EFHSS Questions and Answers - Answer to Question Q00781

I wish to obtain a CE mark for a wipe soaked in disinfecting ingredints, with a label claim for the Disinfection of Medical device instrument and surfaces.
rule 15 of the directive claims that his is a class IIa product, however in additon it also claims that physical action cleaners are not defined in class IIa.

Is a wipe defiend as a physical action cleaner, can this product be CE marked as a class I product?


Rule 15
All devices intended specifically to be used for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact lenses are in Class IIb.
All devices intended specifically to be used for disinfecting medical devices are in Class IIa.
This rule does not apply to products that are intended to clean medical devices other than contact lenses by means of physical action.

Dear David,

I can only give you some ideas of how European regulations see your issue:

Wipes for disinfecting medical devices (instruments) should be classified as CE products class IIa.
Wipes for the pure cleaning of such medical devices are to be classified as CE products class I.

Products for surfaces disinfection are biocide products (according to the European Biocide Product Directive). CE marked disinfection wipes are not to be used for surface disinfection.
Exemptions are made here for all surfaces that are categorized as medical devices (e.g. OR tables or incubators; for further information please see European Medical Device Directive).

As you see, an answer to your question is not as simple as it might seem. I hope that my information is not adding more confusion to your issue...

Best regards
Annette Rittich
Marketing
BODE Chemie GmbH & Co.