GB 18278.1-2015
ActiveSterilization of health care products—Moist heat—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
医疗保健产品灭菌 湿热 第1部分：医疗器械灭菌过程的开发、确认和常规控制要求
Application Summary AI generated
This standard specifies the requirements for developing, validating, and routinely controlling moist heat sterilization processes for medical devices. It is applied by medical device manufacturers and healthcare facilities to ensure the consistent sterility of reusable or terminally sterilized products, such as surgical instruments and implantable devices, using steam sterilization methods. The standard covers process design, performance qualification, and ongoing monitoring to meet safety and efficacy benchmarks.
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.