GB/T 16886.2-2011
Biological evaluation of medical devices.Part 2: Animal welfare requirements (English Version)

Standard No.

GB/T 16886.2-2011

Language

Chinese, Available in English version

Release Date

2011

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Latest

GB/T 16886.2-2011

Replace

GB/T 16886.2-2000

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).

GB/T 16886.2-2011 Referenced Document

• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update

GB/T 16886.2-2011 history

• 2011 GB/T 16886.2-2011 Biological evaluation of medical devices.Part 2: Animal welfare requirements
• 2000 GB/T 16886.2-2000 Biological evaluation of medical devices--Part 2: Animal welfare requirements

GB/T 16886.2-2011 -All Parts