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
        - Vena cava filters - Technical and clinical
        considerations
Annex B (informative) - Descriptions of potential device
        effects of failure and failure modes and descriptions
        of detrimental clinical
Annex C (informative) - Bench and analytical tests
Annex D (informative) - Test methods
Annex E (informative) - Examples of terms for clinical use
        of vena cava filters
Bibliography

Abstract

Describes requirements for vena cava filters, 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 25539-3 : 60.00 (2011)