EN ISO 7198-2017 en Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches《心血管植入物和体外系统-血管-管状血管和血管斑块(ISO 7198 2016)》.pdf

1、BS EN ISO 7198:2017Cardiovascular implants andextracorporeal systems Vascular prostheses Tubularvascular grafts and vascularpatches (ISO 7198:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 7198:2017 BRITISH STANDARDNational forewordThis British Standa

2、rd is the UK implementation of EN ISO 7198:2017. it is identical to ISO 7198:2016. It supersedes BS ISO 7198:1998 and BS EN 12006-2:1998+A1:2009 which are withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/150/2, Cardiovascular implants.A list of organizations

3、represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017.Published by BSI Standards Limited 2017ISBN 978

4、 0 580 82707 5 ICS 11.040.40 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2017.Amendments/corrigenda issued since publicationDate T e x t a f f e c t

5、 e dEUROPEAN 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 cardiovasculai

6、res 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 b

7、y CEN 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 standard

8、s 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 translation under the responsibility of a CEN member into its own language and notif

9、ied 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, Ice

10、land, 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-CENE

11、LEC 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 EBS EN ISO 7198:2017EN ISO 7198:2017 (E) 3 European foreword This document (EN ISO 7198:2017) has been prep

12、ared 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 is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical te

13、xt 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 possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held respons

14、ible 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 European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relations

15、hip 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 organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cypru

16、s, 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

17、 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 are indispensable for the application of this document. For undated references, the latest edition of the referenced document (inclu

18、ding 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 contents can still be considered the gener

19、ally 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 standard, as listed below. NOTE The way in which

20、 these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. BS EN ISO 7198:2017EN ISO 7198:2017 (E) 4 Table Correlations between undated normative references and dated EN and ISO standards Normative references as listed in Clause 2

21、 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 10993-3:2014 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 109

22、93-6:2007 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 10993-10:2013 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 10993-13:2

23、010 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 ISO 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 (a

24、ll 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 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

25、 ISO 14155:2011/AC:2011 ISO 14155:2011 and ISO 14155:2011/Cor. 1:2011 BS EN ISO 7198:2017EN ISO 7198:2017 (E) 5 Normative references as listed in Clause 2 Equivalent 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 1493

26、7:2009 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 17665-2:2009 BS EN ISO 7198:2017EN ISO 7198:2017 (E) 6 Annex ZA (informative) Relationship between this European Standard and the Essential Requi

27、rements 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 Commission and the European Free Trade Association to voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June

28、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 implemented 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

29、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 clause of this standard to the risk management process is made, the risk management process needs to be i

30、n 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 removed, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for dete

31、rmining 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 according to the table of references in the European foreword, replacing the references in the core text. NOTE 4 When an Es

32、sential 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 Directive 93/42/EEC on medical devices Essential Requirements (ERs) of Directive 93/42/EEC Clause(s)/subclause(s) of this Europ

33、ean Standard Remarks/Notes 7.1, first indent 6.2 d), 6.3 d), 6.4 b) and c) With respect to the first indent of ER 7.1, manufacturing is not covered by this standard. Toxicity and flammability are not covered by this standard. For tubular vascular grafts, the first indent of ER 7.1 is covered by 6.2

34、d). For vascular patches, the first indent of ER 7.1 is covered by 6.3 d). For coatings, the first indent of ER 7.1 is covered by 6.4 b) and c). 7.1, second indent 8.5.2, 8.6, 8.7 BS EN ISO 7198:2017EN ISO 7198:2017 (E) 7 Essential Requirements (ERs) of Directive 93/42/EEC Clause(s)/subclause(s) of

35、this European Standard Remarks/Notes 7.2 Clause 12 Covered for design to protect patients from sterilization when the device is used. Manufacturing and packing to minimize these risks are not addressed. 8.1 Clause 12 and 13.5 Requirements are included for devices that are supplied sterile. Maintenan

36、ce of sterility in transit is addressed. Minimizing contamination during use is not addressed. Risk of infection to the user and third party are not addressed. 8.3 Clauses 11, 12, 13 Sterility assurance, manufacturing, packaging design and maintenance of sterility are addressed. 8.4 Clauses 11, 12 M

37、anufacturing, sterilization validation and routine control are addressed. 8.7 13.6.1 i) 9.2, first indent 4.2, 8.7.2.3, 8.7.2.4, 8.7.3.3 Dimensions must be specified and dimensional verification required. 13.1 13.6 13.3 a) 13.6.1 The standard does not address the requirement regarding the authorized

38、 representative where the manufacturer does not have a registered place of business in the Community. 13.3 b) 13.6.1 b), c), d), e), f), g) ER 13.3 b) is only satisfied in respect of the information specified in the standard clauses. 13.3 c) 13.6.1 i) ER 13.3 c) is only satisfied if the word “STERIL

39、E” (or the harmonized symbol) is used. 13.3 d) 13.6.1 k) Only covered if the batch code is preceded by the word LOT. 13.3 e) 13.6.1 m) ER 13.3 e) is only satisfied if the expiration date in the format year and month is given. 13.3 f) 13.6.1 i) Consistency of marking across the community is not cover

40、ed. 13.3 i) 13.6.1 o) Covered for storage instructions. 13.3 k) 13.6.1 n) ER 13.3 k) is only satisfied in respect of damage to the packaging. BS EN ISO 7198:2017EN ISO 7198:2017 (E) 8 Essential Requirements (ERs) of Directive 93/42/EEC Clause(s)/subclause(s) of this European Standard Remarks/Notes 1

41、3.3 m) 13.6.1 j) 13.6 a) 13.6.3 b), 13.6.3 c), 13.6.3 d), 13.6.3 f) Covered for the items listed in 13.3 c), f), i) (handling is not covered), j), and k). Note: 13.3 c) is covered by 13.6.3 d), 13.3 f) is covered by 13.6.3 d), 13.3 i) is covered by 13.6.3 f), 13.3 j) is covered by 13.6.3 c) 13.3 k)

42、is covered by 13.6.3 b)13.6 b) 13.6.3 a), b) Performance is not covered. 13.6 c) 13.6.3 c) Methods for preparation and implantation techniques. Use of endovascular systems involve use of additional medical devices (e.g. syringes, wire guides). 13.6 d) 13.6.3 c) First part covered (installation and p

43、reparation for operation only). 13.6 i) 13.6.3 c) 13.6 q) 13.6.3 g) WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 7198:2017ISO 7198:2016(E)Foreword vIntroduction vi1 Scope . 12 Normative references 23 Terms

44、 and definitions . 24 General requirements . 64.1 Configuration designation for tubular vascular grafts . 64.2 Size designation . 74.2.1 Uniform straight tubular vascular grafts 74.2.2 Uniform bifurcated tubular vascular grafts 74.2.3 Tapered tubular vascular grafts 74.2.4 Other configurations of tu

45、bular vascular grafts 74.2.5 Vascular patches . 74.3 Materials . 74.3.1 General 74.3.2 Classification of tubular vascular grafts and vascular patches 74.3.3 Nomenclature . 84.4 Intended clinical use designation . 85 Intended performance . 96 Design attributes 96.1 General . 96.2 Tubular vascular gra

46、fts 96.3 Vascular patches 96.4 Coatings 106.5 Drug coatings and drug-eluting coatings 107 Materials 108 Design evaluation .108.1 General 108.2 Sampling 118.3 Conditioning of test samples 118.4 Reporting 118.5 Biocompatibility . 128.5.1 Residual chemicals 128.5.2 Biocompatibility 128.6 Biostability.

47、128.7 Bench and analytical tests 138.7.1 General. 138.7.2 Tubular vascular grafts .138.7.3 Vascular patches 159 Preclinical in vivo evaluation test methods for vascular prostheses 169.1 Preclinical in vivo evaluation 169.1.1 Purpose . 169.1.2 Specific aims .179.1.3 Protocol considerations 179.1.4 Da

48、ta acquisition .179.1.5 Test report and additional information 1810 Clinical investigation methods for vascular prostheses .1910.1 Clinical investigation . 1910.1.1 Purpose . 1910.1.2 Specific aims .19 ISO 2016 All rights reserved iiiContents PageBS EN ISO 7198:2017ISO 7198:2016(E)10.1.3 Protocol co

49、nsiderations 1910.1.4 Data acquisition .2010.1.5 Final report 2310.2 Post market surveillance . 2411 Manufacturing 2412 Sterility 2413 Packaging and labelling .2513.1 General 2513.2 Unit container . 2513.3 Outer container . 2513.4 Shipping container 2513.5 Maintenance of sterility in transit . 2513.6 Marking 2513.6.1 Container label .2513.6.2 Record label . 2613.6.3 General information and instructions for use .26Annex A (informative) Test methods .27Bibliography .54iv ISO 2016 All rights reservedBS EN ISO 7198:2017ISO 7198:2016(E)For