EN 60601-2-27:2014

Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

IEC 60601-2-27:2011 applies to electrocardiographic monitoring equipments used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. This particular standard also applies to ECG telemetry systems used in a hospital environment. Electrocardiographic monitoring equipments intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply for those environments of use. This standard is not applicable to electrocardiographic monitors for home use. However, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use. Ambulatory ('Holter') monitors, fetal heart rate monitoring, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard through reformatting and technical changes.

Medizinische elektrische Geräte - Teil 2-27: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektrokardiographie-Überwachungsgeräten

Appareils électromédicaux - Partie 2-27: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de surveillance d'électrocardiographie

La CEI 60601-2-27:2011 s'applique aux appareils de surveillance électrocardiographique utilisés dans un environnement hospitalier, ainsi qu'en dehors de cet environnement, tels que dans les ambulances et les moyens de transport aérien. La présente norme particulière s'applique également aux systèmes de télémétrie ECG utilisés dans un environnement hospitalier. Les appareils de surveillance électrocardiographique conçus pour être utilisés dans des conditions extrêmes ou dans des conditions d'environnement non contrôlées à l'extérieur de l'environnement hospitalier, tels que dans les ambulances ou les moyens de transport aérien, doivent être conformes à la présente norme particulière. Des normes supplémentaires peuvent s'appliquer pour ces environnements d'utilisation. La présente norme ne s'applique pas aux moniteurs d'électrocardiographie pour une utilisation à domicile. Il convient cependant que les fabricants envisagent d'utiliser les articles correspondants de la présente Norme, en fonction de leur application à l'utilisation prévue. Les moniteurs ambulatoires (dits 'Holter'), la surveillance de la fréquence cardiaque foetale, les dispositifs pléthysmographiques de pouls et les autres appareils d'enregistrement d'ECG n'entrent pas dans le domaine d'application de la présente norme particulière. L'objet de la présente troisième édition est de mettre à jour la présente norme particulière en prenant en compte la troisième édition de la norme générale par un reformatage et des modifications techniques.

Medicinska električna oprema - 2-27. del: Posebne varnostne zahteve, vključno z bistvenimi lastnostmi za elektrokardiografsko nadzorno opremo (IEC 60601-2-27:2011)

Ta standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI ELEKTROKARDIOGRAFSKE (ECG) NADZORNE OPREME, kot je določeno v 201.3.63 (v nadaljevanju tudi: MEDICINSKA ELEKTRIČNA OPREMA). Ta standard se uporablja za MEDICINSKO ELEKTRIČNO OPREMO, ki se uporablja v bolnišnicah in zunaj njih, npr. v reševalnih vozilih in zračnem prometu. Ta standard se uporablja tudi za ELEKTROKARDIOGRAFSKE telemetrične sisteme, ki se uporabljajo v bolnišnicah. MEDICINSKA ELEKTRIČNA OPREMA, ki je namenjena za uporabo v izrednih ali nenadzorovanih vremenskih razmerah zunaj bolnišnic, npr. v reševalnih vozilih ali zračnem prometu, mora biti v skladu s tem standardom. Za MEDICINSKO ELEKTRIČNO OPREMO v tovrstnih okoljih se lahko uporabljajo dodatni standardi. Ta standard se ne uporablja za elektrokardiografsko nadzorno opremo, namenjeno za domačo uporabo. Vendar PROIZVAJALCI morajo upoštevati ustrezna določila tega standarda glede na PREDVIDENO UPORABO. Nadzorna oprema v reševalnih vozilih (»Holter«), nadzorna oprema srčnega utripa zarodka, pletizmografske naprave za merjenje pulza in druga elektrokardiografska oprema za beleženje niso zajete v tem standardu.

General Information

• Status: Published
• Publication Date: 21-Aug-2014
• Withdrawal Date: 21-Aug-2017
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 22-Aug-2014
• Completion Date: 22-Aug-2014
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-2-27:2016 - Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (IEC 60601-2-27:2011)

Relations

• Replaces: EN 60601-2-27:2006 - Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2016
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ELVWYHQLPLODVWQRVWPL]DHOHNWURNDUGLRJUDIVNRQDG]RUQRRSUHPR,(&

Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and
essential performance of electrocardiographic monitoring equipment (IEC 60601-2-
27:2011)
Medizinische elektrische Geräte - Teil 2-27: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Elektrokardiographie-
Überwachungsgeräten
Appareils électromédicaux - Partie 2-27 : Exigences particulières pour la sécurité de
base et les performances essentielles des appareils de surveillance
d'électrocardiographie
Ta slovenski standard je istoveten z: EN 60601-2-27:2014
ICS:
11.040.50 Radiografska oprema Radiographic equipment
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-27

NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2014
ICS 11.040.50 Supersedes EN 60601-2-27:2006
English Version
Medical electrical equipment - Part 2-27: Particular requirements
for the basic safety and essential performance of
electrocardiographic monitoring equipment
(IEC 60601-2-27:2011 + corrigendum May 2012)
Appareils électromédicaux - Partie 2-27: Exigences Medizinische elektrische Geräte - Teil 2-27: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils de surveillance wesentlichen Leistungsmerkmale von Elektrokardiographie-
d'électrocardiographie Überwachungsgeräten
(CEI 60601-2-27:2011 + corrigendum Mai 2012) (IEC 60601-2-27:2011 + Berichtigung Mai 2012)
This European Standard was approved by CENELEC on 2011-05-04. 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
© 2014 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-27:2014 E
Foreword
The text of document 62D/900/FDIS, future edition 3 of IEC 60601-2-27, 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 60601-2-27:2014.
The following dates are fixed:
(dop) 2015-02-22
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2017-08-22
standards conflicting with the
document have to be withdrawn
This document supersedes EN 60601-2-27:2006.

In this standard, 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 standard, 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 standard are preceded by the term “Clause” followed by the clause
number. References to subclauses within this particular standard are by number only.
In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
– “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;

- 3 - EN 60601-2-27:2014
– “may” is used to describe a permissible way to achieve compliance with a requirement or test.

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(s) see informative Annex ZZ, which is an integral part of this
document.
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.
Endorsement notice
The text of the International Standard IEC 60601-2-27:2011+ corrigendum May 2012 was approved by
CENELEC as a European Standard without any modification.

Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Annex ZA of the general standard applies, except as follows:

Publication Year Title EN/HD Year

Replacement:
IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
(mod) Part 1-2: General requirements for basic + corr. March 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 + corr. March 2010
safety and essential performance - Collateral
Standard: General requirements, tests and
guidance for alarm systems in medical
electrical equipment and medical electrical
systems
Addition:
IEC 60601-2-2 2009 Medical electrical equipment -  EN 60601-2-2 2009
Part 2-2: Particular requirements for basic + A11 2011
safety and essential performance of high
frequency surgical equipment and high
frequency surgical accessories

IEC 60601-2-25 2011 Medical electrical equipment - EN 60601-2-25 201X
Part 2-25: Particular requirements for basic
safety and essential performance of
electrocardiographs
1)
IEC 60601-2-49 2011 Medical electrical equipment - EN 60601-2-49 201X
Part 2-49: Particular requirements for the
basic safety and essential performance of
multifunction patient monitoring equipment

At draft stage.
- 5 - EN 60601-2-27:2014
Annex ZZ
(informative)
Coverage of Essential Requirements of EC 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 as given in Annex I of the EC Directive 93/42/EEC except as follows:
– Essential Requirement 6a
– Essential Requirement 7.4
– Essential Requirement 7.5 paragraph 2 & 3
– Essential Requirement 13.6 (q)
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING - Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
IEC 60601-2-27 ®
Edition 3.0 2011-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-27: Particular requirements for the basic safety and essential performance
of electrocardiographic monitoring equipment

Appareils électromédicaux –
Partie 2-27: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de surveillance d’électrocardiographie

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XB
CODE PRIX
ICS 11.040.50 ISBN 978-2-88912-430-5

– 2 – 60601-2-27  IEC:2011
CONTENTS
FOREWORD. 4
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 8
201.3 Terms and definitions . 9
201.4 General requirements . 10
201.5 General requirements for testing of ME EQUIPMENT . 11
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 . 17
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 22
201.10 Protection against unwanted and excessive radiation HAZARDS . 22
201.11 Protection against excessive temperatures and other HAZARDS . 22
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 24
201.13 HAZARDOUS SITUATIONS and fault conditions . 41
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 41
201.15 Construction of ME EQUIPMENT . 41
201.16 ME SYSTEMS . 42
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 42
202 Electromagnetic compatibility – Requirements and tests . 42
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 47
Annexes . 53
Annex AA (informative) Particular guidance and rationale . 54
Annex BB (informative) Alarm diagrams of Clause 208/IEC 60601-1-8:2006 . 65
Bibliography . 68
Index of defined terms used in this particular standard . 69

Figure 201.101 – Alternating QRS complexes and ventricular tachycardia waveforms
for testing pattern recognition capability according to 201.7.9.2.9.101 b) 4) and 6). . 16
Figure 201.102 – Test of protection against the effects of defibrillation (differential
mode) . 20
Figure 201.103 – Test of protection against the effects of defibrillation (common mode) . 21
Figure 201.104 – Application of the test voltage between LEAD WIRES to test the energy
delivered by the defibrillator . 22
Figure 201.105 – General test circuit . 26
Figure 201.106 – High frequency response . 31
Figure 201.107 – Test circuit for COMMON MODE REJECTION .
...