CSA序言这是CSA C22的第一版。2第60601-2-35号，医用电气设备-第2-35部分:使用毯子、垫子或床垫并用于医疗加热的加热装置的基本安全和基本性能的特殊要求，采用了相同名称的IEC（国际电工委员会）标准60601-2-35（第二版，2020-09），但有加拿大的偏差。它取代了标题相同的CAN/CSA-C22。2编号80601-2-35:12（采用IEC 80601- 2-35:2009). 它是CSA集团根据《加拿大电气规范》第二部分发布的一系列标准之一。为简洁起见，本标准通篇称为“CSA C22.2编号60601-2-35”。本标准拟与CAN/CSA-C22结合使用。2 No.60601-1:14，医用电气设备-第1部分:基本安全和基本性能的一般要求（采用IEC 60601-1:2005，包括修改件1:2012，带有加拿大偏差）。本标准适用于本标准规定范围内的合格评定。 本标准由CSA消费品和商业产品技术委员会审查，以供加拿大采用，由CSA电气安全要求战略指导委员会管辖，并已由技术委员会正式批准。由于本标准的医疗内容，本标准还得到了CSA健康与福利战略指导委员会管辖下的CSA医疗保健用电技术委员会的批准。 本标准的制定符合加拿大标准委员会对加拿大国家标准的要求。CSA集团已将其作为加拿大国家标准发布。范围和目的通用标准1第1条适用，但以下情况除外:201.1.1*范围替换:60601国际标准的本部分适用于医疗用毯子、垫子或床垫加热装置的基本安全和基本性能，也称为医用电气设备。用于预热床的加热装置包含在本文件的范围内。 如果某一条款或子条款明确规定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应如此说明。如果情况并非如此，则本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）。如果某一条款或子条款特别适用于特定定义类型的医用电气设备，如强制通风装置，则该条款或子条款的标题和内容应如此说明。 如果情况并非如此，则本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）。除通用标准第7.2.13条和第8.4.1条外，本文件中的具体要求未涵盖本文件范围内医用电气设备或医用电气系统预期生理功能所固有的危险。注:另见通用标准的4.2。本文件不适用于:-用于物理治疗的加热设备；-婴儿辐射加热器；有关信息，请参见IEC 60601- 2-21 [1]2;- 婴儿孵化器；有关信息，请参见IEC 60601-2-19[2]；-有关婴儿运输培养箱的信息，请参见IEC 60601-2-20[3]；-冷却设备。201.1.2物品更换:本特定标准的目的是制定特定的基本安全和基本性能要求，以最大限度地减少对患者和使用毯子、垫子或床垫的加热设备操作员以及医疗加热设备操作员的危害，并规定证明符合这些要求的测试。

CSA PrefaceThis is the first edition of CSA C22.2 No. 60601-2-35, Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-35 (second edition, 2020-09). It replaces the identically titled CAN/CSA-C22.2 No. 80601-2-35:12 (adopted IEC 80601-2-35:2009). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code. For brevity, this Standard will be referred to as "CSA C22.2 No. 60601-2-35" throughout.This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, including Amendment 1:2012, with Canadian deviations). This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard. This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Consumer and Commercial Products, under the jurisdiction of the CSA Strategic Steering Committee on Requirements for Electrical Safety, and has been formally approved by the Technical Committee. Due to the medical content of this Standard, it was also approved by the CSA Technical Committee on Application of Electricity in Health Care, under the jurisdiction of the CSA Strategic Steering Committee on Health and Well-being. This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.Scope and objectClause 1 of the general standard1 applies, except as follows: 201.1.1 * Scope Replacement: This part of 60601 International Standard 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. NOTE See also 4.2 of the general standard. This document does not apply to:- HEATING DEVICES intended for physiotherapy;- INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [1]2;- INFANT INCUBATORS; for information, see IEC 60601-2-19 [2];- INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20 [3];- cooling devices. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements, which minimize HAZARDS to PATIENTS, and OPERATORS for HEATING DEVICES using BLANKETS, PADS or MATTRESSES and intended for heating in medical use and to specify tests for demonstrating compliance with these requirements.