EN ISO 26722-2015 en Water treatment equipment for haemodialysis applications and related therapies《血液透析中的应用及相关治疗的水处理设备(ISO 26722 2014)》.pdf

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1、BSI Standards PublicationBS ISO 26722:2014Water treatment equipment forhaemodialysis applications andrelated therapiesBS EN ISO 26722:2015BS EN ISO 26722:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 26722:2015. It is identical to ISO 26722:2014. It s

2、upersedes BS ISO 26722:2014 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/150, Implants for surgery, to Subcommittee CH/150/2, Cardiovascular implants.A list of organizations represented on this subcommittee can be obtained on request to its secre

3、tary.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 88235 7ICS 11.040.20; 11.040.40Compliance with a British Stan

4、dard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2014.Amendments/corrigenda issued since publicationDate Text affected31 December 2015 This corrigendum renumbers BS ISO 26722:2014 as BS

5、 EN ISO 26722:2015. Annex ZA also addedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 26722 December 2015 ICS 11.040.40 English Version Water treatment equipment for haemodialysis applications and related therapies (ISO 26722:2014) quipement de traitement de leau pour des applications en h

6、modialyse et aux thrapies apparentes (ISO 26722:2014) Ausstattung zur Wasseraufbereitung zur Verwendung in der Hmodialyse und in verwandten Therapien (ISO 26722:2014) This European Standard was approved by CEN on 23 November 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulat

7、ions 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 member.

8、 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. CEN

9、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, Po

10、rtugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited 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

11、form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 26722:2015 EEN ISO 26722:2015 (E) 3 European foreword The text of ISO 26722:2014 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of the International Organization for Standardization (ISO) a

12、nd has been taken over as EN ISO 26722:2015 by Technical Committee CEN/TC 205 “Non-active medical devices” 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

13、June 2016, and conflicting national standards shall be withdrawn at the latest by June 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 r

14、ights. 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. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. The f

15、ollowing 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 meani

16、ng of Annex 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 shall be understood as a normati

17、ve reference 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. ISO 2014

18、All rights reservediiBS EN ISO 26722:2015EN ISO 26722:2015 (E)EN ISO 26722:2015 (E) 4 Table 1 Correlation 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 or IEC ISO 13959:2014 EN ISO 13959:201

19、51)ISO 13959:2014 ISO 14971:2007 EN ISO 14971:2012 ISO 14971:2007 IEC 60601-1-8 EN 60601-1-8:2007+Cor.:2010+A1:2013 IEC 60601-1-8:2006+A1:2012 According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Stand

20、ard: 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, Portugal, Romania, Slovakia, Slovenia, Spa

21、in, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 26722:2014 has been approved by CEN as EN ISO 26722:2015 without any modification. 1) To be published. ISO 2014 All rights reserved iiiBS EN ISO 26722:2015EN ISO 26722:2015 (E)EN ISO 26722:2015 (E) 5 Annex ZA

22、(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 mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conform

23、ing to Essential Requirements of the New Approach 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 been implemented as a national standard in at least one Member State, compliance with the clauses of this s

24、tandard 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 associated EFTA regulations. NOTE 1 Where a reference from a clause of this standard to the risk management process is

25、 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 minimum, to the lowest possible level, minimized or removed, according to the wording of the corresponding essential requi

26、rement. 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 Annex ZA is based on normative references according to the table of references in the European foreword, replacing th

27、e 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 Correspondence between this European Standard and Directive 93/42/EEC on medical devices Clause(s)/sub-clause(s) of this EN Essen

28、tial Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4.2.1.1 7.3 4.2.1.1 7.5 4.2.1.4 8 1.2, 4.1.1 9.1 4.1.1 13.3. (a) 4.2.1.4 13.3. (i) 1.2, 1.3 13.6. (c) WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standa

29、rd. ISO 2014 All rights reservedivBS EN ISO 26722:2015EN ISO 26722:2015 (E)BS ISO 26722:2014ISO 26722:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 11.1 General . 11.2 Inclusions . 11.3 Exclusions 12 Normative references 13 Terms and definitions . 24 Require

30、ments 74.1 Dialysis water quality requirements 74.2 Water treatment equipment requirements 85 Tests 135.1 Compliance with dialysis water quality requirements 135.2 Compliance with water treatment equipment requirements .156 Labelling .176.1 General 176.2 Device markings . 176.3 Product literature 18

31、Annex A (informative) Rationale for the development and provisions of this International Standard .20Annex B (informative) Reference tables from ISO 13959 30Bibliography .33BS EN ISO 26722:2015ISO 26722:2014(E) ISO 2014 All rights reserved vviviiBS ISO 26722:2014ISO 26722:2014(E)ForewordISO (the Int

32、ernational 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 technical committees. Each member body interested in a subject for which a technical committee ha

33、s 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 closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical

34、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 needed for the different types of ISO documents should be noted. This document was drafted in acc

35、ordance 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 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Detai

36、ls 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 in this document is information given for the convenience of users and does not constitute an end

37、orsement.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 WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee respo

38、nsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems.This second edition cancels and replaces the first edition (ISO 26722:2009), which has been technically revised.iv ISO 2014 All rights reservedBS EN ISO 26722:2015ISO 2

39、6722:2014(E) ISO 2014 All rights reservedviBS ISO 26722:2014ISO 26722:2014(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 through ISO

40、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 clo

41、sely 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

42、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 pate

43、nt 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

44、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 WTO principles in the Technical Barri

45、ers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems.This second edition cancels and replaces the first edition (ISO 26722:2

46、009), which has been technically revised.iv ISO 2014 All rights reservedBS ISO 26722:2014ISO 26722:2014(E)IntroductionThis International Standard reflects the conscientious efforts of concerned physicians, clinical engineers, nurses, dialysis technicians, and dialysis patients, in consultation with

47、device manufacturers and government representatives, to develop an International Standard for performance levels that could be reasonably achieved at the time of publication. The term “consensus,” as applied to the development of voluntary medical device International Standards, does not imply unani

48、mity of opinion, but rather reflects the compromise necessary in some instances when a variety of interests should be merged.The provisions of this International Standard apply to individual water treatment devices and to water treatment systems assembled from one or more of these devices. In the fi

49、rst instance, this International Standard is directed at the individual or company that specifies the complete water treatment system and, second, at the supplier who assembles and installs the system. Since systems can be assembled from a number of individual water treatment devices, the provisions of this International Standard are also directed at the manufacturers of these devices, provided that the manufacturer indicates that the device is intended for use in haemodialysis applications. This International Standard i