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
Describes requirements for the evaluation of vascular prostheses and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge.
| Committee |
SC 2
|
| DevelopmentNote |
Supersedes AAMI VP20 (07/2002)
|
| DocumentType |
Standard
|
| ISBN |
1-57020-625-2
|
| Pages |
65
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 7198:2016 | Identical |
| 15/30290736 DC : 0 | BS EN ISO 10993-4 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD |
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