Chemické dezinfekční přípravky a antiseptika

Komise : CEN/TC 216 (Chemical disinfectants and antiseptics)
Původce: CEN
K připomínkám do: 7.12.2020
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This document specifies the European Standards to which products have to conform in order to support the claims for microbicidal activity which are referred to in this document.

This document also specifies terms and definitions which are used in European Standards.

It is applicable to products for which activity is claimed against the following microorganisms: vegetative bacteria (including mycobacteria and Legionella), bacterial spores, yeasts, fungal spores and viruses (including bacteriophages).

It is intended to:

a)     enable manufacturers of products to select the appropriate standards to be used in order to provide data which support their claims for a specific product;

b)    enable users of the product to assess the information provided by the manufacturer in relation to the use for which they intend to use the product;

c)     assist regulatory authorities in assessing claims made by the manufacturer or by the person responsible for placing the product on the market.

It is applicable to products to be used in the area of human medicine, the veterinary area and in food, industrial, domestic and institutional areas.

In the area of human medicine (Working Group 1, i.e. WG 1), it is applicable to chemical disinfectants and antiseptics to be used in areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care

—    in hospitals, in community medical facilities, dental institutions and medical laboratories for analyses and research,

—    in clinics of schools, of kindergartens and of nursing homes,

—    and may also occur in the workplace and in the home. It may also include services such as in laundries and kitchens supplying products directly for the patient.

In the veterinary area (WG 2) it is applicable to chemical disinfectants and antiseptics to be used in the areas of breeding, husbandry, veterinary care facilities, production, transport and disposal of animals and veterinary laboratories for analyses and research. It is not applicable to chemical disinfectants used in the food chain following death and entry to the processing industry.

In food, industrial, domestic and institutional areas (WG 3) it is applicable to chemical disinfectants and antiseptics to be used in processing, distribution and retailing of food of animal or vegetable origin. It is also applicable to products for all public areas where disinfection is not medically indicated (homes, catering, schools, nurseries, transports, hotels, offices etc.) and products used in packaging, biotechnology, laboratories (except laboratories for veterinary and medical analyses and research), pharmaceutical, cosmetic etc. industries.

This document is also applicable to active substances and products under development for which no area of application has yet been specified.

This document will be periodically updated to reflect the current published versions of each standard developed in CEN/TC 216. Independent of this update newly published standards should be used, even if they are not yet mentioned in EN 14885.

This document does not refer to methods for testing the toxicological and ecotoxicological properties of products or active substances.