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

Standard No.

ANSI/AAMI/ISO 10993-16:2017

Release Date

2020

Published By

US-AAMI

Latest

ANSI/AAMI/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.

ANSI/AAMI/ISO 10993-16:2017 history

• 2020 ANSI/AAMI/ISO 10993-16:2017 Biological evaluation of medical devices-Part 16: Toxicokinetic study design for degradation products and leachables
• 1997 ANSI/AAMI/ISO 10993-16:1997 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables