1、March 2012 Translation by DIN-Sprachendienst.English price group 31No 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
2、11.040.40!$zcx“1876485www.din.deDDIN EN ISO 25539-3Cardiovascular implants Endovascular devices Part 3: Vena cava filters (ISO 25539-3:2011)English translation of DIN EN ISO 25539-3:2012-03Kardiovaskulre Implantate Endovaskulre Implantate Teil 3: Hohlvenenfilter (ISO 25539-3:2011)Englische bersetzun
3、g von DIN EN ISO 25539-3:2012-03Implants cardiovasculaires Dispositifs endovasculaires Partie 3: Filtres caves (ISO 25539-3:2011)Traduction anglaise de DIN EN ISO 25539-3:2012-03SupersedesDIN EN 12006-3:2009-08www.beuth.deDocument comprises 102 pagesIn case of doubt, the German-language original sha
4、ll be considered authoritative.02.12 DIN EN ISO 25539-3:2012-03 2 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 150 “Implants for surgery”, Subcommittee SC 2 “Cardiovascular implants and extracorporeal systems”, in collaboratio
5、n 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 Standards Committee), Technical Committee NA 027-02-17-01 UA Herz-
6、und Gefimplantate. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 10555-1 DIN EN ISO 10555-1 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 14630 DIN EN ISO 1
7、4630 ISO 14937 DIN EN ISO 14937 ISO 14971 DIN EN ISO 14971 ISO 17665-1 DIN EN ISO 17665-1 DIN EN ISO 25539 Cardiovascular implants Endovascular devices consists of: Part 1: Endovascular prostheses Part 2: Vascular stents Part 3: Vena cava filters Amendments This standard differs from DIN EN 12006-3:
8、2009-08 as follows: a) in Clause 6 design attributes for sheath/dilator kits, endovascular filter systems, filter systems, filters, optional filters, sheath/dilator kits for endovascular retrieval/conversion systems, retrieval/conversion systems and endovascular systems have been specified; b) bench
9、 and analytical tests for the new systems specified in Clause 6 have been included (see 8.5); c) requirements for preclinical in vivo evaluation have been specified (see 8.6); d) requirements for clinical evaluation have been specified (see 8.7); e) additional requirements for packaging and marking
10、have been specified (see Clause 12 and Subclause 12.2); f) Annex A (informative) dealing with attributes of endovascular devices has been included; DIN EN ISO 25539-3:2012-03 3 g) Annex B (informative) giving descriptions of potential device effects of failure and failure modes and descriptions of d
11、etrimental clinical effects has been included; h) Annex C (informative) listing bench and analytical tests has been included; i) Annex D (informative) “Test methods” has been included; j) Annex E (informative) giving examples of terms for clinical use of vena cava filters has been included. Previous
12、 editions DIN EN 12006-3: 1999-01, 2009-08 DIN EN ISO 25539-3:2012-03 4 National Annex NA (informative) Bibliography DIN EN ISO 10555-1, Intravascular catheters Sterile and single-use catheters Part 1: General requirements DIN EN ISO 10993 (all parts), Biological evaluation of medical devices DIN EN
13、 ISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for the 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, validat
14、ion and routine control of a sterilization process for medical devices DIN EN ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems DIN EN ISO 14630, Non-active surgical implants General requirements DIN EN
15、ISO 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 devices DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN
16、 EN ISO 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 devices EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 25539-3 December 2011 ICS 11.040.40 Supersedes EN 12006-3
17、:1998+A1:2009English Version Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011) Implants cardiovasculaires - Dispositifs endovasculaires - Partie 3: Filtres caves (ISO 25539-3:2011) Kardiovaskulre Implantate - Endovaskulre Implantate - Teil 3: Hohlvenenfilt
18、er (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 conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists
19、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, French, German). A version in any other language made by translation under th
20、e 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, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germ
21、any, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG
22、 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 25539-3:2011: EContents Page Foreword . 3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .6
23、4 General requirements . 9 4.1 Classification . 9 4.2 Size 9 5 Intended performance . 9 6 Design attributes . 9 6.1 General . 9 6.2 Sheath/dilator kit for endovascular filter system . 9 6.3 Filter system 9 6.4 Filter 9 6.5 Optional filter .10 6.6 Sheath/dilator kit for endovascular retrieval/convers
24、ion system 10 6.7 Retrieval/conversion system 10 6.8 Endovascular systems 10 7 Materials 11 8 Design evaluation .11 8.1 General 11 8.2 Sampling .11 8.3 Conditioning of test samples .12 8.4 Reporting 12 8.5 Bench and analytical tests .13 8.6 Preclinical in vivo evaluation . 28 8.7 Clinical evaluation
25、 . 32 9 Post-market surveillance 36 10 Manufacturing 36 11 Sterilization 36 11.1 Products supplied sterile 36 11.2 Products supplied non-sterile 37 11.3 Sterilization residuals . 37 12 Packaging . 37 12.1 Protection from damage in storage and transport 37 12.2 Marking . 38 12.3 Information supplied
26、by the manufacturer . 39 Annex A (informative) Attributes of endovascular devices Vena cava filters Technical and clinical considerations 41 Annex B (informative) Descriptions of potential device effects of failure and failure modes and descriptions of detrimental clinical effects 55 Annex C (inform
27、ative) Bench and analytical tests 59 Annex D (informative) Test methods 63 Annex E (informative) Examples of terms for clinical use of vena cava filters 90 Bibliography 92 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC 98EN
28、 ISO 25539-3:2011 (E) DIN EN ISO 25539-3:2012-03 2Foreword 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 DIN. This
29、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 the eleme
30、nts 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 Commission and the
31、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 following cou
32、ntries 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, Slovakia, Slo
33、venia, 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. EN ISO 25539-3:2011 (E) DIN EN ISO 25539-3:2012-03 3 Introduction This part of ISO 25539 provides minimum requirements
34、 for endovascular 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 an
35、d potential 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. EN ISO 25539-3:2011 (E) DIN EN ISO 25539-3:2012-03 41 Scope This part of ISO 25539 specifies requir
36、ements for vena cava filters, 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. This part of ISO 25539 sup
37、plements 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 prevent pulmonary embolism by mechanical filtration in the inferior vena cava (IVC). While this part o
38、f 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 sites; sheath/dilator kits, providing that they comprise an integral component of the access, delivery
39、 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 retrieved or converted, and permanent filters together with their associated endovascular systems. While this
40、 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 outside the scope of this part of ISO 25539: temporary filters (e.g. tethered) that need to be removed after
41、 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 absorbable materials; procedures and devices (e.g. venous entry needle) used prior to the vena cava fil
42、ter 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 references, the latest edition of the referenced document (including any amendments) applies. ISO 10993 (
43、all parts), Biological evaluation of medical devices EN ISO 25539-3:2011 (E) DIN EN ISO 25539-3:2012-03 5 ISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11137-1,
44、 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, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packag
45、ing systems ISO 14630, Non-active surgical implants General requirements ISO 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 devices ISO 14971, Med
46、ical 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 and routine control of a sterilization process for medical devices 3 Terms and definitions For the purposes of this docume
47、nt, 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; subclavian vein; antecubital vein. 3.2 adverse event clinical event complication, failure or device-related observation with pre
48、clinical 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 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 cl
