IEC 80601-2-49:2018
(Main)Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
IEC 80601-2-49:2018 applies to basic safety and essential performance requirements of multifunction patient monitors, hereafter referred to as ME equipment or medical electrical systems. This particular standard applies to multifunction patient monitors intended for use in professional healthcare facilities as well as in the emergency medical service environment or the home healthcare environment.
The scope of this document is restricted to ME equipment or medical electrical systems intended for connection to a single patient that has two or more physiological monitoring units.
For purposes of this document, a pregnant mother and her fetus(es) are considered a single patient.
This document does not specify requirements for individual physiological monitoring units such as ECG, invasive pressure and pulse oximetry. The particular standards related to these physiological monitoring units specify requirements from the perspective of stand-alone ME equipment. This particular standard addresses the additional requirements related to multifunction patient monitors. Multifunction patient monitors can be integrated into other ME equipment or medical electrical systems. When this is the case, other relevant standards also apply.
This document does not apply to implantable parts of multifunction patient monitors.
This first edition cancels and replaces the second edition of IEC 60601-2-49, published in 2011. This edition constitutes a technical revision to align with the current edition and Amendment to IEC 60601-1, new versions of collateral standards and amendments thereto. Major changes are in Clause 208 because many of the former requirements are now addressed by IEC 60601-1-8.
Appareils électromédicaux - Partie 2-49: Exigences particulières pour la sécurité de base et les performances essentielles des moniteurs multifonctions des patients
L’IEC 80601-2-49:2018 s'applique aux exigences pour la sécurité de base et les performances essentielles des moniteurs multifonctions des patients, désignés ci-après par appareils EM ou systèmes électromédicaux. La présente norme particulière s'applique aux moniteurs multifonctions des patients destinés à être utilisés dans les établissements professionnels de santé ainsi que dans l'environnement des services medicaux d'urgence ou dans l'environnement des soins à domicile.
Le domaine d'application du présent document est limité aux appareils EM ou aux systèmes électromédicaux destinés à la connexion à un patient unique qui comportent au minimum deux unités de surveillance physiologique.
Le présent document ne spécifie pas d'exigences pour les unités de surveillance physiologique individuelles telles que l'ECG, la pression prélevée directement et l'oxymétrie de pouls. Les normes particulières relatives à ces unités de surveillance physiologique spécifient des exigences dans la perspective d'appareils EM autonomes. La présente norme particulière aborde les exigences supplémentaires relatives aux moniteurs multifonctions des patients. Les moniteurs multifonctions des patients peuvent être intégrés dans d'autres appareils EM ou systèmes électromédicaux. Lorsque c'est le cas, d'autres normes s'appliquent également.
Le présent document ne s'applique pas aux parties implantables des moniteurs multifonctions des patients.
Cette première édition annule et remplace la deuxième édition de l'IEC 60601-2-49 parue en 2011. Cette édition constitue une révision technique et permet un alignement avec l'édition actuelle de l'IEC 60601-1 et son Amendement, ainsi qu'avec les nouvelles versions des normes collatérales et de leurs amendements. Les modifications majeures concernent l'Article 208, car une grande partie des exigences précédentes sont désormais traitées dans l'IEC 60601-1-8.
General Information
Relations
Buy Standard
Standards Content (Sample)
IEC 80601-2-49
Edition 1.1 2024-09
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-49: Particular requirements for the basic safety and essential performance
of multifunction patient monitors
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 IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
IEC Secretariat Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.
IEC publications search - webstore.iec.ch/advsearchform IEC Products & Services Portal - products.iec.ch
The advanced search enables to find IEC publications by a Discover our powerful search engine and read freely all the
variety of criteria (reference number, text, technical publications previews. With a subscription you will always have
committee, …). It also gives information on projects, replaced access to up to date content tailored to your needs.
and withdrawn publications.
Electropedia - www.electropedia.org
IEC Just Published - webstore.iec.ch/justpublished
The world's leading online dictionary on electrotechnology,
Stay up to date on all new IEC publications. Just Published
containing more than 22 500 terminological entries in English
details all new publications released. Available online and once
and French, with equivalent terms in 25 additional languages.
a month by email.
Also known as the International Electrotechnical Vocabulary
(IEV) online.
IEC Customer Service Centre - webstore.iec.ch/csc
If you wish to give us your feedback on this publication or need
further assistance, please contact the Customer Service
Centre: sales@iec.ch.
IEC 80601-2-49
Edition 1.1 2024-09
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-49: Particular requirements for the basic safety and essential performance
of multifunction patient monitors
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.55 ISBN 978-2-8322-9710-0
REDLINE VERSION – 2 – IEC 80601-2-49:2018+AMD1:2024 CSV
© IEC 2024
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
INTRODUCTION to Amendment 1 . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 11
201.4 General requirements . 11
201.5 General requirements for testing ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 16
201.10 Protection against unwanted and excessive radiation HAZARDS . 16
201.11 Protection against excessive temperatures and other HAZARDS . 16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 17
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 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
202 Electromagnetic disturbances – Requirements and tests . 19
206 USABILITY . 24
208 General requirements, tests and guidance for ALARM SYSTEMS IN MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 24
Annexes . 28
Annex AA (informative) Particular guidance and rationale . 29
Bibliography . 38
Index of defined terms used in this particular standard . 39
Figure 201.101 – MULTIFUNCTION PATIENT MONITOR with single PATIENT circuit (6) with
multiple PHYSIOLOGICAL MONITORING UNITS and multiple PATIENT circuits (7) each with a
single PHYSIOLOGICAL MONITORING UNIT . 15
Figure 202.101 – Test layout for conducted and radiated EMISSIONS and IMMUNITY test . 20
Figure 202.102 – Test circuit for HF SURGICAL EQUIPMENT protection measurement
according to 202.8.102 with PATIENT CONNECTIONS . 22
Figure 202.103 – Test setup for HF SURGICAL EQUIPMENT protection measurement
according to 202.8.102 . 23
Figure 202.104 – Test circuit for HF SURGICAL EQUIPMENT protection measurement
according to 202.8.102 with non-conductive APPLIED PART . 24
Figure AA.1 – Example of a pre-configured MULTIFUNCTION PATIENT MONITOR . 30
Figure AA.2 – Example of a modular MULTIFUNCTION PATIENT MONITOR . 30
Figure AA.3 – Example of a MULTIFUNCTION PATIENT MONITOR connected to
a central station . 30
© IEC 2024
Figure AA.4 – Example of a MULTIFUNCTION PATIENT MONITOR integrated into a ventilator . 31
Figure AA.5 – Single PATIENT circuit with multiple PHYSIOLOGICAL MONITORING UNITS and
PATIENT cables . 33
Table 201.101 – ESSENTIAL PERFORMANCE requirements. 12
REDLINE VERSION – 4 – IEC 80601-2-49:2018+AMD1:2024 CSV
© IEC 2024
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-49: Particular requirements for the basic safety and
essential performance of multifunction patient monitors
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.
This consolidated version of the official IEC Standard and its amendment has been
prepared for user convenience.
IEC 80601-2-49 edition 1.1 contains the first edition (2018-03) [documents
62D/1547/FDIS and 62D/1559/RVD] and its amendment 1 (2024-09) [documents
62D/2146/FDIS and 62D/2164/RVD].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendment 1. Additions are in green text, deletions are in strikethrough
red text. A separate Final version with all changes accepted is available in this
publication.
© IEC 2024
International standard IEC 80601-2-49 has been prepared by a Joint Working Group of IEC
subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical
equipment in medical practice, and of ISO subcommittee SC3: Lung ventilators and related
equipment, of ISO technical committee 121: Anaesthetic and respiratory equipment.
This first edition cancels and replaces the second edition of IEC 60601-2-49, published in
2011. This edition constitutes a technical revision to align with the current edition and
Amendment to IEC 60601-1, new versions of collateral standards and amendments thereto.
Major changes are in Clause 208 because many of the former requirements are now
addressed by IEC 60601-1-8.
It is published as a double logo standard.
Full information on the voting for the approval of this document can be found in the report on
voting indicated in the above table. In ISO, the standard has been approved by XXX P
members out of YYY having cast a vote.
In this document, the following print types are used:
– requirements and definitions: roman type;
– test specifications: italic type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
– "clause" means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this document are preceded by the term "Clause" followed by
the clause number. References to subclauses within this particular standard are by number
only.
In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to
...
IEC 80601-2-49
Edition 1.0 2018-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
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 IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing 21 000 terms and definitions in
Technical Specifications, Technical Reports and other English and French, with equivalent terms in 16 additional
documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical
iPad. Vocabulary (IEV) online.
IEC publications search - webstore.iec.ch/advsearchform IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a 67 000 electrotechnical terminology entries in English and
variety of criteria (reference number, text, technical French extracted from the Terms and Definitions clause of
committee,…). It also gives information on projects, replaced IEC publications issued since 2002. Some entries have been
and withdrawn publications. collected from earlier publications of IEC TC 37, 77, 86 and
CISPR.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Customer Service Centre - webstore.iec.ch/csc
details all new publications released. Available online and If you wish to give us your feedback on this publication or
also once a month by email. need further assistance, please contact the Customer Service
Centre: sales@iec.ch.
A propos de l'IEC
La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.
A propos des publications IEC
Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la
plus récente, un corrigendum ou amendement peut avoir été publié.
Catalogue IEC - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
Application autonome pour consulter tous les renseignements
Le premier dictionnaire en ligne de termes électroniques et
bibliographiques sur les Normes internationales,
électriques. Il contient 21 000 termes et définitions en anglais
Spécifications techniques, Rapports techniques et autres
et en français, ainsi que les termes équivalents dans 16
documents de l'IEC. Disponible pour PC, Mac OS, tablettes
langues additionnelles. Egalement appelé Vocabulaire
Android et iPad.
Electrotechnique International (IEV) en ligne.
Recherche de publications IEC -
Glossaire IEC - std.iec.ch/glossary
webstore.iec.ch/advsearchform
67 000 entrées terminologiques électrotechniques, en anglais
La recherche avancée permet de trouver des publications IEC et en français, extraites des articles Termes et Définitions des
en utilisant différents critères (numéro de référence, texte, publications IEC parues depuis 2002. Plus certaines entrées
comité d’études,…). Elle donne aussi des informations sur les antérieures extraites des publications des CE 37, 77, 86 et
projets et les publications remplacées ou retirées. CISPR de l'IEC.
IEC Just Published - webstore.iec.ch/justpublished Service Clients - webstore.iec.ch/csc
Restez informé sur les nouvelles publications IEC. Just Si vous désirez nous donner des commentaires sur cette
Published détaille les nouvelles publications parues. publication ou si vous avez des questions contactez-nous:
Disponible en ligne et aussi une fois par mois par email. sales@iec.ch.
IEC 80601-2-49
Edition 1.0 2018-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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 978-2-8322-5359-5
– 2 – IEC 80601-2-49:2018 © IEC 2018
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 11
201.4 General requirements . 11
201.5 General requirements for testing ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 16
201.10 Protection against unwanted and excessive radiation HAZARDS . 16
201.11 Protection against excessive temperatures and other HAZARDS . 16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 17
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 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
202 Electromagnetic disturbances – Requirements and tests . 19
206 USABILITY . 24
208 General requirements, tests and guidance for ALARM SYSTEMS IN MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 25
Annexes . 28
Annex AA (informative) Particular guidance and rationale . 29
Bibliography . 38
Index of defined terms used in this particular standard . 39
Figure 201.101 – MULTIFUNCTION PATIENT MONITOR with single PATIENT circuit (6) with
multiple PHYSIOLOGICAL MONITORING UNITS and multiple PATIENT circuits (7) each with a
single PHYSIOLOGICAL MONITORING UNIT . 15
Figure 202.101 – Test layout for conducted and radiated EMISSIONS and IMMUNITY test . 20
Figure 202.102 – Test circuit for HF SURGICAL EQUIPMENT protection measurement
according to 202.8.102 with PATIENT CONNECTIONS . 22
Figure 202.103 – Test setup for HF SURGICAL EQUIPMENT protection measurement
according to 202.8.102 . 23
Figure 202.104 – Test circuit for HF SURGICAL EQUIPMENT protection measurement
according to 202.8.102 with non-conductive APPLIED PART . 24
Figure AA.1 – Example of a pre-configured MULTIFUNCTION PATIENT MONITOR . 30
Figure AA.2 – Example of a modular MULTIFUNCTION PATIENT MONITOR . 30
Figure AA.3 – Example of a MULTIFUNCTION PATIENT MONITOR connected to a central
station . 30
Figure AA.4 – Example of a MULTIFUNCTION PATIENT MONITOR integrated into a ventilator . 31
Figure AA.5 – Single PATIENT circuit with multiple PHYSIOLOGICAL MONITORING UNITS and
PATIENT cables . 33
Table 201.101 – ESSENTIAL PERFORMANCE requirements. 12
– 4 – IEC 80601-2-49:2018 © IEC 2018
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-49: Particular requirements for the basic safety and
essential performance of multifunction patient monitors
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 (inclu
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.