NEN-EN-ISO 10993-16
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
inactive
| Organization: | NEN |
| Publication Date: | 1 September 1997 |
| Status: | inactive |
| Page Count: | 22 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
Gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Circumstances when toxicokinetic studies should be considered are given in annex A.
Document History
January 1, 2018
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
NEN-EN-ISO 10993-16 provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in...
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...
May 1, 2009
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
This part of IS0 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...
August 1, 2008
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...
NEN-EN-ISO 10993-16
September 1, 1997
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Circumstances when toxicokinetic studies should be considered are given in annex A.
January 1, 1996
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Circumstances when toxicokinetic studies should be considered are given in annex A.