EN ISO 374-5-2016 en Protective gloves against dangerous chemicals and microorganisms - Part 5 Terminology and performance requirements for micro-organisms risks《危险化学品和微生物防护手-套第5部分.pdf

1、BS EN ISO 374-5:2016Protective gloves againstdangerous chemicals andmicro-organismsPart 5: Terminology and performancer e q u i r e m e n t s f o r m i c r o - o r g a n i s m s r i s k s ( I S O374-5:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 374

2、-5:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 374-5:2016. It is identical to ISO 374-5:2016.BSI, as a member of CEN, is obliged to publish EN ISO 374-5:2016 as a British Standard. However, attention is drawn to the fact that during the development

3、of this European Standard, the UK committee voted against its approval as a European Standard.Further information on why the UK committee submitted a negative vote can be found in National Annex NA.The UK participation in its preparation was entrusted to Technical Committee PH/3/8, Protective gloves

4、.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017.Published by BSI Stand

5、ards Limited 2017ISBN 978 0 580 89529 6 ICS 01.040.13; 13.340.40 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2017.Amendments/corrigenda issued sin

6、ce publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 374-5 November 2016 ICS 01.040.13; 13.340.40 English Version Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms ris

7、ks (ISO 374-5:2016)Gants de protection contre les micro-organismes - Partie 5: Terminologie et exigences de performance pour des risques par des micro-organisme (ISO 374-5:2016) Schutzhandschuhe gegen Chemikalien und Mikroorganismen - Teil 5: Terminologie und Leistungsanforderungen fr Risiken durch

8、Mikroorganismen (ISO 374-5:2016) This European Standard was approved by CEN on 24 September 2016. 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 any alteration. Up-to

9、-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 language made by translat

10、ion 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, Denmark, Estonia, Finland,

11、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 andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COM

12、IT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 374-5:2016 EBS EN ISO 374-5:2016EN ISO 374-5:2016

13、(E) 3 Europen foreword This document (EN ISO 374-5:2016) has been prepared by Technical Committee CEN/TC 162 “Protective clothing including hand and arm protection and lifejackets“, the secretariat of which is held by DIN, in collaboration with Technical Committee ISO/TC 94 “Personal safety - Protec

14、tive clothing and equipment“. 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 May 2017, and conflicting national standards shall be withdrawn at the latest by May 2017. Attention is drawn to the p

15、ossibility 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 has been prepared under a mandate given to CEN by the European Commission and the European Free Tra

16、de Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are

17、bound to implement this European Standard: Austria, Belgium, 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, Port

18、ugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 374-5:2016 has been approved by CEN as EN ISO 374-5:2016 without any modification. BS EN ISO 374-5:2016EN ISO 374-5:2016 (E) 4 Annex ZA (informative) Relationship between

19、this European Standard and the Essential Requirements of EU Directive 89/686/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Dir

20、ective 89/686/EEC on the approximation of the laws of the Member States relating to personal protective equipment. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance w

21、ith the clauses of this standard given in Table ZA confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations Table ZA Correspondence between this European Standard and Directiv

22、e (Add the reference and title of the Directive) Essential Requirements (ERs) of Directive 89/686/EEC Clause(s)/ subclause(s) of this EN Qualifying remarks/ Notes 1.4 Information supplied by the manufacturer Clause 7 2.12. PPE bearing one or more identification or recognition marks directly or indir

23、ectly relating to health and safety Clause 6 3.10 3.10.2 Protection against dangerous substances and infective agents Protection against cutaneous and ocular contact 5.2, 5.3 5.4 WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this s

24、tandard. BS EN ISO 374-5:2016ISO 374-5:2016(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Sampling 24.1 Sampling for viral penetration testing 24.2 Sampling for bacteria/fungi penetration testing 25 Performance requirement . 35.1 General requirements . 35.2 Penetration

25、 . 35.3 Protection against viruses . 35.4 Requirements for different protection types of gloves 36 Marking 36.1 General . 36.2 Marking of gloves protecting against bacteria and fungi . 36.3 Marking of gloves protecting against viruses, bacteria and fungi. 47 Information supplied by the manufacturer

26、. 4 ISO 2016 All rights reserved iiiContents PageBS EN ISO 374-5:2016ISO 374-5:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out thr

27、ough ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collabo

28、rates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval

29、criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subjec

30、t of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade n

31、ame used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WT

32、O) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.ISO 374-5 was prepared by the European Committee for Standardization (CEN) in collaboration with ISO Technical Committee ISO/TC 94, Personal safety Protective clothing and equipment, Subcommit

33、tee SC 13 Protective clothing in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).ISO 374 consists of the following parts, under the general title Protective gloves against dangerous chemicals and micro-organisms: Part 1: Terminology and performance requi

34、rements for chemical risks Part 5: Terminology and performance requirements for micro-organism risksiv ISO 2016 All rights reservedBS EN ISO 374-5:2016INTERNATIONAL STANDARD ISO 374-5:2016(E)Protective gloves against dangerous chemicals and micro-organisms Part 5: Terminology and performance require

35、ments for micro-organisms risks1 ScopeThis part of ISO 374 specifies the requirements and test methods for protective gloves intended to protect the user against micro-organisms.NOTE If other protection features is to be needed, e.g. chemical risks, mechanical risks, thermal risks, electrostatic dis

36、sipation etc., the appropriate specific performance standard is to be used in addition. Further information on protective gloves standards can be found in the EN 420.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable

37、for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.EN 374-2:2014, Protective gloves against dangerous chemicals and micro-organisms Part 2: Determination of resistance to

38、penetrationEN 420:2009, Protective gloves General requirements and test methodsISO 16604:2004, Clothing for protection against contact with blood and body fluids Determination of resistance of protective clothing materials to penetration by blood-borne pathogens Test method using Phi-X 174 bacteriop

39、hage3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1protective gloves against micro-organismsprotective gloves which form a protective barrier to microbiological agentsNote 1 to entry: Microbiological agents are bacteria or virus or fungi.3.2bac

40、teriavery large group of micro-organisms comprising one of the three domains of living organisms, they are prokaryotic, unicellular, and either free-living in soil or water or parasites of plants or animals3.3virusany of various simple sub-microscopic parasites of plants, animals, and bacteria that

41、often cause disease and that consist essentially of a core of RNA or DNA surrounded by a protein coatNote 1 to entry: Unable to replicate without a host cell, viruses are typically not considered living organisms. ISO 2016 All rights reserved 1BS EN ISO 374-5:2016ISO 374-5:2016(E)3.4fungiany of nume

42、rous eukaryotic organisms of the kingdom Fungi, which lack chlorophyll and vascular tissue and range in form from a single cell to a body mass of branched filamentous hyphae that often produce specialized fruiting bodiesNote 1 to entry: The kingdom includes the yeasts, moulds and smuts.4 Sampling4.1

43、 Sampling for viral penetration testingThe test specimen shall be taken from the palm area. If the glove is longer than or equal to 400 mm and if the cuff is claimed to protect against micro-organism risks, additional test specimens shall be taken where the centre is 80 mm from the end of the cuff (

44、see Figure 1). For further instructions, see ISO 16604:2004, Clause 7.In the case of seams in the hand area, this area shall be tested.Dimensions in millimetresKey1 sampleFigure 1 Additional sample location for gloves longer than 400 mm4.2 Sampling for bacteria/fungi penetration testingThe sampling

45、for bacteria/fungi penetration shall be according to EN 374-2:2014, Clause 5.2 ISO 2016 All rights reservedBS EN ISO 374-5:2016ISO 374-5:2016(E)5 Performance requirement5.1 General requirementsProtective gloves against micro-organism risks shall comply with the requirements given in EN 420:2009, Cla

46、use 4, Clause 5 and Clause 7.5.2 PenetrationProtective gloves against virus, bacteria and fungi shall not leak when tested according to EN 374-2:2014, 7.2 and 7.3.5.3 Protection against virusesProtective gloves against virus shall be tested according to ISO 16604 Procedure B and shall exhibit no det

47、ectable transfer (1 PFU/ml) of the Phi-X174 bacteriophage in the assay titre.5.4 Requirements for different protection types of glovesThe requirements are mentioned in the Table 1.Table 1 Requirements for different protection types of gloves5.1 5.2 5.3Glove protecting against bacteria and fungi X XG

48、love protecting against virus, bacteria and fungiX X XX = required6 Marking6.1 GeneralMarking of protective gloves against micro-organisms shall be in accordance with the marking requirement for protective gloves in EN 420.6.2 Marking of gloves protecting against bacteria and fungiFor gloves protect

49、ing against bacteria and fungi complying with the requirements stated in 5.4, the pictogram in Figure 2 shall be used with reference to this part of ISO 374.Figure 2 Marking of Glove protecting against bacteria and fungi ISO 2016 All rights reserved 3BS EN ISO 374-5:2016ISO 374-5:2016(E)6.3 Marking of gloves protecting against viruses, bacteria and fungiFor gloves protecting against viruses, bacteria and fungi complying with the requirements stated in 5.4, the pictogram in Figure 3 shall be used with reference to ISO 374.Figure 3 Marking