DIN EN ISO 13959-2016 Water for haemodialysis and related therapies (ISO 13959 2014) German version EN ISO 13959 2015《血液透析及相关疗法用水(ISO 13959-2014) 德文版本EN ISO 13959-2015》.pdf

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1、March 2016 English price group 13No 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!%L*“2419707www.din.deDIN

2、 EN ISO 13959Water for haemodialysis and related therapies (ISO 13959:2014);English version EN ISO 13959:2015,English translation of DIN EN ISO 13959:2016-03Wasser fr Hmodialyse und verwandte Therapien (ISO 13959:2014);Englische Fassung EN ISO 13959:2015,Englische bersetzung von DIN EN ISO 13959:201

3、6-03Eau pour hmodialyse et thrapies apparentes (ISO 13959:2014);Version anglaise EN ISO 13959:2015,Traduction anglaise de DIN EN ISO 13959:2016-03www.beuth.deDocument comprises 24 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative

4、.03.16 DIN EN ISO 13959:2016-03 2 A comma is used as the decimal marker. National foreword The text of ISO 13959:2014 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” and has been taken over as EN ISO 13959:2015 by Technical Committee CEN/TC 205 “Non-active medical devices”

5、 (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. EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO

6、13959 December 2015 ICS 11.040.40 English Version Water for haemodialysis and related therapies(ISO 13959:2014) Eau pour hmodialyse et thrapies apparentes(ISO 13959:2014) Wasser fr Hmodialyse und hnliche Therapien(ISO13959:2014) This European Standard was approved by CEN on 23 November 2015. CEN mem

7、bers are bound to comply with the 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 applicat

8、ion to the CEN-CENELEC Management 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 Manage

9、ment Centre has the same status as 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,

10、 Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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 1

11、7, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 13959:2015 EContents PageEuropean foreword .3Introduction 51 Scope 62 Terms and definitions 63 Dialysis water requirements . 103.1 Dialysis water verificat

12、ion and monitoring . 103.2 Microbiological requirements. 103.3 Chemical contaminants 104 Tests for compliance with microbiological and chemical requirements 114.1 Microbiology of dialysis water . 114.2 Chemical contaminants test methods 12Annex A (informative) Rationale for the development and provi

13、sions of this International Standard .15Bibliography .20Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices 19 Foreword 4DIN EN ISO 13959:2016-03 EN ISO 13959:2015 (E) 2European foreword The text of ISO 13959:

14、2014 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 13959:2015 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. This Europe

15、an Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at 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

16、 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 European Commission and the European Free Trade Association, and supports essential

17、requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standa

18、rd: 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, Spai

19、n, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 13959:2014 has been approved by CEN as EN ISO 13959:2015 without any modification. DIN EN ISO 13959:2016-03 EN ISO 13959:2015 (E) 3 ForewordISO (the International Organization for Standardization) is a worldwid

20、e 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 that

21、 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 docume

22、nt 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 Directives

23、, 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 development

24、 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

25、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

26、gery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems.This third edition cancels and replaces the second edition (ISO 13959:2009), which has been technically revised.DIN EN ISO 13959:2016-03 EN ISO 13959:2015 (E) 4 IntroductionAssurance of adequate water quality is one of the m

27、ost important aspects of ensuring a safe and effective delivery of haemodialysis, haemodiafiltration, or haemofiltration.This International Standard contains minimum requirements, chemical and microbiological, for the water to be used for preparation of dialysis fluids, concentrates, and for the rep

28、rocessing of haemodialysers and the necessary steps to ensure compliance with those requirements.Haemodialysis and haemodiafiltration can expose the patient to more than 500 l of water per week across the semi-permeable membrane of the haemodialyser or haemodiafilter. Healthy individuals seldom have

29、 a weekly oral intake above 12 l. This over 40-fold increase in exposure requires control and monitoring of water quality to avoid excesses of known or suspected harmful substances. Since knowledge of potential injury from trace elements and contaminants of microbiological origin over long periods i

30、s still growing and techniques for treating drinking water are continuously developed, this International Standard will evolve and be refined accordingly. The physiological effects attributable to the presence of organic contaminants in dialysis water are important areas for research. At the time th

31、is International Standard was published it was not possible to specify threshold values for organic contaminants permitted in water used for the preparation of dialysis fluids, concentrates, and reprocessing of haemodialysers. The issue of organic contaminants will be reassessed on the next revision

32、 of this International Standard.Within this International Standard, measurement techniques current at the time of publication have been cited. Other standard methods may be used, provided that such methods have been appropriately validated and compared to the cited methods.The final dialysis fluid i

33、s produced from concentrates or salts manufactured, packaged, and labelled according to ISO 13958 mixed with water meeting the requirements of this International Standard. Operation of water treatment equipment and haemodialysis systems, including ongoing monitoring of the quality of water used to p

34、repare dialysis fluids, and handling of concentrates and salts are the responsibility of the haemodialysis facility and are addressed in ISO 23500. Haemodialysis professionals make choices about the various applications (haemodialysis, haemodiafiltration, haemofiltration) and should understand the r

35、isks of each and the requirements for safety for fluids used for each.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” means that compliance with a

36、 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 permissible way to achieve compliance

37、with a requirement or test.This International Standard is directed towards manufacturers and providers of water treatment systems and also to haemodialysis facilities.DIN EN ISO 13959:2016-03 EN ISO 13959:2015 (E) 5 1 ScopeThis International Standard specifies minimum requirements for water to be us

38、ed in haemodialysis and related therapies.This International Standard includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.The operation of water treatment equipment and the

39、 final mixing of treated water with concentrates to produce dialysis fluid are excluded from this International Standard. Those operations are the sole responsibility of dialysis professionals. This International Standard does not apply to dialysis fluid regenerating systems.2 Terms and definitionsF

40、or the purposes of this document, the following terms and definitions apply.2.1action levelconcentration of a contaminant at which steps should be taken to interrupt the trend toward higher, unacceptable levels2.2chlorine, combinedchlorine that is chemically combined, such as in chloramine compounds

41、Note 1 to entry: There is no direct test for measuring combined chlorine, but it can be measured indirectly by measuring both total and free chlorine and calculating the difference.2.3chlorine, freechlorine present in water as dissolved molecular chlorine (Cl), hypochlorous acid (HOCl), and hypochlo

42、rite ion (OCl)Note 1 to entry: The three forms of free chlorine exist in equilibrium.2.4chlorine, totalsum of free and combined chlorineNote 1 to entry: Chlorine can exist in water as dissolved molecular chlorine, hypochlorous acid, and/or hypochlorite ion (free chlorine) or in chemically combined f

43、orms (combined chlorine). Where chloramine is used to disinfect water supplies, chloramine is usually the principal component of combined chlorine.2.5colony-forming unitCFUmeasure of bacterial or fungal cell numbers that theoretically arise from a single cell when grown on solid mediaNote 1 to entry

44、: Colonies can also form from groups of organisms when they occur in aggregates.DIN EN ISO 13959:2016-03 EN ISO 13959:2015 (E) 6 2.6deviceindividual water purification unit, such as a softener, carbon bed, reverse osmosis unit, or deionizerNote 1 to entry: This term is synonymous with the term “comp

45、onent” as used by the US Food and Drug Administration (see Reference 49).2.7dialysis fluiddialysatedialysis solutionaqueous fluid containing electrolytes and, usually, buffer and glucose, which is intended to exchange solutes with blood during haemodialysisNote 1 to entry: The term “dialysis fluid”

46、is used throughout this International Standard to mean the fluid made from dialysis water and concentrates that is delivered to the dialyser by the dialysis fluid delivery system. Such phrases as “dialysate” or “dialysis solution” are used in place of dialysis fluid in some countries; however, that

47、usage is discouraged to avoid confusion.Note 2 to entry: The dialysis fluid entering the dialyser is referred to as “fresh dialysis fluid”, while the fluid leaving the dialyser is referred to as “spent dialysis fluid.”Note 3 to entry: Dialysis fluid does not include prepackaged parenteral fluids use

48、d in some renal replacement therapies, such as haemodiafiltration and haemofiltration.2.8dialysis fluid delivery systemdevice that prepares dialysis fluid online from dialysis water and concentrates or that stores and distributes premixed dialysis fluid, circulates the dialysis fluid through the dialyser, monitors the dialysis fluid for temperature, conductivity (or equivalent), pressure, flow and blood leaks, and prevents dialysis during disinfection or cleaning mode