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

Scope

This document specifies the basic requirements for taking appropriate measures to ensure and demonstrate animal welfare in animal experiments used to evaluate the biocompatibility of materials used in medical devices. This document applies to personnel who commission, design, implement, or evaluate data from animal experiments for the biocompatibility assessment of medical devices or materials intended for use in medical devices. This document provides recommendations and guidance aimed at further reducing the overall number of animals used in the future, optimizing experimental methods to alleviate or eliminate animal pain or discomfort, and adopting other scientifically valid methods that do not require animal experiments as alternatives to animal testing. This document applies to experiments conducted on living vertebrate animals other than humans to determine the biocompatibility of materials or medical devices. This document does not apply to experiments conducted on invertebrates and other less differentiated animals, nor to experiments conducted on tissues and organs isolated from euthanized vertebrate animals (except for aspects related to animal species, sources, health status, and care and feeding regulations).

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