医用电气设备第2-19部分:婴儿孵化器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适用于新生儿暖箱（也称为医用电气设备）的基本安全和基本性能，如201.3.209中定义。如果某个条款或子条款专门旨在仅适用于医用电气设备或仅适用于医用电气系统，则该条款或子条款的标题和内容将予以说明。如果不是这种情况，则条款或子条款适用于医用电气设备和医用电气系统（视情况而定）。本文件范围内医用电气设备或医用电气系统的预期生理功能中固有的危险，除通用标准中的7.2.13和8.4.1外，本文件不作具体规定。参见通用标准中的4.2。本标准规定了新生儿暖箱的安全要求，但如果制造商在其风险管理文件中证明，危险带来的风险在权衡治疗益处后发现处于可接受水平，则通过证明具有同等安全性的替代方法符合特定条款，不会被判定为不符合。本标准不适用于：新生儿转运暖箱；新生儿辐射暖箱；通过毯子、垫子或床垫提供热量的医疗设备；新生儿光疗设备。用于操作婴儿控制暖箱（包括显示值）的皮肤温度传感器不被视为ISO 80601-2-56中规定的医用温度计。 [外文原描述]： IEC 60601-2-19:2020 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition. 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.