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

Standard No.

ISO 10993-16:2017

Release Date

2017

Published By

International Organization for Standardization (ISO)

Latest

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.

ISO 10993-16:2017 Referenced Document

• ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
• ISO 10993-17:2002 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
• ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
• ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements
• ISO 14971:2007 Medical devices - Application of risk management to medical devices

ISO 10993-16:2017 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