DIN EN ISO 7198 E : 2017
Current
The latest, up-to-date edition.
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016)
Hardcopy , PDF
English
01-01-2017
National foreword
National Annex NA (informative) - Bibliography
European foreword
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU Directive
93/42/EEC [OJ L 169] on medical devices
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 labelling
Annex A (informative) - Test methods
Bibliography
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