EN ISO 15883-7-2016 en Washer-disinfectors - Part 7 Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive non-critical thermolabile medica.pdf

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1、BSI Standards PublicationBS EN ISO 15883-7:2016Washer-disinfectorsPart 7: Requirements and tests for washer-disinfectors employing chemical disinfectionfor non-invasive, non-critical thermolabilemedical devices and healthcare equipmentBS EN ISO 15883-7:2016 BRITISH STANDARDNational forewordThis Brit

2、ish Standard is the UK implementation of EN ISO15883-7:2016. The UK participation in its preparation was entrusted to TechnicalCommittee CH/198, Sterilization and Associated Equipment andProcesses.A list of organizations represented on this committee can beobtained on request to its secretary.This p

3、ublication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 73015 3ICS 11.080.10Compliance with a British Standard cannot confer immuni

4、ty fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 March 2016.Amendments/corrigenda issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORMEN ISO 15883-7 March 2016 ICS 11.080.10 Eng

5、lish Version Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016) Laveurs dsinfecteurs - Partie 7: Exigences et essais pour les laveurs dsin

6、fecteurs utilisant la dsinfection chimique pour les dispositifs mdicaux et les quipements de soins thermosensibles non invasifs et non critiques (ISO 15883-7:2016) Reinigungs-Desinfektionsgerte - Teil 7: Anforderungen und Prfverfahren fr Reinigungs-Desinfektionsgerte mit chemischer Desinfektion fr n

7、icht invasive, nicht kritische thermolabile Medizinprodukte und Zubehr im Gesundheitswesen (ISO 15883-7:2016) This European Standard was approved by CEN on 8 February 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this Europe

8、an 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

9、(English, 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, Belg

10、ium, 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, Switze

11、rland, 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 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national

12、 Members. Ref. No. EN ISO 15883-7:2016 EBS EN ISO 15883-7:2016EN ISO 15883-7:2016 (E) 3 European foreword This document (EN ISO 15883-7:2016) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” in collaboration with Technical Committee CEN/TC 102 “Sterilizers

13、for medical purposes” the secretariat of which is held by DIN. 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 September 2016, and conflicting national standards shall be withdrawn at the latest b

14、y September 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 has been prepared under a mandate given to CEN by the

15、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. The following referenced documents are indispensable for the application o

16、f this document. For undated references, the latest edition of the referenced document (including any amendments) applies. For dated references, only the edition cited applies. However, for any use of this standard within the meaning of Annex ZA, the user should always check that any referenced docu

17、ment has not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art. When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a normative reference to the corresponding EN standard, if available, and oth

18、erwise to the dated version of the ISO or IEC standard as listed below. NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. Table Correlation between normative references and dated EN and ISO standards

19、Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO ISO 11737-1 EN ISO 11737-1:2006 +EN ISO 11737-1:2006/AC:2009 ISO 11737-1:2006 + ISO 11737-1:2006/Cor 1:2007 ISO 11737-2 EN ISO 11737-2:2009 ISO 11737-2:2009 ISO 15883-1 EN ISO 15883-1:2009 + EN ISO 15883-

20、1:2009/A1:2014 ISO 15883-1:2006 + ISO 15883-1:2006/Amd1:2014 ISO 15883-2 EN ISO 15883-2:2009 ISO 15883-2:2006 ISO 15883-3 EN ISO 15883-3:2009 ISO 15883-3:2006 ISO 15883-4 EN ISO 15883-4:2009 ISO 15883-4:2008 ISO 15883-6 EN ISO 15883-6:2015 ISO 15883-6:2011 ISO/TS 15883-5 CEN ISO/TS 15883-5:2005 ISO/

21、TS 15883-5:2005 IEC 610102-040 EN 61010-2-040:2005 IEC 61010-2-040:2005 BS EN ISO 15883-7:2016EN ISO 15883-7:2016 (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,

22、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, Switzerland

23、, Turkey and the United Kingdom. Endorsement notice The text of ISO 15883-7:2016 has been approved by CEN as EN ISO 15883-7:2016 without any modification. BS EN ISO 15883-7:2016EN ISO 15883-7:2016 (E) 5 Annex ZA (informative) Relationship between this European Standard and the essential requirements

24、 of Directive 93/42/EEC OJ L 169 aimed to be covered This European Standard has been prepared under a Commissions standardization request M/023 concerning the development of European standards to medical devices to provide one voluntary means of conforming to essential requirements of Council Direct

25、ive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169. Once this standard is cited in the Official Journal of the European Union under that Directive, compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a pr

26、esumption of conformity with the corresponding essential requirements of that Directive, and associated EFTA regulations. NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 93/42/EEC, as

27、 amended by 2007/47/EC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest possible level, minimized or removed, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determining acceptable risk must be in compl

28、iance with Essential Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOTE 3 This Annex ZA is based on normative references according to the table of references in the European foreword, replacing the references in the core text. NOTE 4 When an Essential Requirement does not appear in T

29、able ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this European standard and Annex I of Directive 93/42/EEC OJ L 169 Essential Requirements of EU Directive 93/42/EEC Clause(s)/subclause(s) of this European Standard Remarks/Notes7.2 9 In additio

30、n requirements of EN ISO 15883-1 apply. Reference to IEC 61010-2-040:2005, Clause 5 included in respect of packaging only 7.3 4.1.1, 4.1.47.4 WD is not designed to deal with such medical products 7.5 4.1.1 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.24.1 BS EN ISO 158

31、83-7:2016EN ISO 15883-7:2016 (E) 6 Essential Requirements of EU Directive 93/42/EEC Clause(s)/subclause(s) of this European Standard Remarks/Notes 7.6 4.1.1, 4.7.1 8.1 4.1.1, 4.3, 4.5, 4.7.2 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 4.3.1 9.1 4.1.1, 4.1.3, 5.1.1, 8 a)

32、 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.1.9, 5.1.10, 5.6 and 5.28 9.2 4.1.1, 4.1.3, 5.1.1, 5.1.2 Including reference to IEC 61010-2-040:2005, 5.4.3 and 7.5 9.3 WDs are unlikely to be manufactured of or to contain flammable or explosive substances10.1 Not likely t

33、o apply, see MEDDEV 2.1 11 Intended hazardous radiation is unlikely to be emitted by a WD 12.1 4.1.1 12.5 4.1.1 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.2 12.6 4.1.1 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1 12.7.1 4.1.1 Incl

34、uding reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1 12.7.2 4.1.1 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1 12.7.3 4.1.1 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1 12.7.5 4.1.1 Including reference to EN

35、 ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1 BS EN ISO 15883-7:2016EN ISO 15883-7:2016 (E) 7 Essential Requirements of EU Directive 93/42/EEC Clause(s)/subclause(s) of this European Standard Remarks/Notes 12.9 4.1.1 13.1 4.1.1 13.2 4.1.1 Including reference to EN ISO 15883-1:2009 + EN ISO

36、15883-1:2009/A1:2014, 5.10.3 13.3 a), b), d) 4.1.1 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 9.1 13.3 i) 4.1.1 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2913.3 k) 4.1.1 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/

37、A1:2014, 5.2.3 13.3 I) 4.1.1 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 9.1 13.4 4.1.1 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 8.1 b) 13.6 a) Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 9.1 13.6 b) 8 f) In

38、cluding reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 8.3 13.6 c) 4.1.4, 4.3.4 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 8.2 h) 13.6 d) 8 a), c), h) Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 6.1.3.2, 8.1 and 8.3 g) 13.

39、6 q) 8 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, Clause 8 BS EN ISO 15883-7:2016EN ISO 15883-7:2016 (E) 8 For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on Machinery, in accordance with Article 3 of Directive 93/42/EEC

40、the following Table ZA.2 details the relevant essential requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific than those of Directive 93/42/EEC along with the corresponding clauses of this European Standard. Table ZA.2, however, does not imply any citation i

41、n the OJEU under the machinery directive and thus does not provide presumption of conformity for the machinery directive. Table ZA.2 Relevant Essential Health and Safety Requirements from Directive 2006/42/EC on machinery that are addressed by this European Standard (according to Article 3 of amende

42、d Directive 93/42/EEC) Essential Health and Safety Requirements (EHSRs) of Directive 2006/42/EC Clause(s)/sub-clause(s) of this European Standard Qualifying remarks/Notes 1 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.3 and 5.2.4 1.1.2 4.1.1, 5.1.1, 5.1.2 See in addit

43、ion EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.1 1.1.3 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.1.1, 5.1.2, 5.2 and 5.3.2 a) 1.1.5 4.1.1 See in addition EN ISO 15883-1:2009, 9.2 1.1.6 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014,

44、 5.12.3, 5.27.1 and 6.6.2 1.1.7 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2 1.2.1, 1st dash and 2nd dash 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.2, 5.2.4, 5.12.1, 5.20 and 5.22 1.2.2, 1st dash 4.1.1 See in addition EN ISO 15883-1:

45、2009 + EN ISO 15883-1:2009/A1:2014, 5.2, 5.12.3, 5.12.8 and 5.12.91.2.3 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1 1.2.4.1 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1 and 5.19 BS EN ISO 15883-7:2016EN ISO 15883-7:2016 (E) 9 Essen

46、tial Health and Safety Requirements (EHSRs) of Directive 2006/42/EC Clause(s)/sub-clause(s) of this European Standard Qualifying remarks/Notes 1.2.5 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.18 and 5.19 1.2.6 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1

47、:2009/A1:2014, 5.2 and 5.4.1.9 1.3.1 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1 Including reference to EN 61010-2-040:2005, 7.3 1.3.2 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.1, 5.2.1 and 8.3 g) 1.3.3 4.1.1 See in addition EN ISO

48、15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1 1.3.4 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.1.6 and 5.2.1 Including reference to EN 61010-2-040:2005, Clause 71.3.7 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1 1.3.8 4.1.1 See in

49、 addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1 1.3.9 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1 1.5.1 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1 1.5.2 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1BS EN ISO 15883-7:2016EN ISO 15883-7:2016 (E) 10 Essential Health and Safety Requirements (EHSRs) of Directive 2006/42/EC Clause(s)/sub-clause(s) of this European Standard Qualifying remarks/Notes 1.5.3 4.1.1 See in addition EN IS