Standard No.:	YY/T 1464-2016
English Name:	Sterilization of medical devices—Requirements for the development,validation and routine control of a low temperature steam and formaldehyde sterilization process for medical devices
Chinese Name:	医疗器械灭菌低温蒸汽甲醛灭菌过程的开发、确认和常规控制要求
Chinese Classification:	C47    Public medical equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.080.01 11.080.01    Sterilization and disinfection in general 11.080.01
Source Content Issued by:	China Food and Drug Adminstration
Issued on:	2016-01-26
Implemented on:	2017-1-1
Status:	superseded
Superseded by:	YY/T 1464-2022 Sterilization of health care products-Low temperature steam and formaldehyde-Requirements for development,validation and routine control of a sterilization process for medical devices
Superseded on:	2023-10-1
Target Language:	English
File Format:	PDF
Word Count:	16500 words
Translation Price(USD):	534.0
Delivery:	via email in 1~5 business day

本标准规定了医疗器械灭菌低温蒸汽甲醛灭菌过程的开发、确认和常规控制的要求。
本标准适用于过程开发者、灭菌设备制造商、被灭菌的医疗器械制造商和负责医疗器械灭菌的单位进行医疗器械的灭菌。
本标准也适用于使用混合低温蒸汽甲醛作为灭菌剂、仅在低于环境压力工作的灭菌过程。