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现行 BS EN IEC 60601-2-50:2021
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Medical electrical equipment-Particular requirements for the basic safety and essential performance of infant phototherapy equipment 医用电气设备
发布日期: 2021-08-13
IEC 60601的本部分适用于201.3.203中定义的婴儿光疗设备(也称为医用电气设备)的基本安全和基本性能。 如果某条款或子条款专门适用于医用电气设备,或 仅适用于ME系统,该条款或子条款的标题和内容将说明这一点。如果情况并非如此,则本条款或子条款适用于医用电气设备和医用电气系统(视情况而定)。 本文件中的具体要求不包括本文件范围内医用电气设备或医用电气系统预期生理功能所固有的危险,第7条除外。 通用标准的2.13和8.4.1。购买本文件时可获得的所有当前修订均包含在购买本文件中。
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT PHOTOTHERAPY EQUIPMENT, as defined in 201.3.203, also referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard.All current amendments available at time of purchase are included with the purchase of this document.
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发布单位或类别: 英国-英国标准学会
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