被代替 YY 0679-2008
医用低温蒸汽甲醛灭菌器 医用低温蒸汽甲醛灭菌器 Sterilizers for medical purposes-Low temperature steam and formaldhyde sterilizers
发布日期:2008-10-17
实施日期:2010-06-01
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

起草单位: 洁定医疗器械(苏州)有限公司、 张家港市华菱医疗设备制造有限公司、 洁定贸易(上海)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、 江苏省卫生监督所

起草人: 徐伟雄、 周云峰、 张洁、 胡昌明、 王其鳌、 顾健、 黄秀莲

标准简介

本标准规定了医用低温蒸汽甲醛灭菌器(以下简称灭菌器)的术语和定义、型式与标记、要求、试验方法、检验规则、标志和使用说明书、包装、运输、贮存。本标准规定的灭菌器主要利用低温蒸汽甲醛混合气体对热敏医疗物品进行灭菌。本标准未涉及低温蒸汽甲醛灭菌过程的有效性确认和日常质量控制要求,但本标准中的测试方法和设备可参考用于灭菌器的验证和日常控制。本标准未规定涉及使用风险范围的安全要求

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最后更新时间 2025-08-31