Download The Standards Institution of Israel

The Standards Institution of Israel
Israeli Standard – IS 4501
Shevat 5762 – January 2002
Non-reusable containers for the collection of sharp
medical items used in health care areas
This Standard, exclusive of the amendments and additions
specified therein, is identical to Australian Standard AS
4031-1992
Amendment No. 1 – 1996
Descriptors: disposable, containers, sharps containers, medical equipment, health centres,
medical supplies
IS 4501 (2002)
This Standard was prepared by an expert committee, comprising the following
members:
Reuben (Ruvi) Gilad, Dov Lev, Neil Friedman (Chairman), Pazit Rosenthal
The following participated in the preparation of the Standard:
Morris Luberblatt, Zali Maoz, Yehoshua Neumann, Uziel Zabari, Poriah Katlan,
Ronnie Kleiner, Amos Rabinowitz
The Standard was approved by the Technical Committee 1408 – Rubber and
Plastic Products for Medical Use, comprising the following members:
Kibbutz Industries Association
-
Federation of Israeli Chambers of Commerce -
Aryeh Rotman
Yehoiakim Blutstein,
Joseph Levin
Israel Consumers Association
-
Inbal Karat
Manufacturers Association of Israel
-
Yossi Shahar, Dalit Tsur
Magen David Adom
-
Esther Manheimer
-
Orly Kornberg
-
Israel Paran (Chairman),
Israel Standards Institution – Manufacturers
Division
Ministry of Health
Fernandes Graor,
Fuad Janem
Naftali Pollack coordinated the preparation work for the Standard
2
IS 4501 (2002)
Introduction to the Israeli Standard
This Israeli Standard is the Australian Standard AS 4031 (1992), including
Amendment No.1 from August 1996, which was approved in its English version
as the Israeli Standard, with certain amendments and additions.
The Hebrew version consists of:
-
scope of the Standard with amendments and additions
-
details of the amendments and additions to the Australian Standard
The Australian Standard, including Amendment No.1 to the Standard, is included
in its English language version.
Scope of the Standard (Paragraph 1 of Australian Standard, with amendments
and additions)
This Standard sets out requirements for non-reusable containers intended for the
safe collection and transport of used sharp medical items, which are likely to be
infectious, in health care areas, and are disposed of with their contents.
This Standard applies both to containers supplied as a single unit and to
containers supplied as individual components (container with detachable cover).
The containers to which this Standard applies are those designed to be
assembled by the user and those that are supplied fully assembled.
3
IS 4501 (2002)
2. Referenced documents
- Refer to the Paragraph “Referenced Documents” in the Australian Standard;
- The following Israeli Standards replace some of the Australian Standards
referred to in the Referenced Documents paragraph, as hereunder:
Reference to Australian Standard
AS 1319
Replaced by Israeli Standard
IS 2302 – Dangerous Substances and
Preparations - Classification,
Packaging, Labelling and Marking
AS 1946
IS 1268 Section 1 – Syringes and
Needles: Reusable all-glass or Metal
and Glass Syringes for Medical Use Dimensions
5. Design and Construction
5.1 Handle
This paragraph applies, with the following addition, which is to be inserted
following the first sentence in the paragraph:
The handle or means of carrying the container shall not be an integral part of
the cover. It shall be connected to the container in such a position and in such
a manner as to prevent physical contact or proximity with the opening of the
container.
- Following Paragraph 5.2, the following, designated Paragraph 5.2A, shall
be added:
4
IS 4501 (2002)
5.2A Detachable cover
In containers with a detachable cover, the mechanism by which the cover is
connected to the body of the container shall be such as to prevent
detachment of the cover from the container by means of reasonable force.
6.2 Resistance to penetration
This paragraph shall not apply, and shall be replaced by the following:
When tested in accordance with Appendix C, the average force required to
penetrate any sample taken from any of the areas specified in Paragraph
C4(a) shall be not less than 15 Newtons.
7. Colour
- The word “yellow” shall not apply, and shall be replaced by:
red.
(In other words, the colour of a container for the collection of waste, which
is not radioactive, or which is not cytotoxic, shall be predominantly red.)
- The word “purple” shall not apply, and shall be replaced by:
green.
(In other words, the colour of a container for the collection of cytotoxic
waste shall be predominantly green.)
- The word “red” shall not apply, and shall be replaced by:
yellow.
5
IS 4501 (2002)
(In other words, the colour of a container for the collection of radioactive
waste shall be predominantly yellow.)
-
Following Paragraph 8, paragraphs 9 and 10 are to be added, as follows:
9. Hebrew marking
The container shall be clearly, legibly and durably marked in Hebrew, with all
the information specified in Paragraph 8.
Imported containers:
(a) Shall also be marked with the name, and address of the importer, and the
country of manufacture of the product.
(b) The size of the Hebrew letters and markings, and the area marked, shall
be no less than the equivalent areas carrying the original markings of the
manufacturer.
10. Additional requirements1 for containers designated for moist heat
sterilization (autoclave)
The container shall be made of materials suitable for moist heat pressure
sterilization (such as: polypropylene, non-rust metal, e.g. stainless steel)).
1
See Appendix E
6
IS 4501 (2002)
APPENDIX A
A5. REPORT
(b) The reference to “AS 4031” shall not apply. It shall be replaced by:
IS 4501.
APPENDIX B
B3. (*)
Footnote *
The above footnote applies, with the addition of the following:
A surfactant solution equivalent to DECON-90 may be used.
B5. REPORT
(c) The reference to “AS 4031” shall not apply, and shall be replaced by:
IS 4501.
APPENDIX C
C4. TEST SAMPLE
(a) This paragraph shall not apply, and shall be replaced by:
Using the saw specified in Para. C3(d), or another suitable cutting
instrument, cut 60 samples from the container, each measuring 12 mm X
12 mm; 12 from the base, 12 from the sidewalls, 12 from the closure
7
IS 4501 (2002)
device2, 12 from the detachable cover (or from the upper portion of the
container), apart from the closure device of the opening, and 12 from the
corners and angles of the container.
If the size of the container does not allow for the required number of
samples to be cut from a single container, the maximum possible
number of samples should be cut from one container, and the remainder
of the samples from a minimum number of other containers.
(b) The words “Cut a 25 mm X 25 mm test sample from each strip, and, “
do not apply.
C6. REPORT
(a) This paragraph shall not apply, and shall be replaced by:
The average force needed to penetrate the lower side of the sample is to
be calculated from the results obtained in Para. C5, for each of the sample
groups obtained from the areas specified in Para. C4(a).
(b) The reference to “AS 4031” shall not apply, and shall be replaced by:
IS 4501.
APPENDIX D
D6. REPORT
(c) The reference to “AS 4031” shall not apply, and shall be replaced by:
IS 4501.
Closure device – device used to close or seal the opening for the insertion of objects into an assembled,
ready-to-use container
2
8
IS 4501 (2002)
Appendix E shall be added to the Standard, as follows:
Appendix E – Disposal of non-reusable containers for the collection of
sharp medical items and their contents – moist heat sterilization
(autoclave)
(For information only)
E1. Most non-reusable containers for the collection of sharp medical items,
together with their contents, are sterilized by moist heat, so as to render
their contents sterile before disposal at a waste disposal site.
E2. It is recommended that the following criteria apply to every container that
undergoes moist heat sterilization:
1. Following the sterilization process there shall be no evidence of
softening, cracking or degradation (e.g. dust on the outer surface,
cracks or defects).
2. The cover of the container shall remain attached to the body of the
container, and shall not become detached from it during or after the
sterilization process.
E3. Confirmation of the efficacy of the moist heat sterilization process shall
be in accordance with Israeli Standard IS 4335 - Sterilization of Health
Care Products: Requirements for Validation and Routine Control of Moist
Heat Sterilization in Health Care Facilities.
9
IS 4501 (2002)
AS-4031-1992
Australian Standard®
_____________________________________
Non-reusable containers for the
collection of sharp medical items
used in health care areas
____________________________
(Title allocated by Defence Cataloguing Authority:
COLLECTION DISPOSAL CONTAINRES FOR HEALTH CARE
EQUIPMENT – NSC 6530)
10
IS 4501 (2002)
PREFACE
This Standard was prepared by the Standards Australia Committee on
Hypodermic and Other Equipment for General Medical Use, under the direction
of the Multitechnics Standards Policy Board.
Cognisance has been taken of BS 7320:1990, Specification for sharp containers,
in the development of this Standard.
The committee deliberated at length on the minimum penetration resistance of
12.5 N specified in Clause 6.2. This value was arrived at having regard to BS
7320, the draft Canadian Standard and local testing.
Reusable containers are not dealt with in this Standard, nor are “personal use”
non reusable sharps containers issued in needle exchange programs.
CONTENTS
1
2
3
4
5
6
7
8
SCOPE
REFERENCED DOCUMENTS
DEFINITIONS
MATERIALS
DESIGN AND CONSTRUCTION
PHYSICAL TESTS
COLOUR
MARKING
Page
3
3
3
3
3
3
3
4
APPENDICES
A
B
C
METHOD OF TEST FOR HANDLE INTERGRITY
5
METHOD FOR DETERMINING IMPACT RESISTANCE
6
METHOD FOR DETERMINING RESISTANCE TO PENETRATION 7
© Copyright – STANDARDS AUSTRALIA
Users of Standards are reminded that copyright subsists in all Standards Australia publications and software. Except
where the Copyright Act allows and except where provided for below no publications or software produced by Standards
Australia may be reproduced, stored in retrieval system in any form or transmitted by any means without prior permission
in writing from Standards Australia. Permission may be conditional on an appropriate royalty payment. Requests for
permissions and information on commercial software royalties should be directed to the head office of Standards
Australia.
Standards Australia will permit up to 10 percent of the technical content pages of a Standard to be copied for
use exclusively in-house by purchasers of the Standard without payment of a royalty or advice to Standards
Australia.
Standards Australia will also permit the inclusion of its copyright material in computer software programs for no
royalty payment provided such programs are exclusively in-house by the creators of the programs.
Care should be taken to ensure that material used is from the current edition of the Standard and that it is updated
whenever the Standard is amended or revised. The number and date of the Standard should therefore be clearly
identified.
The use of material in print form or in computer software programs to be used commercially, with or without payment, or in
commercial contracts is subject to the payment of royalty. This police may be varied by Standards Australia at any time.
11