Standard No.:	YY/T 1464-2022
English Name:	Sterilization of health care products-Low temperature steam and formaldehyde-Requirements for development,validation and routine control of a sterilization process for medical devices
Chinese Name:	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
Chinese Classification:	C47    Public medical equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2022-10-17
Implemented on:	2023-10-1
Status:	valid
Superseding:	YY/T 1464-2016 Sterilization of medical devices—Requirements for the development,validation and routine control of a low temperature steam and formaldehyde sterilization process for medical devices
Target Language:	English
File Format:	PDF
Word Count:	18500 words
Translation Price(USD):	555.0
Delivery:	via email in 1~5 business day

本文件规定了医疗器械低温蒸汽甲醛灭菌过程的开发、确认和常规控制的要求。
本文件适用于在负压条件下使用混合低温蒸汽甲醛作为灭菌因子的灭菌过程。
本文件不适用于对海绵状脑病(如羊痒症、牛海绵状脑病和克雅症)病原体灭活过程的开发、确认和常规控制的要求。