1、March 2016 English price group 16No 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 11.040.20!%N%X“2430253www.din.deDI
2、N EN ISO 13958Concentrates for haemodialysis and related therapies (ISO 13958:2014);English version EN ISO 13958:2015,English translation of DIN EN ISO 13958:2016-03Konzentrate fr Hmodialyse und verwandte Therapien (ISO 13958:2014);Englische Fassung EN ISO 13958:2015,Englische bersetzung von DIN EN
3、ISO 13958:2016-03Concentrs pour hmodialyse et thrapies apparentes (ISO 13958:2014);Version anglaise EN ISO 13958:2015,Traduction anglaise de DIN EN ISO 13958:2016-03SupersedesDIN EN 13867:2009-09www.beuth.deDocument comprises 36 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-la
4、nguage original shall be considered authoritative.03.16 DIN EN ISO 13958:2016-03 2 A comma is used as the decimal marker. National foreword The text of ISO 13958:2014 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” and has been taken over as EN ISO 13958:2015 by Technical
5、Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-01-03 AA Extrakorporaler Kreislauf, Apparate und Einmalartikel. The DIN
6、Standards corresponding to the International Standards referred to in this document are as follows: ISO 11663 DIN EN ISO 11663 ISO 13959 DIN EN ISO 13959 ISO 14971 DIN EN ISO 14971 IEC 60601-1 DIN EN 60601-1 IEC 61010-1 DIN EN 61010-1 Amendments This standard differs from DIN EN 13867:2009-09 as fol
7、lows: a) the content of the standard has been fully replaced by ISO 13958:2014. Previous editions DIN EN 13867: 2003-01, 2009-09 National Annex NA (informative) Bibliography DIN EN ISO 11663, Quality of dialysis fluid for haemodialysis and related therapies DIN EN ISO 13959, Water for haemodialysis
8、and related therapies DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN 61010-1, Safety requirements for electrical equipment for measurement,
9、 control, and laboratory use Part 1: General requirements EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13958 December 2015 ICS 11.040.40 Supersedes EN 13867:2002+A1:2009English Version Concentrates for haemodialysis and related therapies(ISO 13958:2014) Concentrs pour hmodialyse et thrap
10、ies 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 CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
11、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 (English, Fr
12、ench, 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, Belgium, Bulgari
13、a, 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, Turke
14、y 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 any form and by any means reserved worldwide for CEN national Members. Re
15、f. No. EN ISO 13958:2015 EContents PageEuropean foreword 3Introduction 61 Scope . 72 Normative references 73 Terms and definitions . 74 Requirements . 134.1 Concentrates 134.2 Manufacturing equipment . 154.3 Systems for mixing concentrate at a dialysis facility . 155 Tests 175.1 General 175.2 Concen
16、trates 175.3 Manufacturing equipment . 195.4 Systems for mixing concentrate at a dialysis facility . 196 Labelling .206.1 General 206.2 General labelling requirements for concentrates 216.3 Labelling requirements for liquid concentrate 216.4 Labelling requirements for powder concentrate . 216.5 Addi
17、tives 236.6 Labelling requirements for concentrate generators . 236.7 Labelling for concentrate mixer systems 24Annex A (informative) Rationale for the development and provisions of this International Standard .26Bibliography .33Annex ZA (informative) Relationship between this European Standard and
18、the Essential Requirements of EU Directive 93/42/EEC on medical devices 31DIN EN ISO 13958:2016-03 EN ISO 13958:2015 (E) 2Foreword 5.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 Standardi
19、zation (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
20、the latest 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
21、 such 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 inf
22、ormative 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 c
23、ited applies. 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 referre
24、d to in 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 determ
25、ines the extent (in whole or in part) to which they apply. DIN EN ISO 13958:2016-03 EN ISO 13958:2015 (E) 3 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
26、 EN ISO 11663:20151ISO 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 Inter
27、nal 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, Hungary, Iceland, Ir
28、eland, 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 13958:2014 has been approved by CEN as EN ISO 13958:2015 without any modification. 1)
29、To be published 2) To be published. DIN EN ISO 13958:2016-03 EN ISO 13958:2015 (E) 4 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 thro
30、ugh 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 that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collabor
31、ates closely 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 c
32、riteria 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
33、 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 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 na
34、me 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 specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technic
35、al Barriers 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 third edition cancels and replaces the second edition (ISO
36、 13958:2009), which has been technically revised.DIN EN ISO 13958:2016-03 EN ISO 13958:2015 (E) 5 IntroductionThe requirements and goals established by this International Standard will help ensure the effective, safe performance of haemodialysis concentrates and related materials. This International
37、 Standard reflects the conscientious efforts of concerned physicians, clinical engineers, nurses, dialysis technicians and dialysis patients, in consultation with device manufacturers and government representatives, to develop a standard for performance levels that could be reasonably achieved at th
38、e time of publication. The term “consensus” as applied to the development of voluntary medical device standards does not imply unanimity of opinion, but rather reflects the compromise necessary in some instances when a variety of interests must be merged.Throughout this International Standard, recom
39、mendations are made to use ISO-quality water. Therefore, it is recommended to review ISO 13959 along with this International Standard.This International Standard does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 11663. The making of dialy
40、sis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the users responsibility to ensure proper use.In addition, this Intern
41、ational Standard does not cover haemodialysis equipment, which is addressed in IEC 60601-2-16:2012.The verbal forms used in this International 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”
42、 means that compliance with a requirement or a test is mandatory for compliance with this International Standard, “should” means that compliance 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 permissib
43、le way to achieve compliance with a requirement or test.DIN EN ISO 13958:2016-03 EN ISO 13958:2015 (E) 6 1 ScopeThis International Standard specifies minimum requirements for concentrates used for haemodialysis and related therapies. For the purpose of this International Standard, “concentrates” are
44、 a mixture of chemicals and water, or chemicals in the form of dry powder 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 concentrat
45、es. In several instances in this International Standard, it became necessary 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,
46、 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
47、the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid. This International Standard also gives requirements for equipment used to mix acid and bicarbonate powders into concentrate at the users facility.Concentrates prepared from prepackaged salt
48、s and water at a dialysis facility for use in that facility are excluded from the scope of this International Standard. Although references to dialysis fluid appear herein, this International Standard does not address dialysis fluid as made by the end user. Also excluded from the scope of this International Standard are requirements for the monitoring frequency of water purity used for the making of dialysis fluid by the dialysis facility. Recommendatio
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