1、May 2013 Translation by DIN-Sprachendienst.English price group 32No 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
2、.040.40!%$*h“2010769www.din.deDDIN EN ISO 25539-2Cardiovascular implants Endovascular devices Part 2: Vascular stents (ISO 25539-2:2012);English version EN ISO 25539-2:2012,English translation of DIN EN ISO 25539-2:2013-05Kardiovaskulre Implantate Endovaskulre Implantate Teil 2: Gefstents (ISO 25539
3、-2:2012);Englische Fassung EN ISO 25539-2:2012,Englische bersetzung von DIN EN ISO 25539-2:2013-05Implants cardiovasculaires Dispositifs endovasculaires Partie 2: Endoprothses vasculaires (ISO 25539-2:2012);Version anglaise EN ISO 25539-2:2012,Traduction anglaise de DIN EN ISO 25539-2:2013-05Superse
4、desDIN EN ISO 25539-2:2009-08www.beuth.deDocument comprises 100 pagesIn case of doubt, the German-language original shall be considered authoritative.04.13 DIN EN ISO 25539-2:2013-05 2 A comma is used as the decimal marker. National foreword This document (EN ISO 25539-2:2012) has been prepared by T
5、echnical Committee ISO/TC 150 “Implants for surgery” in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics
6、 Standards Committee), Working Committee NA 027-02-17-01 UA Herz- und Gefimplantate. This standard contains specifications meeting the essential requirements set out in EU Directive 93/42/EEC on medical devices. DIN Standards corresponding to the International Standards referred to in this document
7、are as follows: ISO 10993 DIN EN ISO 10993 ISO 11135-1 DIN EN ISO 11135-1 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 14155-1 DIN EN ISO 14155-1 ISO 14155-2 DIN EN ISO 14155-2 ISO 14160 DIN EN ISO 14160 ISO 14630 DIN EN ISO 14630 ISO 14971 DIN EN
8、ISO 14971 Amendments This standard differs from DIN EN ISO 25539-2:2009-08 as follows: a) the text of Subclauses 8.6 and 8.7 has been clarified; b) Annex ZA has been brought in line with the requirements of the European Commission; c) the standard has been editorially revised. Previous editions DIN
9、EN 14299: 2004-08 DIN EN ISO 25539-2: 2009-01, 2009-08 DIN EN ISO 25539-2:2013-05 3 National Annex NA (informative) Bibliography DIN EN ISO 10993 (all parts), Biological evaluation of medical devices DIN EN ISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for th
10、e 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, validation and routine control of a sterilization process for medical devices DIN EN ISO 11607-1, Pac
11、kaging 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 2: Validation requirements for forming, sealing and assembly processes DIN EN ISO 14155-1, C
12、linical investigation of medical devices for human subjects Part 1: General requirements DIN EN ISO 14155-2, Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans DIN EN ISO 14160, Sterilization of health care products Liquid chemical sterilizing agents fo
13、r 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-active surgical implants General requirements DIN EN ISO 14971, Medical devi
14、ces Application of risk management to medical devices DIN EN ISO 25539-2:2013-05 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 25539-2 December 2012 ICS 11.040.40 Supersedes EN ISO 25539-2:2009 English Version Cardiovascular implants Endovascular devices
15、 Part 2: Vascular stents (ISO 25539-2:2012) Implants cardiovasculaires Dispositifs endovasculaires Partie 2: Endoprothses 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 20
16、12. 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 may be obtained
17、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 to the CEN-CEN
18、ELEC 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, Ireland, Ita
19、ly, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 1
20、7, 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 25539-2:2012: E Contents PageForeword Introduction 1 Scope 2 Normative references .3 Terms and definitions .4 General requirements .4.1 Classification 4.2
21、Size 4.3 Intended clinical use designation .5 Intended performance 6 Design attributes .6.1 General .6.2 Delivery system and stent system 6.3 Implant 7 Materials .8 Design evaluation 8.1 General .8.2 Sampling 8.3 Conditioning of test samples .8.4 Reporting .8.5 Delivery system and stent system 8.6 S
22、tent 8.7 Preclinical in vivo evaluation .278.8 Clinical evaluation .9 Post-market surveillance .3410 Manufacturing 3411 Sterilization .3411.1 Products supplied sterile 3411.2 Products supplied non-sterile .3511.3 Sterilization residuals .3512 Packaging 3512.1 Protection from damage in storage and tr
23、ansport .3512.2 Marking .3512.3 Information supplied by the manufacturer .36Annex A (informative) Attributes of endovascular devices Vascular stents Technical and clinical consideration .38Annex B (informative) Bench and analytical tests .45Annex C (informative) Definitions of reportable clinical ev
24、ents 49Annex D (informative) Test methods .Annex E (informative) Supplement to fatigue durability test analytical approach .89Bibliography .DIN EN ISO 25539-2:2013-05 EN ISO 25539-2:2012 (E) 234556888999910101111111212121319315296Annex ZA (informative) Relationship between this European Standard and
25、 the Essential Requirements of EU Directive 93/42/EEC . 92 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
26、. 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 June 2013, and conflicting national standards shall be withdrawn at the latest by June 2013. Attention is drawn to the possibility that some of th
27、e 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 25539-2:2009. This document has been prepared under a mandate given to CEN by the European Commission and t
28、he 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 Regulations, the national standards organisations of the following
29、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, Luxembourg, Malta, Netherlands, Norway
30、, Poland, Portugal, 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. “”DIN EN ISO 25539-2:2013-05 EN ISO 25539-2:2012 (E) 3IntroductionTh
31、is part of ISO 25539 has been prepared 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 filter
32、s. ISO/TS 15539, from which this 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 fai
33、lure modes. Tests were then identified to address each of the failure modes. The requirements provided in this part of ISO 25539 are based on that assessment.DIN EN ISO 25539-2:2013-05 EN ISO 25539-2:2012 (E) 41 Scope1.1 This part of ISO 25539 specifies requirements for vascular stents, based upon c
34、urrent 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 supplement to ISO 14630, which specifie
35、s 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. bioabsorbable stents, polymeric stents), accept
36、able 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 stents used to treat vascular lesions o
37、r 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 within the scope of ISO 25539-1. The st
38、ent 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 stent.1.4 Procedures and devices used pr
39、ior 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 is not comprehensive with respect to t
40、he 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 does not address requirements for the e
41、valuation 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 document (including any amendments)
42、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 sterilization process for medical de
43、vicesISO 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: Requirements for materials, sterile barrier sy
44、stems and packaging systemsDIN EN ISO 25539-2:2013-05 EN ISO 25539-2:2012 (E) 5ISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processesISO 14155, Clinical investigation of medical devices for human subjects Good clin
45、ical practiceISO 14160, 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
46、ISO 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, validation and routine control of a sterilization process for medical devicesISO 14971:2007, Medical
47、 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
48、 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 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 ves
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