BS EN ISO 80601-2-12:2020

What is ISO 80601 ‑ 2 ‑ 12 about?

ISO 80601 discusses medical electrical equipment. ISO 80601 ‑ 2 ‑ 12 outlines the basic safety and essential performance of a ventilator in combination with its accessory’s hereafter referred to as ME equipment. Critical care ventilators are intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening, require comprehensive care and constant monitoring in a professional healthcare facility. Critical care ventilators are intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients. Note 1: A critical care ventilator is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings. Note 2: ISO 80601 ‑ 2 ‑ 12 does not apply to ME equipment or an ME system operating in a ventilator operational mode solely intended for patients who are not dependent on artificial ventilation. Note 3: ISO 80601