+AMD1:2023 CSV 医用电气设备第2-20部分：婴儿运输保温箱基本安全和基本性能的特殊要求

[中文适用范围]： 本部分IEC 60601适用于婴儿运输培养箱设备的基本安全和基本性能，如201.3.208所定义，也称为ME设备。如果某条款或子条款仅适用于ME设备或仅适用于ME系统，则该条款或子条款的标题和内容将说明这一点。如果不是这种情况，则该条款或子条款适用于ME设备和ME系统，视情况而定。本文档范围内的ME设备或ME系统的预期生理功能固有的危险不在本文档的具体要求范围内，除了通用标准中的7.2.13和8.4.1。本特定标准规定了婴儿运输培养箱的安全要求，但如果制造商在其风险管理文件中证明，通过证明等效安全性来替代特定条款的合规性方法不会被视为不合规，当权衡设备治疗的利益时，该危险所带来的风险已被发现处于可接受水平。本特定标准不适用于：通过毯子、垫子或床垫提供热量的医疗设备；非婴儿运输培养箱的婴儿培养箱；婴儿辐射加热器；婴儿光疗设备。 [外文原描述]： IEC 60601-2-20:2020+AMD1:2023 CSV applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT TRANSPORT INCUBATOR equipment, as defined in 201.3.208, 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 60601-2-20:2020 specifies safety requirements for INFANT TRANSPORT INCUBATORS, 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. This particular standard does not apply to: - devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35; - INFANT INCUBATORS which are not INFANT TRANSPORT INCUBATOR; for information see IEC 60601-2-19; - INFANT RADIANT WARMERS; for information, see IEC 60601-2-21; - INFANT PHOTOTHERAPY; for information, see IEC 60601-2-50. IEC 60601-2-20:2020 constitutes a technical revision. IEC 60601-2-20:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.