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AAMI/ISO 7198:2016
Cardiovascular implants and extracorporeal systems - Vascular Prostheses - Tubular vascular grafts and vascular patchesMore info
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 standard. This standard should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
| Author | ANSI/AAMI/ISO |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2016-08-02 |
| ICS | 11.040.40 : Implants for surgery, prosthetics and orthotics |
| Replace | ANSI/AAMI/ISO 7198 (2001) |
| Cross references | ISO 7198 (2016-08), IDT |
| Year | 2016 |
| Document history | ANSI/AAMI/ISO 7198 (2016) |
| Country | USA |
| Keyword | ANSI 7198;7198;ANSI/AAMI/ISO 7198, Ed. 4-2016 |