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AAMI 10993-16

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

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Organization: AAMI
Publication Date: 1 January 2017
Status: active
Page Count: 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

AAMI 10993-16
January 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...
January 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...
January 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...
January 1, 1997
Biological evaluation of medical devices-Part 16: Toxicokinetic study design for degradation products and leachables from medical devices
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...
January 1, 1997
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES FROM MEDICAL DEVICES
A description is not available for this item.

References

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