Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

09-10-2023

Publisher

Association for the Advancement of Medical Instrumentation

This document provides principles on designing and performing toxicokinetic studies relevant to medical devices.

Committee	ISO/TC 194
DocumentType	Standard
ISBN	978-1-57020-778-5
Pages	20
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Current
Supersedes	ANSI/AAMI/ISO 10993-16:2017

Standards	Relationship
ISO 10993-16:2017	Identical

ISO/TR 10993-22:2017	Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
ISO 14971:2019	Medical devices Application of risk management to medical devices
ISO 10993-18:2020	Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials within a risk management process