GB/T 18281.8-2024

Upcoming

Sterilization of health care products—Biological indicators—Part 8:Method for validation of a reduced incubation time for a biological indicator

医疗保健产品灭菌 生物指示物 第8部分:缩短生物指示物培养时间的确认方法

Standard Type
GBT
ICS
11.080.01
CCS
C47
Status
Upcoming
Issue Date
2024-11-28
Implementation
2026-06-01
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 method for validating a reduced incubation time for biological indicators used in sterilization processes. It is applied in healthcare settings and medical device manufacturing to confirm that shorter incubation periods still reliably detect microbial growth, ensuring sterilization efficacy while accelerating release of sterilized products.

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.