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

Amendement 1 - 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: 05-Mar-2015
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 03-May-2022

Relations

• Amends: ISO 80601-2-13:2011 - 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

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 80601-2-13
First edition
2011-08-01
AMENDMENT 1
2015-03-01
Medical electrical equipment —
Part 2-13:
Particular requirements for basic
safety and essential performance of an
anaesthetic workstation
AMENDMENT 1
Appareils électromédicaux —
Partie 2-13: Exigences particulières de sécurité de base et de
performances essentielles pour les postes de travail d’anesthésie
AMENDEMENT 1
Reference number
ISO 80601-2-13:2011/Amd.1:2015(E)
©
ISO 2015

---------------------- Page: 1 ----------------------
ISO 80601-2-13:2011/Amd.1:2015(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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2015 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 80601-2-13:2011/Amd.1:2015(E)

Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide standardization. National bodies that are
members of ISO or IEC participate in the development of International Standards through technical
committees established by the respective organization to deal with particular fields of technical
activity. ISO and IEC technical committees collaborate in fields of mutual interest. Other international
organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the
work. In the field of information technology, ISO and IEC have established a joint technical committee,
ISO/IEC JTC 1.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for
the different types of document should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject
of patent rights. ISO and IEC shall not be held responsible for identifying any or all such patent rights.
Details of any patent rights identified during the development of the document will be in the Introduction
and/or on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT), see the following URL: Foreword — Supplementary information.
The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 1, Breathing attachments and anaesthetic machines and Technical Committee IEC/TC
62, Electrical equipment in medical practice, Subcommittee SC D, Electromedical equipment.
© ISO 2015 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO 80601-2-13:2011/Amd.1:2015(E)

Introduction
The first edition of IEC 80601-2-13 was published in 2011. This amendment is intended to update the
references to IEC 60601-1:2005 to include Amendment 1:2012, to update the references to IEC 60601-
1-6:2010 to include Amendment 1:2013, to update the references to IEC 60601-1-8:2006 to include
Amendment 1:2012 and to update the references to IEC 60601-1-10 to include Amendment 1:2012. This
amendment also introduces technical modifications to clarify the relationship between this standard
and IEC 60601-2-49 and to further specify accessories. It amends requirements on the following
aspects, in part due to the publication of the before-mentioned amendments:
— addition of a definition on interchangeable anaesthetic vapour delivery system;
— marking the mass of mobile me equipment;
— movement over a threshold;
— rough handling test;
— multiple socket-outlets;
— specific requirements on anaesthetic gas delivery systems and anaesthetic breathing
systems including instructions for use;
— vapour concentration during and after oxygen flush;
— inspiratory pause.
Where appropriate, this amendment also includes modifications of specific informative annexes related
to the amended requirements as listed above. Finally, minor editorial updates were made.
iv © ISO 2015 – All rights reserved

---------------------- Page: 4 -------
...