INTERNATIONAL STANDARD
Endovasculardevices- Cardiovascularimplants-
Part 1:Endovascularprostheses
Implants cardiovasculaires - Dispositifs endovasculaires -Partie 1: Protheses endovasculaires
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@ ISO 2017 Published in Switzerland
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Contents
Page
Foreword. .VIntroduction. vi1 Scope. 12 Normative references. 23 Terms and definitions. 24 General requirements for endovascular system. 4.1 Type of endovascular prosthesis. 4 44.2 Materials and construction for endovascular system. 44.3 4.4 Configuration and size designation for endovascular prosthesis. Intended clinical use for endovascular system 5 54.5 Balloon designation.. 65 Intended performance. 66 Design attributes... 6.1 General. 6 66.2 9 Endovascular system. Endovascular prosthesis. 66.4 Endovascular system and endovascular prosthesis. 6 77 Materials. 78 Design evaluation. 8.1 General. 78.2 Sampling. Conditioning of test samples. 8 78.4 Reporting 6 68.5 Bench and analytical tests. 8.5.1 Endovascular system and delivery system. 10 108.5.2 Endovascular prosthesis. 128.6 Preclinical in vivo evaluation.. 8.6.1 Purpose. 18 188.6.2 8.6.3 Specific aims. Protocol considerations. 18 198.6.4 Data acquisition. 198.7 Clinical evaluation. 8.6.5 Test report and additional information 21 218.7.1 8.7.2 Purpose. Specific aims 22 218.7.3 Protocol considerations. 228.7.4 8.7.5 Data acquisition. Final report. 23 269 Post-market surveillance. .2710 Manufacturing 2711 Sterilization. Products supplied sterile. 2711.1 11.2 Sterilization residuals. 27 2712 Packaging. 2812.1 Protection from damage in storage and transport. 12.1.1 General. 2812.1.2 12.1.3 Unit container. Outer container.
2828 2812.1.4 Shipping container. 28
12.2 Labelling. 12.1.5 Maintenance of sterility in transit.12.2.2 Record label. 12.2.1 Container label.12.3 Instructions for use..12.3.1General. 12.3.2 Information and instructions for use for endovascular systems. 29Annex A (informative) Relationship between testing requirements and device attributesand potential failure modes. 31Annex B (informative) Description of clinical and device effects of failure.. 45Annex C (informative) Bench and analytical tests. Annex D(informative) Test methods 49 57Bibliography. 121
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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standardsbodies (ISO member bodies). The work of preparing International Standards is normally carried outthrough ISO technical mittees. Each member body interested in a subject for which a technical mittee has been established has the right to be represented on that mittee. InternationalISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of organizations governmental and non-governmental in liaison with ISo also take part in the work.electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance aredifferent types of ISo documents should be noted. This document was drafted in accordance with theeditorial rules of the ISO/IEC Directives Part 2 (see . iso. org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject ofany patent rights identified during the development of the document will be in the Introduction and/oron the ISo list of patent declarations received (see . iso. org/patents).
Any trade name used in this document is information given for the convenience of users and does notconstitute an endorsement.
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Cardiovascular implants and extracorporeal systems. The mittee responsible for this document is ISO/TC 150 Implants for surgery Submittee SC 2
This second edition cancels and replaces the first edition (ISO 25539-1:2003) which has beentechnically revised.
It also incorporates the Amendment ISO 25539-1:2003/Amd1:2005.
