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ISO 80601-2-69:2014

(Main)

Medical electrical equipment -- Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment

Medical electrical equipment -- Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment

ISO 80601-2-69:2014 specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment, including transit-operable use by a single patient in various environments including any private and public transportation as well as in commercial aircraft. ISO 80601-2-69:2014 is applicable to a transit-operable and non-transit-operable oxygen concentrator. It is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems.

General Information

Status
Published
Publication Date
11-May-2014
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
09-Feb-2018
Completion Date
09-Nov-2020
Ref Project

Relations

Revised
ISO 80601-2-69:2020 - Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
Effective Date
05-Sep-2023

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ISO 80601-2-69:2014 - Medical electrical equipment -- Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipmentISO 80601-2-69:2014 - Medical electrical equipment -- Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
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ISO 80601-2-69:2014 - Medical electrical equipment -- Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
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Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 80601-2-69
First edition
2014-07-15

Medical electrical equipment —
Part 2-69:
Particular requirements for basic safety
and essential performance of oxygen
concentrator equipment
Appareils électromédicaux —
Partie 2-69: Exigences particulières pour la sécurité de base et
les performances essentielles des dispositifs concentrateurs
d'oxygène




Reference number
ISO 80601-2-69:2014(E)
©
 ISO 2014

---------------------- Page: 1 ----------------------
ISO 80601-2-69:2014(E)

COPYRIGHT PROTECTED DOCUMENT


©  ISO 2014
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

© ISO 2014 – All rights reserved
ii

---------------------- Page: 2 ----------------------
ISO 80601-2-69:2014(E)
Contents Page
Foreword . 5
Introduction . 7
201.1 Scope, object and related standards . 1
201.2 Normative references . 3
201.3 Terms and definitions . 4
201.4 General requirements . 5
201.5 General requirements for testing of ME EQUIPMENT . 6
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 6
201.7 ME EQUIPMENT identification, marking and documents . 6
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 12
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 12
201.10 Protection against unwanted and excessive radiation HAZARDS . 13
201.11 Protection against excessive temperatures and other HAZARDS . 13
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 16
201.13 HAZARDOUS SITUATIONS and fault conditions . 20
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 20
201.15 Construction of ME EQUIPMENT . 20
201.16 ME SYSTEMS . 20
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 21
201.101 Outlet connector . 21
201.102 Requirements for parts and ACCESSORIES . 21
201.102.1  * General . 21
201.102.2  Labelling . 21
201.102.3  * Fire RISK reduction in ACCESSORIES . 22
201.103 SIGNAL INPUT/OUTPUT PART . 22
201.103.1  General . 22
201.103.2  * Connection to a DISTRIBUTED ALARM SYSTEM . 22
201.103.3  * Connection for remote control . 23
201.104 * Indication of duration of operation . 23
201.105 Integrated CONSERVING EQUIPMENT . 23
202  Medical electrical equipment – Part 1-2: General requirements for basic safety and
essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests .
...

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