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

Standard No.

ISO 10993-16:1997

Release Date

1997

Published By

International Organization for Standardization (ISO)

Status

Withdraw

Replace By

ISO 10993-16:2010

Latest

ISO 10993-16:2017

Scope

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.

ISO 10993-16:1997 history

• 2017 ISO 10993-16:2017 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
• 2010 ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
• 1997 ISO 10993-16:1997 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables