BS EN ISO 25539-2-2012 Cardiovascular implants Endovascular devices Vascular stents《心血管植入物 血管内器械 血管支架》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationCardiovascular implants Endovascular devicesPart 2: Vascular stentsBS EN ISO 25539-2:2012Copyright European Committee for Standardization Provided by IHS under license with CENNo

2、t for ResaleNo reproduction or networking permitted without license from IHS-,-,-National forewordThis British Standard is the UK implementation of EN ISO 25539-2:2012. It supersedes BS EN ISO 25539-2:2009 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committe

3、e CH/150, Implants for surgery, to Subcommittee CH/150/2, Cardiovascular implants.A list of organizations 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 c

4、orrect application. The British Standards Institution 2013.Published by BSI Standards Limited 2013 ISBN 978 0 580 76898 9 ICS 11.040.40Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and

5、Strategy Committee on 31 January 2013.Amendments issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 25539-2:2012Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-E

6、UROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 25539-2 December 2012 ICS 11.040.40 Supersedes EN ISO 25539-2:2009English Version Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012) Implants cardiovasculaires - Dispositifs endovasculaires - Partie 2: E

7、ndoprothses vasculaires (ISO 25539-2:2012) Kardiovaskulre Implantate - Endovaskulre Implantate - Teil 2: Gefstents (ISO 25539-2:2012) This European Standard was approved by CEN on 30 November 2012. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditio

8、ns 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 may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in

9、 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 to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standard

10、s bodies of 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, Sloven

11、ia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for

12、 CEN national Members. Ref. No. EN ISO 25539-2:2012: EBS EN ISO 25539-2:2012Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EN ISO 25539-2:2012 (E) 2 Contents Page Foreword . 3 A

13、nnex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC 4 BS EN ISO 25539-2:2012Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without lice

14、nse from IHS-,-,-EN ISO 25539-2:2012 (E) 3 Foreword This document (EN ISO 25539-2:2012) 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 is held by DIN. This Europea

15、n Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2013, and conflicting national standards shall be withdrawn at the latest by June 2013. Attention is drawn to the possibility that some of the elements of

16、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 25539-2:2009. This document has been prepared under a mandate given to CEN by the European Commission and the European Fr

17、ee 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 Regulations, the national standards organisations of the following countries are

18、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, Luxembourg, Malta, Netherlands, Norway, Poland, Port

19、ugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 25539-2:2012 has been approved by CEN as a EN ISO 25539-2:2012 without any modification. BS EN ISO 25539-2:2012Copyright European Committee for Standardization Provided by

20、 IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EN ISO 25539-2:2012 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared

21、 under a mandate given to CEN by the European Commission and the European Free Trade Association to provide one means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC, Medical devices. Once this standard is cited in the Official Journal of the European Union under that

22、 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 limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Direct

23、ive and associated EFTA regulations. Table ZA.1 Correspondence between Directive 93/42/EEC and this European Standard Clause(s)/sub-clause(s) of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/notes 6,8,10 and 12 7.2 6.3 and 7 7.3 6 7.5 1stsentence 6 and

24、 7 7.6 7 8.2 12.1.5 8.3 11.1 8.4 11.2 8.5 6 and 7 9.2, 2ndindent 12.2.2 13.3 a) 12.2.2 13.3 b) 12.2.2 13.3 c) 12.2.2 13.3 d) 12.2.2 13.3 e) 12.2.2 13.3 f) 12.2.2 13.3 i) 12.2.2 13.3 k) 12.2.2 13.3 m) 5 13.5 12.3.2 13.6 g) 12.3.2 13.6 k) 12.3.2 13.6 q) WARNING: Other requirements and other EU Directi

25、ves may be applicable to the products falling within the scope of this standard. BS EN ISO 25539-2:2012Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO 25539-2:2012(E) ISO 201

26、2 All rights reserved iiiContents PageIntroduction v1 Scope 12 Normative references . 13 Terms and definitions . 24 General requirements . 44.1 Classification 44.2 Size 44.3 Intended clinical use designation . 55 Intended performance 56 Design attributes . 56.1 General . 56.2 Delivery system and ste

27、nt system 66.3 Implant 67 Materials . 78 Design evaluation 78.1 General . 78.2 Sampling 88.3 Conditioning of test samples . 88.4 Reporting . 88.5 Delivery system and stent system 98.6 Stent 158.7 Preclinical in vivo evaluation .238.8 Clinical evaluation .279 Post-market surveillance .3010 Manufactur

28、ing 3011 Sterilization .3011.1 Products supplied sterile 3011.2 Products supplied non-sterile .3111.3 Sterilization residuals .3112 Packaging 3112.1 Protection from damage in storage and transport .3112.2 Marking .3112.3 Information supplied by the manufacturer .32Annex A (informative) Attributes of

29、 endovascular devices Vascular stents Technical and clinical consideration .34Annex B (informative) Bench and analytical tests .41Annex C (informative) Definitions of reportable clinical events 45Annex D (informative) Test methods .48Annex E (informative) Supplement to fatigue durability test analyt

30、ical approach .85Bibliography .88BS EN ISO 25539-2:2012Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO 25539-2:2012(E)IntroductionThis part of ISO 25539 has been prepared in

31、order to provide minimum requirements for endovascular devices and the methods of test that will enable their evaluation. It is the second part of a three-part standard. ISO 25539-1 addresses endovascular prostheses and ISO 25539-3 addresses vena cava filters. ISO/TS 15539, from which this part of I

32、SO 25539 is derived, serves as a rationale for the requirements of this part of ISO 25539. The Technical Specification ISO/TS 15539 was developed by first identifying the design requirements for these devices and listing the potential device and clinical failure modes. Tests were then identified to

33、address each of the failure modes. The requirements provided in this part of ISO 25539 are based on that assessment. ISO 2012 All rights reserved vBS EN ISO 25539-2:2012Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking

34、permitted without license from IHS-,-,-Cardiovascular implants Endovascular devices Part 2: Vascular stents1 Scope1.1 This part of ISO 25539 specifies requirements for vascular stents, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design

35、 attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. It should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.NOTE Due to the variations i

36、n the design of implants covered by this part of ISO 25539 and in some cases due to the relatively recent development of some of these implants (e.g. bioabsorbable stents, polymeric stents), acceptable standardized in vitro tests and clinical results are not always available. As further scientific a

37、nd clinical data become available, appropriate revision of this part of ISO 25539 will be necessary.1.2 The scope of this part of ISO 25539 includes vascular stents used to treat vascular lesions or stenoses, or other vascular abnormalities. These devices might or might not incorporate surface modif

38、ications of the stent such as drug and/or other coatings. Stents covered with materials that significantly modify the permeability of the uncovered stent are within the scope of ISO 25539-1. The stent design might dictate the need to address functional requirements identified in both ISO 25539-1 and

39、 this part of ISO 25539.1.3 Delivery systems are included in this part of ISO 25539 if they comprise an integral component of the deployment of the vascular stent.1.4 Procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty devices, are excluded from t

40、he scope of this part of ISO 25539.1.5 Some pharmacological aspects of drug-eluting stents are addressed in this part of ISO 25539, but this part of ISO 25539 is not comprehensive with respect to the pharmacological evaluation of drug-eluting stents.1.6 Degradation and other time-dependent aspects o

41、f bioabsorbable and polymeric stents and coatings are not addressed by this part of ISO 25539.1.7 With the exception of sterilization, this part of ISO 25539 does not address requirements for the evaluation of animal tissue products.2 Normative referencesThe following referenced documents are indisp

42、ensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a ri

43、sk management processISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for development,

44、 validation and routine control of a sterilization process for medical devicesISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systemsINTERNATIONAL STANDARD ISO 25539-2:2012(E) ISO 2012 All rights reserved 1BS

45、EN ISO 25539-2:2012Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO 25539-2:2012(E)ISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirem

46、ents for forming, sealing and assembly processesISO 14155, Clinical investigation of medical devices for human subjects Good clinical practiceISO 14160, Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivati

47、ves Requirements for characterization, development, validation and routine control of a sterilization process for medical devicesISO 14630:2012, Non-active surgical implants General requirementsISO 14937, Sterilization of health care products General requirements for characterization of a sterilizin

48、g agent and the development, validation and routine control of a sterilization process for medical devicesISO 14971:2007, Medical devices Application of risk management to medical devicesISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices3 Terms and definitionsFor the purposes of this document, the terms and definitions in ISO 14630 and the following apply.NOTE Bench and analytical tests are described in Annex B. Reportable cli