EN 60601-2-27:2006
(Main)Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment
Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment
Specifies the particular safety requirements, including essential performance, for electrocardiographic (ECG) monitoring equipment. This standard is applicable to equipment used in a hospital environment. If the equipment is used outside the hospital environment, such as in ambulances and air transport, the equipment shall comply with this standard.
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 de sécurité, incluant les performances essentielles, des appareils de surveillance d'électrocardiographie
Spécifie les exigences particulières relatives à la sécurité, incluant les performances essentielles des appareils de surveillance d'électrocardiographie (ECG). La présente norme s'applique aux appareils utilisés dans l'environnement hospitalier. Si l'appareil est utilisé hors de l'environnement hospitalier, par exemple dans les transports ambulanciers terrestres et aériens, l'appareil doit être conforme à la présente norme.
Medicinska električna oprema – 2-27. del: Posebne varnostne zahteve, vključno z bistvenimi lastnostmi za elektrokardiografsko nadzorno opremo (IEC 60601-2-27:2005)
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SLOVENSKI SIST EN 60601-2-27:2006
STANDARD
oktober 2006
Medicinska električna oprema – 2-27. del: Posebne varnostne zahteve,
vključno z bistvenimi lastnostmi za elektrokardiografsko nadzorno opremo
(IEC 60601-2-27:2005)
Medical electrical equipment – Part 2-27: Particular requirements for the safety,
including essential performance, of electrocardiographic monitoring equipment (IEC
60601-2-27:2005)
ICS 11.040.50; 11.040.55 Referenčna številka
© Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno
EUROPEAN STANDARD
EN 60601-2-27
NORME EUROPÉENNE
April 2006
EUROPÄISCHE NORM
ICS 11.040.50 Supersedes EN 60601-2-27:1994
English version
Medical electrical equipment
Part 2-27: Particular requirements for the safety,
including essential performance,
of electrocardiographic monitoring equipment
(IEC 60601-2-27:2005)
Appareils électromédicaux Medizinische elektrische Geräte
Partie 2-27: Exigences particulières Teil 2-27: Besondere Festlegungen
de sécurité, incluant les performances für die Sicherheit einschließlich
essentielles, des appareils de surveillance der wesentlichen Leistungsmerkmale
d'électrocardiographie von Elektrokardiographie-
(CEI 60601-2-27:2005) Überwachungsgeräten
(IEC 60601-2-27:2005)
This European Standard was approved by CENELEC on 2005-11-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, the Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels
© 2006 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-27:2006 E
Foreword
The text of document 62D/529/FDIS, future edition 2 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 was approved by CENELEC as EN 60601-2-27 on 2005-11-01.
This European Standard supersedes EN 60601-2-27:1994.
It introduces essential performance to electrocardiographic monitoring equipment such as defibrillator
protection, performance requirements and alarming.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2006-11-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2008-11-01
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 93/42/EEC. See Annex ZZ.
This European Standard makes reference to International Standards. Where the International Standard
referred to has been endorsed as a European Standard or a home-grown European Standard exists, this
European Standard shall be applied instead. Pertinent information can be found on the CENELEC web
site.
In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: roman type;
– notes, explanations, advice, introductions, general statements, exceptions and references: small roman type;
– test specifications: italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL
CAPITALS.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-27:2005 was approved by CENELEC as a European
Standard without any modification.
__________
- 3 - EN 60601-2-27:2006
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.
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.
NORME CEI
INTERNATIONALE
IEC
60601-2-27
INTERNATIONAL
Deuxième édition
STANDARD
Second edition
2005-08
Appareils électromédicaux –
Partie 2-27:
Exigences particulières de sécurité,
incluant les performances essentielles,
des appareils de surveillance d'électro-
cardiographie
Medical electrical equipment –
Part 2-27:
Particular requirements for the safety,
including essential performance,
of electrocardiographic monitoring
equipment
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For price, see current catalogue
60601-2-27 IEC:2005 – 3 –
CONTENTS
FOREWORD.9
INTRODUCTION.13
SECTION ONE – GENERAL
1 Scope and object.15
2 Terminology and definitions.17
4 General requirements for tests .21
5 Classification.21
6 Identification, marking and documents.23
SECTION TWO – ENVIRONMENTAL CONDITIONS
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 Requirements related to classification .29
17 Separation.29
20 Dielectric strength .35
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION
36 Electromagnetic compatibility .37
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE
ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
OTHER SAFETY HAZARDS
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and
disinfection.41
49 Interruption of the power supply .43
SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data .45
51 Protection against hazardous output.63
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly .77
60601-2-27 IEC:2005 – 5 –
Appendix L (normative) References – Publications mentioned in this standard .111
Annex AA (informative) General guidance and rationale .113
Annex BB (informative) Alarm diagrams of Clause 51 .131
INDEX OF DEFINED TERMS.137
Figure 101 – Alternating QRS complexes and ventricular tachycardia waveforms for
testing pattern recognition capability according to 6.8.2 bb) 4) and 6.8.2 bb) 6). .81
Figure 102 – Set-up for radiated and conducted emission test according to
36.201.1b) 1) .83
Figure 103 – Set-up for radiated immunity test according to 36.202.3 .85
Figure 104 – Test circuit for HF surgery protection according to 36.202.101 .87
Figure 105 – Test set-up for HF surgery protection according to 36.202.101.89
Figure 106 – Application of the test voltage to test the energy delivered by the
defibrillator (See 17h)101.1) .91
Figure 107 – Test of protection against the effects of defibrillation (differential mode)
(See 17h)101.2 .93
Figure 108 – Test of protection against the effects of defibrillation (common mode)
(See 17h)101.3).95
Figure 109 – Arrangements of electrodes on sponge (See 17h)101.4) .97
Figure 110 – Test of recovery time from the effects of defibrillation (See 17h)101.4.99
Figure 111 – General test circuit .101
Figure 112 – High frequency response (clause 50.102.8 a).103
Figure 113 – Test waveforms for T-wave rejection (6.8.2 bb) 2, 50.102.13, 50.102.17) .103
Figure 114 – Test circuit for common mode rejection (See 50.102.10) .105
Figure 115 – Baseline reset (See 50.102.11) .107
Figure 116 – Pacemaker pulse (see 50.102.12) .107
Figure 117 – Normal paced rhythm (see 50.102.13 and Figure 119) .109
Figure 118 – Ineffective pacing (heart rate at 30 1/min, pacemaker pulse at 80 1/min)
(see 50.102.13) .109
Figure 119 – Simulated QRS complex (see 50.102.13, 50.102.14 and 50.102.15).109
Figure AA.1 – Applied part with multiple patient connections .129
Figure BB.101 – Non-latching alarms w/o silence/reset.131
Figure BB.102 – Non-latching alarms with silence/reset.131
Figure BB.103 – Latched alarms with silence/reset .133
Figure BB.104 – Two ALARMS with SILENCE/RESET.133
Figure BB.105 – INHIBITION of ALARMS .135
Figure BB.106 – SUSPENSION of ALARMS .135
60601-2-27 IEC:2005 – 7 –
Table 101 – ELECTRODES and NEUTRAL ELECTRODE, their position, identification and
colour .23
Table 102 – Protection against the effect of defibrillation (test conditions) .33
60601-2-27 IEC:2005 – 9 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-27: Particular requirements for the safety, including essential
performance, of electrocardiographic monitoring equipment
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-opera
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