Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables
This standard was last reviewed and confirmed* in 2013.
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.
Document published on: 2010-02 Edition: 2 (Monolingual) ICS: 11.100.20 Status: Published Stage: 90.93 (2013-07-09) TC/SC: ISO/TC 194 Number of Pages: 11
Revised by: ISO/FDIS 10993-16
Revises: ISO 10993-16:1997
No corrigenda or amendments available