ISO 80601-2-70:2015

Title

Language: EN Medical Electrical Equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment

Language: FR Appareils électromédicaux - Partie 2-70: Exigences particulières pour la sécurité de base et les performances essentielles du matériel de traitement respiratoire de l'apnée du sommeil

Abstract

Language: EN ISO 80601-2-70:2015 is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as me equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions. It excludes sleep apnoea breathing therapy equipment intended for use with neonates. ISO 80601-2-70:2015 is applicable to me equipment or an me system intended for those patients who are not dependent on mechanical ventilation. ISO 80601-2-70:2015 is not applicable to me equipment or an me system intended for those patients who are dependent on mechanical ventilation such as patients with central sleep apnoea. ISO 80601-2-70:2015 is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.

Language(s)
Language: FR
Edition
1.0
Date of issue
12.01.2015
TC 62/SC 62D
ICS Codes
11.040.10
Publication number
80601
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Mandatory Standard according current regulation Mandatory Standard according current regulation

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