EN 60601-2-49:2015

SLOVENSKI STANDARD
01-december-2015
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Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and
essential performance of multifunction patient monitoring equipment
Appareils électromédicaux - Partie 2-49: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de surveillance multifonction des patients
Ta slovenski standard je istoveten z: EN 60601-2-49:2015
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-49

NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2015
ICS 11.040.55 Supersedes EN 60601-2-49:2001
English Version
Medical electrical equipment - Part 2-49: Particular requirements
for the basic safety and essential performance of multifunction
patient monitoring equipment
(IEC 60601-2-49:2011)
Appareils électromédicaux - Partie 2-49: Exigences Medizinische elektrische Geräte - Teil 2-49: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils de surveillance multifonction des wesentlichen Leistungsmerkmale von multifunktionalen
patients Patientenüberwachungsgeräten
(IEC 60601-2-49:2011) (IEC 60601-2-49:2011)
This European Standard was approved by CENELEC on 2015-09-15. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-49:2015 E
European foreword
The text of document 62D/886/FDIS, future edition 2 of IEC 60601-2-49, prepared by SC 62D
"Electromedical equipment", of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-49:2015.
The following dates are fixed:
(dop) 2016-06-15
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2018-09-15
• latest date by which the national standards conflicting with
the document have to be withdrawn

This document supersedes EN 60601-2-49:2001.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standard IEC 60601-2-49:2011 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 80601-2-56 NOTE Harmonized as EN 80601-2-56.
IEC 62366 NOTE Harmonized as EN 62366.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is
available here: www.cenelec.eu.

Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Replacement in Annex ZA of EN 60601-1:2006:
IEC 60601-1-2 (mod) 2007 Medical electrical equipment - EN 60601-1-2 2007
Part 1-2: General requirements for basic
- -  + corrigendum Mar. 2010
safety and essential performance -
Collateral standard: Electromagnetic
compatibility - Requirements and tests
IEC 60601-1-8 2006 Medical electrical equipment - EN 60601-1-8 2007
Part 1-8: General requirements for basic
- -  + corrigendum Mar. 2010
safety and essential performance -
Collateral Standard: General
requirements, tests and guidance for
alarm systems in medical electrical
equipment and medical electrical
systems
ISO 15223-1 2007 Medical devices - Symbols to be used
- -
with medical device labels, labelling and
information to be supplied -
Part 1: General requirements
Publication Year Title EN/HD Year
Addition to Annex ZA of EN 60601-1:2006:
IEC 60601-2-2 2009 Medical electrical equipment - EN 60601-2-2 2009
Part 2-2: Particular requirements for the
- -  + A11 2011
basic safety and essential performance
of high frequency surgical equipment and
high frequency surgical accessories
IEC 60601-2-27 2011 Medical electrical equipment - EN 60601-2-27 2014
Part 2-27: Particular requirements for the
basic safety and essential performance
of electrocardiographic monitoring
equipment
IEC 60601-2-34 2011 Medical electrical equipment - EN 60601-2-34 2014
Part 2-34: Particular requirements for the
basic safety and essential performance
of invasive blood pressure monitoring
equipment
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.
IEC 60601-2-49 ®
Edition 2.0 2011-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-49: Particular requirements for the basic safety and essential performance
of multifunction patient monitoring equipment

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

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XA
ICS 11.040.55 ISBN 978-2-88912-369-8

– 2 – 60601-2-49  IEC:2011
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 10
201.4 General requirements . 11
201.5 General requirements for testing of ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents. 12
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 . 18
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18
201.15 Construction of ME EQUIPMENT . 18
201.16 ME SYSTEMS . 18
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 18
202 Electromagnetic compatibility – Requirements and tests . 18
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 26
Annexes . 32
Annex AA (informative) General guidance and rationale . 33
Annex BB (informative) Alarm diagrams of Clause 208/IEC 60601-1-8:2006 . 43
ANNEX CC (informative) Examples of the connection of the measuring device (MD) for
measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT . 46
Bibliography . 49
Index of defined terms used in this particular standard. 50

Figure 202.101 – Test layout for conducted and radiated emission and radiated
immunity test with non-conductive APPLIED PART . 20
Figure 202.102 – Test layout for radiated and conducted emission test and radiated
immunity test with a PATIENT CONNECTION . 21
Figure 202.103 –Test circuit for HF surgery protection measurement according to
subclause 202.6.2.1.101 with PATIENT CONNECTIONS . 24
Figure 202.104 – Test setup for HF surgery protection measurement according to
subclause 202.6.2.1.101 . 25
Figure 202.105 – Test circuit for HF surgery protection measurement according to
subclause 202.6.2.1.101 with non-conductive APPLIED PART . 26
Figure AA.1 – Single APPLIED PART with MULTIPLE FUNCTIONS and PATIENT CONNECTIONS . 35

60601-2-49  IEC:2011 – 3 –
Figure AA.2 – Single APPLIED PART (6) with MULTIPLE FUNCTIONS and
PATIENT CONNECTIONS and multiple APPLIED PARTS (7) with SINGLE FUNCTIONS and
PATIENT CONNECTIONS . 36
Figure BB.1 – NON-LATCHING ALARM SIGNALS without ALARM RESET . 43
Figure BB.2 – NON-LATCHING ALARM SIGNALS with ALARM RESET . 44
Figure BB.3 – LATCHING ALARM SIGNALS with ALARM RESET . 44
Figure BB.4 – Two ALARM CONDITIONS with ALARM RESET . 45
Figure CC.1 – PART LEAKAGE CURRENT measurement of TYPE BF APPLIED PARTS with
MULTIPLE FUNCTIONS . 46
Figure CC.2 – PART LEAKAGE CURRENT measurement of TYPE CF APPLIED PARTS with
MULTIPLE FUNCTIONS .
...