医用电气设备第2-20部分:婴儿运输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 适用于婴儿转运培养箱设备的基本安全和基本性能，如 201.3.211208 中所定义，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予以说明。如果情况并非如此，则该条款或子条款适用于 ME 设备和 ME 系统（如适用）。本文件范围内的 ME 设备或 ME 系统的预期生理功能固有的危险不在本文件的具体要求范围内，除了一般标准的 7.2.13 和 8.4.1。注：另见一般标准的 4.2。本特定标准规定了婴儿转运培养箱的安全要求，但如果制造商在其风险管理文件中证明，通过展示等效安全性来替代特定条款的符合性方法，不会被视为不符合要求，前提是制造商已证明该危险带来的风险在权衡设备治疗益处后处于可接受水平。本特定标准不适用于：- 通过医疗用毯子、垫子或床垫提供热量的设备；相关信息见 IEC 80601-2-35 IEC 60601-2-35 [1]2；- 非婴儿转运培养箱的婴儿培养箱；相关信息见 IEC 60601-2-19 [2]；- 婴儿辐射保暖器；相关信息见 IEC 60601-2-21 [3]；- 婴儿光疗设备；相关信息见 IEC 60601-2-50 [4]。 [外文原描述]： IEC 60601-2-20:2020 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 60601-2-20:2020 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 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition 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.