1、February 2016 English price group 14No 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!%LL:“2414123www.din.d
2、eDIN EN ISO 11663Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014);English version EN ISO 11663:2015,English translation of DIN EN ISO 11663:2016-02Qualitt von Konzentraten fr die Hmodialyse und verwandte Therapien (ISO 11663:2014);Englische Fassung EN ISO 11663:2015
3、,Englische bersetzung von DIN EN ISO 11663:2016-02Qualit des fluides de dialyse pour hmodialyse et thrapies apparentes (ISO 11663:2014);Version anglaise EN ISO 11663:2015,Traduction anglaise de DIN EN ISO 11663:2016-02www.beuth.deDocument comprises 25 pagesDTranslation by DIN-Sprachendienst.In case
4、of doubt, the German-language original shall be considered authoritative.02.16 DIN EN ISO 11663:2016-02 2 A comma is used as the decimal marker. National foreword The text of ISO 11663:2014 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” and has been taken over as EN ISO 1
5、1663:2015 by Technical 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
6、Einmalartikel. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 13958 DIN EN ISO 13958 ISO 13959 DIN EN ISO 13959 National Annex NA (informative) Bibliography DIN EN ISO 13958, Concentrates for haemodialysis and related therapies DIN EN
7、ISO 13959, Water for haemodialysis and related therapies EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11663 November 2015 ICS 11.040.40 English Version Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014) Qualit des fluides de dialyse pour hmodialyse et thra
8、pies apparentes (ISO 11663:2014) Qualitt von Konzentraten fr die Hmodialyse und verwandte Therapien (ISO 11663:2014) This European Standard was approved by CEN on 10 October 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
9、 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. This European Standard exists in three official ve
10、rsions (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 members are the national standards bodies of Austri
11、a, 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, Spain, Sweden,
12、 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 form and by any means reserved worldwide for CEN na
13、tional Members. Ref. No. EN ISO 11663:2015 EContents Page Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices 20 Foreword . 5Introduction . 61 Scope . 72 Normative references 73 Terms and definitions . 74 Requ
14、irements . 124.1 Microbiological contaminants in dialysis fluid . 124.2 Chemical contaminants in dialysis fluid 135 Tests for compliance with microbiological requirements . 13Annex A (informative) Rationale for the development and provisions of this International Standard . 14Annex B (informative) R
15、eference tables from ISO 13959 17Bibliography . 21DIN EN ISO 11663:2016-02 EN ISO 11663:2015(E)2European Foreword . 3European Foreword The text of ISO 11663:2014 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of the International Organization for Standardization (ISO) and
16、 has been taken over as EN ISO 11663:2015 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 Ma
17、y 2016, and conflicting national standards shall be withdrawn at the latest by May 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 right
18、s. 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 follo
19、wing 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 meaning o
20、f 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 normative r
21、eference 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. Table 1 Corre
22、lation 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 13958 EN ISO 13958:20151ISO 13958:2014 ISO 13959 EN ISO 13959:20152ISO 13959:2014 1) To be published 2) To be published. DIN E
23、N ISO 11663:2016-02 EN ISO 11663:2015(E)3 According to the CEN-CENELEC Internal 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 Y
24、ugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, 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 11663:2014
25、 has been approved by CEN as EN ISO 11663:2015 without any modification. DIN EN ISO 11663:2016-02 EN ISO 11663:2015(E)4 ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Sta
26、ndards 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 committee. International organizations, governmental and non-governmental, in liaison with ISO, also
27、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 document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In
28、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, Part 2 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements
29、 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 of the document will be in the Introduction and/or on the ISO list of patent declarations received (s
30、ee 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 specific terms and expressions related to conformity assessment, as well as information about ISOs adherence
31、 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 surgery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems.This second edition cancel
32、s and replaces the first edition (ISO 11663:2009) which has been technically revised.DIN EN ISO 11663:2016-02 EN ISO 11663:2015(E)5 IntroductionHaemodialysis patients are directly exposed to large volumes of dialysis fluid, with the dialyser membrane being the only barrier against transfer of hazard
33、ous contaminants from the dialysis fluid to the patient. It has long been known that there could be hazardous contaminants in the water and concentrates used to prepare the dialysis fluid. To minimize this hazard, ISO 13958 and ISO 13959 set forth quality requirements for the water and concentrates
34、used to prepare dialysis fluid. However, if the dialysis fluid is not prepared carefully, it could contain unacceptable levels of contaminants even though it is prepared from water and concentrates, meeting the requirements of ISO 13958 and ISO 13959. Further, the dialysis fluid might be used as the
35、 starting material for the online preparation of fluids intended for infusion into the patient, for example, in therapies such as online haemodiafiltration. For these reasons, this International Standard for dialysis fluid quality was developed to complement the existing International Standards for
36、water and concentrates, ISO 13959 and ISO 13958, respectively. Guidelines to aid the user in routinely meeting the requirements of this International Standard and ISO 13959 can be found in ISO 23500.Within these International Standards, measurement techniques current at the time of preparation have
37、been cited. Other standard methods can be used, provided that such methods have been appropriately validated and compared to the cited methods.This International Standard reflects the conscientious efforts of healthcare professionals, patients, and medical device manufacturers to develop recommendat
38、ions for the quality of dialysis fluid. This International Standard is directed at the healthcare professionals involved in the management of dialysis facilities and the routine care of patients treated in dialysis facilities, since they are responsible for the final preparation of dialysis fluid. T
39、he recommendations contained in this International Standard are not intended for regulatory application.The requirements of this International Standard aim to help protect haemodialysis patients from adverse effects arising from known chemical and microbiological contaminants that can be found in im
40、properly prepared 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 verbal forms used in this International Standard conform to u
41、sage 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 compliance with a requirement
42、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.The concepts incorporated in this International Standard should not be considered inflexible or static. The
43、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 11663:2016-02 EN ISO 11663:2015(E)6 1 ScopeThis International Standard specifies minimum qu
44、ality requirements for dialysis fluids used in haemodialysis and related therapies.This International Standard includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.This International Standard does not address
45、the requirements for the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other International Standards.Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems
46、 for continuous renal replacement therapy that use prepackaged solutions, and systems and solutions for peritoneal dialysis are excluded from this International Standard.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensa
47、ble for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 13958, Concentrates for haemodialysis and related therapiesISO 13959, Quality of water for haemodialysis and rel
48、ated therapies3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1acid concentrateA-concentrateacidified concentrated mixture of salts that, when diluted with dialysis water and bicarbonate concentrate, yields dialysis fluid for use in dialysisNote 1 to entry: The term “acid” refers to the small amount of acid (for example, acetic acid or citric acid) that is included in the concentrate.Note 2 to entry: Acid con
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