Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Intended performance
6 Design attributes
7 Materials
8 Design evaluation
9 Post-market surveillance
10 Manufacturing
11 Sterilization
12 Packaging
Annex A (informative) - Attributes of endovascular devices -
        Vascular stents - Technical and clinical consideration
Annex B (informative) - Bench and analytical tests
Annex C (informative) - Definitions of reportable clinical events
Annex D (informative) - Test methods
Annex E (informative) - Supplement to fatigue durability test
        analytical approach
Bibliography

Abstract

Describes requirements for vascular stents, 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 25539-2 : 60.00 (2012)