Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for endovascular system
5 Intended performance
6 Design attributes
7 Materials
8 Design evaluation
9 Post-market surveillance
10 Manufacturing
11 Sterilization
12 Packaging
Annex A (informative) - Relationship between testing
        requirements and device attributes and potential
        failure modes
Annex B (informative) - Description of clinical and
        device effects of failure
Annex C (informative) - Bench and analytical tests
Annex D (informative) - Test methods
Bibliography

Abstract

Describes requirements for the evaluation of endovascular systems (prostheses and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer based upon current medical knowledge.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 150
Supersedes	ISO/DIS 25539-1 : 60.00 (2016)