+AMD1:2023 CSV 医用电气设备第2-50部分：婴儿光疗设备基本安全和基本性能的特殊要求

[中文适用范围]： 本IEC 60601标准的第2-50部分适用于由201.3.203定义的新生儿光疗设备（也称为医用电气设备）的基本安全和基本性能。如果条款或子条款明确仅适用于医用电气设备或仅适用于医用系统，则其标题和内容将予以说明。否则，该条款或子条款适用于相关的医用设备和医用系统。本文档范围内的医用设备或医用系统固有的预期生理功能危险不受本文档具体要求的覆盖，除非在通用标准7.2.13和8.4.1中另有规定。本特别标准规定了新生儿光疗设备的安全要求，但制造商如果在风险管理文件中证明设备产生的危险风险在权衡治疗收益后处于可接受水平，则通过证明等效安全来符合特定条款的替代方法不被视为不合规。本文档不适用于：通过毯子、垫子或床垫提供热量的医疗用设备；新生儿培养箱；新生儿转运培养箱；新生儿辐射加热器。 [外文原描述]： IEC 60601-2-50:2020+AMD1:2023 CSV 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. IEC 60601-2-50:2020 specifies safety requirements for INFANT PHOTOTHERAPY EQUIPMENT, but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non-compliant if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device. IEC 60601-2-50:2020 does not apply to: - devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35; - INFANT INCUBATORS; for information, see IEC 60601-2-19; - INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20; - INFANT RADIANT WARMERS; for information, see IEC 60601-2-21. IEC 60601-2-50:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-50:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.