浅析重症护理呼吸机ISO 80601-2-12:2020标准  

Discussion on ISO 80601-2-12:2020 Standard of Critical Care Ventilators

作　　者：马小建 王伟 张巍 MA Xiao-jian;WANG Wei;ZHANG Wei(Shenzhen Mindray Bio-Medical Electronics Co.,Ltd.,Guangdong Shenzhen 518057;Shanghai Institute of Medical Device Testing,Shanghai,Shanghai 201318)

机构地区：[1]深圳迈瑞生物医疗电子股份有限公司,广东深圳518057 [2]上海市医疗器械检验研究院,上海201318

出　　处：《中国医疗器械信息》2023年第9期30-33,共4页China Medical Device Information

摘　　要：对ISO 80601-2-12:2020《Medical electrical equipment–Part 2-12:Particular requirements for basic safety and essential performance of critical care ventilators》标准进行介绍与分析,希望为重症护理呼吸机行业的监督管理机构、生产厂商、第三方检测机构等针对新标准的学习、理解和贯彻执行提供帮助。This article briefly introduces and analyzes ISO 80601-2-12:2020 Medical electrical equipment–Part 2-12:Particular requirements for basic safety and essential performance of critical care ventilators standards,hoping to help the supervision and management agencies,manufacturers,and third-party testing institutions of the critical care ventilator industry,to better understand and implement new standards.

关 键 词：呼吸机 气道压力 危险输出 报警系统 生物相容性 内部电源 

分 类 号：TH778[机械工程—仪器科学与技术]