CEN - EN ISO 10993-16
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
active, Most Current
| Organization: | CEN |
| Publication Date: | 1 December 2017 |
| Status: | active |
| Page Count: | 28 |
| 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
EN ISO 10993-16
December 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 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...
April 1, 2009
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
A description is not available for this item.
September 1, 1997
Biological Evaluation of Medical Devices - Part 16: Toxicokinetic Study Design for Degradation Products and Leachables
A description is not available for this item.