ANSI/AAMI/ISO 10993-16:2020/(R)2022

ANSI/AAMI/ISO 10993-16:2020/(R)2022

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

Verfügbarkeit: Auf Lager

153,00 €

Details

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. This third edition cancels and replaces the second edition (ISO 10993-16:2010), which has been technically revised. Annex 3

Zusätzliche Information

Autor Association for the Advancement of Medical Instrumentation (AAMI)
Veröffentlicht von AAMI
Document type Normen
Thema Biological Evaluation
Datum der Bestätigung 2022-01-01
Seitenzahl 20
Ersetzt ANSI/AAMI/ISO 10993-16:2017
Schlagwort ANSI/AAMI/ISO 10993-16:2020/(R)2022