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

Standard No.

EN ISO 10993-16:2017

Release Date

2017

Published By

CEN - European Committee for Standardization

Latest

EN ISO 10993-16:2017

Scope

This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

EN ISO 10993-16:2017 history

• 2017 EN ISO 10993-16:2017 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
• 2010 EN ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
• 2009 EN ISO 10993-16:2009 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
• 1997 EN ISO 10993-16:1997 Biological Evaluation of Medical Devices - Part 16: Toxicokinetic Study Design for Degradation Products and Leachables ISO 10993-16: 1997