Historical
BS EN ISO 10993-16:2010
Biological evaluation of medical devices. Toxicokinetic study design for degradation products and leachables (British Standard)
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.
British Standards Institution [bsi]