EN 16615:2015

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
Annex A (informative) - Referenced strains in national collections
Annex B (informative) - Neutralizers
Annex C (informative) - Graphical representations of the test method
Annex D (informative) - Example of a typical test report
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of
         EU Directive 93/42/EEC
Bibliography

This European Standard specifies a test method and the minimum requirements for bactericidal and yeasticidal 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 non-porous surfaces including surfaces of medical devices by wiping – regardless if they are covered by the 93/42/EEC Directive on Medical Devices or not.This European Standard includes ‘ready-to-use wipes‘ which are impregnated 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.NOTEThis 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”.