GB/T 40365-2021

Active

General guide for cell sterility testing

细胞无菌检测通则

Standard Type
GBT
ICS
07.080
CCS
A40
Status
Active
Issue Date
2021-08-20
Implementation
2022-03-01
Centralized Committee
国家标准委
Issuing Authority
国家市场监督管理总局、中国国家标准化管理委员会

Application Summary AI generated

This standard provides a general framework for sterility testing of cells used in biomedical research and manufacturing. It is applied in laboratories and production facilities handling cell-based products, such as cell therapies, tissue engineering, and vaccine development, to ensure that cell samples are free from microbial contamination. The guide specifies testing methods, sampling procedures, and result interpretation to maintain quality control and safety in cell-related applications.

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.