NEN-EN-ISO 80601-2-80:2019 en

Current standard
85 Pages
Publication date 2019-09-01
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Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
NEN-EN-ISO 80601-2-80 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of VENTILATORY SUPPORT EQUIPMENT, as defined in 201.3.205, for VENTILATORY INSUFFICIENCY, as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT, in combination with its ACCESSORIES: - intended for use in the HOME HEALTHCARE ENVIRONMENT; - intended for use by a LAY OPERATOR; - intended for use with PATIENTS who have VENTILATORY INSUFFICIENCY or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation; - intended for TRANSIT-OPERABLE use; - not intended for PATIENTS who are dependent on artificial ventilation for their immediate life support.
Extra information
Registration date
ISO/TC 121
ICS code
11.040.10 Anaesthetic, Respiratory And Reanimation Equipment
Related to
ISO 80601-2-80:2018 en, IDT * EN ISO 80601-2-80, IDT
Health services - Anaesthetic equipment - Anaesthesiology - Medical equipment - Medical gas equipment - Medical gases - Breathing apparatus - Respiratory protective devices

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