+AMD1:2023 CSV 医用电气设备 第 2-21 部分：婴儿辐射取暖器基本安全和基本性能的特殊要求

[中文适用范围]： 本文件适用于IEC 60601标准中定义的婴儿辐射保暖器（也称为医疗电气设备）的基本安全和基本性能。如果特定条款或子条款仅适用于医疗电气设备或医疗系统，其标题和内容会明确说明。否则，该条款同时适用于医疗电气设备和医疗系统。本文件不覆盖医疗设备或系统固有生理功能相关的危险，除非在第7.2.13条和第8.4.1条中另有规定。本规范不适用于：通过毯子、垫子或床垫提供热量的医疗设备（见IEC 60601-2-35）；婴儿保温箱（见IEC 60601-2-19）；婴儿转运保温箱（见IEC 60601-2-20）；婴儿光疗设备（见IEC 60601-2-50）。用于操作婴儿温控辐射保暖器的皮肤温度传感器（包括显示值）不被视为ISO 80601-2-56标准中的临床体温计。 [外文原描述]： IEC 60601-2-21:2020+AMD1:2023 CSV applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT RADIANT WARMERS as defined in 201.3.204, 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 60601-2-21:2020 specifies the safety requirements for INFANT RADIANT WARMERS, 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; for information, see IEC 60601-2-19; - INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20; - INFANT PHOTOTHERAPY EQUIPMENT, for information, see IEC 60601-2-50. SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED RADIANT WARMER including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense of the particular standard ISO 80601-2-56. IEC 60601-2-21:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-21:2020 includes the following significant technical change with respect to the previous edition: alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.