include the following assessment:
3026
3027
6.10.2.5.2.1
The base plus fog density shall be within 0.03 of the established
operating level.
3028
3029
6.10.2.5.2.2
The mid-density shall be within ± 0.15 of the established
operation level.
3030
3031
3032
3033
3034
6.10.2.5.2.3
The density difference shall be within ± 0.15 of the established
operation level. For any mammography registrant using film processors
at multiple locations, such as a mobile service processor performance by
sensitometric strips shall be performed prior to the development of
patient's films.
3035
6.10.2.5.3
Weekly Quality Control Tests.
3036
3037
(1)
Facilities with screen-film systems shall perform an image quality evaluation test,
using an FDA-approved phantom, at least weekly.
3038
(2)
The test shall include the following assessment:
3039
3040
6.10.2.5.3.1
The optical density at the center of the phantom image shall be
at least 1.20 when using clinical technique factors.
3041
3042
6.10.2.5.3.2
The optical density at the center of the phantom image shall not
change by more than ± 0.20 from the established operating level.
3043
3044
3045
6.10.2.5.3.3
The phantom image shall achieve at least the minimum score to
observe the image of a 0.75 mm fiber, 0.32 mm speck, and a 0.75 mm
mass.
3046
3047
3048
6.10.2.5.3.4
The density difference between the background of the phantom
and an added test object, used to assess image contrast, shall not vary
by more than ± 0.05 from the established operating level.
3049
6.10.2.5.4
Quarterly Quality Control Tests.
3050
3051
(1)
3052
6.10.2.5.4.1
3053
3054
Facilities with screen-film systems shall perform the following tests at least
quarterly:
(a)
6.10.2.5.4.2
Fixer Retention in Film.
The residual fixer shall be no more than 5 micrograms per square cm.
Repeat Analysis.
3055
3056
3057
(a)
If the total repeat or reject rate changes from the previously determined
rate by more than two (2) percent of the total films included in the
analysis, the reason(s) for the change shall be determined.
3058
3059
(b)
Any corrective actions shall be recorded and the results of these
corrective actions shall be assessed.
6 - 90
Colorado Radiation Regulations, Proposed Revised Part 6
3060
6.10.2.5.5
May 12, 2017
Semiannual Quality Control Tests.
3061
3062
(1)
Facilities with screen-film systems shall perform the following tests at least
semiannually:
3063
6.10.2.5.5.1
Darkroom Fog.
3064
3065
(a)
The darkroom fog level of a phantom image with an optical density of at
least 1.20 and shall not exceed 0.05 OD.
3066
3067
(b)
The fog test film shall be exposed to typical darkroom conditions for two
(2) minutes with the emulsion side up.
3068
6.10.2.5.5.2
Screen-film Contact.
3069
3070
(a)
All cassettes used at the facility for mammography shall be tested using
40 mesh copper screen.
3071
3072
3073
(b)
Cassettes shall not be used for mammography if one or more areas >1
cm in diameter or poor contact that are not eliminated by screen
cleaning.
3074
3075
(c)
Five or more small areas <1 cm in diameter are acceptable, and the
cassette may be returned to clinical use.
3076
6.10.2.5.5.3
3077
3078
3079
3080
3081
(a)
6.10.2.6
Compression Device Performance.
A compression force of at least 111 newtons (25 pounds) shall be
provided. Effective October 28, 2002, tThe maximum compression force
of the initial power drive shall be between 111 newtons (25 pounds) and
209 newtons (47 pounds).
Quality Assurance - Facility and Equipment Evaluation.
3082
3083
(1)
Facilities with screen-film systems shall perform the following tests in 6.10.5.7(3)
through 6.10.5.7(12) at least annually.
3084
3085
6.10.2.6.1
All tests specified in RH 6.10.2.6 shall be performed by a mammography
approved qualified inspector.
3086
3087
3088
3089
3090
3091
3092
3093
6.10.2.6.
Automatic Exposure Control Performance. The AEC shall be capable of
maintaining film optical density (OD) within ± 0.30 of the mean OD when
thickness of a homogeneous material is varied over a range of 2 to 6 cm and the
kVp is varied appropriately for such thicknesses over the kVp range used
clinically. If this requirement cannot be met, a technique chart shall be developed
showing appropriate techniques (kVp and density control settings) for different
breast thicknesses and compositions that must be used so that an OD within ±
0.30 of the average under phototimed conditions can be produced.
3094
3095
6.10.2.6.2.1
After October 28, 2002, the AEC shall be capable of maintaining
film OD within ± 0.15 of the mean OD.
3096
3097
6.10.2.6.2.2
The OD at the center of the phantom image shall not be less
than 1.20.
6 - 91
Colorado Radiation Regulations, Proposed Revised Part 6
3098
3099
May 12, 2017
6.10.2.6.3
kVp Accuracy and Reproducibility. The kVp shall be accurate within ±
five (5) percent of the indicated kVp at:
3100
3101
6.10.2.6.3.1
The lowest clinical kVp that can be measured by a kVp test
device;
3102
6.10.2.6.3.2
The most commonly used clinical kVp;
3103
6.10.2.6.3.3
The highest available clinical kVp; and
3104
3105
3106
3107
6.10.2.6.3.4
At the most commonly used clinical settings of kVp, the
coefficient of variation of reproducibility of the kVp shall be equal to or
less than 0.02. Not all commonly used clinical settings of kVp need to be
tested.
3108
3109
3110
3111
6.10.2.6.4
Focal Spot Condition. Focal spot condition shall be evaluated either by
determining system resolution or by measuring focal spot dimensions. After
October 28, 2002, facilities shall evaluate focal spot condition only by
determining the system resolution.
3112
3113
3114
3115
3116
3117
6.10.2.6.4.1
System Resolution. Mammography systems, in combination with
the mammography screen-film combination, shall provide a minimum
resolution of 11 cycles/millimeter (line-pairs/mm) when a high contrast
resolution bar test pattern is oriented with the bars perpendicular to the
anode-cathode axis, and a minimum resolution of 13 line-pairs/mm when
the bars are parallel to that axis.
3118
3119
3120
3121
6.10.2.6.4.1.1 The bar pattern shall be placed 4.5 cm above the breast
support surface, centered with respect to the chest wall edge of
the image receptor, and with the edge of the pattern within one
cm of the chest wall edge of the image receptor.
3122
3123
3124
3125
6.10.2.6.4.1.2 When more than one target is provided, the
measurement described in RH 6.10.2.6.3.1 shall be made using
the magnification and contact radiography with all available
targets.
3126
3127
6.10.2.6.4.1.3 When more than one SID is provided, the test shall be
performed at the most commonly used clinical SID.
3128
3129
3130
3131
6.10.2.6.4.1.4 The kVp shall be set at the clinical value for a standard
breast and the system resolution test shall be performed such
that the background optical density of the film should be between
1.2 and 1.8.
3132
3133
3134
3135
6.10.2.6.4.2
Focal Spot Dimensions. Measured values of the focal spot length
(dimension parallel to the anode cathode axis) and width (dimension
perpendicular to the anode cathode axis) shall be within the tolerance
limits specified in Table I.
6 - 92
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
Table I
Focal Spot Tolerance Limit
Maximum Measured Dimensions
Nominal Focal Spot
Size (mm)
3136
Width (mm)
Length (mm)
0.10
0.15
0.15
0.15
0.23
0.23
0.20
0.30
0.30
0.30
0.45
0.65
0.40
0.60
0.85
0.50
0.90
1.30
6.10.2.6.5
3137
Beam Quality and Half-value Layer (HVL).
The HVL shall meet the following specifications for minimum HVL.
kVp
______
≤
HVL
100
3138
3139
6.10.2.6.
Breast Entrance Air Kerma and AEC Reproducibility.
The coefficient of variation for both air kerma and mAs shall not exceed 0.05.
3140
3141
3142
3143
6.10.2.6.
Dosimetry.
The average glandular dose delivered during a single
cranio-caudal view of an FDA-accepted phantom simulating a standard breast,
using the clinical technique factors and conditions for that phantom, shall not
exceed 3.0 milligray (0.3rad) per exposure.
3144
3145
3146
3147
6.10.2.6.8
X-ray Field/Light Field/Image Receptor/Compression Alignment. All
systems shall have beam -limiting devices that allow the useful x-ray beam to
extend to or beyond the edges of the image receptor but by no more than two (2)
percent of the SID at the chest wall side.
3148
3149
3150
3151
3152
6.10.2.6.8.1
If a light localizer is provided, the resultant light field shall be
aligned with the x-ray field so that the total of any misalignment of the
edges of the light field and the x-ray field along either the length or the
width of the visually defined field at the plane of the breast support
surface shall not exceed two (2) percent of the SID.
6 - 93
Colorado Radiation Regulations, Proposed Revised Part 6
3153
3154
3155
3156
3157
3158
6.10.2.6.8.2
The chest wall edge of the compression paddle shall not extend
beyond the chest wall edge of the image receptor by more than one
percent of the SID when tested with the compression paddle placed
above the breast support surface at a distance equivalent to standard
breast thickness.
6.10.2.6.9
3159
3160
3161
3162
May 12, 2017
(a)
6.10.2.6.0
Uniformity of Screen Speed.
Uniformity of screen speed of all the cassettes shall be tested and the
difference between the maximum and minimum optical densities shall
not exceed 0.3. Screen artifacts shall also be evaluated during this test.
System Artifacts.
3163
3164
(a)
System artifacts shall be performed for all cassettes sizes using a grid
appropriate for the cassette size being tested.
3165
3166
(b)
System artifacts shall also be evaluated for all available focal spot sizes
and target filter combinations used clinically.
3167
6.10.2.6.1
Radiation Output.
3168
3169
3170
3171
3172
3173
3174
3175
(a)
3176
3177
6.10.2.6.11.1The system shall be capable of maintaining the required minimum
radiation output averaged over a three (3) second period.
3178
3179
3180
The system shall be capable of producing a minimum output of 4.5 mGy
air kerma per second (513 mR per second) when operating at 28 kVp in
the moly/moly mode at any SID where the system is designed to operate
and when measured by a detector with its center located 4.5 cm above
the breast support surface with the compression paddle in place as
clinically used. After October 28, 2002, the system, under the same
measuring conditions shall be capable of producing a minimum output of
7.0 mGy air kerma per second (800 milliroentgen per second).
6.10.2.6.2
Decompression. If the system is equipped with a provision for automatic
decompression after completion of an exposure or interruption of power to the
system, the system shall be tested to confirm that it provides:
3181
6.10.2.6.12.1
An override capability to allow maintenance of compression;
3182
6.10.2.6.12.2
A continuous display of the override status; and
3183
3184
3185
3186
3187
3188
3189
3190
6.10.2.6.12.3 A manual emergency compression release that can be
activated in the event of power or automatic release failure.
6.10.2.7
Additional Mammography Equipment Evaluations.
An evaluation of mammography units or image processors shall be conducted whenever
a new unit or processor is installed, a unit or processor is dissembled and reassembled at
the same or new location, or major components of a mammography unit or processor
equipment are changed or repaired. These evaluations shall be performed by a
mammography approved qualified inspector.
6 - 94
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
3191
3192
3193
3194
3195
6.10.2.8
Quality Control Tests - Other Modalities. For systems with image receptor
modalities other than screen-film, the quality assurance program shall be substantially
the same as the quality assurance program recommended by the image receptor
manufacturer, except that the maximum allowable dose shall not exceed the maximum
allowable dose for screen-film systems as specified in 6.10.2.6.6.
3196
3197
3198
3199
6.10.2.9
Mobile Units. Mobile mammography systems shall meet the requirements of
6.10.2.5 through 6.10.2.8. In addition, at each examination location, the registrant shall
verify satisfactory performance of such units using a test methods that, establishes the
adequacy of the image quality produced by the unit, prior to its use on patients.
3200
6.10.2.10
3201
3202
3203
3204
Facility Cleanliness.
The registrant shall establish and implement adequate protocols for maintaining
darkroom, screen, and view box cleanliness. The registrant shall document that all
cleaning procedures are performed at the frequencies specified in the protocols.
6.10.2.11
Infection Control.
3205
3206
3207
The registrant shall establish and comply with a system specifying procedures to be
followed by the facility for cleaning and disinfecting mammography systems, after contact
with blood or other potentially infectious materials.
3208
3209
3210
3211
3212
3213
3214
3215
3216
6.10.2.12
Quality Assurance - Mammography Medical Outcomes Audit. Each registrant
shall establish and maintain a mammography medical outcomes audit program to follow
up positive mammographic assessments and to correlate pathology results with the
interpreting physician's findings. The facility's first audit analysis shall be initiated no later
than twelve (12) months after the date the facility becomes certified, or twelve (12)
months after the effective date of these Regulations whichever date is latest. This audit
analysis shall be completed within an additional twelve (12) months to permit completion
of diagnostic procedures and data collection. Subsequent audit analyses will be
conducted at least once every twelve (12) months.
3217
3218
3219
3220
3221
6.10.2.13
All mammography facilities which have a current MQSA certificate or provisional
certificate and a certification evaluation (not exceeding twelve (12) months old) performed
by a qualified inspector authorized in mammography are considered to have met the
requirements of RH 6.10, only if any deficiencies or violations cited have been corrected
within thirty (30) days
3222
3223
3224
3225
3226
3227
RH 6.11
Severability.
6.11.1 The provisions of these Regulations are severable, and if any provisions or the
application of the provisions to any circumstances is held invalid, the application of such
provision to other circumstances, and the remainder of these Regulations shall not be
affected thereby.
6 - 95
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
3228
PART 6, APPENDIX 6A:
3229
INFORMATION REQUIRED FOR EVALUATION OF RADIATION SHIELDING REVIEWS5
3230
3231
3232
3233
5
3234
3235
3236
6A.1
3237
Exceptions from the above design requirements may be granted by the Department. To apply for such an exception, the
facility registrant must submit a facility design review from a Qualified Expert to the Department. The review must specify the
reason for the exception and it must demonstrate that the operator will have equivalent protection from radiation by use of the
proposed shielding design.
In order to provide an evaluation, AND technical advice, and official approval on shielding
requirements for a radiation installation, the following information shall be submitted to the
qualified expert or registered medical physicist.
6A.1.1. The planSUBMITTALs shall show, as a minimum, AT LEAST the following:
3238
3239
3240
3241
(1a)
The normal location of the x-ray IMAGING system's radiation port; the port's
travel and traverse limits; general direction(s) of the useful beam; locations of any
windows and doors; the location of the operator's booth; and the location of the xray control panel.
3242
3243
(2b)
The structural composition and thickness or lead equivalent of all walls, doors,
partitions, floor, and ceiling of the room(s) concerned.
3244
3245
(3c)
The dimensions of the room(s) concerned and inter-floor distances if SPACE
ABOVE OR BELOW IS occupied.
3246
3247
(4d)
The type of occupancy of all adjacent areas inclusive of space above and below
the room(s) concerned.
3248
3249
(5)
If there is an exterior wall, show THE distance to the closest area(s) where it is
likely that individuals may be present.
3250
3251
3252
(6e)
A DESCRIPTION OF THE X-RAY IMAGING SYSTEM AND COMPONENTS,
INCLUDING Tthe make and model of the equipment., the maximum technique
factors, and the energy waveform (single phase, three phase, etc.)
3253
3254
(7f)
The type of examination(s) or treatment(s) which THAT will be performed with
the equipment.
3255
3256
6A.1.2. Information on the anticipated workload of the x-ray IMAGING system(s).
6 - 96
Colorado Radiation Regulations, Proposed Revised Part 6
3257
PART 6 APPENDIX 6B:
3258
DESIGN REQUIREMENTS FOR AN OPERATOR'S BOOTH
3259
6B.1.
May 12, 2017
Space Requirements:
3260
3261
6B.1.1(a)
The operator shall be allotted not less than 7.5 square feet (0.697 m2 (8 FT2) of
unobstructed floor space in the booth.
3262
3263
6B.1.2(b)
The operator's booth may be of any geometric configuration with no dimension of
less than 2 feet (0.61 m (2 FT).
3264
3265
6B.1.3(c)
The space shall be allotted excluding any encumbrance by the x-ray control
panel, such as overhang, cables, or other similar encroachments.
3266
3267
3268
6B.1.4(d)
The booth shall be located or constructed such that unattenuated direct scatter
radiation originating on the examination table or at the wall cassette cannot reach the
operator's location within the booth.
3269
6B.2.
Structural Requirements:
3270
3271
6B.2.1(a)
The booth walls shall be permanently fixed barriers of at least 7 feet
(2.13 m (7 FT) high.
3272
3273
3274
6B.2.2(b)
When a door or movable panel is used as an integral part of the booth structure,
it must have an interlock which THAT will prevent an exposure when the door or panel is
not closed in its shielding position.
3275
3276
6B.2.3(c)
Shielding shall be provided to meet the requirements of Part 4 of these
Regulations.
3277
3278
6B.3.
Viewing System Requirements:
6B.3.1(a)
Each booth shall have at least one viewing device which THAT will:
3279
(1)
Be so placed that the operator can view the patient during any exposure, and
3280
3281
3282
3283
3284
3285
(2)
The device shall be so placed that the operator can have full view of any
occupant of the room and should be so placed that the operator can view any
entry into the room. If any door which THAT allows access to the room cannot be
seen from the booth, then that door must have either an interlock controlling the
exposure which THAT will prevent the exposure if the door is not closed; or a
warning light must be activated at the control panel when the door is opened.
6 - 97
Colorado Radiation Regulations, Proposed Revised Part 6
3286
6B.3.2(b)
May 12, 2017
When the viewing system is a window, the following requirements also apply:
3287
(1)
The viewing area shall be at least 1 square foot (0.10929 m2) (1 FT2).
3288
3289
3290
(2)
The design of the booth shall be such that the operator's expected position when
viewing the patient and operating the x-ray system is at least 18 inches (0.5457
m (1.5 FT) from the edge of the booth.
3291
3292
(3)
The material constituting the window shall have the same lead equivalence as
that required in the booth's wall in which it is mounted.
3293
3294
(c)
When the viewing system is by mirrors, the mirror(s) shall be so located as to accomplish
the general requirements of 6B.3.1paragraph 3.(a) of this Appendix.
3295
(d)
When the viewing system is by electronic means:
3296
3297
(1)
The camera shall be so located as to accomplish the general requirements of
6B.3.1paragraph 3.(a) of this Appendix.
3298
3299
3300
(2)
There shall be an alternate viewing system as a backup for the primary system,
unless the x-ray room is not used in the case of viewing system failure.
6 - 98
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
3301
PART 6, APPENDIX 6C:
3302
STANDARD FORMAT AND CONTENT OF A SHIELDING DESIGN
3303
3304
3305
3306
6C.1
EACH WRITTEN SHIELDING DESIGN PREPARED BY A QUALIFIED EXPERT SHALL
INCLUDE IDENTIFYING INFORMATION, IF AVAILABLE, SUCH AS THE FACILITY NAME,
ADDRESS, OWNER, CONTACT TELEPHONE NUMBERS AND CONTACT E-MAIL
ADDRESSES.
3307
3308
6C.2
EACH WRITTEN SHIELDING DESIGN PREPARED BY A QUALIFIED EXPERT SHALL
INCLUDE:
3309
3310
3311
3312
6C.2.2 EVALUATION FROM A RADIATION PROTECTION POINT-OF-VIEW OF THE
OVERALL LAYOUT OF THE ROOM(S) FLOOR PLAN, INCLUDING THE LOCATION
AND CONFIGURATION ANY RADIATION PRODUCING MACHINES IN EACH ROOM,
BASED ON THE INFORMATION REQUIRED IN APPENDIX 6A AND 6B.
3313
3314
3315
6C.1.3 EVALUATION OF SUITABLE WORKLOAD, BASED ON THE VOLUME OF WORK
AND EQUIPMENT USAGE ANTICIPATED IN THE INFORMATION PROVIDED
PURSUANT TO 6A.1.2, IN RELATION TO THE OVERALL LAYOUT.
3316
3317
3318
3319
6C.1.4 DETAILED CONSIDERATION, USING GUIDELINES BASED ON NATIONAL
COUNCIL ON RADIATION PROTECTION AND MEASUREMENTS REPORT NO. 147,
“STRUCTURAL SHIELDING DESIGN FOR MEDICAL IMAGING FACILITIES”, OR
EQUIVALENT GUIDANCE, OF:
3320
3321
6C.1.4.1
LOCATION AND TYPES OF PERMANENT AND TEMPORARY
BARRIERS AND SHIELDING;
3322
6C.1.4.2
LOCATION OF CONTROLS AND CONTROL BOOTH;
3323
6C.1.4.3
LOCATION OF EXPOSURE SWITCH; AND
3324
3325
6C.1.4.4
INTERIOR AND EXTERIOR WALLS, DOORS AND WINDOWS, AND
FLOORS AND CEILINGS.
3326
3327
6C.1.5 CALCULATIONS OF POTENTIAL EXPOSURES BASED ON OCCUPANCY AND
WORKLOAD DISTRIBUTION.
3328
3329
3330
3331
3332
3333
6C.1.6 FOR EACH ROOM IN WHICH A STATIONARY X-RAY IMAGING SYSTEM IS
LOCATED, A CURRENT DIMENSIONAL DRAWING AS REQUIRED BY 6.3.2.3 WITH
ACCOMPANYING SPECIFICATIONS FOR CONSTRUCTION AND LAYOUT TO MEET
ALL REQUIREMENTS OF THESE REGULATIONS, IN PARTICULAR TO PRECLUDE
AN INDIVIDUAL FROM RECEIVING A DOSE IN EXCESS OF THE LIMITS IN 4.6, 4.12,
4.13, 4.14 AND 4.15.
3334
3335
3336
6C.1.7 THE SIGNATURE OF THE QUALIFIED EXPERT WHO PREPARED THE SHIELDING
DESIGN AND THE DATE SIGNED.
6 - 99
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
3337
3338
INFORMATION TO BE SUBMITTED BY PERSONS PROPOSING TO CONDUCT HEALING ARTS
SCREENING
3339
3340
Persons requesting that the Agency approve a healing arts screening program shall submit the following
information and evaluation:
3341
3342
1.
Name and address of the applicant and, when applicable, the names and addresses of
all locations within this State, where the service will be provided.
3343
2.
Diseases or conditions for which the x-ray examinations are to be used in diagnoses.
3344
3.
A detailed description of the x-ray examinations proposed in the screening program.
3345
3346
4.
Description of the population to be examined in the screening program, i.e., age, sex,
physical condition, and other appropriate information.
3347
3348
3349
5.
An evaluation of any known alternate methods not involving ionizing radiation which
could achieve the goals of the screening program and why these methods are not used
instead of the x-ray examinations.
3350
3351
3352
6.
An evaluation by a qualified expert of the x-ray system(s) to be used in the screening
program prior to being placed into operation. The evaluation by the qualified expert shall
show that such system(s) do satisfy all requirements of these Regulations.
3353
7.
A description of the diagnostic film quality control program, if applicable.
3354
8.
A copy of the technique chart for the x-ray examination procedures to be used.
3355
3356
3357
3358
9.
The qualifications of each individual who will be operating the x-ray system(s). In the
case of non-licensed operators of bone densitometry unit(s), include a copy of the waiver
granted by the Board of Medical Examiners to the non-licensed operators from taking the
limited scope examination.
3359
3360
3361
10.
The qualifications of the individual who will be supervising the operators of the x-ray
system(s). The extent of supervision and the method of work performance evaluation
shall be specified.
3362
3363
11.
The name and address of the individual who will interpret the radiograph(s) or other
results from the x-ray examinations.
3364
3365
12.
Name and current license from Board of Medical Examiners of Physician(s) who will
oversee the program.
3366
3367
13.
A copy of the order prescribed by a Colorado licensed practitioner for the healing art
screening program to be conducted.
3368
3369
3370
14.
A description of the procedures to be used in advising the individuals screened and their
private practitioners of the healing arts of the results of the screening procedure and any
further medical needs indicated.
3371
3372
3373
15.
A description of the procedures for the retention or disposition of the radiographs, if
applicable, and other records pertaining to the x-ray examinations.
6 - 100
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
3374
PART 6, APPENDIX 6D:
3375
3376
CRITERIA FOR CLASSIFYING A RADIATION MACHINE UNSAFE FOR ROUTINE HUMAN, ANIMAL
OR OTHER USE
3377
3378
3379
6D.1
The operating condition of an x-ray RADIATION machine and related equipment may SHALL
NOT be such that the continued operation of that machine endangers the public health and
safety.
3380
3381
6D.2
An x-ray RADIATION machine shall be considered unsafe for human, ANIMAL OR OTHER use
if:
3382
3383
3384
3385
3386
6D.2.1. The x-ray RADIATION machine system has a malfunctioning component or components
that could result in an inadvertent exposure to members of the public, the operator, or the
patient. Examples include but are not limited to: a timer that fails to terminate the
exposure, an exposure switch when activated once produces multiple exposures, a
system that produces x-rays without activation of the exposure switch.
3387
3388
6D.2.2. The x-ray RADIATION machine is not equipped with a means of determining when
x-rays are in production.
3389
3390
3391
3392
3393
6D.2.3. The x-ray RADIATION machine is equipped with variable technique factors EXPOSURE
SETTINGS and the selectors and/or indicators of these technique factors EXPOSURE
SETTINGS do not permit the operator to determine the factors in use or if the indicated
versus the technique factor(s) EXPOSURE SETTINGS are in error by fifty (50) percent or
more, except for exposure times selected less than 50 millisecond.
3394
3395
3396
3397
6D.2.4. The collimation of the x-ray beam of a fluoroscopic/spot film system is such that either the
length or width of the x-ray field in the plane of the image receptor differs (in excess) from
the corresponding image receptor dimensions by more than 25 percent of the source to
image distance (SID).
3398
3399
6D.2.5. The half-value layer of aluminum (or equivalent) filtration in the useful beam is more than
fifty (50) percent below the values specified in 6.4.2.5.1.
6 - 101
Colorado Radiation Regulations, Proposed Revised Part 6
3400
3401
3402
May 12, 2017
6D.2.6. In addition to the above items, a fluoroscopic x-ray RADIATION machine system will be
considered unsafe if:
(1)
In normal fluoroscopic mode:
3403
3404
(a).
No operational image intensifier OR DIRECT DIGITAL IMAGE
RECEPTOR is provided.
3405
3406
3407
(b).
Except for radiation oncology simulators, the primary protective barrier
does not intercept 100 percent of the x-ray beam of a fluoroscopic x-ray
system.
3408
3409
3410
(c).
Except for radiation oncology simulators, the fluoroscopic x-ray system is
capable of producing x-rays when the primary protective barrier is not in
position to intercept the beam.
3411
3412
3413
(d).
The fluoroscopic x-ray system has a tabletop entrance exposure rate
AKR equal to or greater than 220 mGy PER MINUTE (25 R/min) at the
point where the useful beam enters the patient, except:
3414
(1i)
During the recording of fluoroscopic images, or
3415
(2ii)
When an optional high-level control is activated.
3416
3417
3418
3419
3420
3421
(2)
Note that this is normal fluoroscopic mode, and tThe FDA's regulations
(21 CFR 1020.32(e)(2)(II), April 1, 2004) allow up to 176 mGy PER MINUTE
(20 R/min) when recording or using high-level control.
6D.2.7. An electro-mechanical defect exists that endangers human life OR SAFETY when a
radiograph is made or fluoroscopy is performed.
6 - 102
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
3422
PART 6, APPENDIX 6E: HUMAN USE OF PORTABLE HAND-HELD X-RAY EQUIPMENT
3423
3424
3425
3426
6E.1
3427
THE FOLLOWING REQUIREMENTS ARE APPLICABLE, AS DETERMINED BY THE
DEPARTMENT, TO ANY HUMAN USE X-RAY RADIOGRAPHIC DEVICE, IN PARTICULAR
FOR DENTAL INTRAORAL USE, THAT IS DESIGNED TO BE OPERATED AS A HAND-HELD
UNIT.
6E.1.1 REQUIREMENTS FOR ANY LOCATION:
3428
3429
6E.1.1.1
EACH OPERATOR OF A HAND-HELD DEVICE SHALL BE
SPECIFICALLY TRAINED TO OPERATE SUCH EQUIPMENT.
3430
3431
3432
3433
6E.1.1.2
THE OPERATOR SHALL ENSURE THERE ARE NO BYSTANDERS
WITHIN A RADIUS OF AT LEAST 2 METERS (SIX FEET) FROM THE
PATIENT BEING EXAMINED WITH A HAND-HELD INTRAORAL
RADIOGRAPHIC UNIT.
3434
3435
3436
6E.1.1.3
IF A HAND-HELD DEVICE WAS DESIGNED WITH AN OPTIONAL,
REMOVABLE SECONDARY RADIATION BLOCK, IT SHALL BE INSTALLED
AND USED DURING PATIENT EXAMINATION.
3437
3438
3439
3440
3441
6E.1.1.4
THE DEVICE SHALL BE HELD WITHOUT ANY MOTION, IN ORDER
TO PREVENT REPEAT IMAGING DUE TO MOTION THAT REDUCES IMAGE
QUALITY. IF THE OPERATOR HAS DIFFICULTY IN HOLDING THE DEVICE
STATIONARY, THE OPERATOR SHALL USE A STAND OR TRIPOD TO
IMMOBILIZE THE DEVICE.
3442
3443
3444
3445
3446
6E.1.1.5
THE OPERATOR SHALL BE PROTECTED FROM DIRECT SCATTER
RADIATION BY PROTECTIVE MATERIAL OF NOT LESS THAN 0.25
MILLIMETER LEAD EQUIVALENT AND A THYROID COLLAR UNLESS THE
RADIATION SAFETY OFFICER AND DEPARTMENT DETERMINE THAT NO
ADDED PROTECTION IS NEEDED FOR THE DEVICE MODEL AND/OR USE.
3447
3448
6E.1.1.6
PERSONNEL MONITORING SHALL BE AT LEAST AS REQUIRED BY
6.3.3.10.
3449
6E.1.2 ADDITIONAL REQUIREMENTS FOR OPERATIONS IN PERMANENT FACILITIES:
3450
3451
6E.1.2.1
AS PROVIDED IN 6.3.2.4, A HAND-HELD DEVICE IS EXEMPT FROM
6.3.2.1 AND CONSEQUENTLY IS EXEMPT FROM 6.3.2.2 AND 6.3.2.3.
3452
3453
6E.1.2.2
A HAND-HELD DEVICE SHALL NOT BE USED FOR PATIENT
EXAMINATIONS IN HALLWAYS AND WAITING ROOMS.
3454
3455
3456
6E.2
PORTABLE HAND-HELD X-RAY EQUIPMENT SHALL BE KEPT IN A SECURED LOCATION
WHEN NOT IN USE.
6 - 103
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
3457
PART 6, APPENDIX 6F:
3458
3459
INFORMATION TO BE SUBMITTED BY A PERSON PROPOSING TO CONDUCT HEALING ARTS
SCREENING
3460
3461
3462
6F.1
A PERSON REQUESTING THAT THE DEPARTMENT APPROVE A HEALING ARTS
SCREENING PROGRAM SHALL SUBMIT THE FOLLOWING INFORMATION AND
EVALUATION WHEN COMPLETING DEPARTMENT FORM R-300:
3463
3464
3465
6F.1.1 NAME AND ADDRESS OF THE APPLICANT AND, WHEN APPLICABLE, THE
NAMES AND ADDRESSES OF ALL LOCATIONS WITHIN THIS STATE, WHERE THE
SERVICE WILL BE PROVIDED.
3466
3467
6F.1.2 DISEASES OR CONDITIONS FOR WHICH THE X-RAY EXAMINATIONS ARE TO BE
USED IN DIAGNOSES.
3468
3469
6F.1.3 A DETAILED DESCRIPTION OF THE X-RAY EXAMINATIONS PROPOSED IN THE
SCREENING PROGRAM.
3470
3471
3472
6F.1.4 DESCRIPTION OF THE POPULATION TO BE EXAMINED IN THE SCREENING
PROGRAM, I.E., AGE, SEX, PHYSICAL CONDITION, AND OTHER APPROPRIATE
INFORMATION.
3473
3474
3475
3476
6F.1.5 AN EVALUATION OF ANY KNOWN ALTERNATE METHODS NOT INVOLVING
IONIZING RADIATION THAT COULD ACHIEVE THE GOALS OF THE SCREENING
PROGRAM AND WHY THESE METHODS ARE NOT USED INSTEAD OF THE X-RAY
EXAMINATIONS.
3477
3478
3479
3480
6F.1.6 AN EVALUATION BY A QUALIFIED EXPERT OF THE X-RAY SYSTEM(S) TO BE
USED IN THE SCREENING PROGRAM PRIOR TO BEING PLACED INTO
OPERATION. THE EVALUATION BY THE QUALIFIED EXPERT SHALL SHOW THAT
SUCH SYSTEM(S) DO SATISFY ALL REQUIREMENTS OF THESE REGULATIONS.
3481
3482
6F.1.7 A DESCRIPTION OF THE IMAGE PROCESSING QUALITY CONTROL PROGRAM, IF
APPLICABLE.
3483
3484
6F.1.8 A COPY OF THE TECHNIQUE PROTOCOLS FOR THE X-RAY EXAMINATION
PROCEDURES TO BE USED AS REQUIRED UNDER 6.3.3.2.
3485
3486
3487
6F.1.9 DOCUMENTATION THAT EACH INDIVIDUAL WHO WILL BE OPERATING THE
X-RAY SYSTEM(S) FULFILLS DEPARTMENT REQUIREMENTS FOR ADEQUATE
RADIATION SAFETY TRAINING AND EXPERIENCE.
3488
3489
3490
3491
3492
6F.1.10 DOCUMENTATION THAT EACH INDIVIDUAL WHO WILL BE SUPERVISING THE
OPERATORS OF THE X-RAY SYSTEM(S) FULFILLS DEPARTMENT
REQUIREMENTS FOR ADEQUATE RADIATION SAFETY TRAINING AND
EXPERIENCE. THE EXTENT OF SUPERVISION AND THE METHOD OF WORK
PERFORMANCE EVALUATION SHALL BE SPECIFIED.
3493
3494
6F.1.11 THE NAME AND ADDRESS OF THE INDIVIDUAL WHO WILL INTERPRET THE
RADIOGRAPH(S) OR OTHER RESULTS FROM THE X-RAY EXAMINATIONS.
6 - 104
Colorado Radiation Regulations, Proposed Revised Part 6
May 12, 2017
3495
3496
3497
3498
6F.1.12 NAME OF WHO WILL OVERSEE THE PROGRAM WITH A CURRENT LICENSE
FROM BOARD OF MEDICAL EXAMINERS OF PHYSICIAN(S) OF A PHYSICIAN,
CHIROPRACTOR, DENTIST OR PODIATRIST WHO HAS A CURRENT ACTIVE
STATE OF COLORADO LICENSE TO PRACTICE THE HEALING ARTS.
3499
3500
3501
3502
6F.1.13 A COPY OF THE ORDER FOR THE SCREENING PROGRAM TO BE CONDUCTED,
PRESCRIBED BY A PHYSICIAN, CHIROPRACTOR, DENTIST OR PODIATRIST WHO
HAS A CURRENT ACTIVE STATE OF COLORADO LICENSE TO PRACTICE THE
HEALING ARTS.
3503
3504
3505
3506
3507
6F.1.14 A DESCRIPTION OF THE PROCEDURES TO BE USED BY A PHYSICIAN,
CHIROPRACTOR, DENTIST OR PODIATRIST WHO HAS A CURRENT ACTIVE
STATE OF COLORADO LICENSE TO PRACTICE THE HEALING ARTS OF THE TO
ADVISE THE INDIVIDUALS SCREENED ABOUT THE RESULTS OF THE
SCREENING PROCEDURE AND ANY FURTHER MEDICAL NEEDS INDICATED.
3508
3509
3510
6F.1.15 A DESCRIPTION OF THE PROCEDURES FOR THE RETENTION OR DISPOSITION
OF THE RADIOGRAPHS, IF APPLICABLE, AND OTHER RECORDS PERTAINING TO
THE X-RAY EXAMINATIONS.
3511
6F.1.16 A SHIELDING ANALYSIS, IF APPLICABLE.
3512
3513
3514
6F.1.17 A COPY OF THE POLICY AND PROCEDURES TO ENSURE THAT ALL APPLICABLE
DOSE LIMITATION REQUIREMENTS OF PART 4, “STANDARDS FOR PROTECTION
AGAINST RADIATION”, ARE MET.
3515
6F.1.18 A COPY OF THE ALARA POLICY AND PROCEDURES.
3516
3517
6F.1.19 COPIES OF PERSONNEL MONITORING REPORTS FOR ANY EMPLOYEE
INVOLVED IN SCREENING.
3518
3519
6F.1.20 ANY ADDITIONAL INFORMATION THAT HAS BEEN REQUESTED BY THE
DEPARTMENT.
6 - 105