GB/T 19973.2-2018
AbolishedSterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition，validation and maintenance of a sterilization process
医疗器械的灭菌 微生物学方法 第2部分：用于灭菌过程的定义、确认和维护的无菌试验
Application Summary AI generated
GB/T 19973.2-2018 specifies microbiological test methods for sterility used during the definition, validation, and maintenance of sterilization processes for medical devices. It is applied in healthcare and medical device manufacturing to ensure that sterilization procedures, such as ethylene oxide or steam sterilization, consistently achieve the required sterility assurance level. The standard is used by quality control and regulatory professionals to conduct sterility tests on devices, process challenge devices, and biological indicators.
Related Standards
GB/Z 44877-2024
Sterilization of medical devices—Guidance on using parametric release for ethylene oxide sterilization process
GB/T 16931-1997
Medical and classificational standard of winter sports for disabled athletes
GB/T 16932.3-1997
Urine absorbing aids--Vocabulary--Part 3:Identification of product types
GB/T 16932.2-1997
Urine absorbing aids--Vocabulary--Part 2:Products
GB/T 16932.1-1997
Urine absorbing aids--Vocabulary--Part 1:Conditions of urinary incontinence
GB/T 26373-2010
Hygienic standard for alcohol disinfectants
GB/T 26371-2010
Hygienic standard for peroxide disinfectants
GB/T 26370-2010
Hygienic standard for disinfectants with bromine
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.