GB/T 32310-2015

Active

Sterilization of health care products—Chemical indicators—Guidance for selection,use and interpretion of results

医疗保健产品灭菌 化学指示物 选择、使用和结果判断指南

Standard Type
GBT
ICS
11.080.99
CCS
C47
Status
Active
Issue Date
2015-12-10
Implementation
2016-09-01
Centralized Committee
国家药监局
Issuing Authority
中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

Application Summary AI generated

This standard provides guidance on selecting, using, and interpreting chemical indicators for sterilization processes in healthcare settings. It is applied by hospitals, medical device manufacturers, and sterilization service providers to verify that sterilization conditions (e.g., steam, ethylene oxide) have been met for wrapped or packaged health care products. The standard ensures consistent and reliable monitoring of sterilization cycles to maintain patient safety and regulatory compliance.

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.