IEC 60601-2-35:2020 医用电气设备.第2-35部分:医用加热用毯子、垫子和床垫加热装置的基本安全和基本性能的特殊要求

标准编号：IEC 60601-2-35:2020

中文名称：医用电气设备.第2-35部分:医用加热用毯子、垫子和床垫加热装置的基本安全和基本性能的特殊要求

英文名称：Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use

发布日期：2020-09-21

标准范围

IEC 60601-2-35:2020适用于医疗用途中使用毯子、垫子或床垫的加热设备（也称为ME设备）的基本安全和基本性能。用于预热床的加热装置包括在本文件的范围内。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。如果一个条款或子条款特别旨在适用于一个特别定义的ME设备类型，如强制通风设备的情况，那么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。除通用标准7.2.13和8.4.1中的规定外，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。IEC 60601-2-35:2020不适用于:-用于物理治疗的加热装置；-婴儿辐射取暖器；有关信息，请参见IEC 60601-2-21；-婴儿保温箱；有关信息，请参见IEC 60601-2-19；-婴儿运输保温箱，有关信息，请参见IEC 60601-2-20；-冷却装置。IEC 60601-2-35:2020取消并取代2009年发布的IEC 80601-2-35和修正案1:20 16。本版构成技术修订版。IEC 60601-2-35:2020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 60601-2-35:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT. HEATING DEVICES intended to prewarm a bed are included in the scope of this document.
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.
If a clause or subclause is specifically intended to be applicable to a specifically defined type of ME EQUIPMENT, as is the case with FORCED AIR DEVICES, then 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 60601-2-35:2020 does not apply to:
- HEATING DEVICES intended for physiotherapy;
- INFANT RADIANT WARMERS; for information, see IEC 60601-2-21;
- INFANT INCUBATORS; for information, see IEC 60601-2-19;
- INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20;
- cooling devices.
IEC 60601-2-35:2020 cancels and replaces IEC 80601-2-35 published in 2009 and Amendment 1:2016. This edition constitutes a technical revision.
IEC 60601-2-35:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.

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