GB/T 16886.16-2021: Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

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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.
This Document applies to toxicokinetic studies of medical device degradation products and
leachables.

Basic Data

Standard ID	GB/T 16886.16-2021 (GB/T16886.16-2021)
Description (Translated English)	Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Word Count Estimation	18,150
Issuing agency(ies)	State Administration for Market Regulation, China National Standardization Administration