DIN EN 14885-2015 Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics German version EN 14885 2015《化学消毒剂和防腐剂 采用化学消.pdf

1、November 2015 English price group 22No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 71.100.35!%GF7“2363520www.din.d

2、eDIN EN 14885Chemical disinfectants and antiseptics Application of European Standards for chemical disinfectants and antiseptics;English version EN 14885:2015,English translation of DIN EN 14885:2015-11Chemische Desinfektionsmittel und Antiseptika Anwendung Europischer Normen fr chemische Desinfekti

3、onsmittel und Antiseptika;Englische Fassung EN 14885:2015,Englische bersetzung von DIN EN 14885:2015-11Antiseptiques et dsinfectants chimiques Application des Normes europennes sur les antiseptiques et dsinfectants chimiques;Version anglaise EN 14885:2015,Traduction anglaise de DIN EN 14885:2015-11S

4、upersedesDIN EN 14885:2007-01www.beuth.deDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.Document comprises 61 pages 10.15 DIN EN 14885:2015-11 2 A comma is used as the decimal marker. National foreword This document (EN 14885:2015)

5、 has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics” (Secretariat: AFNOR, France) with the active participation of German experts. The responsible German body involved in its preparation was the DIN-Normenausschuss Medizin (DIN Standards Committee Medicine),

6、Working Committee NA 063-04-07 AA Chemische Desinfektionsmittel und Antiseptika in der Humanmedizin. Amendments This standard differs from DIN EN 14885:2007-01 as follows: a) Clause 3 “Terms and definitions” has been revised; b) the relevance of phase 1 tests has been clarified; c) the relationship

7、between claims for a given product and test results has been described in more detail; d) the use of standards outside their defined scope has been defined; e) the fields of application in the different areas have been described in more detail; f) recommendations how to deal with the imprecision of

8、the test methods have been included; g) recommendations how to use the standards for proficiency testing (quality control) have been included; h) the impact of changes of standards, e.g. introduction of transitional periods, have been defined; i) the main aims, scope, safety aspects, design, perform

9、ance and evaluation of results of phase 3 tests (field tests) have been described; j) the standard has been editorially revised and harmonized with other standards of CEN/TC 216. Previous editions DIN EN 14885: 2007-01 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 14885 August 2015 ICS 71.100

10、.35 Supersedes EN 14885:2006English Version Chemical 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 Desi

11、nfektionsmittel und Antiseptika - Anwendung Europischer 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

12、 Standard the status of a national standard without 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 (E

13、nglish, French, German). A version in any other language 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, Belgiu

14、m, Bulgaria, Croatia, Cyprus, Czech Republic, 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, Switzerl

15、and, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR 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 M

16、embers. Ref. No. EN 14885:2015 EEN 14885:2015 (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 te

17、rms 12 4 Procedures for claiming activity . 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 Chemi

18、cal disinfectants and antiseptics for 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 l

19、abelling regarding efficacy claims and 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 disinfe

20、ction and antisepsis 52 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 . 54 Annex C (informative) Phase 3 tests 55 C.1 General . 55 C.2 Comparison with phase 2 tests . 55 C.3 Requirement for

21、a Phase 3 Test 55 C.4 Scope of Phase 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 DIN EN 14885:2015-11 EN 14885:2015 (E) 3 European foreword This document (EN 14885:2015) has been prepared by

22、Technical Committee CEN/TC 216 “Chemical 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 n

23、ational standards shall be withdrawn at the 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 sup

24、ersedes EN 14885:2006. EN 14885:2006 was 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 spe

25、cifying requirements and test methods. The 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

26、 or will be prepared for each of the following 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

27、 described in Clause 2. It is likely that 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 stru

28、cture and wording and to improve its readability 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 p

29、roduct and test results is described in greater 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; recommendati

30、ons how to use the standards for proficiency 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 impa

31、ct on the use of test results obtained with reference to the former version of EN 14885. DINEN 14885:2015-11EN 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, B

32、elgium, Bulgaria, Croatia, Cyprus, Czech Republic, 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, Swi

33、tzerland, Turkey and the United Kingdom. DIN EN 14885:2015-11 EN 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 prope

34、rties appropriate to their intended application. 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

35、for particular situations. The CEN standards relate 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

36、 considered in choosing the test organisms. The test 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 suspensi

37、on as compared with surface tests, and the relevance 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

38、) and of unnecessary use. DIN EN 14885:2015-11 EN 14885:2015 (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 s

39、pecifies 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 bacterioph

40、ages). 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 wh

41、ich 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, do

42、mestic 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 a

43、nd 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 d

44、isinfectants 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 area

45、s 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, transpor

46、ts, 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 re

47、fer to methods for testing the toxicological and ecotoxicological properties of products or active substances. DIN EN 14885:2015-11 EN 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 appli

48、cation. For dated references, only the edition cited applies. 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

49、 disinfectants and antiseptics used in food, industrial, domestic 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) EN 1650, Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation