现行 YY/T 1276-2016
医疗器械干热灭菌过程的开发、确认和常规控制要求 医疗器械干热灭菌过程的开发、确认和常规控制要求 Requirements for the development,validation and routine control of dry heat sterilization process for medical devices
发布日期:2016-03-23
实施日期:2017-01-01
分类信息
研制信息

归口单位: 全国消毒技术与设备标准化技术委员会(SAC/TC 200)

起草单位: 山东新华医疗器械股份有限公司、 国家食品药品监督管理局广州医疗器械质量监督检验中心

起草人: 刘永保、 邱纬宇、 王洪敏、 胡昌明、 朱晓明

标准简介

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

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