GB 18281.3-2000

Abolished

Sterilization of health care products--Biological indicators--Part 3:Biological indicators for moist heat sterilization

医疗保健产品灭菌 生物指示物 第3部分:湿热灭菌用生物指示物

Standard Type
GB
ICS
11.080
CCS
C47
Status
Abolished
Issue Date
2000-12-18
Implementation
2001-05-01
Centralized Committee
国家药监局
Issuing Authority
国家药监局

Application Summary AI generated

This standard specifies the requirements for biological indicators used to validate and monitor moist heat sterilization processes, such as autoclaving, in healthcare settings. It is applied in hospitals, pharmaceutical manufacturing, and medical device production to ensure that sterilization cycles effectively eliminate resistant microorganisms like Geobacillus stearothermophilus spores. The standard defines performance criteria, testing methods, and labeling for these indicators to confirm sterility assurance in products like surgical instruments and implantable devices.

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.