RO
SR EN ISO 10993-16:2018
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
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.
Status :
Valid
Approval date : 5/31/2018
Number of pages : 29
ICS : 11.100.20 Biological evaluation of medical devices
Technical Committee : 377 - Medical devices
- Replaces SR EN ISO 10993-16:2010