DIN EN ISO 23500-2015 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies (ISO 23500 2014) German version EN ISO 23500 2015《血液透析和相.pdf

1、December 2015 English price group 31No 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!%Jw_“2398460www.din.d

2、eDIN EN ISO 23500Guidance for the preparation and quality management of fluids for haemodialysis and related therapies (ISO 23500:2014);English version EN ISO 23500:2015,English translation of DIN EN ISO 23500:2015-12Leitfaden fr die Vorbereitung und das Qualittsmanagement von Konzentraten fr die Hm

3、odialyse und verwandte Therapien (ISO 23500:2014);Englische Fassung EN ISO 23500:2015,Englische bersetzung von DIN EN ISO 23500:2015-12Directives concernant la prparation et le management de la qualit des fluides dhmodialyseet de thrapies annexes (ISO 23500:2014);Version anglaise EN ISO 23500:2015,T

4、raduction anglaise de DIN EN ISO 23500:2015-12www.beuth.deDocument comprises 92 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.12.15 DIN EN ISO 23500:2015-12 2 A comma is used as the decimal marker. National foreword The text

5、of ISO 23500:2014 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” and has been taken over as EN ISO 23500:2015 by Technical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normen

6、ausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-01-03 AA Extrakorporaler Kreislauf, Apparate und Einmalartikel. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 11663 DIN EN ISO 11663 ISO 13958 DIN EN ISO 1

7、3958 ISO 13959 DIN EN ISO 13959 ISO 26722 DIN EN ISO 26722 IEC 60529 DIN EN 60529 IEC 60601-1 DIN EN 60601-1 IEC 60601-2-16 DIN EN 60601-2-16 National Annex NA (informative) Bibliography DIN EN ISO 11663, Quality of dialysis fluid for haemodialysis and related therapies DIN EN ISO 13958, Concentrate

8、s for haemodialysis and related therapies DIN EN ISO 13959, Water for haemodialysis and related therapies DIN EN ISO 26722, Water treatment equipment for haemodialysis applications and related therapies DIN EN 60529, Degrees of protection provided by enclosures (IP code) DIN EN 60601-1, Medical elec

9、trical equipment Part 1: General requirements for basic safety and essential performance DIN EN 60601-2-16, Medical electrical equipment Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment EUROPEAN STANDARD

10、NORME EUROPENNE EUROPISCHE NORM EN ISO 23500 October 2015 ICS 11.040.40 English Version Guidance for the preparation and quality management of fluids for haemodialysis and related therapies (ISO 23500:2014) Directives concernant la prparation et le management de la qualit des fluides dhmodialyse et

11、de thrapies annexes (ISO 23500:2014) Leitfaden fr die Vorbereitung und das Qualittsmanagement von Konzentraten fr die Hmodialyse und verwandte Therapien (ISO 23500:2014) This European Standard was approved by CEN on 27 September 2015. CEN members are bound to comply with the CEN/CENELEC Internal Reg

12、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

13、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.

14、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

15、, 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

16、 any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 23500:2015 EContents PageForeword .4Introduction 51 Scope .61.1 General . 61.2 Inclusions . 61.3 Exclusions 62 Normative references 63 Terms and definitions . 74 Summary of quality requirements of ISO 13958, ISO

17、13959 and ISO 11663 .144.1 Dialysis water 144.2 Requirements for concentrate 164.3 Requirements for dialysis fluid 164.4 Record retention . 175 Critical aspects of system design 175.1 Technical aspects . 185.2 Microbiological aspects 186 Validation of system performance 196.1 Validation plan . 196.2

18、 Installation and operational qualification 206.3 Performance qualification 216.4 Routine monitoring and revalidation .217 Quality management .227.1 General 227.2 Monitoring of fluid quality . 227.3 Monitoring of water treatment equipment .237.4 Monitoring of dialysis water storage and distribution

19、267.5 Monitoring of concentrate preparation 287.6 Monitoring of concentrate distribution 287.7 Monitoring of dialysis fluid proportioning 288 Strategies for microbiological control 298.1 General 298.2 Disinfection . 298.3 Microbiological monitoring methods .319 Environment 3310 Personnel 34Annex A (

20、informative) Rationale for the development and provisions of this International Standard .35Annex B (informative) Equipment .39Annex C (informative) Monitoring guidelines for water treatment equipment, distribution systems, and dialysis fluid .57Annex D (informative) Strategies for microbiological c

21、ontrol .62Annex E (informative) Validation 67Annex F (informative) Special considerations for home haemodialysis 70Annex G (informative) Special considerations for acute haemodialysis 76Bibliography .81DIN EN ISO 23500:2015-12 EN ISO 23500:2015 (E) 2European foreword .3European foreword The text of

22、ISO 23500:2014 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 23500:2015 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. T

23、his 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 April 2016, and conflicting national standards shall be withdrawn at the latest by April 2016. Attention is drawn to the possibility that some of the

24、 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. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement th

25、is European Standard: 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, Slovak

26、ia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 23500:2014 has been approved by CEN as EN ISO 23500:2015 without any modification. DIN EN ISO 23500:2015-12 EN ISO 23500:2015 (E) 3 ForewordISO (the International Organization for Standardizat

27、ion) 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 has been established has the right to be r

28、epresented 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 standardization.The procedures used to d

29、evelop 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 accordance with the editorial rules of the

30、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. Details of any patent rights identified durin

31、g 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 endorsement.For an explanation on the meani

32、ng 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 responsible for this document is ISO/TC 150,

33、Implants for surgery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems.This second edition cancels and replaces the first edition (ISO 23500:2011), which has been technically revised.DIN EN ISO 23500:2015-12 EN ISO 23500:2015 (E) 4 IntroductionThis International Standard was dev

34、eloped by ISO/TC 150/SC 2. The objective was to provide users with guidance for handling water and concentrates and for the production and monitoring of dialysis fluid used for haemodialysis. The need for such guidance is based on the critical role of dialysis fluid quality in providing safe and eff

35、ective haemodialysis, and the recognition that day-to-day dialysis fluid quality is under the control of the healthcare professionals who deliver dialysis therapy.Quality requirements for the water and concentrates used to prepare dialysis fluid, and for that dialysis fluid, are provided in ISO 1395

36、9, ISO 13958, and ISO 11663, respectively. This International Standard does not address clinical issues that might be associated with inappropriate usage of the water, dialysis water, concentrates, or dialysis fluid. Healthcare professionals involved in the provision of treatment for kidney failure

37、should make the final decision regarding the applications with which these fluids are used, for example, haemodialysis, haemodiafiltration, high-flux haemodialysis, and the reprocessing of dialysers, and need to be aware of the issues that the use of inappropriate fluid quality raises in each of the

38、 therapies.The equipment used in the various stages of dialysis fluid preparation is generally obtained from specialized vendors. Dialysis practitioners are generally responsible for maintaining that equipment following its installation. Therefore, this International Standard provides guidance on mo

39、nitoring and maintenance of the equipment to ensure that dialysis fluid quality is acceptable at all times. At various places throughout this International Standard, the user is advised to follow the manufacturers instructions regarding the operation and maintenance of equipment. In those instances

40、in which the equipment is not obtained from a specialized vendor, it is the responsibility of the user to validate the performance of the equipment in the haemodialysis setting and to ensure that appropriate operating and maintenance manuals are available. Annex B provides a general description of t

41、he system components that are used for water treatment, concentrate, and dialysis fluid preparation at a dialysis facility. These descriptions are intended to provide the user with a basis for understanding why certain equipment might be required and how it should be configured; they are not intende

42、d as detailed design standards. Requirements for water treatment equipment are provided in ISO 26722.The verbal forms used in this International Standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2:2004. For the purposes of this International standard, the auxiliary verb:

43、 “shall” 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; “may” is used to describe a permi

44、ssible way to achieve compliance with a requirement or test.This International Standard reflects the conscientious efforts of healthcare professionals, patients, and medical device manufacturers to develop recommendations for handling water and concentrates and for the production and monitoring of d

45、ialysis fluid for haemodialysis. This International Standard is directed towards the healthcare professionals involved in the management or routine care of haemodialysis patients and responsible for the quality of dialysis fluid. The recommendations contained in this International Standard might not

46、 be applicable in all circumstances and they are not intended for regulatory application.The guidance provided by this International Standard should help protect haemodialysis patients from adverse effects arising from known chemical and microbial contaminants that might be found in improperly prepa

47、red dialysis fluid. However, the physician in charge of dialysis has the ultimate responsibility for ensuring that the dialysis fluid is correctly formulated and meets the requirements of all applicable quality standards.The concepts incorporated in this International Standard should not be consider

48、ed inflexible or static. The recommendations presented here should be reviewed periodically in order to assimilate increased understanding of the role of dialysis fluid purity in patient outcomes and technological developments.DIN EN ISO 23500:2015-12 EN ISO 23500:2015 (E) 5 1 Scope1.1 GeneralThis International Standard provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofil