This part of ISO 10993 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.
BS EN ISO 10993-16:2010 Referenced Document
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*, 2018-08-01 Update
ISO 10993-2 Biological evaluation of medical devices — Part 2: Animal welfare requirements*, 2022-11-03 Update
ISO 14971 Medical devices - Application of risk management to medical devices*, 2019-12-01 Update
BS EN ISO 10993-16:2010 history
0000 BS EN ISO 10993-16:2017(2020)
2020BS EN ISO 10993-16:2017 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
2010BS EN ISO 10993-16:2010 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
0000 BS EN ISO 10993-16:2009
1997BS EN ISO 10993-16:1997 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables