EN 13727:2012+A1:2013/FprA2:2015

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1) EN 13727:2012+A1:2013/FprA2:2015

General information

50.60 Close of voting. Proof returned by secretariat   Jul 2, 2015

CEN

CEN/TC 216 Chemical disinfectants and antiseptics

European Norm

11.080.20   Disinfectants and antiseptics

Scope

This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water, or - in the case of ready-to-use products - with water. Products can only be tested at a concentration of 80 % or less (97 % with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance. This European Standard applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, surgical handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means. This European Standard applies to areas and situations where disinfection or antisepsis 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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
EN 13727:2012+A1:2013

NOW

IN_DEVELOPMENT
EN 13727:2012+A1:2013/FprA2:2015
50.60 Close of voting. Proof returned by secretariat
Jul 2, 2015