Standard No.:	YY/T 1276-2016
English Name:	Requirements for the development,validation and routine control of dry heat sterilization process for medical devices
Chinese Name:	医疗器械干热灭菌过程的开发、确认和常规控制要求
Chinese Classification:	C47    Public medical equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.30 11.040.30    Surgical instruments and materials 11.040.30
Issued by:	China Food and Drug Adminstration
Issued on:	2016-03-23
Implemented on:	2017-1-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	21000 words
Price(USD):	630.00
Delivery:	via email in 1~5 business day

本标准适用于采取干热方式对医疗器械进行灭菌和去热原的过程。
本标准规定了医疗器械在干热灭菌过程中的开发、确认和常规控制要求。
本标准不适用于红外线或微波灭菌。