IEC 80601-2-26:2019/Amd 1:2024

Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs — Amendment 1

Appareils électromédicaux — Partie 2-26: Exigences particulières pour la sécurité de base et les performances essentielles des électroencéphalographes — Amendement 1

General Information

• Status: Published
• Publication Date: 14-Feb-2024
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: ISO/TC 121/SC 3 - Respiratory devices and related equipment used for patient care
• Drafting Committee: ISO/TC 121/SC 3 - Respiratory devices and related equipment used for patient care
• Current Stage: 6060 - International Standard published
• Start Date: 15-Feb-2024
• Due Date: 08-Mar-2024
• Completion Date: 15-Feb-2024

Standards Content (Sample)

FINAL
AMENDMENT ISO
DRAFT
80601-2-
26:2019
FDAM 1
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Voting begins on:
Part 2-26:
2023-11-15
Particular requirements for the basic
Voting terminates on:
safety and essential performance of
2024-01-10
electroencephalographs
AMENDMENT 1
Appareils électromédicaux —
Partie 2-26: Exigences particulières pour la sécurité de base et les
performances essentielles des électroencéphalographes
AMENDEMENT 1
This draft is submitted to a parallel vote in ISO and in IEC.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO 80601-2-26:2019/FDAM 1:2023(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2023

---------------------- Page: 1 ----------------------
ISO 80601-2-26:2019/FDAM 1:2023(E)
FINAL
AMENDMENT ISO
DRAFT
80601-2-
26:2019
FDAM 1
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Voting begins on:
Part 2-26:
2023-11-15
Particular requirements for the basic
Voting terminates on:
safety and essential performance of
2024-01-10
electroencephalographs
AMENDMENT 1
Appareils électromédicaux —
Partie 2-26: Exigences particulières pour la sécurité de base et les
performances essentielles des électroencéphalographes
AMENDEMENT 1
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
This draft is submitted to a parallel vote in ISO and in IEC.
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: [phone]
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: [e-mail]
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO 80601-2-26:2019/FDAM 1:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
  © ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023

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IEC FDIS 80601-2-26:2019/AMD1 – 3 –
© IEC:2023
The text of this Amendment is based on the following documents:
Draft Report on voting
62D/XX/XXXX 62D/XX/XXX

Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this Amendment is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/standardsdev/publications/.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn,or
• revised.

NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC or
ISO publication in which to make products in accordance with the new requirements and to equip themselves for
conducting new or revised tests. It is the recommendation of the committee that the content of this publication be
adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.
__________

Introduction
Replace, in the existing first paragraph, “IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012”
with “IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020”.
Replace the existing second paragraph with the following:
The aim of this document is to bring this particular standard up to date with reference to
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
IEC 60601-1-2:2014, IEC 60601-1-2:2014/
...