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ISO 80601-2-13:2011

(Main)

Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

ISO/IEC 80601-2-13:2011 is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator. ISO/IEC 80601-2-13:2011 specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification:
- anaesthetic gas delivery system;
- anaesthetic breathing system;
- anaesthetic gas scavenging system;
- anaesthetic vapour delivery system;
- anaesthetic ventilator;
- monitoring equipment;
- alarm system;
- protection device.
ISO/IEC 80601-2-13:2011 is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation. If a clause or subclause is specifically intended to be applicable to anaesthetic workstation components only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to an anaesthetic workstation and its individual components, as relevant. Hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components within the scope of ISO/IEC 80601-2-13:2011 are not covered by specific requirements in ISO/IEC 80601-2-13:2011 except in 7.2.13 and 8.4.1 of IEC 60601-1:2005. ISO/IEC 80601-2-13:2011 is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.

Appareils électromédicaux - Partie 2-13: Exigences particulières de sécurité de base et de performances essentielles pour les postes de travail d'anesthésie

General Information

Status
Published
Publication Date
10-Aug-2011
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 2 - TC 62/SC 62D/JWG 2
Current Stage
DELPUB - Deleted Publication
Start Date
07-Sep-2018
Completion Date
03-May-2022
Ref Project

Relations

Amended By
ISO 80601-2-13:2011/AMD1:2015 - Amendment 1 - Medical electrical equipment -- Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
Effective Date
05-Sep-2023
Amended By
ISO 80601-2-13:2011/AMD2:2018 - Amendment 2 - Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
Effective Date
05-Sep-2023
Revised
ISO 80601-2-13:2022 - Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
Effective Date
05-Sep-2023

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ISO 80601-2-13:2011 - Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstationISO 80601-2-13:2011 - Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
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ISO 80601-2-13:2011 - Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
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Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 80601-2-13
First edition
2011-08-01

Medical electrical equipment —
Part 2-13:
Particular requirements for basic safety
and essential performance of an
anaesthetic workstation
Appareils électromédicaux —
Partie 2-13: Exigences particulières de sécurité de base et de
performance essentielle pour les systèmes d'anesthésie




Reference number
ISO 80601-2-13:2011(E)
©
ISO 2011

---------------------- Page: 1 ----------------------
ISO 80601-2-13:2011(E)

COPYRIGHT PROTECTED DOCUMENT


©  ISO/IEC 2011
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 2011 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 80601-2-13:2011(E)
Contents Page
Foreword .v
Introduction.vi
201.1 Scope, object and related standards.1
201.2 Normative references.3
201.3 Terms and definitions .5
201.4 General requirements.9
201.5 General requirements for testing ME EQUIPMENT .11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .11
201.7 ME EQUIPMENT identification, marking and documents .11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT.15
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS.16
201.10 Protection against unwanted and excessive radiation HAZARDS .17
201.11 Protection against excessive temperatures and other HAZARDS .17
201.12 Accuracy of controls and instruments and protection against hazardous outputs .19
201.13 HAZARDOUS SITUATIONS and fault conditions.24
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .24
201.15 Construction of ME EQUIPMENT.25
201.16 ME SYSTEMS .25
201.17 Electromagnetic compatibility of ME EQUIPMENT AND ME SYSTEMS.26
201.101 Additional requirements for ANAESTHETIC GAS DELIVERY SYSTEMS.26
201.102 Additional requirements for an ANAESTHETIC BREATHING SYSTEM .32
201.103 Additional requirements for an ANAESTHETIC GAS SCAVENGING SYSTEM.39
201.104 Additional requirements for an ANAESTHETIC VAPOUR DELIVERY SYSTEM.43
201.105 Additional requirements for an ANAESTHETIC VENTILATOR.47
201.105.7 * Timed ventilatory pause .50
201.105.7.1 Expiratory pause .50
201.105.7.2 Inspiratory pause.50
201.106 Display loops.
...

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