SR EN ISO 10993-16:2003

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)

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 studies in the biological evaluation of medical devices.

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General information

Status : Withdrawn
Approval date : 9/17/2003
Publish date : 9/18/2003
Withdrawal date : 2/28/2010
Number of pages : 20
ICS : 11.100.20 Biological evaluation of medical devices
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaced by SR EN ISO 10993-16:2009