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ISO 80601-2-72:2015

(Main)

Medical electrical equipment -- Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

Medical electrical equipment -- Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

ISO 80601-2-72:2015 applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as me equipment: intended for use in the home healthcare environment; intended for use by a lay operator; intended for use with patients who are dependent on mechanical ventilation for their life support. ISO 80601-2-72:2015 is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator. ISO 80601-2-72:2015 is a particular International Standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.

Appareils électromédicaux - Partie 2-72: Exigences particulières pour la sécurité de base et les performances essentielles de ventilateurs utilisés dans l'environnement des soins à domicile pour les patients ventilo-dépendants

General Information

Status
Published
Publication Date
31-Aug-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
29-Jul-2021
Completion Date
04-Jul-2023
Ref Project

Relations

Revised
ISO 80601-2-72:2023 - Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
Effective Date
05-Sep-2023

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ISO 80601-2-72:2015 - Medical electrical equipment -- Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patientsISO 80601-2-72:2015 - Medical electrical equipment -- Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
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ISO 80601-2-72:2015 - Medical electrical equipment -- Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
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Standards Content (Sample)

INTERNATIONAL  ISO
STANDARD 80601-2-72
First edition
2015‐09‐01
Medical electrical equipment
Part 2‐72:
Particular requirements for basic
safety and essential performance of
home healthcare environment
ventilators for ventilator-dependent
patients
Appareils électromédicaux
Partie 2-72: Exigences particulières pour la sécurité de base et
les performances essentielles des ventilateurs utilisés dans
l'environnement des soins à domicile pour les patients ventilo-
dépendants
Reference number
ISO 80601‐2‐72:2015(E)
©
ISO 2015

---------------------- Page: 1 ----------------------
ISO 80601-2-72:2015(E)
COPYRIGHT PROTECTED DOCUMENT
©  ISO 2015
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized
otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the
internet or an intranet, without prior written permission. Permission can be requested from either ISO at the
address below or ISO’s member body in the country of the requester.
ISO copyright office
Ch. de Blandonnet 8  CP 401
CH‐1214 Vernier, Geneva, Switzerland
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 80601-2-72:2015(E)
Contents Page
Foreword . vii
Introduction . ix
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 . 7
201.4.3 ESSENTIAL PERFORMANCE . 7
201.4.3.101 *Additional requirements for ESSENTIAL PERFORMANCE . 8
201.4.6 *ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT . 8
201.4.10.2 *SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS. 8
201.4.11.101  *Additional requirements for pressurized gas input . 9
201.4.11.101.1 Overpressure requirement . 9
201.4.11.101.2 Compatibility requirement . 9
201.5 General requirements for testing of ME EQUIPMENT . 10
201.5.101 *Additional requirements for general requirements for testing of ME EQUIPMENT .10
test co .
201.5.101.1 VENTILATOR nditions 10
201.5.101.2 *Gas flowrate and leakage specifications . 10
201.5.101.3 *VENTILATOR testing errors . 10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 10
201.7 ME EQUIPMENT identification, marking and documents . 10
201.7.2.3 *Consult ACCOM
...

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EXAMPLE Automated sphygmomanometer as given in IEC 80601-2-30 undergoing clinical investigation according to this document.
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These healthcare fields include, but are not limited to:
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[1] Numbers in square brackets refer to the Bibliography.
[2] Under preparation. Stage at the time of publication: ISO/FDIS 80601-2-12:2018.
[3] Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2018.

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