GB/T 16886.2-2026

Upcoming

Biological evaluation of medical devices—Part 2: Animal welfare requirements

医疗器械生物学评价 第2部分:动物福利要求

Standard Type
GBT
ICS
11.100.20
CCS
C30
Status
Upcoming
Issue Date
2026-01-28
Implementation
2027-02-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、国家标准化管理委员会

Application Summary AI generated

This standard specifies the animal welfare requirements for conducting biological evaluation tests on medical devices, ensuring humane treatment and ethical use of animals in preclinical safety assessments. It applies to manufacturers, testing laboratories, and regulatory bodies involved in the biocompatibility testing of medical devices, particularly during in vivo studies for tissue or systemic responses. The standard is used in the healthcare and medical device industry to align testing protocols with international animal welfare principles.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.