ISO 10993-16:2010 PDF
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
Title (English):
ISO 10993-16:2010
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
- Document status:
- Withdrawn
- Format:
- Electronic (PDF)
- Number of pages:
- 11
- Publication date:
- February 9, 2010
- Edition:
- ISO IS 10993 edition 2 version 1
- ICS:
- 11.100.20
Description (English):
ISO 10993-16:2010 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
Technical details
- Technical committee
- ISO/TC 194 - Biological and clinical evaluation of medical devices
- SKU
- ISO 10993-16:2010
