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

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Scope

This part of GB/T 16886 is applicable to commissioning, designing and conducting tests or evaluating animal test data for materials used in medical devices or
The process of evaluating the biocompatibility of the device. This section sets out the most basic requirements to ensure evaluation through the corresponding regulations
Medical Device Materials Biocompatibility Animals are used for animal welfare and documented.
This section also provides recommendations and guidelines to further reduce the overall number of animals and optimize test methods to reduce or eliminate animals.
Pain or pain, as well as other scientifically effective methods that do not require animal testing to replace animal testing.
This section applies to live vertebrate tests other than humans, which are used to determine the biocompatibility of materials or medical devices.
This section does not apply to tests performed on invertebrates and other less differentiated animals, nor does it apply to implementation.
Tests performed on human tissues and organs isolated from human vertebrate (except animal species, source, health status, feeding and management regulations)
Fixed aspects).

Basic Data

Standard ID	GB/T 16886.2-2011 (GB/T16886.2-2011)
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	11.040.01
Word Count Estimation	15,127
Date of Issue	2011-12-30
Date of Implementation	2012-05-01
Older Standard (superseded by this standard)	GB/T 16886.2-2000
Quoted Standard	ISO 10993-1
Adopted Standard	ISO 10993-2-2006, IDT
Regulation (derived from)	Announcement of Newly Approved National Standards No. 22 of 2011
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary	This standard applies to commissioned to design and conduct animal testing or evaluation of test data to the materials used for medical devices or device biocompatibility evaluation process. This section provides a basic requirement to pass the corresponding provisions laid down to ensure the evaluation of biocompatibility of medical devices used in the test animals, animal welfare, and documented. This section also gives advice and guidance in order to facilitate further reduce the overall number of animals to optimize test methods to reduce or eliminate pain or suffering of animals, and the use of other unwanted animal testing scientifically valid alternatives to animal testing. This section applies in humans in vivo testing on vertebrate animals outside the class test is used to determine the biocompatibility of materials, or medical devices. This section does not apply to invertebrates and other low degree of differentiation tests carried out on animals, nor does it apply killed humanely in the implementation of vertebrate tissues and organs on separate tests conducted (in addition to animal species, source, state of health, feeding and management provisions).