GB/T 19973.2-2005

Abolished

Sterilization of medical devices -- Microbiological methods -- Part 2: Test of sterility performed in the validation of a sterilization process

医用器材的灭菌 微生物学方法 第二部分:确认灭菌过程的无菌试验

Standard Type
GBT
ICS
11.100
CCS
C30
Status
Abolished
Issue Date
2005-11-04
Implementation
2006-04-01
Centralized Committee
国家药监局
Issuing Authority
中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies the microbiological methods for conducting sterility tests during the validation of sterilization processes for medical devices. It is applied in healthcare manufacturing and quality control settings to confirm that sterilization procedures, such as ethylene oxide or steam sterilization, effectively eliminate microbial contamination. The standard ensures that devices meet safety requirements before clinical use.

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.