This standard has been reviewed* and then 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.
Edition: 2 (Monolingual) ICS: 11.100.20 Status: Published Stage: 90.93 (2013-07-09) TC/SC: ISO/TC 194 Number of Pages: 11
Revises: ISO 10993-16:1997