医用电气设备第2-50部分:婴儿光疗设备基本安全和基本性能的特殊要求

[中文适用范围]： 该部分IEC 60601适用于婴儿光疗设备（定义为201.3.203，也称为医疗电气设备）的基本安全和主要性能。如果条款或子条款明确旨在仅适用于医疗电气设备或仅适用于医疗系统，则该条款或子标题的内容将予以说明。如果不是这种情况，该条款或子标题将同时适用于医疗设备和医疗系统（如相关）。本文件范围内的医疗设备或医疗系统的预期生理功能所固有的危害，除一般标准的7.2.13和8.4.1外，未被本文件的特定要求所涵盖。见一般标准的4.2。本特定标准规定了婴儿光疗设备的安全要求，但如果制造商在其风险管理文件中证明，危害带来的风险在权衡设备治疗带来的好处后被发现有可接受的水平，则通过展示等效安全来符合特定条款的替代方法不会被判定为不合规。本文件不适用于：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）；婴儿辐射加热器（见IEC 60601-2-21）。 [外文原描述]： IEC 60601-2-50:2020 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 60601-2-50:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT PHOTOTHERAPY EQUIPMENT, as defined in 201.3.203, 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 60601-2-50:2020 specifies safety requirements for INFANT PHOTOTHERAPY EQUIPMENT, 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 60601-2-50:2020 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 RADIANT WARMERS; for information, see IEC 60601-2-21. IEC 60601-2-50:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-50:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.