标准摘要
[中文适用范围]: IEC 60601-2-76:2018+AMD1:2023适用于低能电离气体止血设备的基本安全和基本性能。除通用标准 7.2.13 和 8.4.1 之外,本文件中的具体要求不涵盖本文件范围内 ME 设备或 ME 系统的预期生理功能所固有的危害。本标准对 IEC 60601-1:2005 和 IEC 60601-1:2005/AMD1:2012 进行了修订和补充。 [外文原描述]: IEC 60601-2-76:2018+AMD1:2023 CSV applies to the basic safety and essential performance of low energy ionized gas haemostasis equipment. Hazards inherent in the intended physiological function of ME Equipment or ME Systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. This particular standard amends and supplements IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.
英文名称Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment