10.99 New project approved Apr 19, 2023
CEN
CEN/TC 216 Chemical disinfectants and antiseptics
European Norm
This European Standard specifies a test method and the minimum requirements for virucidal 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 any non-porous surfaces including surfaces of medical devices by wiping or mopping – regardless if they are covered by the 93/42/EEC Directive on Medical Devices or not.
This European Standard is applicable for disinfectant solutions to be used to soak dry wipes or mops and for “ready-to-use wipes” which are pre-impregnated (either by the user or by the manufacturer) with a microbicidal solution.
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, of kindergartens and of 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.
NOTE This method corresponds to a phase 2, step 2 test.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
Legislation related to this standard
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
IN_DEVELOPMENT
cen:proj:77937
10.99
New project approved
Apr 19, 2023