IEC 80601-2-49:2018/Amd 1:2024

Medical electrical equipment — Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment — Amendment 1

Appareils électromédicaux — Partie 2-49: Exigences particulières pour la sécurité de base et les performances essentielles des moniteurs multifonctions des patients — Amendement 1

General Information

• Status: Published
• Publication Date: 12-Sep-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: 13-Sep-2024
• Due Date: 08-Mar-2024
• Completion Date: 13-Sep-2024

Standards Content (Sample)

IEC 80601-2-49
Edition 1.0 2024-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Medical electrical equipment –
Part 2-49: Particular requirements for the basic safety and essential performance
of multifunction patient monitors

Appareils électromédicaux –
Partie 2-49: Exigences particulières pour la sécurité de base et les performances
essentielles des moniteurs multifonctions des patients

IEC 80601-2-49:2018-03/AMD1:2024-09(en-fr)

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IEC 80601-2-49
Edition 1.0 2024-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –

Part 2-49: Particular requirements for the basic safety and essential performance

of multifunction patient monitors

Appareils électromédicaux –
Partie 2-49: Exigences particulières pour la sécurité de base et les performances

essentielles des moniteurs multifonctions des patients

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55 ISBN 978-2-8322-9641-7

– 2 – IEC 80601-2-49:2018/AMD1:2024
© IEC 2024
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-49: Particular requirements for the basic safety
and essential performance of multifunction patient monitors

AMENDMENT 1
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC Publication(s)"). Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
Amendment 1 to IEC 80601-2-49:2018 has been prepared by subcommittee 62D: Particular
medical equipment, software, and systems, of IEC technical committee 62: Medical equipment,
software, and systems.
The text of this Amendment is based on the following documents:
Draft Report on voting
62D/2146/FDIS 62D/2164/RVD
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.

IEC 80601-2-49:2018/AMD1:2024 – 3 –
© IEC 2024
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/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,
• replaced by a revised edition, or
• amended.
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 to Amendment 1
At the October 2019 meeting of IEC SC 62D in Shanghai, China, the subcommittee discussed
the need for administrative/technical changes to most 62D standards after completion of the
amendment projects within the IEC 60601-1 series. Those projects were all completed and the
amendments published in 2020.
The full list of IEC SC 62D documents that will be amended or revised may be found within the
IEC document 62D/1792/DC. The results and comments on the DC may be found within
62D/1808/INF. The review report for this amendment is 62D/1835A/RR.
___________
201.1 Scope, object and related standards
Replace the existing text of footnote 1 with the following new text:
The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
201.1.3 Collateral standards
Replace the existing second paragraph with the following new paragraph:
IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010,
IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020, as well as
IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020
apply as modified in Clauses 202, 206 and 208 respectively. IEC 60601-1-3 and IEC 60601-1-9
do not apply. All other published collateral standards in the IEC 60601-1 series apply as
published.
– 4 – IEC 80601-2-49:2018/AMD1:2024
© IEC 2024
201.1.4 Particular standards
Replace the existing third paragraph with the following new paragraph:
For brevity, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 are referred to in this particular standard as the general
standard. Collateral standards are referred to by their document number.
th
Replace, in the second sentence of the 8 paragraph, "3.1 through 3.147" with "3.1 through
3.154".
201.2 Normative references
Replace the existing references to IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8,
IEC 60601-1, IEC 60601-1-11 and IEC 60601-1-12 with the following new references:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic disturbances –
Requirements and tests
IEC 60601-1-2:2014/AMD1:2020
IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral standard: Usability
IEC 60601-1-6:2010/AMD1:2013
IEC 60601-1-6:2010/AMD2:2020
IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic
safety and essential performance – Collateral standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-1-8:2006/AMD1:2012
IEC 60601-1-8:2006/AMD2:2020
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: General requirements for basic
safety and essential performance – Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems used in the home
...

FINAL DRAFT
Amendment
IEC 80601-2-
49:2018/
FDAM 1
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-49:
Voting begins on:
2024-06-21
Particular requirements for
the basic safety and essential
Voting terminates on:
2024-08-16
performance of multifunction
patient monitoring equipment
AMENDMENT 1
Appareils électromédicaux —
Partie 2-49: Exigences particulières pour la sécurité de base et
les performances essentielles des moniteurs multifonctions des
patients
AMENDEMENT 1
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
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
This draft is submitted to a parallel vote in ISO and in IEC.
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.
Reference number
IEC 80601­2­49:2018/FDAM 1:2024(en) © IEC 2024

FINAL DRAFT
IEC 80601-2-49:2018/FDAM 1:2024(en)
Amendment
IEC 80601-2-
49:2018/
FDAM 1
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-49:
Voting begins on:
Particular requirements for 2024-06-21
the basic safety and essential
Voting terminates on:
2024-08-16
performance of multifunction
patient monitoring equipment
AMENDMENT 1
Appareils électromédicaux —
Partie 2-49: Exigences particulières pour la sécurité de base et
les performances essentielles des moniteurs multifonctions des
patients
AMENDEMENT 1
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.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
This draft is submitted to a parallel vote in ISO and in IEC.
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
IEC 80601­2­49:2018/FDAM 1:2024(en) © IEC 2024

© IEC 2024 – All rights reserved
ii
– 2 – IEC FDIS 80601-2-49:2018/AMD1
© IEC 2024
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-49: Particular requirements for the basic safety
and essential performance of multifunction patient monitors

AMENDMENT 1
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
Amendment 1 to IEC 80601-2-49:2018 has been prepared by subcommittee 62D: Particular
medical equipment, software, and systems, of IEC technical committee 62: Medical equipment,
software, and systems.
The text of this Amendment is based on the following documents:
Draft Report on voting
62D/XX/FDIS 62D/XX/RVD
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.

IEC FDIS 80601-2-49:2018/AMD1 – 3 –
© IEC 2024
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/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,
• replaced by a revised edition, or
• amended.
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 to Amendment 1
At the October 2019 meeting of IEC SC 62D in Shanghai, China, the subcommittee discussed
the need for administrative/technical changes to most 62D standards after completion of the
amendment projects within the IEC 60601-1 series. Those projects were all completed and the
amendments published in 2020.
The full list of IEC SC 62D documents that will be amended or revised may be found within the
IEC document 62D/1792/DC. The results and comments on the DC may be found within
62D/1808/INF. The review report for this amendment is 62D/1835A/RR.

_____________
201.1 Scope, object and related standards
Replace the existing text of footnote 1 with the following new text:
The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.

– 4 – IEC FDIS 80601-2-49:2018/AMD1
© IEC 2024
201.1.3 Collateral standards
Replace the existing second paragraph with the following new paragraph:
IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010,
IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020, as well as
IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020
apply as modified in Clauses 202, 206 and 208 respectively. IEC 60601-1-3 and IEC 60601-1-9
do not apply. All other published collateral standards in the IEC 60601-1 series apply as
published.
201.1.4 Particular standards
Replace the existing third paragraph with the following new paragraph:
For brevity, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 are referred to in this particular standard as the general
standard. Collateral standards are referred to by their document number.
th
Replace, in the second sentence of the 8 paragraph, “3.1 through 3.147” with “3.1 through
3.154”.
201.2 Normative references
...