BS EN 14885-2015 Chemical disinfectants and antiseptics Application of European Standards for chemical disinfectants and antiseptics《化学消毒剂和防腐剂 化学消毒剂和防腐剂欧洲标准的应用》.pdf

1、BSI Standards PublicationBS EN 14885:2015Chemical disinfectants andantiseptics Applicationof European Standards forchemical disinfectants andantisepticsBS EN 14885:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 14885:2015. Itsupersedes BS EN 14885:2006 whi

2、ch is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/216, Chemical disinfectants and antiseptics.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessarypr

3、ovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 85228 2ICS 11.080.20; 71.100.35Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard

4、was published under the authority of theStandards Policy and Strategy Committee on 31 August 2015.Amendments issued since publicationDate Text affectedBS EN 14885:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 14885 August 2015 ICS 71.100.35 Supersedes EN 14885:2006English Version Chemical

5、 disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics Antiseptiques et dsinfectants chimiques - Application des Normes europennes sur les antiseptiques et dsinfectants chimiques Chemische Desinfektionsmittel und Antiseptika - Anwendung Europisc

6、her Normen fr chemische Desinfektionsmittel und Antiseptika This European Standard was approved by CEN on 3 July 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without

7、any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other lang

8、uage made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmar

9、k, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE F

10、OR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 14885:2015 EBS EN 14885:2015EN 1

11、4885:2015 (E) 2 Contents Page European foreword .3 Introduction .5 1 Scope 6 2 Normative references 7 3 Terms and definitions .8 3.1 Chemical disinfectant or antiseptic procedures and product types 8 3.2 Chemical disinfectant or antiseptic action .9 3.3 General terms 12 4 Procedures for claiming act

12、ivity . 12 4.1 Category of tests. 12 4.2 General . 13 4.3 Chemical disinfectants and antiseptics for use in the medical area . 14 4.3.1 General . 14 4.3.2 Fields of application / Standards necessary to be passed for basic and additional label claims . 15 4.4 Chemical disinfectants and antiseptics fo

13、r use in the veterinary area . 25 4.5 Chemical disinfectants and antiseptics for use in food, industrial, domestic and institutional areas . 32 5 Precision of the test methods (Repetitions) 50 6 Proficiency testing 50 7 Minimum information for the user including labelling regarding efficacy claims a

14、nd use recommendations . 50 8 Changes in European Standards 51 8.1 Revision of European Standards 51 8.2 Impact of changes of EN 14885 on other European Standards . 51 Annex A (informative) Recommendations on the use of terms and definitions in the area of disinfection and antisepsis 52 Annex B (inf

15、ormative) Recommendations on claims of activity on the basis of tests additional to or other than the tests specified in this European Standard . 54 Annex C (informative) Phase 3 tests 55 C.1 General . 55 C.2 Comparison with phase 2 tests . 55 C.3 Requirement for a Phase 3 Test 55 C.4 Scope of Phase

16、 3 tests . 56 C.5 Safety . 56 C.6 Design of a Phase 3 Test . 57 C.7 Performance of a Phase 3 Test . 58 C.8 Results of a Phase 3 Test 58 Bibliography . 59 BS EN 14885:2015EN 14885:2015 (E) 3 European foreword This document (EN 14885:2015) has been prepared by Technical Committee CEN/TC 216 “Chemical

17、disinfectants and antiseptics”, the secretariat of which is held by AFNOR. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2016, and conflicting national standards shall be withdrawn at t

18、he latest by February 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 14885:2006. EN 14885:2006 was

19、revised to update the information on existing standards, to include standards published since 2006 and to give more details how to use the standards for making claims. CEN/TC 216 has prepared a series of standards on chemical disinfectants and antiseptics specifying requirements and test methods. Th

20、e purpose of this European Standard is to specify the relationship of the various standards to one another and to claims and use recommendations. To allow for different requirements in different areas of application, separate tests and pass criteria have been or will be prepared for each of the foll

21、owing three areas of application: medical, veterinary, and a group comprising food, industrial, domestic and institutional areas. This European Standard only refers to test methods which are currently included in the work programme of CEN/TC 216 and which are described in Clause 2. It is likely that

22、 additional standards which relate to specific situations, e.g. chemical disinfection of textiles, will be produced at a later time. This document was revised to adapt it to the latest state of science, to correct errors and ambiguities, to harmonize the structure and wording and to improve its read

23、ability and thereby make it more understandable. The following is a list of significant changes since the last edition: some definitions were added, some were changed; the relevance of phase 1 tests was clarified; the relationship between claims for a given product and test results is described in g

24、reater detail; the use of standards outside their defined scope is now defined; the fields of application in the different areas are described in much greater detail; recommendations how to deal with the imprecision of the test methods are given; recommendations how to use the standards for proficie

25、ncy testing (quality control) are given; the impact of changes of standards are defined; the main aims, scope, safety aspects, design, performance and evaluation of results of phase 3 tests (field tests) are described. The changes mentioned above have no impact on the use of test results obtained wi

26、th reference to the former version of EN 14885. BS EN 14885:2015EN 14885:2015 (E) 4 According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Rep

27、ublic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS

28、EN 14885:2015EN 14885:2015 (E) 5 Introduction This European Standard specifies the laboratory methods to be used for testing the activity of products, i.e. chemical disinfectants and antiseptics in order to support claims that they have specific properties appropriate to their intended application.

29、These laboratory methods may also be used for active substances and products under development. This European Standard is not intended to represent disinfection policy guidelines, i.e. guidelines for choosing and assessing the suitability of products for particular situations. The CEN standards rela

30、te to only a limited range of microbial species. These have been chosen as representative species taking into account their relative resistance and their relevance to practical use. The handling properties and the microbiological safety have also been considered in choosing the test organisms. The t

31、est methods in this European Standard are based on the current scientific state of the art. It is recognized that at the present time there is only limited knowledge regarding the relationship between the activity of products as determined by suspension as compared with surface tests, and the releva

32、nce of the results of both tests to conditions of use. Chemical disinfectants and antiseptics should always be used responsibly. This should take into account the environmental impact of inappropriate product in-use concentrations (too high or too low) and of unnecessary use. BS EN 14885:2015EN 1488

33、5:2015 (E) 6 1 Scope 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 Europ

34、ean 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 p

35、roducts 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 regulato

36、ry 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 m

37、edicine, 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 kind

38、ergartens 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 o

39、f 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 antis

40、eptics 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 packagi

41、ng, 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 ecoto

42、xicological properties of products or active substances. BS EN 14885:2015EN 14885:2015 (E) 7 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applie

43、s. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 1276, Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, do

44、mestic and institutional areas Test method and requirements (phase 2, step 1) EN 1499, Chemical disinfectants and antiseptics Hygienic handwash Test method and requirements (phase 2/step 2) EN 1500, Chemical disinfectants and antiseptics Hygienic handrub Test method and requirements (phase 2/step 2)

45、 EN 1650, Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic, and institutional areas Test method and requirements (phase 2, step 1) EN 1656, Chemical disinfectants

46、 and antiseptics Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area Test method and requirements (phase 2, step 1) EN 1657, Chemical disinfectants and antiseptics Quantitative suspension test for the evaluati

47、on of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area Test method and requirements (phase 2, step 1) EN 12791, Chemical disinfectants and antiseptics Surgical hand disinfection - Test method and requirement (phase 2/step 2) EN 13610, Chemical

48、disinfectants Quantitative suspension test for the evaluation of virucidal activity against bacteriophages of chemical disinfectants used in food and industrial areas Test method and requirements (phase 2, step 1) EN 13623, Chemical disinfectants and antiseptics Quantitative suspension test for the

49、evaluation of bactericidal activity against Legionella of chemical disinfectants for aqueous systems Test method and requirements (phase 2, step 1) EN 13624, Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area Test method and requirements (phase 2, step 1) EN 13697, Chemical disinfectants and antiseptics Quantitative non-porous surface test for the evaluation of bactericidal and/or fungicidal activity of chemical disinfec