ISO 10993-16:2017
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
OVERVIEW
ISO 10993-16:2017 provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
COMMENTS
-
PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2017 |
| No. of Pages | 13 |
| ICS Classification | 11.100.20 Biological evaluation of medical devices |
| Committee | ISO/TC 194 |
| Available for Purchase | For sale in Singapore only |
| Adoption | ISO |