标准摘要
[中文适用范围]： 本国际标准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，如3.1所定义，并在制造商的使用说明书中指定。本国际标准无论ME设备或ME系统是计划由非专业操作人员还是由经过培训的卫生专业人员使用均适用。 家庭医疗保健环境包括： - 患者居住的住所； - 其他患者所在的地方，包括室内和室外，但不包括有医疗培训的操作人员在场时患者在场的专业医疗保健设施环境。 本国际标准不适用于仅计划在紧急医疗服务环境（由IEC 60601-1-12涵盖）中使用的ME设备和ME系统，或仅计划在专业医疗保健设施（由IEC 60601-1涵盖，且无IEC 60601-1-12或本旁路标准的补充）中使用的ME设备和ME系统。尽管如此，ME设备或ME系统可以计划用于多个使用环境，如果也计划用于家庭医疗保健环境，则属于本标准的范围。 [外文原描述]： 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.
英文名称Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment