医用电气设备第 1-11 部分：基本安全和基本性能的一般要求 并列标准：家庭保健环境中使用的医用电气设备和医用电气系统要求

[中文适用范围]： 本国际标准适用于医疗电气设备和医疗电气系统@的基本安全和基本性能，以下简称ME设备和ME系统@，其制造商打算在3.2@中定义的家庭医疗保健环境@中使用，无论ME 设备或 ME 系统是否供非专业操作员或经过培训的医疗人员使用。注 1：家庭医疗保健环境 ME 设备和 ME 系统也可用于其他环境@例如@专业医疗保健机构。本国际标准不适用于仅供紧急医疗服务或仅供专业医疗机构使用的 ME 设备和 ME 系统。注 2：家庭医疗保健环境 ME 设备和 ME 系统经常用于电源不可靠和电气接地不良的场所。目的 本并列标准的目的是规定通用标准之外的通用要求，并作为特定标准的基础。 [外文原描述]： IEC 60601-1-11:2010 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems which are intended by their manufacturer for use in the home healthcare environment, regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The object of IEC 60601-1-11:2010 is to specify general requirements that are in addition to those of the general standard IEC 60601-1:2005 and to serve as the basis for particular standards. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 3 years from the date of publication. The contents of the corrigendum of April 2011 have been included in this copy.