EN ISO 25539-2-2012 en Cardiovascular implants - Endovascular devices - Part 2 Vascular stents《心血管植入血管内设备 第2部分 血管支架》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationCardiovascular implants Endovascular devicesPart 2: Vascular stentsBS EN ISO 25539-2:2012National forewordThis British Standard is the UK implementation of EN ISO 25539-2:2012. I

2、t supersedes BS EN ISO 25539-2:2009 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/150, Implants for surgery, to Subcommittee CH/150/2, Cardiovascular implants.A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

3、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 2013.Published by BSI Standards Limited 2013 ISBN 978 0 580 76898 9 ICS 11.040.40Compliance with a British Standard

4、cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2013.Amendments issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 25539-2:2012EUROPEAN STANDARD NORME EUROPENNE EUROPIS

5、CHE 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: Endoprothses vasculaires (ISO 25539-2:201

6、2) 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 conditions for giving this European Standard the

7、 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 official versions (English, Frenc

8、h, 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 Austria, Belgium, Bulgaria,

9、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, Sweden, Switzerland, Turkey a

10、nd 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 CEN national Members. Ref. No. EN ISO 2

11、5539-2:2012: EBS EN ISO 25539-2:2012EN ISO 25539-2:2012 (E) 2 Contents Page Foreword . 3 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC 4 BS EN ISO 25539-2:2012EN ISO 25539-2:2012 (E) 3 Foreword This document (EN ISO 25539-

12、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 European Standard shall be given the status of a national standard, either by publicati

13、on 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 this document may be the subject of patent rights. CEN and/or CENELEC shall not

14、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 Free Trade Association, and supports essential requirements of EU Directive. For r

15、elationship 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 bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,

16、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, Sweden, Switzerland, Turkey and the Un

17、ited 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 25539-2:2012EN ISO 25539-2:2012 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive

18、93/42/EEC This European Standard has been prepared 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

19、 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 limits of the scope of this standard, a presumption of conformity with the c

20、orresponding Essential Requirements of that Directive 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 6,8,1

21、0 and 12 7.2 6.3 and 7 7.3 6 7.5 1stsentence 6 and 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

22、) WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this standard. BS EN ISO 25539-2:2012ISO 25539-2:2012(E) ISO 2012 All rights reserved iiiContents PageIntroduction v1 Scope 12 Normative references . 13 Terms and definitions . 24 Gene

23、ral 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 stent system 66.3 Implant 67 Materials . 78 Design evaluation 78.1 General . 78.2 Sampling 88.3 Conditioning of test sample

24、s . 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 Manufacturing 3011 Sterilization .3011.1 Products supplied sterile 3011.2 Products supplied non-sterile .3111.3 Sterilization resi

25、duals .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 endovascular devices Vascular stents Technical and clinical consideration .34Annex B (informative) Bench and analytical

26、 tests .41Annex C (informative) Definitions of reportable clinical events 45Annex D (informative) Test methods .48Annex E (informative) Supplement to fatigue durability test analytical approach .85Bibliography .88BS EN ISO 25539-2:2012ISO 25539-2:2012(E)IntroductionThis part of ISO 25539 has been pr

27、epared in 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

28、 part of ISO 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 iden

29、tified to 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 25539-2:2012Cardiovascular implants Endovascular devices Part 2: Vascular stents1 Scope1.1 This part of ISO 25539 specifies requireme

30、nts for vascular stents, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. It should be considered as a su

31、pplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.NOTE Due to the variations in 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. bioabsorba

32、ble stents, polymeric stents), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and 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 st

33、ents used to treat vascular lesions or stenoses, or other vascular abnormalities. These devices might or might not incorporate surface modifications of the stent such as drug and/or other coatings. Stents covered with materials that significantly modify the permeability of the uncovered stent are wi

34、thin the scope of ISO 25539-1. The stent design might dictate the need to address functional requirements identified in both ISO 25539-1 and 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 ste

35、nt.1.4 Procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty devices, are excluded from the 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 i

36、s not comprehensive with respect to the pharmacological evaluation of drug-eluting stents.1.6 Degradation and other time-dependent aspects of 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 do

37、es not address requirements for the evaluation of animal tissue products.2 Normative referencesThe 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 the referenced

38、 document (including any amendments) applies.ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a

39、 sterilization process for medical devicesISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requireme

40、nts for materials, sterile barrier systems and packaging systemsINTERNATIONAL STANDARD ISO 25539-2:2012(E) ISO 2012 All rights reserved 1BS EN ISO 25539-2:2012ISO 25539-2:2012(E)ISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and

41、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 derivatives Requirements for character

42、ization, 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 sterilizing agent and the development, v

43、alidation 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 ste

44、rilization 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 clinical events are defined in Annex C.3.1balloon-assisted deploymentuse

45、 of a balloon to facilitate the complete deployment (or expansion) of a self-expanding stent3.2balloon wingingcross-sectional shape of the balloon when deflated which can cause problems during withdrawalNOTE Examples include stent migration, damage to host vessel or balloon, and inability to remove

46、the balloon.3.3delivery systemsystem or mechanism used to deliver the stent to the targeted position and to deploy the stentNOTE The delivery system is removed after stent placement. Examples of delivery systems include balloon catheters or mechanically activated systems.3.4determineto quantitativel

47、y appraise or analyseNOTE Also see evaluate (3.8).3.5dogboningdumbbell-shaped balloon observed during stent deployment when the unconstrained ends of the balloon expand beyond the dilated stent outer diameter3.6coatingorganic or inorganic material, other than living cells, intentionally applied by a

48、 manufacturer to a substrateNOTE This coating can be intended to be permanent or temporary, and can be applied to the external and/or internal surface.2 ISO 2012 All rights reservedBS EN ISO 25539-2:2012ISO 25539-2:2012(E)3.7drug contentamount of drug present on the surface(s) of a coating, as part

49、of a coating or within the stent3.8evaluateto qualitatively appraise or analyseNOTE Also see determine (3.4).3.9lumen reductionreduction of diameter or cross sectional area as observed by imaging3.10reportable clinical eventscomplications, failures or device-related observations, including all adverse events and adverse device effects, that might be observed with clinical use of the stent systemNOTE Examples are listed in Annex C. These events might not have clinical significance and might not be attributable to