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 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，在投入使用之前、维护、检查期间的测试、维修和维修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。对于未按照 IEC 60601-1 制造的设备，可以在考虑设计安全标准和设备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： – “一般要求”，其中包含普遍关注的条款，以及 – “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1：现阶段没有特殊要求。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。本标准未定义 ME 设备或 ME 系统的维修、更换组件和修改的要求。注 2：按照制造商的说明进行的所有维护、检查、维修和修理均符合设备设计所用的标准。否则，必须评估和验证是否符合适用要求。本标准也适用于修理后的测试。测试应根据所执行的工作范围和制造商的适用指导来定义。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，则可使用附录 F 来帮助建立此类间隔。 [外文原描述]： 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, 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 also applicable to tests after repair. The testing shall be defined according to the extent of work performed and applicable guidance from the manufacturer.