Standard Number: YY/T 1464-2022(YY/T1464-2022)
Chinese:医疗保健产品灭菌 低温蒸汽甲醛 医疗器械灭菌过程的开发、确认和常规控制要求
English:Sterilization of health care products-Low temperature steam and formaldehyde-Requirements for development, validation and routine control of a sterilization process for medical devices
Effective Date:2023-10-01
ICS:11.080.01
Standard Applicability:This document specifies requirements for the development, validation and routine control of cryogenic steam formaldehyde sterilization processes for medical devices. This document applies to sterilization processes that use mixed cryogenic steam formaldehyde as a sterilizing factor under negative pressure. This document does not apply to the requirements for the development, validation and routine control of processes for the inactivation of pathogens of spongiform encephalopathies (e.g., sheep itch, bovine spongiform encephalopathy, and Creutzfeldt-Jakob disease).
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