ISO 25539-1 2017 心血管植入物 血管内装置 第一部分 血管内支架(英文版).pdf

2017,25539,ISO,植入物,血管,国外及港澳台标准
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INTERNATIONAL STANDARD

Endovasculardevices- Cardiovascularimplants-

Part 1:Endovascularprostheses

Implants cardiovasculaires - Dispositifs endovasculaires -Partie 1: Protheses endovasculaires

COPYRIGHTPROTECTEDDOCUMENT

@ ISO 2017 Published in Switzerland

Allrights reserved. Unles otherwise speciied no part of this publiation may be reproduced or utilized otherwise n any formor by any means electronic or mechanical including photocopying or posting on the internet or an intranet without prior written permission. Permission can be requested from either ISO at the address below or ISO's member body in the country ofthe requester.

ISO copyright officeCh. de Blandonnet 8 ▪ CP 401 CH-1214 Vernier Geneva SwitzerlandTel. 41 22 749 01 11 Fax 41 22 749 09 47copyright@

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

28 2828 292929

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.

For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment as well as information about ISO's adherence to the World Trade Organization (WTO) principles in theTechnical Barriers to Trade (TBT) see the following URL: .iso. org/iso/foreword. html.

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.

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