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.
| CSA Group | |
|---|---|
| Product Category | Standards and Technical Documents |
| Product Number | ISO 10993-16:2017 |
| Product Name | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables |
