GB/T 18281.1-2024

Active

Sterilization of health care products—Biological indicators—Part 1: General requirements

医疗保健产品灭菌 生物指示物 第1部分:通则

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 general requirements for biological indicators used in sterilization processes for health care products, including their production, labeling, and performance testing. It is applied in hospitals, medical device manufacturers, and sterilization service facilities to validate and monitor the efficacy of sterilization methods such as steam, ethylene oxide, or radiation. The standard ensures consistent quality and reliability of biological indicators across different sterilization contexts.

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.