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Publication details

Publication CODE Title
ISO 80601-2-70:2015 (2015-01) MEDICAL ELECTRICAL EQUIPMENT PART 2-70: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SLEEP APNOEA BREATHING THERAPY EQUIPMENT
 
Price Excl. VAT Total number of pages, tables and drawings
183.00 € 46 P.
Description
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.
Class  C990  (IEC PUBLICATIONS IEC PUBLICATIONS)
Available files
EN version

FR version

Status
Status IEC PUBLICATION
Situation Withdrawn
Replaced by  ISO 80601-2-70:2020
Origin
Committee TC 62/SC 62D
ELECTROMEDICAL EQUIPMENT
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2015-01-12
Registration 155701
ICS-Code (International Standards Classification) 19.040
NBN Status New
IEC publication date 2015-01-12