医疗电气设备 - 第2-19部分:婴儿培养箱基本安全和基本性能的特殊要求

[中文适用范围]： IEC 60601-2-19 规定了婴儿 incubators（定义为 201.3.209）的基本安全和关键性能，也称为医用电气设备。本标准适用于婴儿 incubators，但不适用于：婴儿运输 incubator；婴儿辐射加热器；通过毯子、垫子或床垫提供热量的设备；婴儿光疗设备。如果制造商在其风险管理文件中证明，与设备治疗带来的益处相比，由危害带来的风险已达到可接受水平，则通过替代方法符合特定条款的要求不会被判定为不符合。 [外文原描述]： IEC 60601-2-19:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT INCUBATORS, as defined in 201.3.209, 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 60601-2-19:2020 specifies safety requirements for INFANT 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. IEC 60601-2-19:2020 does not apply to: - INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20; - INFANT RADIANT WARMERS; for information, see IEC 60601-2-21; - devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35; - INFANT PHOTOTHERAPY EQUIPMENT; for information see IEC 60601-2-50. SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED INCUBATOR including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense of the particular standard ISO 80601-2-56. IEC 60601-2-19:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-19:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.