ÖNORM EN ISO 80601-2-12:2024 05 15
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Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2023)
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15-05-2024
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows: 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; - 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.
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