GB/T 19972-2018

Abolished

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

医疗保健产品灭菌 生物指示物 选择、使用和结果判断指南

Standard Type
GBT
ICS
11.080.01
CCS
C47
Status
Abolished
Issue Date
2018-03-15
Implementation
2018-10-01
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 for selecting, using, and interpreting biological indicators to validate sterilization processes for healthcare products. It is applied in medical device manufacturing, hospital sterilization departments, and laboratory testing to ensure effective sterilization of items like surgical instruments and implants. The standard helps professionals determine whether sterilization parameters (e.g., time, temperature, chemical concentration) have been met by analyzing biological indicator results.

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.