AAMI - 10993-16
Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables
active, Most Current
| Organization: | AAMI |
| Publication Date: | 1 January 2020 |
| 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
10993-16
January 1, 2020
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, 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
A description is not available for this item.
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...