DIN EN ISO 8637-2014 Cardiovascular implants and extracorporeal systems - Haemodialysers haemodiafilters haemofilters and haemoconcentrators (ISO 8637 2010 including Amendment 1 20.pdf

1、March 2014 Translation by DIN-Sprachendienst.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

2、11.040.20!%,H“2099537www.din.deDDIN EN ISO 8637Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators(ISO 8637:2010, including Amendment 1:2013-04-01);English version EN ISO 8637:2014,English translation of DIN EN ISO 8637:2014-03Kardi

3、ovaskulre Implantate und extrakorporale Systeme Hmodialysatoren, Hmodiafilter, Hmofilter und Hmokonzentratoren (ISO 8637:2010,einschlielich nderung 1:2013-04-01);Englische Fassung EN ISO 8637:2014,Englische bersetzung von DIN EN ISO 8637:2014-03Implants cardiovasculaires et systmes extracorporels Hm

4、odialyseurs, hmodiafiltres, hmofiltres et hmoconcentrateurs (ISO 8637:2010,Amendement 1:2013-04-01 inclus);Version anglaise EN ISO 8637:2014,Traduction anglaise de DIN EN ISO 8637:2014-03Together withDIN EN ISO 8638:2014-03,supersedesDIN EN 1283:1996-06www.beuth.deIn case of doubt, the German-langua

5、ge original shall be considered authoritative.Document comprises 28 pages03.14 DIN EN ISO 8637:2014-03 2 A comma is used as the decimal marker. National foreword The text of ISO 8637:2010 including Amd.1:2013-04-01 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” and has be

6、en taken over as EN ISO 8637:2014 by Technical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-01-03 AA Extrakorporaler Kreis

7、lauf, Apparate und Einmalartikel. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 10993-1 DIN EN ISO 10993-1 ISO 10993-4 DIN EN ISO 10993-4 ISO 10993-7 DIN EN ISO 10993-7 ISO 10993-11 DIN EN ISO 10993-11 Amendments This standard differs

8、 from DIN EN 1283:1996-06 as follows: a) normative references have been updated; b) Clause 3 “Terms and definitions” has been revised and extended; c) Clause 4 “Requirements” has been revised/restructured and requirements for the expiry date have been added; d) Clause 5 “Test methods” has been revis

9、ed/restructured and Subclause 5.7 “Expiry date” has been added; e) Figure 1 of DIN EN 1283:1996-06 has been revised; f) Figure 2 of DIN EN 1283:1996-06 has not been included; g) Figure 4 of DIN EN 1283:1996-06 has been revised; h) diagrams have been added to Subclauses 5.6.1.3 “Clearance test proced

10、ure” and 5.6.2.3 “Test procedure”; i) the former Clause 6 “Packaging” has not been included; j) Clause 6 “Labelling” has been revised, extended and restructured; k) the standard has been editorially revised. Previous editions DIN 58352-1:1982-10 DIN 13090-3:1983-04, 1991-05 DIN 58352-2:1983-04 DIN 5

11、8353-1:1987-07 DIN 58353-2:1988-03 DIN 58352-3:1988-03, 1988-06 DIN 58351-1:1988-11 DIN 58352-4:1989-10 DIN EN 1283:1996-06 DIN EN ISO 8637:2014-03 3 National Annex NA (informative) Bibliography DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk

12、 management system DIN EN ISO 10993-4, Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood DIN EN ISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals DIN EN ISO 10993-11, Biological evaluation of medical dev

13、ices Part 11: Tests for systemic toxicity DIN EN ISO 8637:2014-03 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM January 2014 ICS 11.040.40 Supersedes EN 1283:1996English Version Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilter

14、s, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01) Implants cardiovasculaires et systmes extracorporels - Hmodialyseurs, hmodiafiltres, hmofiltres et hmoconcentrateurs (ISO 8637:2010, Amendement 1 2013-04-01 inclus) Kardiovaskulre Implantate und extrakorporale S

15、ysteme - Hmodialysatoren, Hmodiafilter, Hmofilter und Hmokonzentratoren (ISO 8637:2010, einschlielich nderung 1 2013-04-01) This European Standard was approved by CEN on 1 December 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for givi

16、ng 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 member. This European Standard exists in three offi

17、cial 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. CEN members are the national standards bodies of

18、 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, Spain,

19、Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for C

20、EN national Members. Ref. No. EN ISO 8637:2014 EEN ISO 8637 Contents Page Foreword . 3 Introduction . 4 1 Scope . 5 2 Normative references. 5 3 Terms and definitions 6 4 Requirements . 8 4.1 Biological safety . 8 4.2 Sterility 8 4.3 Non-pyrogenicity 8 4.4 Mechanical characteristics . 8 4.5 Performan

21、ce characteristics . 10 4.6 Expiry date 11 5 Test methods 11 5.1 General 11 5.2 Biological safety . 11 5.3 Sterility 11 5.4 Non-pyrogenicity 12 5.5 Mechanical characteristics . 12 5.6 Performance characteristics . 13 5.7 Expiry date 18 6 Labelling 18 6.1 Labelling on the device . 18 6.2 Labelling on

22、 the unit containers . 18 6.3 Labelling on the outer containers 19 6.4 Accompanying documentation . 19 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices 22 Bibliography 24 2DIN EN ISO 8637:2014-03 EN ISO 863

23、7:2014 (E) Foreword The text of ISO 8637:2010, including Amendment 1 2013-04-01 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of the International Organisation for Standardization (ISO) and has been taken over as EN ISO 8637:2014 by Technical Committee CEN/TC 205 “Non-ac

24、tive 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 July 2014, and conflicting national standards shall be withdrawn at the latest by Jul

25、y 2014. 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 rights. This document supersedes EN 1283:1996. According to the CEN-CENELEC Internal R

26、egulations, 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

27、, 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 8637:2010 has been approved by CEN as EN ISO 8637:2014 without any modification. 3DIN EN IS

28、O 8637:2014-03EN ISO 8637:2014 (E)Introduction This International Standard is concerned with devices intended for haemodialysis, haemodiafiltration, haemofiltration and haemoconcentration in humans. The requirements specified in this International Standard will help to ensure safety and satisfactory

29、 function. It was not found practicable to specify materials of construction. This International Standard therefore requires only that materials have been tested and that the methods and results are made available upon request. There is no intention to specify, or to set limits on, the performance c

30、haracteristics of the devices because such restrictions are unnecessary for the qualified user and would limit the alternatives available when choosing a device for a specific application. The dimensions of the blood ports and the dialysis fluid or filtrate ports have been specified to ensure compat

31、ibility of the device with the extracorporeal blood circuit specified in ISO 8638. The design and dimensions have been selected in order to minimize the risk of leakage of blood and the ingress of air. This International Standard reflects the consensus of physicians, manufacturers and other interest

32、ed parties for devices that are approved for clinical use. Conformance with this International Standard is voluntary and it does not supersede any national regulation. 4DIN EN ISO 8637:2014-03 EN ISO 8637:2014 (E) 1 Scope This International Standard specifies requirements for haemodialysers, haemodi

33、afilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans. This International Standard is not applicable to: extracorporeal blood circuits; plasmafilters; haemoperfusion devices; vascular access devices; blood pumps; pressure monitors for

34、the extracorporeal blood circuit; air detection devices; systems to prepare, maintain or monitor dialysis fluid; systems used to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration; reprocessing procedures and equipment. NOTE Requirements for the extracorporeal blood cir

35、cuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8638. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of t

36、he referenced document (including any amendments) applies. ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management p

37、rocess ISO 10993-4, Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood ISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals ISO 10993-11, Biological evaluation of medical devices Part 11: Tests for systemic

38、toxicity 5DIN EN ISO 8637:2014-03EN ISO 8637:2014 (E)3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 blood compartment part of a haemodialyser (3.12), haemodiafilter (3.10), haemofilter (3.14) or haemoconcentrator (3.9) through which blood is

39、 intended to pass NOTE For hollow-fibre devices, the blood compartment includes the volume of the hollow fibres plus the headers. 3.2 clearance volume of a solution from which a solute is completely removed per unit time 3.3 convection transport of solutes across a semipermeable membrane, along with

40、 filtered fluid, caused by a pressure gradient or pressure differential across the membrane 3.4 dialysis fluid aqueous fluid containing electrolytes and, usually, buffer and glucose, which is intended to exchange solutes with blood during haemodialysis (3.13) or haemodiafiltration (3.11) NOTE 1 The

41、term “dialysis fluid” is used throughout this International Standard to mean the fluid (made from dialysis water and concentrates) which is delivered to the haemodialyser or haemodiafilter by the dialysis fluid delivery system. Such phrases as “dialysate”, “dialysis solution” or “dialysing fluid” ca

42、n be used in place of dialysis fluid. NOTE 2 The dialysis fluid entering the haemodialyser or haemodiafilter is referred to as “fresh dialysis fluid”, while the fluid leaving the haemodialyser or haemodiafilter is referred to as “spent dialysis fluid”. NOTE 3 Dialysis fluid does not include pre-pack

43、aged parenteral fluids used in some renal replacement therapies, such as haemodiafiltration and haemofiltration. 3.5 dialysis fluid compartment part of a haemodialyser (3.12) or haemodiafilter (3.10) through which dialysis fluid (3.4) is intended to pass 3.6 diffusion transport of solutes across a s

44、emipermeable membrane, caused by a concentration gradient 3.7 filtrate fluid removed from the blood across the semipermeable membrane into the dialysis fluid or filtrate compartment of a haemodialyser (3.12), haemodiafilter (3.10), haemofilter (3.14) or haemoconcentrator (3.9), due to a pressure gra

45、dient (including the contributions of both hydrostatic and oncotic pressures) across the semipermeable membrane 3.8 haemoconcentration process whereby plasma water and electrolytes are removed from diluted blood across a semipermeable membrane 6DIN EN ISO 8637:2014-03 EN ISO 8637:2014 (E) 3.9 haemoc

46、oncentrator device intended to perform haemoconcentration (3.8) 3.10 haemodiafilter device intended to perform haemodiafiltration (3.11) 3.11 haemodiafiltration process whereby solute imbalances in a patients blood are corrected by means of simultaneous convection and diffusion across a semipermeabl

47、e membrane, and by replacement with an appropriate physiological fluid NOTE Normally, the process also includes a net fluid removal. 3.12 haemodialyser device intended to perform haemodialysis (3.13) 3.13 haemodialysis process whereby solute imbalances in a patients blood are corrected, mainly by di

48、ffusion across a semipermeable membrane NOTE Normally, the process also includes a net fluid removal. 3.14 haemofilter device intended to perform haemofiltration (3.15) 3.15 haemofiltration process whereby solute imbalances in a patients blood are corrected, mainly by convection across a semipermeab

49、le membrane and replacement with an appropriate physiological fluid NOTE Normally, the process also includes a net fluid removal. 3.16 labelling written, printed, graphic or electronic matter that: is affixed to a medical device or any of its containers or wrappers or accompanies a medical device and which is related to identification, technical description and use of that medical device, but excluding shipping documents 3.17