DIN EN ISO 374-5-2017 Protective gloves against dangerous chemicals and micro-organisms - Part 5 Terminology and performance requirements for micro-organisms risks (ISO 374-5 2016).pdf

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1、March 2017 English price group 8No 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 13.340.40!%bVX“2635153www.din.deDIN

2、 EN ISO 374-5Protective gloves against dangerous chemicals and microorganisms Part 5: Terminology and performance requirements for microorganisms risks (ISO 3745:2016);English version EN ISO 3745:2016,English translation of DIN EN ISO 374-5:2017-03Schutzhandschuhe gegen gefhrliche Chemikalien und Mi

3、kroorganismen Teil 5: Terminologie und Leistungsanforderungen fr Risiken durch Mikroorganismen (ISO 3745:2016);Englische Fassung EN ISO 3745:2016,Englische bersetzung von DIN EN ISO 374-5:2017-03Gants de protection contre les microorganismes Partie 5: Terminologie et exigences de performance pour de

4、s risques par des microorganismes (ISO 3745:2016);Version anglaise EN ISO 3745:2016,Traduction anglaise de DIN EN ISO 374-5:2017-03www.beuth.deDocument comprises 11 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.03.17 DIN EN I

5、SO 374-5:2017-03 2 A comma is used as the decimal marker. National foreword This standard includes safety requirements. 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” (Secretariat: DIN, Ger

6、many) in collaboration with Technical Committee ISO/TC 94, Subcommittee SC 13 “Personal safety Protective clothing and equipment”. The responsible German body involved in its preparation was DIN-Normenausschuss Persnliche Schutzausrstung (DIN Standards Committee Personal Protective Equipment), Worki

7、ng Committee NA 075-05-08 AA Handschutz. EUROPEAN 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 risk

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

9、ikroorganismen (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-

10、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 translati

11、on 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, F

12、ormer 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 COMI

13、T 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 EEuropean foreword .31 Scope . 52 Normat

14、ive references 53 Terms and definitions . 54 Sampling 64.1 Sampling for viral penetration testing 64.2 Sampling for bacteria/fungi penetration testing 65 Performance requirement . 75.1 General requirements . 75.2 Penetration . 75.3 Protection against viruses . 75.4 Requirements for different protect

15、ion types of gloves 76 Marking 76.1 General . 76.2 Marking of gloves protecting against bacteria and fungi . 76.3 Marking of gloves protecting against viruses, bacteria and fungi. 87 Information supplied by the manufacturer .8Contents PageAnnex ZA (informative) Relationship between this European Sta

16、ndard and the Essential Requirements of EU Directive 89/686/EEC 9 DIN EN ISO 374-5:2017-03 EN ISO 374-5:2016 (E)2.Foreword 4Europen 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“,

17、the secretariat of which is held by DIN, in collaboration with Technical Committee ISO/TC 94 “Personal safety - Protective 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

18、May 2017, and conflicting national standards shall be withdrawn at the latest by May 2017. 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 rig

19、hts. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade 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. A

20、ccording 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 Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germ

21、any, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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 374-5:2

22、016 without any modification. DIN EN ISO 374-5:2017-03 EN ISO 374-5:2016 (E)3 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 through ISO

23、 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 collaborates cl

24、osely 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 criteria

25、 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 subject of pat

26、ent 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 name used

27、 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 (WTO) princ

28、iples 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, Subcommittee SC 1

29、3 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 requirements

30、for chemical risks Part 5: Terminology and performance requirements for micro-organism risksDIN EN ISO 374-5:2017-03 EN ISO 374-5:2016 (E)4 1 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

31、 protection features is to be needed, e.g. chemical risks, mechanical risks, thermal risks, electrostatic dissipation 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

32、 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 applies. For undated references, the latest edition of the referenced document (including any amendments) applies.EN 374-2:20

33、14, Protective gloves against dangerous chemicals and micro-organisms Part 2: Determination of resistance to 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 o

34、f protective clothing materials to penetration by blood-borne pathogens Test method using Phi-X 174 bacteriophage3 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 b

35、arrier to microbiological agentsNote 1 to entry: Microbiological agents are bacteria or virus or fungi.3.2bacteriavery 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 pl

36、ants or animals3.3virusany of various simple sub-microscopic parasites of plants, animals, and bacteria that 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 consid

37、ered living organisms.DIN EN ISO 374-5:2017-03 EN ISO 374-5:2016 (E)5 3.4fungiany of numerous 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 fruiti

38、ng bodiesNote 1 to entry: The kingdom includes the yeasts, moulds and smuts.4 Sampling4.1 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, addi

39、tional test specimens shall be taken where the centre is 80 mm from the end of the cuff (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

40、gloves longer than 400 mm4.2 Sampling for bacteria/fungi penetration testingThe sampling for bacteria/fungi penetration shall be according to EN 374-2:2014, Clause 5.DIN EN ISO 374-5:2017-03 EN ISO 374-5:2016 (E)6 5 Performance requirement5.1 General requirementsProtective gloves against micro-organ

41、ism risks shall comply with the requirements given in EN 420:2009, Clause 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

42、 be tested according to ISO 16604 Procedure B and shall exhibit no detectable 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 type

43、s of gloves5.1 5.2 5.3Glove protecting against bacteria and fungi X XGlove 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 Mar

44、king of gloves protecting against bacteria and fungiFor gloves protecting 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 fungiDIN EN ISO

45、 374-5:2017-03 EN ISO 374-5:2016 (E)7 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 of glo

46、ves protecting against viruses, bacteria and fungi7 Information supplied by the manufacturerThe information supplied by the manufacturer shall be in accordance with the requirements for information as defined in EN 420. For protective gloves that are marked offering protection against micro-organism

47、s and complying with the requirements in 5.4, this shall be stated in the user instructions.The following warning shall be added that this information does not reflect the actual performance in the workplace: ”The penetration resistance has been assessed under laboratory conditions and relates only to the tested specimen.”If not tested against viruses, the following warning shall be added: “Not tested against viruses”.DIN EN ISO 374-5:2017-03 EN ISO 374-5:2016 (E)8 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 89/686/E