GB/T 16886.2-2011 in English

《GB/T 16886.2-2011医疗器械生物学评价 第2部分：动物福利要求》由TC248（全国医疗器械生物学评价标准化技术委员会）归口，主管部门为国家药品监督管理局。

Scope

This part of GB/T 16886 applies to the process of entrusting, designing and conducting tests or evaluating animal test data to evaluate the biocompatibility of materials or devices used in medical devices. This section specifies the most basic requirements to ensure the welfare of animals used in animal tests for the evaluation of biocompatibility of medical device materials through the corresponding regulations, and form a document. This section also gives suggestions and guidelines to further reduce the overall number of animals, optimize test methods to reduce or eliminate animal pain or suffering, and use other scientifically valid methods that do not require animal testing to replace animal testing. This section applies to tests on live vertebrates other than humans, which are used to determine the biocompatibility of materials or medical devices. This section does not apply to tests conducted on invertebrates and other animals with a lower degree of differentiation, nor does it apply to tests conducted on isolated tissues and organs of vertebrates that have been humanely sacrificed (except for animal species, sources , health status, feeding and management regulations).