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ISO 80601-2-67:2014

(Main)

Medical electrical equipment -- Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment

Medical electrical equipment -- Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment

ISO 80601-2-67:2014 is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as me equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator. ISO 80601-2-67:2014 is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment.

General Information

Status
Published
Publication Date
13-May-2014
ICS
01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
11.040.10 - Anaesthetic, respiratory and reanimation equipment
31.220.10 - Plug-and-socket devices. Connectors
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
02-Nov-2020
Ref Project

Relations

Revised
ISO 80601-2-67:2020 - Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment
Effective Date
05-Sep-2023

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ISO 80601-2-67:2014 - Medical electrical equipment -- Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipmentISO 80601-2-67:2014 - Medical electrical equipment -- Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment
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ISO 80601-2-67:2014 - Medical electrical equipment -- Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment
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Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 80601-2-67
First edition
2014-06-01

Medical electrical equipment —
Part 2-67:
Particular requirements for basic safety
and essential performance of oxygen
conserving equipment
Appareils électromédicaux —
Partie 2-67: Exigences particulières pour la sécurité de base et
les performances essentielles des économiseurs d'oxygène




Reference number
ISO 80601-2-67:2014(E)
©
 ISO 2014

---------------------- Page: 1 ----------------------
ISO 80601-2-67:2014(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 80601-2-67:2014(E)
Contents Page
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 . 7
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 7
201.7 ME EQUIPMENT identification, marking and documents . 7
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 13
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 13
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 . 15
201.13 HAZARDOUS SITUATIONS and fault conditions . 18
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18
201.15 Construction of ME EQUIPMENT . 18
201.16 ME SYSTEMS . 19
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 19
201.101 Gas connections . 19
201.101.1  Oxygen inlet connector . 19
201.101.2  Connection to the MEDICAL GAS PIPELINE SYSTEM . 19
201.101.3  Oxygen outlet connector . 19
201.102 Requirements for parts and ACCESSORIES . 20
201.102.1  General . 20
201.102.2  Labelling . 20
201.102.3  Fire RISK reduction in ACCESSORIES . 20
201.103 Oxygen pressure regulators . 21
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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