prEN 16615 rev

Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4- field test) - Test method and requirements (phase 2, step 2) prEN 16615 rev

Scope

This European Standard specifies a test method and the minimum requirements for bactericidal and yeasticidal, fungicidal, 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 European Standard applies 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 93/42/EEC Directive on Medical Devices or not.
Due to the new methods of application of surface disinfectants like pre-impregnated wipes this standard was established to cover the different application method..
The EN 16615 is applicable for four method 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) preimpregnation of specified wipes or mop by the manufacturer as ready-to-use wipes or mops.
In all types of application the water control has to be done with the standard wipe [5.3.2.17 a)], because it is a process or method control.
This European standard does not apply to products that are sprayed on or flooding surfaces, then left until the contact application phase 2, step 2 standards without mechanical action should be used and their methods performed.
The test surface (5.3.2.16) was selected as standard surface and should cover all non-porous surfaces. It was not intended to cover the influence of each different surface.
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”.