dnaSRPS EN 16615:2026

Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of bactericidal and yeasticidal and/or fungicidal and/or tuberculocidal and/or mycobactericidal activity on non-porous surfaces with mechanical action employing wipes or mops in the medical area (4- field test) - Test method and requirements (phase 2, step 2)

Scope

This document specifies a test method and the minimum requirements for bactericidal and yeasticidal and/or fungicidal and/or tuberculocidal and/or mycobactericidal 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 document is applicable to products that are used in the medical area for disinfecting non-porous surfaces including surfaces of medical devices by wiping or mopping - regardless if they are covered by the Medical Device Regulation [7] or not.
Due to the new methods of application of surface disinfectants like pre-impregnated wipes this document was established to cover the different application methods.
EN 16615 is applicable for four methods of application of products for wiping and/or mopping:
a) soaking any non-specified wipe or mop with product;
b) spraying the product on any non-specified wipe and / or mop or a specified wipe or mop;
c) impregnation of specified wipes or mops by the user with the product according to the manufacturer’s recommendation;
d) pre-impregnation of specified wipes or mop by the manufacturer as ready-to-use wipes or mops.
In all types of application, the water control is done with the standard wipe (5.3.2.17.1), because it is a process or method control.