SNV - SN EN ISO 10993-16
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
active, Most Current
| Organization: | SNV |
| Publication Date: | 1 June 2010 |
| Status: | active |
| Page Count: | 24 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
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.
Document History
SN EN ISO 10993-16
June 1, 2010
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
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...
August 1, 2009
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
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