Back

ISO 10993-16:2010

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

General information
Withdrawn from 16.05.2017
Directives or regulations
None
Standard history
Status
Date
Type
Name
16.05.2017
Main
Main
ISO 10993-16:1997
ISO 10993-16:2010 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
*
*
*
PDF
64.44 € incl tax
Paper
64.44 € incl tax
Standard monitoring