DIN EN ISO 7198-2017 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198 2016) German version EN ISO 7.pdf

1、July 2017 English price group 25No 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!%gg)“2686806www.din.deDIN

2、 EN ISO 7198Cardiovascular implants and extracorporeal systems Vascular prostheses Tubular vascular grafts and vascular patches (ISO 7198:2016);English version EN ISO 7198:2017,English translation of DIN EN ISO 7198:2017-07Kardiovaskulre Implantate und extrakorporale Systeme Vaskulre Prothesen Tubul

3、are vaskulre Transplantate und Gefpatches (ISO 7198:2016);Englische Fassung EN ISO 7198:2017,Englische bersetzung von DIN EN ISO 7198:2017-07Implants cardiovasculaires et systmes extracorporels Prothses vasculaires Greffons vasculaires tubulaires et pices vasculaires (ISO 7198:2016);Version anglaise

4、 EN ISO 7198:2017,Traduction anglaise de DIN EN ISO 7198:2017-07SupersedesDIN EN 120062:200908See start of applicationwww.beuth.deDocument comprises 69 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.06.17 DIN EN ISO 7198:2017-

5、07 2 A comma is used as the decimal marker. Start of application The start of application of this standard is 2017-07-01. For DIN 12006-2:2009-08 there is a transition period ending on 2020-03-31. National foreword This document (EN ISO 7198:2017) has been prepared by Technical Committee ISO/TC 150,

6、 Subcommittee SC 2 “Cardiovascular implants and extracorporeal systems” (Secretariat: ANSI, USA) in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Feinmechan

7、ik und Optik (DIN Standards Committee Optics and Precision Mechanics), Working Committee NA 027-02-17-01 UA “Cardiovascular implants”. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 10993 (all parts) DIN EN ISO 10993 (all parts) ISO 11

8、135 DIN EN ISO 11135 ISO 11137 (all parts) DIN EN ISO 11137 (all parts) ISO 11607-1 DIN EN ISO 11607-1 ISO 12417-1 DIN EN ISO 12417-1 ISO 13485 DIN EN ISO 13485 ISO 14155 DIN EN ISO 14155 ISO 14160 DIN EN ISO 14160 ISO 14630 DIN EN ISO 14630 ISO 14937 DIN EN ISO 14937 ISO 14971 DIN EN ISO 14971 ISO

9、17665 (all parts) DIN EN ISO 17665-1 and DIN ISO/TS 17665-2 ISO 25539-1 DIN EN ISO 25539-1 ISO 25539-2 DIN EN ISO 25539-2 Amendments This standard differs from DIN EN 12006-2:2009-08 as follows: a) the ISO standard has been adopted. Previous editions DIN EN 12006-2: 1998-05, 2009-08 DIN EN ISO 7198:

10、2017-07 3 National Annex NA (informative) Bibliography DIN EN ISO 10993 (all parts), Biological evaluation of medical devices 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

11、 devices DIN EN ISO 11137 (all parts), Sterilization of health care products Radiation 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 12417-1, Cardiovascular implants and extracorpor

12、eal systems Vascular device-drug combination products Part 1: General requirements DIN EN ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes DIN EN ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practice DIN EN ISO 14160,

13、 Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices DIN EN ISO 14630, Non-

14、active surgical implants General requirements DIN EN ISO 14937, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 14971, Medical devices

15、Application of risk management to medical devices DIN EN ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices DIN ISO/TS 17665-2, Sterilization of health care products Moist h

16、eat Part 2: Guidance on the application of ISO 17665-1 DIN EN ISO 25539-1, Cardiovascular implants Endovascular devices Part 1: Endovascular prostheses DIN EN ISO 25539-2, Cardiovascular implants Endovascular devices Part 2: Vascular stents DIN EN ISO 7198:2017-07 4 This page is intentionally blank

17、EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7198 March 2017 ICS 11.040.40 Supersedes EN 12006-2:1998+A1:2009English Version Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) Implants cardiovasculaires

18、et systmes extracorporels - Prothses vasculaires - Greffons vasculaires tubulaires et pices vasculaires (ISO 7198:2016) Kardiovaskulre Implantate und extrakorporale Systeme - Vaskulre Prothesen - Tubulare vaskulre Transplantate und Gefpatches (ISO 7198:2016) This European Standard was approved by CE

19、N on 8 July 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 alteration. Up-to-date lists and bibliographical references concerning such national standards ma

20、y 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 translation under the responsibility of a CEN member into its own language and notified

21、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, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland

22、, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC

23、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 7198:2017 EForeword 10Introduction 111 Scope . 122 Normative references 133 Terms and definitions . 134 General requireme

24、nts . 174.1 Configuration designation for tubular vascular grafts . 174.2 Size designation . 184.2.1 Uniform straight tubular vascular grafts 184.2.2 Uniform bifurcated tubular vascular grafts 184.2.3 Tapered tubular vascular grafts 184.2.4 Other configurations of tubular vascular grafts 184.2.5 Vas

25、cular patches . 184.3 Materials . 184.3.1 General 184.3.2 Classification of tubular vascular grafts and vascular patches 184.3.3 Nomenclature . 194.4 Intended clinical use designation . 195 Intended performance . 206 Design attributes 206.1 General . 206.2 Tubular vascular grafts 206.3 Vascular patc

26、hes 206.4 Coatings . 216.5 Drug coatings and drug-eluting coatings . 217 Materials .218 Design evaluation 218.1 General . 218.2 Sampling . 228.3 Conditioning of test samples . 228.4 Reporting . 228.5 Biocompatibility 238.5.1 Residual chemicals .238.5.2 Biocompatibility .238.6 Biostability 238.7 Benc

27、h and analytical tests . 248.7.1 General 248.7.2 Tubular vascular grafts 248.7.3 Vascular patches .269 Preclinical in vivo evaluation test methods for vascular prostheses .279.1 Preclinical in vivo evaluation . 279.1.1 Purpose 279.1.2 Specific aims 289.1.3 Protocol considerations . 289.1.4 Data acqu

28、isition 289.1.5 Test report and additional information .29Contents Page European foreword 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC OJ L 169 on medical devices 7 . DIN EN ISO 7198:2017-07 EN ISO 7198:2017 (E) 2 10.1.

29、3 Protocol considerations 3010.1.4 Data acquisition .3110.1.5 Final report 3410.2 Post market surveillance . 3511 Manufacturing 3512 Sterility 3513 Packaging and labelling .3613.1 General 3613.2 Unit container . 3613.3 Outer container . 3613.4 Shipping container 3613.5 Maintenance of sterility in tr

30、ansit . 3613.6 Marking 3613.6.1 Container label .3613.6.2 Record label .3713.6.3 General information and instructions for use .37Annex A (informative) Test methods .38Bibliography .6510 Clinical investigation methods for vascular prostheses .3010.1 Clinical investigation . 3010.1.1 Purpose . 3010.1.

31、2 Specific aims .30DIN EN ISO 7198:2017-07 EN ISO 7198:2017 (E) 3 European foreword This document (EN ISO 7198:2017) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which

32、 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 September 2017, and conflicting national standards shall be withdrawn at the latest by March 2020. Attention is drawn to the possib

33、ility 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 12006-2:1998+A1:2009. This document has been prepared under a mandate given to CEN by the

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

35、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, Latvia, Lithuania, Luxembo

36、urg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 7198:2016 has been approved by CEN as EN ISO 7198:2017 without any modification. The following referenced documents ar

37、e 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 of Annex ZA, the user should

38、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 reference to the correspondin

39、g 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. DIN EN ISO 7198:2017-07 EN ISO 7198:2017

40、(E) 4 Table Correlations between undated normative references and dated EN and ISO standards Normative references as listed in Clause 2 Equivalent dated standard EN ISO ISO 10993 (all parts) EN ISO 10993-1:2009 ISO 10993-1:2009 EN ISO 10993-2:2006 ISO 10993-2:2006 EN ISO 10993-3:2014 ISO 10993-3:201

41、4 EN ISO 10993-4:2009 ISO 10993-4:2002 and ISO 10993-4:2002/Amd 1:2006 EN ISO 10993-5:2009 ISO 10993-5:2009 EN ISO 10993-6:2009 ISO 10993-6:2007 EN ISO 10993-7:2008 and EN ISO 10993-7:2008/AC:2009 ISO 10993-7:2008 and ISO 10993-7:2008/Cor 1:2009 EN ISO 10993-9:2009 ISO 10993-9:2009 EN ISO 10993-10:2

42、013 ISO 10993-10:2010 EN ISO 10993-11:2009 ISO 10993-11:2006 EN ISO 10993-12:2012 ISO 10993-12:2012 EN ISO 10993-13:2010 ISO 10993-13:2010 EN ISO 10993-14:2009 ISO 10993-14:2001 EN ISO 10993-15:2009 ISO 10993-15:2000 EN ISO 10993-16:2010 ISO 10993-16:2010 EN ISO 10993-17:2009 ISO 10993-17:2002 EN IS

43、O 10993-18:2009 ISO 10993-18:2005 - ISO/TS 10993-19:2006 - ISO/TS 10993-20:2006 ISO 11135 EN ISO 11135:2014 ISO 11135:2014 ISO 11137 (all parts) EN ISO 11137-1:2015 ISO 11137-1:2006 and ISO 11137-1:2006/Amd 1:2013 EN ISO 11137-2:2015 ISO 11137-2:2013 EN ISO 11137-3:2006 ISO 11137-3:2006 ISO 11607-1

44、EN ISO 11607-1:2009 and EN ISO 11607-1:2009/A1:2014 ISO 11607-1:2006 and ISO 11607-1:2006/Amd 1:2014 ISO 14155 EN ISO 14155:2011 and EN ISO 14155:2011/AC:2011 ISO 14155:2011 and ISO 14155:2011/Cor. 1:2011 DIN EN ISO 7198:2017-07 EN ISO 7198:2017 (E) 5 Normative references as listed in Clause 2 Equiv

45、alent dated standard EN ISO ISO 14160 EN ISO 14160:2011 ISO 14160:2011 ISO 14630:2012 EN ISO 14630:2012 ISO 14630:2012 ISO 14937 EN ISO 14937:2009 ISO 14937:2009 ISO 14971 EN ISO 14971:2012 ISO 14971:2007 ISO 17665 (all parts) EN ISO 17665-1:2006 ISO 17665-1:2006 CEN ISO/TS 17665-2:2009 ISO/TS 17665

46、-2:2009 DIN EN ISO 7198:2017-07 EN ISO 7198:2017 (E) 6 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC OJ L 169 on medical devices This European Standard has been prepared under a mandate given to CEN by the European Commiss

47、ion and the European Free Trade Association to 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 Directive and has been imple

48、mented as a national standard in at least one Member State, compliance with the 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 refere