2. Getting involved
3. Standards Committees
4. NAGESUTECH

DIN Standards Committee Health Technologies

Overview

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 European Standard. 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, bacterial spores, yeasts, fungal spores and viruses. 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, 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 and dental institutions, - 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 it is applicable to chemical disinfectants and antiseptics to be used in the areas of breeding, husbandry, production, transport and disposal of animals. 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 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, pharmaceutical, cosmetic etc. industries. This European Standard is also applicable to active substances and products under development for which no area of application has yet been specified. This document does not refer to methods for testing the toxicological and ecotoxicological properties of products or active substances. This standard differs from DIN EN 14885:2007-01 as follows: a) the clause Definition has been revised and supplemented; b) the importance of phase 1 testing has been clarified; c) the relationship between product claims and test results has been described in more detail; d) the use of standards outside their actual scope has been defined; e) the areas of application in the various sectors have been described in more detail; f) recommendations on how to deal with inaccuracies in test methods have been included; g) recommendations on how to use standards for proficiency testing (quality control) have been included; h) the effects of changes in standards, such as transition periods, have been specified; i) the main objectives, scope, safety aspects, design, implementation and evaluation of results of phase 3 tests (field tests) have been described; j) the standard has been editorially revised and harmonised with other CEN/TC 216 standards. The committee responsible for German collaboration is Working Committee NA 063-04-07 AA "Chemische Desinfektionsmittel und Antiseptika in der Humanmedizin" ("Chemical disinfectants and antiseptics in human medicine") at DIN Standards Committee Medicine (NAMed).

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-03-06 AA - Chemical disinfectants and antiseptics in human medicine  

Responsible european committee

CEN/TC 216/WG 5 - Strategy Group