GB/T 16886.1-2022: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

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Scope

This document specifies.
- the general principles governing the biological evaluation of medical devices
within a risk management process;
- the general categorization of medical devices based on the nature and duration of
their contact with the body;
- the evaluation of existing relevant data from all sources.
Other parts of GB/T 16886 cover specific aspects of biological assessments and related
tests. Device-specific or product standards address mechanical testing.

Basic Data

Standard ID	GB/T 16886.1-2022 (GB/T16886.1-2022)
Description (Translated English)	Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Word Count Estimation	39,375
Issuing agency(ies)	State Administration for Market Regulation, China National Standardization Administration