DS DS/EN ISO 10993-16 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
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DS DS/EN ISO 10993-16 Document Information:
Title
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Biologisk vurdering af medicinsk udstyr. Del 16: Toksikokinetisk undersøgelse for nedbrydnings- og udvaskningsprodukter
Dansk Standard
Publication Date:
Sep 30, 1997
Scope:
This part of the standard 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.
Keywords:
- MEDICAL EQUIPMENT
- MEDICAL DEVICES
- MATERIALS
- TOXICITY
- TESTS
- BIOLOGICAL TESTS
- DETERMINATION
- TOXICOKINETICS
- GENERAL CONDITIONS
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