SS-EN ISO 80601-2-12:2024

This document applies to the basic safety and essential performance of a critical care ventilator incombination with its accessories, hereafter referred to as ME equipment: - intended for use in an environment that provides specialized care for patients whose conditions canbe life-threatening and who can require comprehensive care and constant monitoring in aprofessional healthcare facility; - intended to be operated by a healthcare professional operator; and - intended for those patients who need differing levels of support from artificial ventilation includingfor ventilator-dependent patients.