ANSI/AAMI/ISO 7198:2016
Current
The latest, up-to-date edition.
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES
Hardcopy , PDF
English
02-08-2016
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 7198:2016
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 Preclinical in vivo evaluation test methods
for vascular prostheses
10 Clinical investigation methods for vascular
Prostheses
11 Manufacturing
12 Sterility
13 Packaging and labeling
Annex A (informative) - Test methods
Bibliography
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