NEN-EN-ISO 80601-2-79:2019
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Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
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English
01-09-2019
NEN-EN-ISO 80601-2-79 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of VENTILATORY SUPPORT EQUIPMENT, as defined in 201.3.205, for VENTILATORY IMPAIRMENT, as defined in 201.3.202, hereafteralso 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; and - intended for use with PATIENTS who have VENTILATORY IMPAIRMENT, the most fragile of these PATIENTS, would not likely experience injury with the loss of this artificial ventilation; and - not intended for PATIENTS who are dependent on artificial ventilation for their immediate life support.
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