医用电气设备 第 1-11 部分：基本安全和基本性能的通用要求 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的要求

[中文适用范围]： IEC 60601-1-11:2015 RLV 包含官方 IEC 国际标准及其红线版本。 Redline 版本仅提供英文版本，为您提供了一种快速、简单的方法来比较官方 IEC 标准与其先前版本之间的所有更改。 IEC 60601-1-11:2015 适用于家庭医疗保健环境中使用的医疗电气设备和医疗电气系统的基本安全和基本性能。无论医疗电气设备或医疗电气系统是供非专业操作员还是由经过培训的医护人员使用，它都适用。家庭医疗环境包括： - 患者居住的居所； - 病人在室内和室外出现的其他地方，不包括在病人在场时受过医疗培训的操作员随时待命的专业医疗机构环境。第二版取消并取代了 2010 年发布的 IEC 60601-1-11 第一版，并构成技术修订版。与前一版本相比最显着的变化包括以下修改： - 修正了 35 °C 以上温度下相对湿度控制的测试方法； - 重新起草对通用标准或其他并列标准进行修改而不是添加的子条款； - 与通用标准和其他并列标准修订案的变更保持一致。 [外文原描述]： IEC 60601-1-11:2015 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition. IEC 60601-1-11:2015 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. It applies 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 home healthcare environment includes: - the dwelling place in which a patient lives; - other places where patients are present both indoors and outdoors, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present. This second edition cancels and replaces the first edition of IEC 60601-1-11, published in 2010, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications: - correction of test method for relative humidity control at temperatures above 35 °C; - redrafting of subclauses that altered instead of adding to the general standard or other collateral standards; and - harmonizing with the changes to the amendments to the general standard and other collateral standards.