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ISO 10993-16:2017

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

Standard Details

ISO 10993-16:2017 provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

General Information

Status : Published
Standard Type: Main
Document No: ISO 10993-16:2017
Document Year: 2017
Pages: 13
Edition: 3
  • Section Volume:
  • ISO/TC 194. Biological evaluation of medical devices
  • ICS:
  • 11.100.20 Biological evaluation of medical devices

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ISO 10993-16:2017
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