Standard No.:	YY 0970-2013
English Name:	Sterilization of single-use medical devices incorporating materials of animal origin―Validation and routine control of sterilization by liquid sterilants
Chinese Name:	含动物源材料的一次性使用医疗器械的灭菌液体灭菌剂灭菌的确认与常规控制
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	YY    Professional Standard - Pharmaceutics
Source Content Issued by:	China Food and Drug Administration
Issued on:	2013-10-21
Implemented on:	2014-10-1
Status:	to be superseded
Superseded by:	YY 0970-2023 Sterilization of health care products--Liquid chemical sterilizing agents forsingle-use medical devices utilizing animal tissues and their derivatives-Requirements for haracterization ,development,validation and routinecontrol of a sterilization process for medical device
Superseded on:	2026-5-1
Target Language:	English
File Format:	PDF
Word Count:	10500 words
Translation Price(USD):	310.0
Delivery:	via email in 1~5 business day

本标准规定了使用液体化学灭菌剂对全部或部分含有动物源性材料的一次性使用医疗器械灭菌的开发、确认、过程控制和监视的要求。
本标准不适用于人体来源的材料。
本标准不涉及用于控制整个生产阶段的质量保证体系、病毒灭活确认的方法。
本标准不包括医疗器械中灭菌剂残留量的水平。