GB/T 16886.23-2023

Active

Biological evaluation of medical devices—Part 23: Tests for irritation

医疗器械生物学评价 第23部分:刺激试验

Standard Type
GBT
ICS
11.100.20
CCS
C30
Status
Active
Issue Date
2023-11-27
Implementation
2024-12-01
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 test methods for evaluating the potential of medical devices to cause irritation to skin, mucous membranes, or other tissues. It is applied in the biological safety assessment of medical devices, including surgical instruments, implants, and wound dressings, to ensure they do not produce harmful local reactions during clinical use. The standard is used by manufacturers and testing laboratories for preclinical evaluation and regulatory compliance in China.

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.