EN 14563:2008

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area - Test method and requirements (phase 2, step 2)

Publication date:   Feb 27, 2009

General information

90.60 Close of review   Sep 2, 2021

CEN

CEN/TC 216 Chemical disinfectants and antiseptics

European Norm

11.080.20   Disinfectants and antiseptics

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Scope

This European Standard specifies a test method and the minimum requirements for mycobactericidal or tuberculocidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted with hard water, or – in the case of ready-to-use products – with water.
This European Standard applies to products that are used in the medical area for disinfecting instruments by immersion – even if they are not covered by the EEC/93/42 Directive on Medical Devices.
This European Standard applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
 in hospitals, in community medical facilities and in dental institutions;
 in clinics of schools, kindergartens and nursing homes;
and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
NOTE This method corresponds to a phase 2, step 2 test.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

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PUBLISHED
EN 14563:2008
90.60 Close of review
Sep 2, 2021