前言:这是CAN/CSA-C22的合并版2.1。2 No.80601-2-35，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，采用加拿大偏差，标题相同的IEC（国际电工委员会）标准80601-2-35（版本2:2009合并修订1:2016）。它取代了2012年作为CAN/CSA-C22发布的第一版。2编号80601-2-35（采用IEC 80601-2-35:2009）。这是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。 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）。如果本合并版与出版版及其修订版之间存在差异，则以这些文件为准。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集团已将其作为国家标准发布。范围和目的:本国际标准适用于医疗用毯子、垫子或床垫加热设备（也称为医用电气设备）的基本安全和基本性能。 用于预热床的加热装置包括在本国际标准的范围内。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专门适用于特定定义类型的医用电气设备，如强制通风装置，则该条款或子条款有权适用。适用于本标准范围内所有类型医用电气设备的条款或子条款没有明确的标题。 除通用标准第7.2.13条和第8.4.1条外，本标准的具体要求不包括本标准范围内医用电气设备或医用电气系统预期生理功能的固有危险。注:另见通用标准的4.2。本特殊标准不适用于:物理治疗用加热装置；辐射加热器；有关信息，请参见IEC 60601-2-21[12]2；孵化器；有关信息，请参见IEC 60601-2-19[10]；运输培养箱，有关信息，请参见IEC 60601-2-20[11]；冷却设备。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的危害，并指定用于证明符合这些要求的测试。

Preface:This is consolidated edition 2.1 of CAN/CSA-C22.2 No. 80601-2-35,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 80601-2-35 (edition 2:2009 consolidated with Amendment 1:2016). It supersedes the first edition, published in 2012 as CAN/CSA-C22.2 No. 80601-2-35 (adopted IEC 80601-2-35:2009). It is one in a series of Standards issued by CSA Group under Part II of theCanadian Electrical Code.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).Where differences exist between this consolidated edition and the published edition and its amendments, those documents will take precedence.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 by CSA Group.Scope and object:This 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 International Standard.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 apply to a specifically defined type of ME EQUIPMENT, as is the case with FORCED AIR DEVICES, then the clause or subclause is entitled as such. Clauses or subclauses that apply to all types of ME EQUIPMENT within the scope of this standard are not specifically entitled.HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.NOTE See also 4.2 of the general standard.This particular standard does not apply to:HEATING DEVICES intended for physiotherapy;radiant warmers; for information, see IEC 60601-2-21 [12]2;incubators; for information, see IEC 60601-2-19 [10];transport incubators, for information, see IEC 60601-2-20 [11];cooling devices.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.