This European Standard 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 European Standard 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 (incl.mycobacteria and Legionella), bacterial spores, yeasts, fungal spores and viruses (incl. 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, 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 European Standard does not refer to methods for testing the toxicological and ecotoxicological properties of products or active substances.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 4<\/td>\n | Contents Page <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | European foreword <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | 1 Scope <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | 3 Terms and definitions 3.1 Chemical disinfectant or antiseptic procedures and product types <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 3.2 Chemical disinfectant or antiseptic action <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 3.3 General terms 4 Procedures for claiming activity 4.1 Category of tests <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 4.2 General <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 4.3 Chemical disinfectants and antiseptics for use in the medical area 4.3.1 General Table 1 \u2014 Medical area \u2013 Standard test methods to be used to substantiate claims for products <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 4.3.2 Fields of application \/ Standards necessary to be passed for basic and additional label claims 4.3.2.1 General <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 4.3.2.2 Hygienic handrub 4.3.2.3 Hygienic handwash 4.3.2.4 Surgical handrub and handwash 4.3.2.5 Instrument disinfection <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 4.3.2.6 Surface disinfection without mechanical action 4.3.2.7 Surface disinfection with mechanical action 4.3.2.8 Textile disinfection 4.3.2.9 Water treatment for control of Legionella <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | Table 1a \u2014 Medical area \u2013 Test conditions and requirements of standard test methods to be used to substantiate claims for bactericidal activity of products <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | Table 1b \u2014 Medical area \u2013 Test conditions and requirements of standard test methods to be used to substantiate claims for fungicidal and yeasticidal activity of products <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | Table 1c \u2014 Medical area \u2013 Test conditions and requirements of standard test methods to be used to substantiate claims for virucidal activity of products <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | Table 1d \u2014 Medical area \u2013 Test conditions and requirements of standard test methods to be used to substantiate claims for mycobactericidal and tuberculocidal activity of products <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 4.4 Chemical disinfectants and antiseptics for use in the veterinary area Table 2 \u2014 Veterinary area \u2013 Standard test methods to be used to substantiate claims for products <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | Table 2a \u2014 Veterinary area \u2013 Test conditions and requirements of standard test methods to be used to substantiate claims for bactericidal activity of products) <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | Table 2b \u2014 Veterinary area \u2013 Test conditions and requirements of standard test methods to be used to substantiate claims for fungicidalb and yeasticidalb activity of products <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | Table 2c \u2014 Veterinary area \u2013 Test conditions and requirements of standard test methods to be used to substantiate claims for virucidal activity of products <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | Table 2d \u2014 Veterinary area \u2013 Test conditions and requirements of standard test methods to be used to substantiate claims for mycobactericidal activity of products <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 4.5 Chemical disinfectants and antiseptics for use in food, industrial, domestic and institutional areas <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | Table 3 \u2014 Food, industrial, domestic and institutional area \u2013 Standard test methods to be used to substantiate claims for products <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | Table 3a \u2014 Food, industrial, domestic and institutional area \u2013 Test conditions and requirements of standard test methods to be used to substantiate claims for bactericidal activity of products <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | Table 3b \u2014 Food, industrial, domestic and institutional area \u2013 Test conditions and requirements of standard test methods to be used to substantiate claims for fungicidal and yeasticidal activity of products <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | Table 3c \u2014 Food, industrial, domestic and institutional area \u2013 Test conditions and requirements of standard test methods to be used to substantiate claims for virucidal activity of products Table 3d \u2014 Food, industrial, domestic and institutional area \u2013 Test conditions and requirements of standard test methods to be used to substantiate claims for sporicidal activity of products <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | Table 3e \u2014 Application of standards: dairies <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | Table 3f \u2014 Application of standards: food processing (e.g. meat, fish, prepared food) <\/td>\n<\/tr>\n | ||||||
| 44<\/td>\n | Table 3g \u2014 Application of standards: alcoholic beverages (e.g. beer, wine) <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | Table 3h \u2014 Application of standards: non-alcoholic beverages (e.g. mineral water, soft drinks) <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | Table 3i \u2014 Application of standards: food professional handling (e.g. professional kitchen) <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | Table 3j \u2014 Application of standards: pharmaceutical industry <\/td>\n<\/tr>\n | ||||||
| 50<\/td>\n | Table 3k \u2014 Application of standards: cosmetic industry <\/td>\n<\/tr>\n | ||||||
| 52<\/td>\n | 5 Precision of the test methods (Repetitions) 6 Proficiency testing 7 Minimum information for the user including labelling regarding efficacy claims and use recommendations <\/td>\n<\/tr>\n | ||||||
| 53<\/td>\n | 8 Changes in European Standards 8.1 Revision of European Standards 8.2 Impact of changes of EN 14885 on other European Standards <\/td>\n<\/tr>\n | ||||||
| 54<\/td>\n | Annex A (informative) Recommendations on the use of terms and definitions in the area of disinfection and antisepsis <\/td>\n<\/tr>\n | ||||||
| 56<\/td>\n | Annex B (informative) Recommendations on claims of activity on the basis of tests additional to or other than the tests specified in this European Standard <\/td>\n<\/tr>\n | ||||||
| 57<\/td>\n | Annex C (informative) Phase 3 tests C.1 General C.2 Comparison with phase 2 tests C.3 Requirement for a Phase 3 Test <\/td>\n<\/tr>\n | ||||||
| 58<\/td>\n | C.4 Scope of Phase 3 tests C.5 Safety <\/td>\n<\/tr>\n | ||||||
| 59<\/td>\n | C.6 Design of a Phase 3 Test <\/td>\n<\/tr>\n | ||||||
| 60<\/td>\n | C.7 Performance of a Phase 3 Test C.8 Results of a Phase 3 Test <\/td>\n<\/tr>\n | ||||||
| 61<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Chemical disinfectants and antiseptics. Application of European Standards for chemical disinfectants and antiseptics<\/b><\/p>\n |