GB/T 18281.7-2024

Active

Sterilization of health care products—Biological indicators—Part 7:Guidance for the selection, use and interpretation of results

医疗保健产品灭菌 生物指示物 第7部分:选择、使用和结果判断指南

Standard Type
GBT
ICS
11.080.01
CCS
C47
Status
Active
Issue Date
2024-09-29
Implementation
2025-10-01
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 provides comprehensive guidance on selecting appropriate biological indicators, using them correctly in sterilization processes, and interpreting the results to validate sterilization efficacy. It is applied in healthcare settings, medical device manufacturing, and pharmaceutical industries where sterilization of health care products is critical for patient safety. The standard ensures consistent and reliable validation of sterilization methods such as steam, ethylene oxide, and radiation.

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.