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ISO 80601-2-70:2015

(Main)

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

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

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.

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

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.

General Information

Status
Published
Publication Date
11-Jan-2015
ICS
01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
SC 62D - Particular medical equipment, software, and systems
Drafting Committee
JWG 12 - TC 62/SC 62D/JWG 12
Current Stage
DELPUB - Deleted Publication
Start Date
15-Feb-2019
Completion Date
20-Nov-2020
Ref Project

Relations

Revised
ISO 80601-2-70:2020 - Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
Effective Date
05-Sep-2023

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ISO 80601-2-70:2015 - Medical Electrical Equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipmentISO 80601-2-70:2015 - Medical Electrical Equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
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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
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Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 80601-2-70
First edition
2015-01-15

Medical electrical equipment —
Part 2-70:
Particular requirements for basic safety
and essential performance of sleep
apnoea breathing therapy equipment
Appareils électromédicaux —
Partie 2-70: Exigences particulières pour la sécurité de base et les
performances essentielles de l'équipement de thérapie respiratoire pour
l'apnée du sommeil




Reference number
ISO 80601-2-70:2015(E)
©
 ISO 2015

---------------------- Page: 1 ----------------------
ISO 80601-2-70:2015(E)

COPYRIGHT PROTECTED DOCUMENT


©  ISO 2015
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland

ii © ISO 2015 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 80601-2-70:2015(E)
Contents Page
Foreword . vi
Introduction . viii
201.1 Scope, object and related standards. 1
201.1.1 Scope . 1
201.1.2 Object . 2
201.1.3 Collateral standards . 2
201.1.4 Particular standards . 2
201.2 Normative references . 3
201.3 Terms and definitions . 5
201.4 General requirements . 6
201.4.3 ESSENTIAL PERFORMANCE . 6
201.4.3.101 Additional requirements for ESSENTIAL PERFORMANCE . 6
201.4.6 ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT . 6
201.5 General requirements for testing of ME EQUIPMENT . 6
201.5.101 Additional requirements for general requirements for testing of ME EQUIPMENT . 7
201.5.101.1 Gas flowrate and pressure specifications . 7
201.5.101.2 SLEEP APNOEA BREATHING THERAPY EQUIPMENT testing errors . 7
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 7
201.7 ME EQUIPMENT identification, marking and documents . 7
201.7.1.2 Legibility of markings . 7
201.7.2.4.101 Additional requirements for ACCESSORIES . 7
201.7.2.13.101 Additional requirements for physiological effects . 7
201.7. .17.101 Additional requirements for protective packaging . 8
201.7.2.101 Additional requirements for marking on the outside of ME EQUIPMENT or
ME EQUIPMENT parts . 8
201.7.4.3 Units of measurement . 8
201.7.9.1 Additional general requirements . 9
201.7.9.2.1.101 Additional general requirements .
...

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