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

Standard No.

ISO 10993-16:2010

Release Date

2010

Published By

International Organization for Standardization (ISO)

Status

Be replaced

Replace By

ISO 10993-16:2017

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 10993-16:2010 Referenced Document

• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
• ISO 10993-2 Biological evaluation of medical devices — Part 2: Animal welfare requirements*， 2022-11-03 Update
• ISO 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update

ISO 10993-16:2010 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