DIN EN ISO 7199-2017 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199 2016) German version EN ISO 7199 2017《心血管植入物和人工器官 血液-氧气交换机(氧合器)(IS.pdf

1、May 2017 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 11.040.40!%d3“2659416www.din.deDIN E

2、N ISO 7199Cardiovascular implants and artificial organs Bloodgas exchangers (oxygenators) (ISO 7199:2016);English version EN ISO 7199:2017,English translation of DIN EN ISO 7199:2017-05Kardiovaskulre Implantate und knstliche Organe Blutgasaustauscher (Oxygenatoren) (ISO 7199:2016);Englische Fassung

3、EN ISO 7199:2017,Englische bersetzung von DIN EN ISO 7199:2017-05Implants cardiovasculaires et organes artificiels changeurs gaz/sang extracorporels (oxygnateurs) (ISO 7199:2016);Version anglaise EN ISO 7199:2017,Traduction anglaise de DIN EN ISO 7199:2017-05SupersedesDIN EN ISO 7199:201411www.beuth

4、.deDocument comprises 28 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.05.17 DIN EN ISO 7199:2017-05 2 A comma is used as the decimal marker. National foreword This document (DIN EN ISO 7199:2017) has been prepared by Technic

5、al Committee ISO/TC 150 “Implants for surgery” in collaboration with CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany), with the active participation of German experts. The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee

6、Medicine), Working Committee NA 063-01-03 AA “Extracorporeal circuits, equipment and disposables”. In addition to the legal units of measurement, this standard also uses the unit “psi”. It is important to note that according to the German law on units in metrology, the use of these units is not perm

7、itted in official or business communications within Germany. Conversion: Non-SI unit SI unit Conversion psi Pa 1 psi = 6 894,757 Pa The DIN Standards corresponding to the International Standards referred to in this document are follows: ISO 8637:2010 DIN EN ISO 8637 2014-03 ISO 10993-1 DIN EN ISO 10

8、993-1 ISO 10993-4 DIN EN ISO 10993-4 ISO 10993-7 DIN EN ISO 10993-7 ISO 10993-11 DIN EN ISO 10993-11 ISO 11135 DIN EN ISO 11135 ISO 11137-1 DIN EN ISO 11137-1 ISO 11607-1 DIN EN ISO 11607-1 ISO 11607-2 DIN EN ISO 11607-2 ISO 13485 DIN EN ISO 13485 ISO 17665-1 DIN EN ISO 17665-1 ISO 14971 DIN EN ISO

9、14971 Amendments This standard differs from DIN EN ISO 7199:2014-11 as follows: a) it has been specified that this standard is not applicable for separate arterial line filters; b) Clause 2 “Normative references” has been revised; c) terms have been specified for “integral arterial filters” and “fil

10、tration efficiency”; d) performance characteristics for integral arterial filters have been specified for the first time; e) the pressure for the determination of the integrity of blood pathways has been changed from 40 kPa to 150 kPa; f) requirements for filtration efficiency, flow rate of the inte

11、gral arterial filter and the air handling capability of the integral arterial filter have been specified for the first time. DIN EN ISO 7199:2017-05 3 Previous editions DIN EN 12022: 1999-03 DIN EN ISO 7199: 2014-11 National Annex NA (informative) Bibliography DIN EN ISO 8637:2014-03, Cardiovascular

12、 implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1:2013-04-01) DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 10993-4,

13、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 devices Part 11: Tests for systemic toxici

14、ty DIN EN ISO 11135, Sterilization of health care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for development, validati

15、on and routine control of a sterilization process for medical devices DIN EN ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems DIN EN ISO 11607-2, Packaging for terminally sterilized medical devices Part

16、 2: Validation requirements for forming, sealing and assembly processes DIN EN ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes DIN EN ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for development, validation and routine

17、control of a sterilization process for medical devices DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 7199:2017-05 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7199 January 2017 ICS 11.040.40 Supersedes EN

18、 ISO 7199:2014English Version Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016) Implants cardiovasculaires et organes artificiels - changeurs gaz/sang extracorporels (oxygnateurs) (ISO 7199:2016) Kardiovaskulre Implantate und knstliche Organe - Blutga

19、saustauscher (Oxygenatoren) (ISO 7199:2016)This European Standard was approved by CEN on 6 November 2016. CEN members 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 alteratio

20、n. 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, French, German). A version in any other language made by

21、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, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, F

22、inland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR ST

23、ANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 7199:2017 EForeword 10Introductio

24、n .111 Scope 122 Normative references . 123 Terms and definitions 134 Requirements . 144.1 Biological characteristics 144.1.1 Sterility and non-pyrogenicity 144.1.2 Biocompatibility 144.2 Physical characteristics 154.2.1 Blood pathway integrity . 154.2.2 Heat exchanger fluid pathway integrity 154.2.

25、3 Blood volumes . 154.2.4 Connectors . 154.3 Performance characteristics. 154.3.1 Oxygen and carbon dioxide transfer rates 154.3.2 Heat exchanger performance factor . 154.3.3 Integral arterial filtration efficiency. 154.3.4 Integral arterial filter flow rate capacity 154.3.5 Integral arterial filter

26、 air handling capability 154.3.6 Blood cell damage 164.3.7 Time-dependent performance changes 164.3.8 Shelf life 165 Tests and measurements to determine compliance with this document . 165.1 General 165.2 Biological characteristics 165.2.1 Sterility and non-pyrogenicity 165.2.2 Biocompatibility 165.

27、3 Physical characteristics 175.3.1 Blood pathway integrity . 175.3.2 Heat exchanger water pathway integrity. 175.3.3 Blood volumes . 175.3.4 Connectors . 175.4 Performance characteristics. 185.4.1 Oxygen and carbon dioxide transfer rates 185.4.2 Heat exchanger performance factor . 195.4.3 Blood cell

28、 damage 195.4.4 Shelf life 195.4.5 Filtration efficiency . 205.4.6 Integral arterial filter flow rate 205.4.7 Air-handling capability of integral arterial filter. 206 Information supplied by the manufacturer 216.1 Information on the oxygenator 216.2 Information on the packaging . 226.2.1 Unit contai

29、ner 226.2.2 Shipping container 226.3 Information in the accompanying documents 226.4 Information in the accompanying documents in a prominent form .237 Packaging 23Bibliography .24ContentsPage European foreword 3 Annex ZA (informative) Relationship between this European standard and the essential re

30、quirements of Directive 93/42/EEC OJ L 169 aimed to be covered 5 .DIN EN ISO 7199:2017-05 EN ISO 7199:2017 (E) 2 European foreword This document (EN ISO 7199:2017) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” in collaboration with Technical Committee CEN/TC 205 “Non-act

31、ive 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 2017, and conflicting national standards shall be withdrawn at the latest by July

32、 2017. 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 ISO 7199:2014. This document has been prepared unde

33、r 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. According to the CEN-CENELEC Internal Regulation

34、s, 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, Italy,

35、Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. The following referenced documents are indispensable for the application of this document. For undated references, the latest e

36、dition 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 of Annex ZA“, the user should always check that any referenced document has not been superseded and that its relevant

37、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 reference to the corresponding EN standard, if available, and otherwise to the dated version of the ISO or IEC standa

38、rd, 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. DIN EN ISO 7199:2017-05 EN ISO 7199:2017 (E)3 Table Correlations between undated normative references and dated EN and ISO standa

39、rds Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009 ISO 10993-4 EN ISO 10993-4:2009 ISO 10993-4:2002 and Amd 1:2006 ISO 10993-7 EN ISO 10993-7:2008 and EN ISO 10993-7:2008/AC:2009 ISO 10993-7:2008 and IS

40、O 10993-7:1/Cor 1:2009 ISO 10993-11 EN ISO 10993-11:2009 ISO 10993-11:2006 ISO 11135 EN ISO 11135:2014 ISO 11135:2014 ISO 11137-1 EN ISO 11137-1:2006 and EN ISO 11137-1:2006/A1:2013 ISO 11137-1:2006 and Amd 1:2013 ISO 11607-1 EN ISO 11607-1:2009 and EN ISO 11607-1:2009/A1:2014 ISO 11607-1:2006 and A

41、md 1:2014 ISO 11607-2 EN ISO 11607-2:2006 and EN ISO 11607-2:2006/A1:2014 ISO 11607-2:2006 and Amd 1:2014 ISO 15675 ISO 15675:2009 ISO 17665-1 EN ISO 17665-1:2006 ISO 17665-1:2006 Endorsement notice The text of ISO 7199:2016 has been approved by CEN as EN ISO 7199:2017 without any modification. DIN

42、EN ISO 7199:2017-05 EN ISO 7199:2017 (E) 4 Annex ZA (informative) Relationship between this European standard and the essential requirements of Directive 93/42/EEC OJ L 169 aimed to be covered This European Standard has been prepared under a Commissions standardization request M/023 concerning the d

43、evelopment of European standards related to medical devices to provide a voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169. Once this standard is cited in the Official Journal of the European Union under that Di

44、rective, compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding essential requirements of that Directive, and associated EFTA regulations. NOTE 1 Where a reference from a

45、clause of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This means that risks have to be reduced “as far as possible“, “to a minimum“, “to the lowest possible level“, “minimized“ or “remo

46、ved“, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determining acceptable risk must be in compliance with Essential Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOTE 3 This Annex ZA is based on normative references accordin

47、g to the table of references in the European foreword, replacing the references in the core text. NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this European Standard and Annex I of D

48、irective 93/42/EEC OJ L 169 Essential Requirements (ERs) of Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Remarks/Notes 7.2 4.1.1; 4.1.2; 5.2; 5.2.1; 5.2.2; 5.3; 5.3.1; 5.3.1.1; 5.3.1.2; 5.3.2; 5.3.2.1; 5.3.2.2; 6.2.1 d); 6.2.2 d); 6.3 u) 1) 4.1.1 and 4.1.2 address manufacturers requirements to ensure product sterility, non-pyrogenicity, and biocompatibility. 5.2 and 5.3 with associated sub-clauses address testing for the above to verify compliance that products are sterile, non-pyrogeni