ISO 80601-2-70:2015

Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment

Publication date:   Jan 12, 2015

95.99 Withdrawal of Standard   Nov 17, 2020

General information

95.99 Withdrawal of Standard   Nov 17, 2020

ISO

ISO/TC 121/SC 3 Respiratory devices and related equipment used for patient care

International Standard

11.040.10   Anaesthetic, respiratory and reanimation equipment

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Scope

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.

Life cycle

PREVIOUSLY

Revises
ISO 17510-1:2007

NOW

WITHDRAWN
ISO 80601-2-70:2015
95.99 Withdrawal of Standard
Nov 17, 2020

REVISED BY

PUBLISHED
ISO 80601-2-70:2020