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ISO 10993-16:2017
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachablesMore info
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.
| Author | ISO/TC 194 Biological and clinical evaluation of medical devices |
|---|---|
| Editor | ISO |
| Document type | Standard |
| Format | Paper |
| Edition | 3 |
| ICS | 11.100.20 : Biological evaluation of medical devices |
| Number of pages | 13 |
| Replace | ISO 10993-16:2010 |
| Weight(kg.) | 0.1221 |
| Year | 2017 |
| Country | Switzerland |