IEC 62353:2014适用于符合IEC 60601-1:19 88（第二版）及其修订版和IEC 60601-1:20 05（第三版）及其修订版的医用电气设备和医用电气系统（以下简称ME设备和ME系统）或此类设备或系统的部件的测试，在投入使用之前、维护、检查、维修期间和维修后，或在评估此类ME设备或ME系统或其部件的安全性的重复测试期间。对于未按照IEC 60601-1制造的设备，可以使用这些要求，同时考虑设计的安全标准和该设备使用说明中的信息。本标准包含与IEC 60601-1不同版本相关的允许值表。就本标准而言，测量方法的应用与ME设备或ME系统设计所依据的版本无关。本标准包含“一般要求”和“特殊要求”，前者包含一般关注的条款，后者包含处理特殊类型的ME设备或ME系统的条款，并与“一般要求”一起适用。本标准不适用于评估ME设备或ME系统或任何其他设备是否符合其设计的相关标准。本标准不适用于ME系统的装配。有关ME系统的组装，请参见IEC 60601-1:20 05+IEC 60601-1:20 05/AMD1:2012的第16条。本标准没有定义ME设备或ME系统的维修、部件更换和修改的要求。根据制造商的说明进行的所有维护、检查、保养和修理都符合设备设计所用的标准。否则，在执行本标准的试验之前，应评估和验证是否符合适用要求。本标准也适用于修复后的试验。第二版取消并取代了2007年发布的IEC 62353第一版。本版构成技术修订版，包括以下主要修订内容: -在5.3.4.1中澄清，根据IEC 60601-1得出的测试配置测量泄漏电流是一种允许的替代方法，并在附录A中包含信息性解释； -修订使用多个插座的ME系统的保护接地电阻要求，以考虑IEC 60601-1:2005/AMD1:2012关于插入式设备保护接地电阻的安全允许值； -在表2中包括预期的最小绝缘电阻值；和 -附录B中测试顺序的重新排序。

IEC 62353:2014 applies to testing of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems, or parts of such equipment or systems, which comply with IEC 60601-1:1988 (second edition) and its amendments and IEC 60601-1:2005 (third edition) and its amendments, before putting into service, during maintenance, inspection, servicing and after repair or on occasion of recurrent tests to assess the safety of such ME equipment or ME systems or parts thereof. For equipment not built to IEC 60601-1 these requirements may be used taking into account the safety standards for the design and information in the instructions for use of that equipment. This standard contains tables with allowable values relating to different editions of IEC 60601-1. For the purpose of this standard, the application of measuring methods is independent of the edition according to which the ME equipment or ME system is designed. This standard contains "general requirements", which contain clauses of general concern, and "particular requirements", further clauses handling special types of ME equipment or ME systems and applying in connection with the "General requirements". This standard is not suitable to assess whether ME equipment or ME systems or any other equipment comply with the relevant standards for their design. This standard is not applicable to the assembly of ME systems. For assembling ME systems see Clause 16 of IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012. This standard does not define requirements for repair, exchange of components and modification of ME equipment or ME systems. All maintenance, inspection, servicing, and repair done in accordance with the manufacturer's instructions maintain the conformity to the standard used for the design of the equipment. Otherwise conformity to applicable requirements should be assessed and verified, before the tests of this standard are performed. This standard is also applicable to tests after repair. This second edition cancels and replaces the first edition of IEC 62353 published in 2007. This edition constitutes a technical revision including the following main revisions:
- clarification in 5.3.4.1 that measurements of leakage currents based on test configurations derived from IEC 60601-1 are an allowable alternative method and the inclusion of informative explanation in Annex A;
- revision of the protective earth resistance requirements for ME systems using multiple socket outlets to take account of IEC 60601-1:2005/AMD1:2012 on the safe allowed values of protective earth resistance of plugged-in equipment;
- the inclusion of expected minimum insulation resistance values in Table 2; and
- a reordering of the sequence of testing in Annex B.