IEC 60601-2-49:2001

Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment

Specifies requirements for the safety of multifunction patient monitoring equipment. The scope of this standard is restricted to equipment having either more than one applied part or more than one single function, intended for connection to a single patient. This is the bilingual version of the English version published in July 2001.

Appareils électromédicaux - Partie 2-49: Règles particulières de sécurité des appareils de surveillance multifonction des patients

Spécifie des exigences de sécurité pour les appareils de surveillance multifonction des patients. Le domaine d'application de la présente norme est restreint aux appareils qui comportent soit plusieurs parties appliquées, soit plusieurs fonctions uniques, destinés à la connexion à un patient unique. C'est la version bilingue de la version anglaise publiée en Juillet 2001.

General Information

• Status: Published
• Publication Date: 23-Jul-2001
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 25-Feb-2011

Relations

• Revised: IEC 60601-2-49:2011 - Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD
60601-2-49
First edition
2001-07
Medical electrical equipment –
Part 2-49:
Particular requirements for the safety
of multifunction patient monitoring equipment
Appareils électromédicaux –
Partie 2-49:
Règles particulières de sécurité des appareils
de surveillance multifonction des patients
Reference number
Publication numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series. For example, IEC 34-1 is now referred to as IEC 60034-1.
Consolidated editions
The IEC is now publishing consolidated versions of its publications. For example,
edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the base publication, the
base publication incorporating amendment 1 and the base publication incorporating
amendments 1 and 2.
Further information on IEC publications
The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology. Information relating to
this publication, including its validity, is available in the IEC Catalogue of
publications (see below) in addition to new editions, amendments and corrigenda.
Information on the subjects under consideration and work in progress undertaken
by the technical committee which has prepared this publication, as well as the list
of publications issued, is also available from the following:
• IEC Web Site (www.iec.ch)
• Catalogue of IEC publications
The on-line catalogue on the IEC web site (www.iec.ch/catlg-e.htm) enables
you to search by a variety of criteria including text searches, technical
committees and date of publication. On-line information is also available on
recently issued publications, withdrawn and replaced publications, as well as
corrigenda.
• IEC Just Published
This summary of recently issued publications (www.iec.ch/JP.htm) is also
available by email. Please contact the Customer Service Centre (see below) for
further information.
• Customer Service Centre
If you have any questions regarding this publication or need further assistance,
please contact the Customer Service Centre:
Email: [e-mail]
Tel: [phone]
Fax: [phone]
INTERNATIONAL IEC
STANDARD
60601-2-49
First edition
2001-07
Medical electrical equipment –
Part 2-49:
Particular requirements for the safety
of multifunction patient monitoring equipment
Appareils électromédicaux –
Partie 2-49:
Règles particulières de sécurité des appareils
de surveillance multifonction des patients
 IEC 2001  Copyright - all rights reserved
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 the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
S
International Electrotechnical Commission
For price, see current catalogue

– 2 – 60601-2-49  IEC:2001(E)
CONTENTS
FOREWORD.3
INTRODUCTION.5
SECTION ONE – GENERAL
1 Scope and object .6
2 Terminology and definitions.7
5 Classification .9
6 Identification, marking and documents.9
SECTION TWO – ENVIRONMENTAL CONDITIONS
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 Requirements related to classification .10
17 Separation .10
19 Continuous leakage currents and patient auxiliary currents.12
20 Dielectric strength .14
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION
*36 Electromagnetic compatibility .15
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE
ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
49 Interruption of the power supply .16
SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data.16
51 Protection against hazardous output.16
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly.23
Appendix L – References – Publications mentioned in this standard .25
Annex AA (informative) Guidance and rationale .26
Annex BB (informative) Alarm diagrams of clause 51.33
Annex EE (informative) Survey of insulation paths and test circuit.36
Annex KK (informative) Examples of patient leakage current measurements.37
Index of defined terms .44

60601-2-49  IEC:2001(E) – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-49: Particular requirements for the safety
of multifunction patient monitoring equipment
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the 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, the IEC publishes International Standards. 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. The 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 the 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 National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-49 has been prepared by subcommittee 62D: Electro-
medical equipment, of IEC technical committee 62: Electrical equipment in medical practice.
The text of this standard is based upon the following documents:
FDIS Report on voting
62D/409/FDIS 62D/412/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 3.
Annexes AA, BB, EE and KK are for information only.

– 4 – 60601-2-49  IEC:2001(E)
In this Particular Standard the following print types are used:
– requirements, compliance with which can be tested, and definitions: in roman type;
– notes, explanations, advice, introductions, general statements, exceptions and references: in smaller type;
– test specifications, headings of subclauses and headings of items: in italic type;
–TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL
CAPITALS.
The committee has decided that the contents of this publication will remain unchanged until
2006. At this date, the publication will be:
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
A bilingual version of this publication may be issued at a later date.

60601-2-49  IEC:2001(E) – 5 –
INTRODUCTION
This Particular Standard concerns the safety of multifunction patient monitoring equipment. It
amends and supplements IEC 60601-1 (second edition 1988), hereinafter referred to as the
General Standard. The requirements of this Particular Standard take priority over those of the
General Standard, entitled “Medical electrical equipment – Part 1: General requirements for
safety”.
A “General guidance and rationale” for the requirements of this Particular Standard is included
in annex AA.
It is considered that knowledge of the reasons for these requirements will not only facilitate the
proper application of the standard but will, in due course, expedite any revision necessitated by
changes in clinical practice or as a result of developments in technology. However, this annex
does not form part of the requirements of this Standard.
An asterisk (*) by a clause or subclause number indicates that some explanatory notes are
given in Annex A of this Particular Standard.
At the time of the publication of this Particular Standard, work was in progress to create a joint
ISO/IEC collateral standard addressing “General requirements and guidelines for the
application of alarms in medial electrical equipment”. It is intended to harmonize this standard
with the above-mentioned collateral standard after its publication.

– 6 – 60601-2-49  IEC:2001(E)
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-49: Particular requirements for the safety
of multifunction patient monitoring equipment
SECTION ONE – GENERAL
This section of the General Standard applies except as follows:
1 Scope and object
*1.1 Scope
This Particular Standard applies to the safety requirements of MULTIFUNCTION PATIENT
MONITORING EQUIPMENT as defined in subclause 2.2.101.
The scope of this standard is restricted to EQUIPMENT having either more than one APPLIED
PART or more than one SINGLE FUNCTION, intended for connection to a single PATIENT.
This standard does not specify requirements for individual monitoring functions.
1.2 Object
The object of this Particular Standard is to specify requirements for the safety of MULTIFUNCTION
PATIENT MONITORING EQUIPMENT.
1.3 Particular Standards
Addition:
This Particular Standard refers to IEC 60601-1 (1988): Medical electrical equipment – Part 1:
General requirements for safety as amended by its amendment 1 (1991) and amendment 2
(1995).
For brevity, Part 1 is referred to in this Particular Standard either as the “General Standard” or
as the “General Requirement(s)”.
The numbering of sections, clauses and subclauses of this Particular Standard corresponds to
that of the General Standard. Changes to the text of the General Standard are specified by the
use of the following words:
“Replacement” means that the clause or subclause of the General Standard is replaced
completely by the text of this Particular Standard.
“Addition” means that the text of this Particular Standard is additional to the requirements of
the General Standard.
“Amendment” means that the clause or subclause of the General Standard is amended as
indicated by the text of this Particular Standard.

60601-2-49  IEC:2001(E) – 7 –
Subclauses or figures which are additional to those of the General Standard are numbered
starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb),
etc.
The term “this Standard” is used to make reference to the General Standard and this Particular
Standard taken together.
Where there is no corresponding section, clause or subclause in this Particular Standard, the
section, clause or subclause of the General Standard, although possibly not relevant, applies
without modification; where it is intended that any part of the General Standard, although
possibly relevant, is not to be applied, a statement to that effect is given in this Particular
Standard.
The requirements of this Particular Standard take priority over those of the General Standard
and Collateral Standard mentioned above.
1.5 Collateral standards
Addition:
IEC 60601-1-2:1993, Medical electrical equipment – Part 1: General requirements for safety –
2. Collateral Standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-1-4:1996, Medical electrical equipment – Part 1: General requirements for safety –
4.Collateral standard: Programmable electric medical systems
Amendment 1 (1999)
2 Terminology and definitions
*2.1.5
APPLIED PART
Delete second dash.
Additional definitions:
2.2. EQUIPMENT types (classification)
2.2.101
MULTIFUNCTION PATIENT MONITORING EQUIPMENT (hereinafter referred to as EQUIPMENT)
modular or pre-config
...

IEC 60601-2-49
Edition 1.0 2001-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-49: Particular requirements for the safety of multifunction patient
monitoring equipment
Appareils électromédicaux –
Partie 2-49: Règles particulières de sécurité des appareils de surveillance
multifonction 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 la CEI ou du Comité national de la CEI du pays du demandeur.
Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette
publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.

IEC Central Office
3, rue de Varembé
CH-1211 Geneva 20
Switzerland
Email: [e-mail]
Web: www.iec.ch
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.
ƒ Catalogue of IEC publications: www.iec.ch/searchpub
The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,…).
It also gives information on projects, withdrawn and replaced publications.
ƒ IEC Just Published: www.iec.ch/online_news/justpub
Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available
on-line and also by email.
ƒ Electropedia: www.electropedia.org
The world's leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions
in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical
Vocabulary online.
ƒ Customer Service Centre: www.iec.ch/webstore/custserv
If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service
Centre FAQ or contact us:
Email: [e-mail]
Tel.: [phone]
Fax: [phone]
A propos de la CEI
La Commission Electrotechnique Internationale (CEI) 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 CEI
Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possédez
l’édition la plus récente, un corrigendum ou amendement peut avoir été publié.
ƒ Catalogue des publications de la CEI: www.iec.ch/searchpub/cur_fut-f.htm
Le Catalogue en-ligne de la CEI vous permet d’effectuer des recherches en utilisant différents critères (numéro de référence,
texte, comité d’études,…). Il donne aussi des informations sur les projets et les publications retirées ou remplacées.
ƒ Just Published CEI: www.iec.ch/online_news/justpub
Restez informé sur les nouvelles publications de la CEI. Just Published détaille deux fois par mois les nouvelles
publications parues. Disponible en-ligne et aussi par email.
ƒ Electropedia: www.electropedia.org
Le premier dictionnaire en ligne au monde de termes électroniques et électriques. Il contient plus de 20 000 termes et
définitions en anglais et en français, ainsi que les termes équivalents dans les langues additionnelles. Egalement appelé
Vocabulaire Electrotechnique International en ligne.
ƒ Service Clients: www.iec.ch/webstore/custserv/custserv_entry-f.htm
Si vous désirez nous donner des commentaires sur cette publication ou si vous avez des questions, visitez le FAQ du
Service clients ou contactez-nous:
Email: [e-mail]
Tél.: [phone]
Fax: [phone]
IEC 60601-2-49
Edition 1.0 2001-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-49: Particular requirements for the safety of multifunction patient
monitoring equipment
Appareils électromédicaux –
Partie 2-49: Règles particulières de sécurité des appareils de surveillance
multifonction des patients
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
X
CODE PRIX
ICS 11.040.55 ISBN 2-8318-8475-6
– 2 – 60601-2-49 © CEI:2001
SOMMAIRE
AVANT-PROPOS .6
INTRODUCTION.10

SECTION UN – GÉNÉRALITÉS
1 Domaine d’application et objet .12
2 Terminologie et définitions .14
5 Classification.18
6 Identification, marquage et documentation .18

SECTION DEUX – CONDITIONS D’ENVIRONNEMENT

SECTION TROIS – PROTECTION CONTRE LES RISQUES DE CHOCS
ÉLECTRIQUES
14 Exigences relatives à la classification .20
17 Séparation.20
19 Courants de fuite permanents et courants auxiliaires patient .24
20 Tension de tenue .28

SECTION QUATRE – PROTECTION CONTRE LES RISQUES MÉCANIQUES

SECTION CINQ – PROTECTION CONTRE LES RISQUES DUS AUX
RAYONNEMENTS NON DÉSIRÉS OU EXCESSIFS
*36 Compatibilité électromagnétique .30

SECTION SIX – PROTECTION CONTRE LES RISQUES DE COMBUSTION DES
MÉLANGES ANESTHÉSIQUES INFLAMMABLES

SECTION SEPT – PROTECTION CONTRE LES TEMPÉRATURES EXCESSIVES ET
LES AUTRES RISQUES
49 Coupure de l’alimentation .32

SECTION HUIT – PRÉCISION DES CARACTÉRISTIQUES DE FONCTIONNEMENT
ET PROTECTION CONTRE LES CARACTÉRISTIQUES DE SORTIE
PRÉSENTANT DES RISQUES
50 Précision des caractéristiques de fonctionnement .32
51 Protection contre les caractéristiques de sortie présentant des risques.34

SECTION NEUF – FONCTIONNEMENT ANORMAL ET CONDITIONS DE DÉFAUT;
ESSAIS D’ENVIRONNEMENT
60601-2-49 © IEC:2001 – 3 –
CONTENTS
FOREWORD.7
INTRODUCTION.11

SECTION ONE – GENERAL
1 Scope and object .13
2 Terminology and definitions .15
5 Classification.19
6 Identification, marking and documents .19

SECTION TWO – ENVIRONMENTAL CONDITIONS

SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 Requirements related to classification .21
17 Separation.21
19 Continuous leakage currents and patient auxiliary currents.25
20 Dielectric strength.29

SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS

SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION
*36 Electromagnetic compatibility.31

SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE
ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
OTHER SAFETY HAZARDS
49 Interruption of the power supply .33

SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION AGAINST
HAZARDOUS OUTPUT
50 Accuracy of operating data.33
51 Protection against hazardous output .35

SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
– 4 – 60601-2-49 © CEI:2001
SECTION DIX – RÈGLES DE CONSTRUCTION
56 Composants et ensembles.46

Annexe L (normative) Références – Publications mentionnées dans la présente norme .50
Annexe AA (informative) Lignes directrices et justifications.52
Annexe BB (informative) Diagrammes d’alarme de l’Article 51 .68
Annexe EE (informative) Etude des chemins d'isolation et du circuit d'essai.74
Annexe KK (informative) Exemples de mesurages du COURANT DE FUITE PATIENT .76

INDEX DES TERMES DÉFINIS .90

60601-2-49 © IEC:2001 – 5 –
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly.47

Appendix L (normative) References – Publications mentioned in this standard.51
Annex AA (informative) Guidance and rationale .53
Annex BB (informative) Alarm diagrams of clause 51.69
Annex EE (informative) Survey of insulation paths and test circuit.75
Annex KK (informative) Examples of PATIENT LEAKAGE CURRENT measurements .77

INDEX OF DEFINED TERMS .91

– 6 – 60601-2-49 © CEI:2001
COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE
___________
APPAREILS ÉLECTROMÉDICAUX –
Partie 2-49: Règles particulières de sécurité
des appareils de surveillance multifonction des patients

AVANT-PROPOS
1) La Commission Électrotechnique Internationale (CEI) est une organisation mondiale de normalisation composée
de l'ensemble des comités électrotechniques nationaux (Comités nationaux de la CEI). La CEI a pour objet de
favoriser la coopération internationale pour toutes les questions de normalisation dans les domaines de
l'électricité et de l'électronique. A cet effet, la CEI – entre autres activités – publie des Normes internationales,
des Spécifications techniques, des Rapports techniques, des Spécifications accessibles au public (PAS) et des
Guides (ci-après dénommés "Publication(s) de la CEI"). Leur élaboration est confiée à des comités d'études,
aux travaux desquels tout Comité national intéressé par le sujet traité peut participer. Les organisations
internationales, gouvernementales et non gouvernementales, en liaison avec la CEI, participent également aux
travaux. La CEI collabore étroitement avec l'Organisation Internationale de Normalisation (ISO), selon des
conditions fixées par accord entre les deux organisations.
2) Les décisions ou accords officiels de la CEI concernant les questions techniques représentent, dans la mesure
du possible, un accord international sur les sujets étudiés, étant donné que les Comités nationaux de la CEI
intéressés sont représentés dans chaque comité d’études.
3) Les Publications de la CEI se présentent sous la forme de recommandations internationales et sont agréées
comme telles par les Comités nationaux de la CEI. Tous les efforts raisonnables sont entrepris afin que la CEI
s'assure de l'exactitude du contenu technique de ses publications; la CEI ne peut pas être tenue responsable de
l'éventuelle mauvaise utilisation ou interprétation qui en est faite par un quelconque utilisateur final.
4) Dans le but d'encourager l'uniformité internationale, les Comités nationaux de la CEI s'engagent, dans toute la
mesure possible, à appliquer de façon transparente les Publications de la CEI dans leurs publications
nationales et régionales. Toutes divergences entre toutes Publications de la CEI et toutes publications
nationales ou régionales correspondantes doivent être indiquées en termes clairs dans ces dernières.
5) La CEI n’a prévu aucune procéd
...