Norm

ISO/DIS 80601-2-79:2017 en

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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Over deze norm

Status Ontwerp
Aantal pagina's 91
Commissie Anesthesie- en beademingssystemen
Gepubliceerd op 01-06-2017
Taal Engels
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of VENTILATORY  SUPPORT EQUIPMENT, as defined in 201.3.204, for VENTILATORY IMPAIRMENT, as defined in  201.3.201, 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; and  - intended for use with PATIENTS who have VENTILATORY IMPAIRMENT, but who are not  dependent on mechanical ventilation for their life support.  EXAMPLES 1 PATIENTS with mild to moderate chronic obstructive pulmonary disease (COPD).

Details

ICS-code 11.040.10
Nederlandse titel Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
Engelse titel 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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