BS EN ISO 13958-2015 Concentrates for haemodialysis and related therapies《血液透析和有关治疗用浓缩物》.pdf

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1、BSI Standards PublicationBS EN ISO 13958:2015Concentrates for haemodialysis and related therapiesBS EN ISO 13958:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO13958:2015. It is identical to ISO 13958:2014. It supersedes BS EN13867:2002+A1:2009 which is

2、 withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/150/2, Cardiovascular implants.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a cont

3、ract. Users are responsible for its correctapplication. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 88236 4ICS 11.040.40; 11.120.99Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published unde

4、r the authority of theStandards Policy and Strategy Committee on 31 December 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13958 December 2015 ICS 11.040.40 Supersedes EN 13867:2002+A1:2009English Version Conce

5、ntrates for haemodialysis and related therapies (ISO 13958:2014) Concentrs pour hmodialyse et thrapies apparentes (ISO 13958:2014) Konzentrate fr Hmodialyse und hnliche Therapien (ISO 13958:2014) This European Standard was approved by CEN on 23 November 2015. CEN members are bound to comply with the

6、 CEN/CENELEC Internal Regulations 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

7、 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 translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status a

8、s the official versions. 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, Ne

9、therlands, Norway, Poland, 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

10、rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 13958:2015 E3 European foreword The text of ISO 13958:2014 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of the International Organization for Standardization

11、 (ISO) and has been taken over as EN ISO 13958:2015 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 la

12、test by 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

13、patent rights. This document supersedes EN 13867:2002+A1:2009. 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 informati

14、ve Annex ZA, which is an integral part of this document. The following 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 a

15、pplies. However, for any use of this standard within the meaning 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 i

16、n the ISO standard text, this shall be understood as a normative 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 t

17、he extent (in whole or in part) to which they apply. BS EN ISO 13958:2015EN ISO 13958:2015 (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 11663 EN ISO 116

18、63:20151ISO 11663:2014 ISO 13959 EN ISO 13959:20152ISO 13959:2014 ISO 14971 EN ISO 14971:2012 ISO 14971:2007 IEC 60601-1 EN 60601-1:2006+Cor.:2010+A1:2013 IEC 60601-1:2005+Cor.:2006+Cor.:2007+A1:2012 IEC 61010-1 EN 61010-1:2010 IEC 61010-1:2010+Cor.:2011 According to the CEN-CENELEC Internal Regulat

19、ions, 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, Hungary, Iceland, Ireland, Ital

20、y, 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 13958:2014 has been approved by CEN as EN ISO 13958:2015 without any modification. 1) To be publi

21、shed 2) To be published. BS EN ISO 13958:2015EN ISO 13958:2015 (E) 5 Annex 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 mandate given to CEN by the European Co

22、mmission and the European Free Trade Association to provide a means of conforming 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 nationa

23、l standard in at least one Member State, compliance with the 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 associated EFTA regulations. NOTE 1 Wher

24、e 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 minimum, to the lowest possible level, minim

25、ized 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 Annex ZA is based on normative referenc

26、es 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 Correspondence between this European Standard and D

27、irective 93/42/EEC on medical devices Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 6.3 7.2 6.4 7.3 5.3 7.5 4.1.4.2 8 4.1.10 8.3 4 8.6 4 9.1 4.2, 4.3 9.2 6 13.1 6.2, 6.3, 6.4 13.2 6.2, 6.3, 6.4 13.3. (a) 6.2, 6.3, 6.4 13.3. (b) BS EN

28、ISO 13958:2015EN ISO 13958:2015 (E) 6 Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 6.2, 6.3, 6.4 13.3. (d) 6.2, 6.3, 6.4 13.3. (e) 6.2, 6.3, 6.4 13.3. (g) 6.2, 6.3, 6.4 13.3. (i) 6.2, 6.3, 6.4 13.3. (j) 6.2, 6.3, 6.4 13.3. (k) 6.2, 6

29、.3, 6.4 13.3. (l) 6.2, 6.3, 6.4 13.4 6.2, 6.3, 6.4 13.6. (q) WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 13958:2015EN ISO 13958:2015 (E) BS EN ISO 13958:2015ISO 13958:2014(E) ISO 2014 All rights reserved

30、iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 74.1 Concentrates . 74.2 Manufacturing equipment 94.3 Systems for mixing concentrate at a dialysis facility 95 Tests 115.1 General 115.2 Concentrates 115.3 Manufacturing equipment .

31、135.4 Systems for mixing concentrate at a dialysis facility .136 Labelling .146.1 General 146.2 General labelling requirements for concentrates 156.3 Labelling requirements for liquid concentrate 166.4 Labelling requirements for powder concentrate .166.5 Additives 176.6 Labelling requirements for co

32、ncentrate generators .176.7 Labelling for concentrate mixer systems 18Annex A (informative) Rationale for the development and provisions of this International Standard .20Bibliography .25BS EN ISO 13958:2015ISO 13958:2014(E)ForewordISO (the International Organization for Standardization) is a worldw

33、ide 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 has been established has the right to be represented on th

34、at 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 standardization.The procedures used to develop this docu

35、ment 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 accordance with the editorial rules of the ISO/IEC Directiv

36、es, 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. Details of any patent rights identified during the developmen

37、t 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 endorsement.For an explanation on the meaning of ISO specif

38、ic 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 responsible for this document is ISO/TC 150, Implants for sur

39、gery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems.This third edition cancels and replaces the second edition (ISO 13958:2009), which has been technically revised.iv ISO 2014 All rights reservedBS EN ISO 13958:2015ISO 13958:2014(E)IntroductionThe requirements and goals estab

40、lished by this International Standard will help ensure the effective, safe performance of haemodialysis concentrates and related materials. This International Standard reflects the conscientious efforts of concerned physicians, clinical engineers, nurses, dialysis technicians and dialysis patients,

41、in consultation with device manufacturers and government representatives, to develop a 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 standards does not imply unanimity of op

42、inion, but rather reflects the compromise necessary in some instances when a variety of interests must be merged.Throughout this International Standard, recommendations are made to use ISO-quality water. Therefore, it is recommended to review ISO 13959 along with this International Standard.This Int

43、ernational Standard does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 11663. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the labe

44、l requirements for dialysis fluid are placed on the labelling of the concentrate, it is the users responsibility to ensure proper use.In addition, this International Standard does not cover haemodialysis equipment, which is addressed in IEC 60601-2-16:2012.The verbal forms used in this International

45、 Standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this International Standard, the auxiliary verb “shall” means that compliance with a requirement or a test is mandatory for compliance with this International Standard, “should” means that complian

46、ce with a requirement or a test is recommended but is not mandatory for compliance with this International Standard, and “may” is used to describe a permissible way to achieve compliance with a requirement or test. ISO 2014 All rights reserved vBS EN ISO 13958:2015BS EN ISO 13958:2015Concentrates fo

47、r haemodialysis and related therapies1 ScopeThis International Standard specifies minimum requirements for concentrates used for haemodialysis and related therapies. For the purpose of this International Standard, “concentrates” are a mixture of chemicals and water, or chemicals in the form of dry p

48、owder or other highly concentrated media, that are delivered to the end user to make dialysis fluid used to perform haemodialysis and related therapies. This International Standard is addressed to the manufacturer of such concentrates. In several instances in this International Standard, it became n

49、ecessary to address the dialysis fluid, which is made by the end user, to help clarify the requirements for manufacturing concentrates. Because the manufacturer of the concentrate does not have control over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of the manufacturer.This International Standard includes concentrates in both liquid and powder forms. Also included are additives, also called spikes, which are chemicals that may be added to the concentrate to increase the concentratio