GB/T 18281.5-2024

Active

Sterilization of health care products—Biological indicators—Part 5:Biological indicators for low-temperature steam and formaldehyde sterilization processes

医疗保健产品灭菌 生物指示物 第5部分:低温蒸汽甲醛灭菌用生物指示物

Standard Type
GBT
ICS
11.080.01
CCS
C47
Status
Active
Issue Date
2024-11-28
Implementation
2025-12-01
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 the requirements for biological indicators used to validate and monitor low-temperature steam and formaldehyde sterilization processes for health care products. It is applied in hospitals, medical device manufacturing, and sterilization service facilities to ensure the effectiveness of sterilization cycles for heat-sensitive medical equipment. The standard defines test organisms, performance criteria, and testing methods specific to formaldehyde-based low-temperature sterilization systems.

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.