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ISO 10993-16

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

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Organization: ISO
Publication Date: 1 May 2017
Status: active
Page Count: 20
ICS Code (Biological evaluation of medical devices): 11.100.20
scope:

This document 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

Document History

ISO 10993-16
May 1, 2017
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the...
February 15, 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...
September 1, 1997
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...

References

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