NEN-EN-ISO 7198
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
| Organization: | NEN |
| Publication Date: | 1 March 2017 |
| Status: | active |
| Page Count: | 73 |
| ICS Code (Implants for surgery, prosthetics and orthotics): | 11.040.40 |
scope:
NEN-EN-ISO 7198 specifies 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. Guidance for the development of in vitro test methods is included in an informative annex to this International Standard. This International Standard can be considered as a supplement to ISO 14630:2012, which specifies general requirements for the performance of non-active surgical implants.
Document History