现行 YY 0601-2009
医用电气设备 呼吸气体监护仪的基本安全和主要性能专用要求 医用电气设备 呼吸气体监护仪的基本安全和主要性能专用要求 Medical electrical equipment Particular requirements for basic safety and essential performance of respiratory gas monitors
发布日期:2009-12-30
实施日期:2011-06-01
分类信息
研制信息

归口单位: 国家药监局

标准简介

除以下内容外,GB 9706.1-2007第1章适用。修改(在1.1的末尾增加):本标准规定了预期连续运行,并应用于患者的呼吸气体监护仪(RGM)(由3.15定义)的基本安全和主要性能的专用要求。本标准规定了下列要求:a)麻醉气体监测;b)二氧化碳监测;c)氧气监测。本标准不适用于预期与可燃性麻醉剂一起使用的呼吸气体监护仪。本标准的要求取代或修订GB 9706,1-2007的相关要求,并将优先于相应的通用要求。环境方面见附录CC

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最后更新时间 2025-08-31