Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacturing
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
Annex A (informative) - Definitions of potential clinical
        and technical events
Annex B (informative) - Local information regarding
        submission issues for VDDCPs
Bibliography

Abstract

Provides requirements for vascular device-drug combination products (VDDCPs) based upon current technical and medical knowledge.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 150
Supersedes	ISO/DIS 12417-1 : 60.00 (2015) ISO TS 12417 : 2011