+AMD1:2023 CSV 医用电气设备第2-19部分：婴儿保育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 适用于本文档中定义的新生儿保育箱（也称为医疗设备）的基本安全和性能要求。如果条款或子条款专门适用于仅医疗设备或仅医疗系统，其标题和内容会明确指出。否则，该条款或子条款适用于相关的医疗设备和医疗系统。本文档范围以内的医疗设备或医疗系统固有的生理功能相关的危害不受本文档特定要求的覆盖，除非在通用标准的 7.2.13 和 8.4.1 中提及。本标准规定了新生儿保育箱的安全要求，但如果制造商已在风险管理文件中证明，在权衡治疗设备带来的益处后，特定危险带来的风险已处于可接受水平，则通过证明同等安全性来符合特定条款的替代方法将被视为合规。本标准不适用于：新生儿运输保育箱（见 IEC 60601-2-20）；新生儿辐射式暖箱（见 IEC 60601-2-21）；通过毯子、垫子或床垫供热的医疗设备（见 IEC 60601-2-35）；新生儿光疗设备（见 IEC 60601-2-50）。用于操作婴儿控制型保育箱（包括显示值）的皮肤温度传感器不被视为 ISO 80601-2-56 特定标准意义上的临床温度计。 [外文原描述]： IEC 60601-2-19:2020+AMD1:2023 CSV 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 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.