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BS EN 14885:2015

BS EN 14885:2015

$198.66

Chemical disinfectants and antiseptics. Application of European Standards for chemical disinfectants and antiseptics

Published By Publication Date Number of Pages
BSI 2015 64
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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.

PDF Catalog

PDF Pages PDF Title
4 Contents Page
5 European foreword
7 Introduction
8 1 Scope
9 2 Normative references
10 3 Terms and definitions
3.1 Chemical disinfectant or antiseptic procedures and product types
11 3.2 Chemical disinfectant or antiseptic action
14 3.3 General terms
4 Procedures for claiming activity
4.1 Category of tests
15 4.2 General
16 4.3 Chemical disinfectants and antiseptics for use in the medical area
4.3.1 General
Table 1 — Medical area – Standard test methods to be used to substantiate claims for products
17 4.3.2 Fields of application / Standards necessary to be passed for basic and additional label claims
4.3.2.1 General
18 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
19 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
20 Table 1a — Medical area – Test conditions and requirements of standard test methods to be used to substantiate claims for bactericidal activity of products
23 Table 1b — Medical area – Test conditions and requirements of standard test methods to be used to substantiate claims for fungicidal and yeasticidal activity of products
25 Table 1c — Medical area – Test conditions and requirements of standard test methods to be used to substantiate claims for virucidal activity of products
26 Table 1d — Medical area – Test conditions and requirements of standard test methods to be used to substantiate claims for mycobactericidal and tuberculocidal activity of products
27 4.4 Chemical disinfectants and antiseptics for use in the veterinary area
Table 2 — Veterinary area – Standard test methods to be used to substantiate claims for products
29 Table 2a — Veterinary area – Test conditions and requirements of standard test methods to be used to substantiate claims for bactericidal activity of products)
31 Table 2b — Veterinary area – Test conditions and requirements of standard test methods to be used to substantiate claims for fungicidalb and yeasticidalb activity of products
32 Table 2c — Veterinary area – Test conditions and requirements of standard test methods to be used to substantiate claims for virucidal activity of products
33 Table 2d — Veterinary area – Test conditions and requirements of standard test methods to be used to substantiate claims for mycobactericidal activity of products
34 4.5 Chemical disinfectants and antiseptics for use in food, industrial, domestic and institutional areas
35 Table 3 — Food, industrial, domestic and institutional area – Standard test methods to be used to substantiate claims for products
36 Table 3a — Food, industrial, domestic and institutional area – Test conditions and requirements of standard test methods to be used to substantiate claims for bactericidal activity of products
38 Table 3b — Food, industrial, domestic and institutional area – Test conditions and requirements of standard test methods to be used to substantiate claims for fungicidal and yeasticidal activity of products
40 Table 3c — Food, industrial, domestic and institutional area – Test conditions and requirements of standard test methods to be used to substantiate claims for virucidal activity of products
Table 3d — Food, industrial, domestic and institutional area – Test conditions and requirements of standard test methods to be used to substantiate claims for sporicidal activity of products
41 Table 3e — Application of standards: dairies
42 Table 3f — Application of standards: food processing (e.g. meat, fish, prepared food)
44 Table 3g — Application of standards: alcoholic beverages (e.g. beer, wine)
45 Table 3h — Application of standards: non-alcoholic beverages (e.g. mineral water, soft drinks)
46 Table 3i — Application of standards: food professional handling (e.g. professional kitchen)
48 Table 3j — Application of standards: pharmaceutical industry
50 Table 3k — Application of standards: cosmetic industry
52 5 Precision of the test methods (Repetitions)
6 Proficiency testing
7 Minimum information for the user including labelling regarding efficacy claims and use recommendations
53 8 Changes in European Standards
8.1 Revision of European Standards
8.2 Impact of changes of EN 14885 on other European Standards
54 Annex A (informative) Recommendations on the use of terms and definitions in the area of disinfection and antisepsis
56 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
57 Annex C (informative) Phase 3 tests
C.1 General
C.2 Comparison with phase 2 tests
C.3 Requirement for a Phase 3 Test
58 C.4 Scope of Phase 3 tests
C.5 Safety
59 C.6 Design of a Phase 3 Test
60 C.7 Performance of a Phase 3 Test
C.8 Results of a Phase 3 Test
61 Bibliography

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BS EN 14885:2015
$198.66