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Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables


Document Number: ISO 10993-16:2010
File Size: 213 kB
Language: English
Provider: ANSI
Shipping: Available for download - Link will be provided in My ComplianceOnline section

Price: $85.00
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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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