GB 18281.1-2015

Abolished

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
GB
ICS
11.080.01
CCS
C47
Status
Abolished
Issue Date
2015-12-10
Implementation
2017-01-01
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 specifies general requirements for biological indicators used to monitor sterilization processes for health care products. It is applied by medical device manufacturers and healthcare facilities to validate and routine-monitor sterilization methods such as steam, ethylene oxide, and radiation. The standard ensures consistent performance and quality of biological indicators across testing and production environments.

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.