ISO 80601-2-12:2020現行
Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
出版：International Organization for Standardization
專家解讀視頻
This document applies to the basic safety and essential performance of a 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 1 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 2 For the purposes of this document, such a ventilator can provide transport within a professional healthcare facility (i.e. be a transit-operable ventilator). NOTE 3 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator.
