IEC 60601-1-11:20 15+A1:2020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由非专业操作员使用还是由训练有素的医疗保健人员使用，它都适用。家庭医疗保健环境包括: -患者居住的住所； -患者在室内和室外的其他场所，不包括在患者在场时受过医疗培训的操作员持续可用的专业医疗保健设施环境。 第二版取消并取代了2010年发布的第一版IEC 60601-1-11，并构成技术修订。与上一版本相比，最显著的变化包括以下修改:-校正温度高于35℃时相对湿度控制的测试方法； -重新起草修改而不是增加一般标准或其他附属标准的子条款；和 -与一般准则及其他抵押品准则修订的变动保持一致。 该合并版本由第二版（2015年）及其修正案1（2020年）组成。因此，除本出版物外，无需下令修订。

IEC 60601-1-11:2015+A1:2020 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.
This consolidated version consists of the second edition (2015) and its amendment 1 (2020). Therefore, no need to order amendment in addition to this publication.