GB/T 19973.1-2015

Abolished

Sterilization of medical devices—Microbiological methods—Part 1: Determination of a population of microorganisms on products

医疗器械的灭菌 微生物学方法 第1部分:产品上微生物总数的测定

Standard Type
GBT
ICS
11.080.01
CCS
C47
Status
Abolished
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 specifies the methods for determining the number of viable microorganisms on medical devices, including sampling techniques and enumeration procedures. It is applied in the healthcare industry during the sterilization validation and routine quality control of medical devices, such as surgical instruments and implants, to ensure they meet required bioburden limits before sterilization.

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.