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ISO 10993-16:2010
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables
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Abstract
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.
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Edition: 2 (Monolingual) ICS: 11.100.20 Status: Published Stage: 60.60 (2010-02-09) TC/SC: ISO/TC 194 Number of Pages: 11 -
Revises: ISO 10993-16:1997
