EN ISO 15883-6-2015 en Washer-disinfectors - Part 6 Requirements and tests for washer-disinfectors employing thermal disinfection for noninvasive non-critical medical devices and h.pdf

1、BSI Standards PublicationBS EN ISO 15883-6:2015Washer-disinfectorsPart 6: Requirements and tests for washer-disinfectors employing thermal disinfectionfor non-invasive, non-critical medicaldevices and healthcare equipmentBS EN ISO 15883-6:2015 BRITISH STANDARDNational forewordThis British Standard i

2、s the UK implementation of EN ISO 15883-6:2015. It supersedes BS EN ISO 15883-6:2011 which iswithdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization and Associated Equipment and Processes.A list of organizations represented on this committee can b

3、e 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 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 91544 4 ICS 11.080.10 Compli

4、ance 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 30 September 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUR

5、OPENNE EUROPISCHE NORM EN ISO 15883-6 August 2015 ICS 11.080.10 Supersedes EN ISO 15883-6:2011English Version Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883

6、-6:2011) Laveurs dsinfecteurs - Partie 6: Exigences et essais pour les laveurs dsinfecteurs utilisant une dsinfection thermique pour les dispositifs mdicaux non invasifs, non critiques et pour lquipement de soins de sant (ISO 15883-6:2011) Reinigungs-Desinfektionsgerte - Teil 6: Anforderungen und Pr

7、fverfahren fr Reinigungs-Desinfektionsgerte mit thermischer Desinfektion fr nicht invasive, nicht kritische Medizinprodukte und Zubehr im Gesundheitswesen (ISO 15883-6:2011) This European Standard was approved by CEN on 4 August 2015. CEN members are bound to comply with the CEN/CENELEC Internal Reg

8、ulations which stipulate the conditions for giving this European 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 mem

9、ber. This European Standard exists in three official versions (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.

10、CEN members are the national standards bodies of 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

11、, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, 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

12、 any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15883-6:2015 EBS EN ISO 15883-6:2015European foreword This document (EN ISO 15883-6:2015) has been prepared by Technical Committee ISO/TC 198 “Sterilization of healthcare products” in collaboration with CEN/TC 10

13、2 “Sterilizers 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 February 2016, and conflicting national standards shall be withdrawn

14、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 supersedes EN ISO 15883-6:2011. This doc

15、ument 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. The following

16、referenced documents are indispensable for the application of 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 Ann

17、ex ZA, the user should always check that any referenced document 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 refer

18、ence to the corresponding EN standard, if available, and otherwise 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

19、between normative references and dated EN and ISO standards Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO ISO 15883-1 EN ISO 15883-1:2009+A1:2014 ISO 15883-1:2006+Amd1:2014 ISO/TS 15883-5 CEN/ISO/TS 15883-5:2005 ISO/TS 15883-5:2005 According to the C

20、EN-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, Germany, Greece, Hung

21、ary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. EN ISO 15883-6:2015 (E)BS EN ISO 15883-6:2015Endorsement notice The text of ISO 15883-6:2011 has been app

22、roved by CEN as EN ISO 15883-6:2015 without any modification. EN ISO 15883-6:2015 (E)BS EN ISO 15883-6:2015Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices This European Standard has been prepared under a m

23、andate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to the Essential Requirements of the Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has

24、been implemented as a national standard in at least one Member State, compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and a

25、ssociated 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 amended by 2007/47/EC. This means that risks have to be reduced as far as possible, to a mini

26、mum, 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 compliance with essential requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOTE 3 This

27、 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 Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Corresponde

28、nce between this European Standard and Directive 93/42/EEC on medical devices Clauses/subclauses of this European Standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 9 7.2 In addition requirements of EN ISO 15883-1 apply. 4.1.1,8 7.2 This part shall comply also w

29、ith the requirements of EN ISO 15883-1 in which the essential requirements are covered 4.1.1, 4.1.5 7.3 This part shall comply also with the requirements of EN ISO 15883-1 in which the essential requirements are covered 4.1.1 7.5 This part shall comply also with the requirements of EN ISO 15883-1 in

30、 which the essential requirements are covered 4.1.1 7.6 This part shall comply also with the requirements of EN ISO 15883-1 in which the essential requirements EN ISO 15883-6:2015 (E)BS EN ISO 15883-6:2015Clauses/subclauses of this European Standard Essential requirements (ERs) of EU Directive 93/42

31、/EEC Qualifying remarks/Notes are covered 4.1.1 8.1 This part shall comply also with the requirements of EN ISO 15883-1 in which the essential requirements are covered 4.1.2, 4.1.3, 4.1.5, 4.2, 4.3, 5.1, 5.2, 6.2, 6.3, 8 8.1 6.1 8.1 Testing for conformity according to EN ISO 15883-1 4.1.1 9.1 This p

32、art shall comply also with the requirements of EN ISO 15883-1 in which the essential requirements are covered 4.1.2, 4.1.3, 7 9.1 4.1.1 9.2, 9.3 This part shall comply also with the requirements of EN ISO 15883-1 in which the essential requirements are covered 4.1.1 12.1 This part shall comply also

33、with the requirements of EN ISO 15883-1 in which the essential requirements are covered 4.1.1 12.5 This part shall comply also with the requirements of EN ISO 15883-1 in which the essential requirements are covered 4.1.1 12.6 This part shall comply also with the requirements of EN ISO 15883-1 in whi

34、ch the essential requirements are covered 4.1.1 12.7.1 This part shall comply also with the requirements of EN ISO 15883-1 in which the essential requirements are covered 4.1.1 12.7.2 This part shall comply also with the requirements of EN ISO 15883-1 in which the essential requirements are covered

35、4.1.1 12.7.3 This part shall comply also with the requirements of EN ISO 15883-1 in which the essential requirements are covered 4.1.1 12.7.5 This part shall comply also with the requirements of EN ISO 15883-1 in which the essential requirements are covered EN ISO 15883-6:2015 (E)BS EN ISO 15883-6:2

36、015Clauses/subclauses of this European Standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 4.1.1 13.1 This part shall comply also with the requirements of EN ISO 15883-1 in which the essential requirements are covered 4.1.1 13.3 This part shall comply also with t

37、he requirements of EN ISO 15883-1 in which the essential requirements are covered 4.1.1 13.4 This part shall comply also with the requirements of EN ISO 15883-1 in which the essential requirements are covered 4.1.1 13.3 a) This relevant Essential Requirement is partly addressed in EN ISO 15883-1 7 1

38、3.6 WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. 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 the

39、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 in th

40、e 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 amended Di

41、rective 93/42/EEC) Clause(s)/sub-clause(s) of this European Standard Essential Health and Safety Requirements (EHSRs) of Directive 2006/42/EC Qualifying remarks/Notes 4.1.1 1 4.1.1 1.1.3 See in addition EN ISO 15883-1:2009+A1:2014, 5.1.1, 5.1.2, 5.2 and 5.3.2 a) 4.1.1 1.1.5 See in addition EN ISO 15

42、883-1:2009+A1:2014, 9.2 4.1.1 1.1.6 See in addition EN ISO 15883-1:2009+A1:2014, 5.12.3, 5.27.1 and 6.6.2 4.1.1 1.1.7 See in addition EN ISO 15883-1:2009+A1:2014, 5.2 4.1.1 1.2.1, 1stand 2nddash See in addition EN ISO 15883-1:2009+A1:2014, 5.2.2, 5.2.4, 5.12.1, 5.20 and 5.22 EN ISO 15883-6:2015 (E)B

43、S EN ISO 15883-6:2015Clause(s)/sub-clause(s) of this European Standard Essential Health and Safety Requirements (EHSRs) of Directive 2006/42/EC Qualifying remarks/Notes 4.1.1 1.2.2, 1stdash See in addition EN ISO 15883-1:2009+A1:2014, 5.2, 5.12.3, 5.12.8 and 5.12.9 4.1.1 1.2.3 See in addition EN ISO

44、 15883-1:2009+A1:2014, 5.2.1 4.1.1 1.2.4 4.1.1 1.2.5 See in addition EN ISO 15883-1:2009+A1:2014, 5.18 and 5.19 4.1.1 1.2.6 See in addition EN ISO 15883-1:2009+A1:2014, 5.2 and 5.4.1.9 4.1.1 1.3.1 See in addition EN ISO 15883-1:2009+A1:2014, 5.2.1 Including reference to EN 61010-2-040:2005, 7.3 4.1.

45、1 1.3.2 See in addition EN ISO 15883-1:2009+A1:2014, 5.1, 5.2.1 and 8.3 g) 4.1.1 1.3.3 See in addition EN ISO 15883-1:2009+A1:2014, 5.2.1 4.1.1 1.3.4 See in addition EN ISO 15883-1:2009+A1:2014, 5.1.6 and 5.2.1 Including reference to EN 61010-2-040:2005, clause 7 4.1.1 1.3.7 See in addition EN ISO 1

46、5883-1:2009+A1:2014, 5.2.1 4.1.1 1.3.8 See in addition EN ISO 15883-1:2009+A1:2014, 5.2.1 4.1.1 1.5.1 See in addition EN ISO 15883-1:2009+A1:2014, 5.2.1 4.1.1 1.5.2 See in addition EN ISO 15883-1:2009+A1:2014, 5.2.1 4.1.1 1.5.3 See in addition EN ISO 15883-1:2009+A1:2014, 5.2.1 4.1.1 1.5.4 See in ad

47、dition EN ISO 15883-1:2009+A1:2014, EN ISO 15883-6:2015 (E)BS EN ISO 15883-6:2015Clause(s)/sub-clause(s) of this European Standard Essential Health and Safety Requirements (EHSRs) of Directive 2006/42/EC Qualifying remarks/Notes 5.2.1 and 8.3 4.1.1 1.5.5 See in addition EN ISO 15883-1:2009+A1:2014,

48、5.2.1 4.1.1 1.5.6 See in addition EN ISO 15883-1:2009+A1:2014, 5.2.1 and 5.8 4.1.1 1.5.8 See in addition EN ISO 15883-1:2009+A1:2014, 5.2.1 4.1.1 1.5.13 See in addition EN ISO 15883-1:2009+A1:2014, 5.2.1 and 8.1 b) Including reference to EN 61010-2-040:2005, clause 11 4.1.1 1.5.14 See in addition EN

49、 ISO 15883-1:2009+A1:2014, 5.2.1 Including reference to EN 61010-2-040:2005, clause 15 4.1.1 1.6.1 See in addition EN ISO 15883-1:2009+A1:2014, 5.1.5 and 5.2.1 4.1.1 1.6.2 See in addition EN ISO 15883-1:2009+A1:2014, 5.1.5 and 5.2.1 4.1.1 1.6.3 See in addition EN ISO 15883-1:2009+A1:2014, 5.2.1 and 8.2 a) and b) 4.1.1 1.6.4 See in addition EN ISO 15883-1:2009+A1:2014, 5.2.1 and 5.4.1.6 4.1.1 1.6.5 See in addition EN ISO 15883-1:2009+A1:2014, 4.2.1.1 and 5.1.10 4.1.1 1.7.1 See in addition EN ISO 15883-1:2009+A1:2014, 5.2.1, 5.10.2, 5.10.3 and 5.