1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 25539-3:2011Cardiovascular implants Endovascular devicesPart 3: Vena cava filters (ISO 25539-3:2011)BS EN ISO 25539-3:2011 BRITISH STANDARDNational forewordThis British
2、 Standard is the UK implementation of EN ISO 25539-3:2011. Together with BS EN ISO 25539-1:2009 and BS EN ISO 22539-2:2009, it supersedes BS EN 12006-3:1998+A1:2009 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/150/2, Cardiovascular implants.A lis
3、t 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 correct application. The British Standards Institution 2012. Published by BSI Standards
4、Limited 2012ISBN 978 0 580 66358 1 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 2012.Amendments issued since publicationDate Text affec
5、tedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 25539-3 December 2011 ICS 11.040.40 Supersedes EN 12006-3:1998+A1:2009English Version Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011) Implants cardiovasculaires - Dispositifs endovasculaires - P
6、artie 3: Filtres caves (ISO 25539-3:2011) Kardiovaskulre Implantate - Endovaskulre Implantate - Teil 3: Hohlvenenfilter (ISO 25539-3:2011) This European Standard was approved by CEN on 30 November 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the con
7、ditions 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 exis
8、ts 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-CENELEC Management Centre has the same status as the official versions. CEN members are the national sta
9、ndards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and
10、 United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 255
11、39-3:2011: EBS EN ISO 25539-3:2011EN ISO 25539-3:2011 (E) 3 Foreword This document (EN ISO 25539-3:2011) 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
12、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 June 2012, and conflicting national standards shall be withdrawn at the latest by June 2012. Attention is drawn to the possibility that some of
13、 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 12006-3:1998+A1:2009. This document has been prepared under a mandate given to CEN by the European Commissio
14、n and the 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 organizations of the fol
15、lowing countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slo
16、vakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 25539-3:2011 has been approved by CEN as a EN ISO 25539-3:2011 without any modification. BS EN ISO 25539-3:2011EN ISO 25539-3:2011 (E) 4 Annex ZA (informative) Relationship between this European St
17、andard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices as amended by Directi
18、ve 2007/47/EC. 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 limits of the scope of this
19、 standard, a presumption of conformity with the corresponding 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 D
20、irective 93/42/EEC Qualifying remarks/notes 6,8,10 and 12 7.2 7 7.36 7.5 1stsentence 6 and 7 7.6 7 8.212.1.5 8.311.1 8.4 11.2 8.56 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
21、.6 g)12.3.2 13.6 k) 12.3.2 13.6 q) WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 25539-3:2011ISO 25539-3:2011(E) ISO 2011 All rights reserved iiiContents Page Foreword . v Introduction vi 1 Scope 1 2 Normat
22、ive references 1 3 Terms and definitions . 2 4 General requirements . 5 4.1 Classification . 5 4.2 Size 5 5 Intended performance . 5 6 Design attributes . 5 6.1 General . 5 6.2 Sheath/dilator kit for endovascular filter system . 5 6.3 Filter system 5 6.4 Filter 5 6.5 Optional filter . 6 6.6 Sheath/d
23、ilator kit for endovascular retrieval/conversion system 6 6.7 Retrieval/conversion system 6 6.8 Endovascular systems 6 7 Materials . 7 8 Design evaluation 7 8.1 General . 7 8.2 Sampling 7 8.3 Conditioning of test samples . 8 8.4 Reporting 8 8.5 Bench and analytical tests . 9 8.6 Preclinical in vivo
24、evaluation . 24 8.7 Clinical evaluation . 28 9 Post-market surveillance 32 10 Manufacturing 32 11 Sterilization 32 11.1 Products supplied sterile 32 11.2 Products supplied non-sterile 33 11.3 Sterilization residuals . 33 12 Packaging . 33 12.1 Protection from damage in storage and transport 33 12.2
25、Marking . 34 12.3 Information supplied by the manufacturer . 35 Annex A (informative) Attributes of endovascular devices Vena cava filters Technical and clinical considerations 37 Annex B (informative) Descriptions of potential device effects of failure and failure modes and descriptions of detrimen
26、tal clinical effects 51 Annex C (informative) Bench and analytical tests 55 Annex D (informative) Test methods 59 BS EN ISO 25539-3:2011ISO 25539-3:2011(E) iv ISO 2011 All rights reservedAnnex E (informative) Examples of terms for clinical use of vena cava filters 86 Bibliography 88 BS EN ISO 25539-
27、3:2011ISO 25539-3:2011(E) ISO 2011 All rights reserved vForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees
28、. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the Intern
29、ational Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Sta
30、ndards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subj
31、ect of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 25539-3 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems. ISO 25539 consists of the following parts, u
32、nder the general title Cardiovascular implants Endovascular devices: Part 1: Endovascular prostheses Part 2: Vascular stents Part 3: Vena cava filters BS EN ISO 25539-3:2011ISO 25539-3:2011(E) vi ISO 2011 All rights reservedIntroduction This part of ISO 25539 provides minimum requirements for endova
33、scular devices and the methods of test that will enable their evaluation. It is derived from ISO/TS 15539, which serves as a rationale for its requirements. ISO/TS 15539 was developed by first identifying the design requirements for these devices and listing the potential failure modes and potential
34、 device and detrimental clinical effects. Tests were then identified to address each of the failure modes. The requirements specified in this part of ISO 25539 are based on that assessment. BS EN ISO 25539-3:2011INTERNATIONAL STANDARD ISO 25539-3:2011(E) ISO 2011 All rights reserved 1Cardiovascular
35、implants Endovascular devices Part 3: Vena cava filters 1 Scope This part of ISO 25539 specifies requirements for vena cava filters, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufactu
36、ring, sterilization, packaging and information supplied by the manufacturer. This part of ISO 25539 supplements ISO 14630, which specifies general requirements for the performance of non-active surgical implants. The following are within the scope of this part of ISO 25539: vena cava filters used to
37、 prevent pulmonary embolism by mechanical filtration in the inferior vena cava (IVC). While this part of ISO 25539 might be useful with respect to filters implanted in other venous locations (e.g. superior vena cava, iliac veins), it does not specifically address use of filters in other implantation
38、 sites; sheath/dilator kits, providing that they comprise an integral component of the access, delivery or retrieval/conversion of the vena cava filter; delivery systems, providing that they comprise an integral component of the deployment of the vena cava filter; optional filters that can be retrie
39、ved or converted, and permanent filters together with their associated endovascular systems. While this part of ISO 25539 might be useful with respect to the evaluation of repositioning filters after chronic implantation, it does not specifically address filter repositioning. The following are outsi
40、de the scope of this part of ISO 25539: temporary filters (e.g. tethered) that need to be removed after a defined period of time; coatings, surface modifications, and/or drugs; issues associated with viable tissues and non-viable biological materials; degradation and other time-dependent aspects of
41、absorbable materials; procedures and devices (e.g. venous entry needle) used prior to the vena cava filter procedure. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated re
42、ferences, the latest edition of the referenced document (including any amendments) applies. ISO 10993 (all parts), Biological evaluation of medical devices BS EN ISO 25539-3:2011ISO 25539-3:2011(E) 2 ISO 2011 All rights reservedISO 11135-1, Sterilization of health care products Ethylene oxide Part 1
43、: Requirements for development, validation and routine control of a sterilization process for medical devices 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 ISO 11607-1,
44、Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems ISO 14630, Non-active surgical implants General requirements ISO 14937, Sterilization of health care products General requirements for characterization of a sterilizi
45、ng agent and the development, validation and routine control of a sterilization process for medical devices ISO 14971, Medical devices Application of risk management to medical devices ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation
46、and routine control of a sterilization process for medical devices 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 14630 and the following apply. 3.1 access site vein that is used for accessing the vena cava EXAMPLE Jugular vein; femoral vein; subcla
47、vian vein; antecubital vein. 3.2 adverse event clinical event complication, failure or device-related observation with preclinical in vivo and clinical use of the endovascular system or endovascular retrieval/conversion system NOTE 1 This term relates to the definition of a hazardous situation that
48、might lead to harm, as found in ISO 14971, when the consequences are to the patient. NOTE 2 A clinical event might lead to a detrimental clinical effect. 3.3 conversion system component of the endovascular conversion system that is intended to structurally alter an optional filter after implantation
49、 so that it no longer functions as a filter 3.4 delivery system component of the filter system, excluding the sheath/dilator, used to deliver the filter to the targeted position and to deploy the filter NOTE The delivery system is removed after filter placement. 3.5 determine requirement to quantitatively appraise or analyse NOTE Also see evaluate (3.9). BS EN ISO 25539-3:2011ISO 25539-3:2011(E) ISO 2011 All rights reserved 33.6 detrimental clinical effect discernable negative effec
