医疗电气设备.医疗电气设备的循环试验和维修后试验

[中文适用范围]： “本国际标准适用于符合 IEC 60601-1:1988（第二版）及其修正案的医疗电气设备和医疗电气系统@（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IEC 60601-1：2005（第三版）及其修正案@投入使用前@维护@检查@维修期间以及修理后或进行定期测试以评估此类ME设备或ME系统或其部件的安全性。对于不按照 IEC 60601-1 制造的设备，可以在考虑该设备的设计安全标准和使用说明中的信息的情况下使用这些要求。本标准包含与 IEC 60601-1 不同版本相关的允许值表格. 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： ?C “一般要求”@ 其中包含一般关注的条款@ ?C“特殊要求”@处理特殊类型ME设备或ME系统并与“一般要求”结合应用的其他条款。注：在此阶段@没有特殊要求。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系统的组装。有关组装 ME 系统，请参阅 IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:20121 第 16 条。本标准没有定义组件更换和 ME 设备或 ME 系统修改的要求。根据制造商的说明进行的所有维护、检查、维修和维修均保持符合设备设计标准。否则，在执行本标准的测试之前，应评估和验证是否符合适用的要求。本标准也适用于修理后的测试。 IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012 要求@作为风险管理流程的一部分@制造商考虑如何在产品生命周期内确保ME设备或ME系统的安全。作为风险管理流程的一部分，制造商可能已经确定了维护程序。这包括定义 ME 设备或 ME 系统的相应测试。制造商可能已在使用说明或其他随附文件中定义了必要的测量设置和方法，包括性能保证测试。该标准提供了一致的测试程序。本标准无意定义重复测试的时间间隔。如果制造商未定义此类间隔，则附件 F 可用于帮助建立此类间隔。本标准不包括对医疗场所电气装置@（包括电源和相关接线@）的测试。 IEC 60364-7-710 或国家同等标准涵盖了此类测试@” [外文原描述]： 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.