标准摘要
[中文适用范围]: 本文件提供了实用方法,帮助在ME设备或ME系统的预期使用寿命内,针对可能出现的电磁干扰(EM DISTURBANCES)实现基本安全(BASIC SAFETY)和基本性能(ESSENTIAL PERFORMANCE)。这些实用方法试图解决ME设备或ME系统中可能由电磁干扰引起的所有不同类型错误、故障或失效。本文件的目的是为ME设备或ME系统中使用的系统、硬件、软件和固件的设计、验证和确认提供技术措施建议,以帮助在预期使用寿命内针对可能出现的电磁干扰实现基本安全和基本性能。 [外文原描述]: IEC TS 60601-4-6:2024 provides practical methods to help achieve basic safety and essential performance with regard to the possible effects of em disturbances throughout the expected service life of me equipment or an me system. These practical methods attempt to address all of the different types of errors, malfunctions or failures that can be caused by em disturbances in me equipment or me systems. The purpose of this document is to provide recommendations for the techniques and measures used in the design, verification, and validation of systems, hardware, software, and firmware used in me equipment or me systems to help achieve basic safety and essential performance with regard to the em disturbances that could occur throughout the expected service life.
英文名称Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances