GB/T 16886.2-2026: Biological evaluation of medical devices - Part 2: Animal welfare requirements

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Scope

This document specifies the basic requirements for appropriate measures to ensure and
demonstrate animal welfare during animal tests conducted to evaluate the biocompatibility of
materials used in medical devices. It applies to personnel involved in commissioning, design,
implementation, or data evaluation of animal tests for the biocompatibility evaluation of
medical devices or materials intended for use in medical devices.
This document provides recommendations and guidance aimed at further reducing the total
number of animals used, optimizing test methods to alleviate or eliminate animal pain or
discomfort, and adopting scientifically valid alternatives that do not require animal testing.
This document applies to tests conducted on living non-human vertebrates to determine the
biocompatibility of materials or medical devices.
This document does not apply to tests conducted on invertebrates or other less differentiated
animals, nor to tests conducted on isolated tissues and organs from euthanized vertebrates
(except provisions for animal species, source, health status, care and husbandry).

Basic Data

Standard ID	GB/T 16886.2-2026 (GB/T16886.2-2026)
Description (Translated English)	Biological evaluation of medical devices - Part 2: Animal welfare requirements
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.100.20
Date of Issue	2026-01-28
Date of Implementation	2027-02-01
Older Standard (superseded by this standard)	GB/T 16886.2-2011