现行 YY 0784-2010
医用电气设备 医用脉搏血氧仪设备基本安全和主要性能专用要求 医用电气设备 医用脉搏血氧仪设备基本安全和主要性能专用要求 Medical electrical equipment.Particular requirements for the basic safety and essential performance of pulse oximeter equipement for medical use
发布日期:2010-12-27
实施日期:2012-06-01
分类信息
研制信息

归口单位: 全国医用电器标准化技术委员会

起草单位: 深圳迈瑞生物医疗电子股份有限公司、 广东宝莱特医用科技股份有限公司

起草人: 张旭、 李天宝

标准简介

引用GB 9706.1-2007的第1章,不包括以下内容。修改(增加在1.1末尾处)本标准详细描述了适用于人体使用的脉搏血氧仪设备的基本安全和主要性能的专用要求,该设备包括在正常使用中的任何必要的部件,如脉搏血氧监护仪、脉搏血氧探头、探头电缆延长线等。这些要求也适用于经再加工的脉搏血氧仪设备,包括脉搏血氧监护仪,血氧探头和探头电缆延长线等。脉搏血氧仪设备的应用范围包括,而不仅限于,在医疗保健机构和家庭中估计患者的动脉血氧饱和度和脉率。本标准不适用于实验室研究使用的脉搏血氧仪设备,也不适

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