标准编号：ISO 80601-2-12:2023
中文名称：医用电气设备 第2-12部分：危重护理呼吸机的基本安全和基本性能专用要求
英文名称：Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
发布日期：2023-11
标准范围
This document applies to the basic safety and essential performance of a critical care ventilator in combination with its accessories, hereafter referred to as ME equipment: ？ intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility; NOTE 2 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining. NOTE 3 For the purposes of this document, such a critical care ventilator can provide ventilation during transport within a professional healthcare facility (i.e. be a transit-operable ventilator). NOTE 4 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator. ？ intended to be operated by a healthcare professional operator; and ？ intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
标准预览图
立即下载标准文件