Download 087 CE-Marking of biological and chemical indicators

gke - Technical Information
CE-Marking of
Biological and Chemical Indicators
for Sterilization Monitoring
730-087-EN
Version 03
Created by
Changed by
Checked by
Released by
03.09.2007
28.04.2014
07.05.2014
07.05.2014
JM
UK
UK
UK
Page 1 of 2
gke develops and produces cleaning and sterilization monitoring and documentation
materials.
Cleaning and sterilization processes are used to reprocess medical devices.
Washer/disinfectors and sterilizers are accessories for medical devices. The
indicators used for monitoring and documentation are “accessories for the accessory
sterilizer for medical devices” and are no medical devices. Therefore biological and
chemical indicators are not allowed to carry a CE-mark according to the medical
device directive (MDD).
The following background information is taken from the “Guide to the implementation
of directives based on the New Approach and the Global Approach” published by the
European Commission. This document is available on the gke homepage
www.gke.eu under „Downloads / Laws/Regulations“.
Currently the European Commission is preparing an amendment of the Directive
93/42 ECC. One of the modifications is the reclassification of washer-disinfectors and
sterilizers, which are currently “accessories”, into “medical devices class IIb”.
Consequently indicators for these machines will be “accessories class I” and will
have to carry a CE-mark. However, transition periods will be allowed. This
amendment will earliest be approved in 2015. gke is already preparing this change.
Standards of security relevant areas
Among the technical standards the standards in the security relevant area have an
exceptional position: Their application is mandatory. Other standards “only”
determine the state of the art. If the product has been tested for standard conformity,
the CE-mark has to be put on the product and the declaration of conformity has to be
presented to surveillance authorities.
Mostly the manufacturer or his authorized person can check and confirm conformity
of class I medical devices. Exceptions are complex medical devices or sterilizers
(class II a, II b or III): A notified body to check conformity with the standards has to be
involved.
Which products have to carry a CE-mark?
All products concerning the scope of one or more of the EU-guidelines regarding
product security, have to carry a CE-mark. There are more than 20 EU-guidelines
concerning product security, e.g. for
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gke - Technical Information
CE-Marking of
Biological and Chemical Indicators
for Sterilization Monitoring
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730-087-EN
Version 03
Created by
Changed by
Checked by
Released by
03.09.2007
28.04.2014
07.05.2014
07.05.2014
JM
UK
UK
UK
Page 2 of 2
Low voltage devices
Simple pressure reservoirs
Toys
Building products
Electro-magnetic compatibility [98/13/EG] (13) 6.11.1992
Machines
Personal protective equipment
Non-automatic scales
Gas consumption appliances
Hot water boiler
Explosive materials for civil purposes
Medical devices
Explosive areas
Pleasure crafts
Elevators
Cooling and freezing devices
Pressure devices
In-vitro diagnostics
Radio installations and telecommunication equipment for end users, etc.
With the CE-mark the manufacturer or importer documents that the marked product
conforms to the requirements of the harmonized guidelines or standards, which have
to be applied, and is allowed to market. The CE-mark also may only be applied, if the
product belongs to one or more of these harmonized guidelines and it is proven that
the requirements are fulfilled.
A product belonging to the scope of one of these guidelines must not be marketed or
used without CE-mark. Also the marketing of a product with a CE-mark must not be
obstructed as long as there is no reasonable suspicion that the CE-mark has been
applied unjustifiably.
Products which don’t belong to one of these guidelines – this is the case with
monitoring and documentation materials for sterilization processes – must not carry a
CE-mark.
Responsibility
The CE-mark has to be applied by the manufacturer or his EU-representative.
Usually the CE-mark is applied on the product itself or on the attached label. If type
and consistence of the product don’t allow any attachment, the CE-mark is put on the
package and on the documents inside. It must be well visible, readable and fixed
durably. A minimum font size of 5 mm is required.
G:\Gke Intern (0)\Marketing\Technische Info\Englisch\Word-Vorlagen\TI730-087-EN V03 CE-Marking.doc