IEC 60601-2-19:2020 医用电气设备.第2-19部分:婴儿保温箱的基本安全和基本性能的特殊要求

标准编号：IEC 60601-2-19:2020

中文名称：医用电气设备.第2-19部分:婴儿保温箱的基本安全和基本性能的特殊要求

英文名称：Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

发布日期：2020-09-02

标准范围

IEC 60601-2-19:20 20作为IEC 60601-2-19:20 20 RLV提供，其中包含国际标准及其红线版本，显示了与上一版本相比技术内容的所有变化。IEC 60601-2-19:20 20适用于201.3.209中定义的婴儿培养箱的基本安全性和基本性能，也称为ME设备。如果一个条款或子条款特别旨在仅适用于ME设备，或仅适用于ME系统，该条款或子条款的标题和内容将如此说明。如果不是这种情况，该条款或子条款适用于相关的ME设备和ME系统。本文件范围内的医用电气设备或医用电气系统预期生理功能中固有的危害不在本文件的具体要求范围内，第7条除外。通用标准的2.13和8.4.1。IEC 60601-2-19:20 20规定了婴儿培养箱的安全性要求，但如果制造商已在其风险管理文件中证明，当与器械的治疗益处进行权衡时，发现危害带来的风险处于可接受水平，则通过证明等效安全性来遵守特定条款的替代方法不会被判定为不合规。IEC 60601-2-19:20 20不适用于:-婴儿运输保温箱；有关信息，请参见IEC 60601-2-20；-婴儿辐射取暖器；有关信息，请参见IEC 60601-2-21；-在医疗用途中通过毯子、垫子或床垫提供热量的装置；有关信息，请参见IEC 60601-2-35；-婴儿光疗设备；有关信息，请参见IEC 60601-2-50.应用于操作包括显示值的婴儿控制培养箱的皮肤温度传感器不被认为是特定标准ISO 80601-2-56意义上的临床温度计。IEC 60601-2-19:20 20取消并取代2009年发布的第二版和修正案1:20 16。本版构成技术修订版。IEC 60601-2-19:20 20相对于上一版本包括以下重大技术变更:重新确定规范性参考文献的日期。

IEC 60601-2-19:2020 is available as IEC 60601-2-19:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the 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.

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