SIST EN 60601-2-25:2015
Medical electrical equipment - Part 2-25: Particular requirements for basic safety and essential performance of electrocardiographs
Medical electrical equipment - Part 2-25: Particular requirements for basic safety and essential performance of electrocardiographs
IEC 60601-2-25:2011 applies to the basic safety and essential performance of electrocardiographs intended by themselves or as a part of a medical electrical system, for the production of electrocardiogram reports for diagnostic purposes. The equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to Medical electrical equipment for those environments of use. Not included within the scope of this particular standard are: a) the part of Medical electrical equipment that provides vectorcardiographic loops; b) ambulatory electrocardiographic medical electrical equipment covered by IEC 60601-2-47 where not intended for obtaining electrocardiogram reports for diagnostic purposes; c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining electrocardiographic reports for diagnostic purposes. This second edition cancels and replaces the first edition of IEC 60601-2-25, published in 1993 and the first edition of IEC 60601-2-51, published in 2003. Updating the particular standards to refer to the third edition of the general standard provided the opportunity to merge the first editions of IEC 60601-2-25 and IEC 60601-2-51 into one standard. Reformatting and technical changes were both made. This second edition of IEC 60601-2-25 constitutes a technical revision of both those standards.
Medizinische elektrische Geräte - Teil 2-25: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektrokardiographen
Appareils électromédicaux - Partie 2-25 : Règles particulières de sécurité de base et de performances essentielles des électrocardiographes
La CEI 60601-2-25:2011 s'applique à la sécurité de base et aux performances essentielles des électrocardiographes, destinés de par leur nature ou comme partie intégrante d'un système électro-médical, à la production de rapports d'électrocardiographie à des fins de diagnostic. Les appareils destinés à être utilisés dans des conditions environnementales extrêmes ou non maîtrisées à l'extérieur d'un hôpital ou du cabinet d'un médecin, telles que dans des ambulances et dans un aéronef, doivent satisfaire à la présente norme particulière. Des normes supplémentaires peuvent s'appliquer pour ces environnements d'utilisation. Ne relèvent pas du domaine d'application de la présente norme particulière: a) la partie des appareils électro-médicaux qui fournit des boucles vecto-cardiographiques; b) les appareils électro-médicaux de surveillance électrocardiographique ambulatoire couverts par la CEI 60601-2-47, lorsqu'ils ne sont pas destinés à obtenir des rapports d'électrocardiographie à des fins de diagnostic; c) les moniteurs cardiaques couverts par la CEI 60601-2-27 lorsqu'ils ne sont pas destinés à obtenir des rapports d'électrocardiographie à des fins de diagnostic. Cette deuxième édition annule et remplace la première édition de la CEI 60601-2-25, parue en 1993, et la première édition de la CEI 60601-2-51, parue en 2003. La mise à jour des normes particulières afin de faire référence à la troisième édition de la norme générale a permis de fusionner les premières éditions de la CEI 60601-2-25 et de la CEI 60601-2-51 en une seule norme. Une remise en forme et des modifications techniques ont été effectuées. Cette deuxième édition de la CEI 60601-2-25 constitue une révision technique de ces deux normes.
Medicinska električna oprema - 2-25. del: Posebne zahteve za osnovno varnost in bistvene lastnosti elektrokardiografov
IEC 60601-2-25:2011 se uporablja za osnovno varnost in bistvene lastnosti elektrokardiografov, ki so kot samostojne enote ali del medicinskega električnega sistema namenjeni za izdelavo elektrokardiografskih izvidov. Oprema, ki je namenjena za uporabo v izrednih ali nenadzorovanih vremenskih razmerah zunaj bolnišnic ali zdravniških ordinacij (npr. v reševalnih vozilih ali zračnem prometu), mora biti v skladu s tem standardom. Za medicinsko električno opremo v takih okoljih se morda uporabljajo dodatni standardi. Področje uporabe tega standarda ne vključuje naslednjih naprav: a) del medicinske električne opreme, ki prikazuje vektorkardiografske zanke; b) elektrokardiografska medicinska električna oprema v reševalnih vozilih, ki jo obravnava IEC 60601-2-47 in ni namenjena za izdelavo elektrokardiografskih izvidov za namene diagnoze; c) srčni monitorji, ki jih obravnava IEC 60601-2-27 in niso namenjeni za izdelavo elektrokardiografskih izvidov za namene diagnoze. Ta druga izdaja preklicuje in nadomešča prvo izdajo standarda IEC 60601-2-25, objavljeno leta 1993, ter prvo izdajo standarda IEC 60601-2-51, objavljeno leta 2003. Ker so bili posamezni standardi posodobljeni tako, da se nanašajo na tretjo izdajo splošnega standarda, se je ponudila priložnost za združitev prvih izdaj standardov IEC 60601-2-25 in IEC 60601-2-51 v en standard. Izvedeno je bilo preoblikovanje in uvedene so bile tehnične spremembe. Ta druga izdaja standarda IEC 60601-2-25 tvori tehnično popravljeno izdajo obeh teh standardov.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 60601-2-25:2015
01-december-2015
1DGRPHãþD
SIST EN 60601-2-25:1998
SIST EN 60601-2-25:1998/A1:2002
SIST EN 60601-2-51:2004
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLHOHNWURNDUGLRJUDIRY
Medical electrical equipment - Part 2-25: Particular requirements for basic safety and
essential performance of electrocardiographs
Medizinische elektrische Geräte - Teil 2-25: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Elektrokardiographen
Appareils électromédicaux - Partie 2-25 : Règles particulières de sécurité de base et de
performances essentielles des électrocardiographes
Ta slovenski standard je istoveten z: EN 60601-2-25:2015
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN 60601-2-25:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 60601-2-25:2015
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SIST EN 60601-2-25:2015
EUROPEAN STANDARD EN 60601-2-25
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2015
ICS 11.040.55; 11.040.99 Supersedes EN 60601-2-25:1995, EN 60601-2-51:2003
English Version
Medical electrical equipment - Part 2-25: Particular requirements
for the basic safety and essential performance of
electrocardiographs
(IEC 60601-2-25:2011)
Appareils électromédicaux - Partie 2-25: Exigences Medizinische elektrische Geräte - Teil 2-25: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des électrocardiographes wesentlichen Leistungsmerkmale von Elektrokardiographen
(IEC 60601-2-25:2011) (IEC 60601-2-25:2011)
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 60601-2-25:2015 E
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SIST EN 60601-2-25:2015
EN 60601-2-25:2015
European foreword
The text of document 62D/944/FDIS, future edition 2 of IEC 60601-2-25, 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 60601-2-25:2015.
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 60601-2-25:1995 and EN 60601-2-51:2003.
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 60601-2-25:2011 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 60601-2-27 NOTE Harmonized as EN 60601-2-27.
IEC 60601-2-47 NOTE Harmonized as EN 60601-2-47.
2
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SIST EN 60601-2-25:2015
EN 60601-2-25:2015
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
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
3
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SIST EN 60601-2-25:2015
EN 60601-2-25:2015
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.
4
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SIST EN 60601-2-25:2015
IEC 60601-2-25
®
Edition 2.0 2011-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-25: Particular requirements for the basic safety and essential performance
of electrocardiographs
Appareils électromédicaux –
Partie 2-25: Exigences particulières pour la sécurité de base et les performances
essentielles des électrocardiographes
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XD
ICS 11.040.55; 11.040.99 ISBN 978-2-88912-719-1
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
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SIST EN 60601-2-25:2015
– 2 – 60601-2-25 IEC:2011
CONTENTS
FOREWORD . 5
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 . 12
201.5 General requirements for testing of ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 16
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 21
201.10 Protection against unwanted and excessive radiation HAZARDS . 21
201.11 Protection against excessive temperatures and other HAZARDS . 21
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 22
201.13 HAZARDOUS SITUATIONS and fault conditions . 37
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 37
201.15 Construction of ME EQUIPMENT . 37
201.16 ME SYSTEMS. 37
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 37
202 Electromagnetic compatibility – Requirements and tests . 38
Annexes . 43
Annex AA (informative) Particular guidance and rationale . 44
Annex BB (informative) ELECTRODES, their positions, identifications and colour codes . 51
Annex CC (informative) LEADS, their identification and colour codes (other than those
specified in 201.12.4.102) . 53
Annex DD (informative) Polarity of PATIENT LEADS (other than those specified in
201.12.4.102) . 54
Annex EE (informative) Additional marking of ELECTRODES . 55
Annex FF (informative) Definitions and rules for the measurement of
ELECTROCARDIOGRAMS . 56
Annex GG (informative) Calibration and test data sets . 61
Annex HH (informative) CTS test atlas . 63
Bibliography . 94
Index of defined terms used in this particular standard. 95
Figure 201.101 – ELECTRODE position according to Frank . 14
Figure 201.102 – Test of protection against the effects of defibrillation (differential
mode) (see 201.8.5.5.1) . 19
Figure 201.103 – Test of protection against the effects of defibrillation (common mode)
(see 201.8.5.5.1) . 20
Figure 201.104 – Application of the test voltage between LEAD WIRES to test the energy
delivered by the defibrillator . 21
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SIST EN 60601-2-25:2015
60601-2-25 IEC:2011 – 3 –
Figure 201.105 – Test circuit for COMMON MODE REJECTION and NOISE level . 28
Figure 201.106 – General test circuit . 30
Figure 201.107 – Triangular waveforms for test E of Table 201.107 . 32
Figure 201.108 – Input impulse signal and ELECTROCARDIOGRAPH response . 32
Figure 201.109 – Circuit for test of linearity. 34
Figure 201.110 – Result of linearity test . 34
Figure 201.111 – Pacemaker overload test circuit . 36
Figure 202.101 – Set-up for radiated and conducted emission test . 39
Figure 202.102 – Set-up for radiated immunity test . 40
Figure 202.103 – Test circuit for HF surgery protection measurement . 42
Figure 202.104 – Test setup for HF surgery protection measurement. 43
Figure BB.1a – LEADS and colours for fetal ECG (see Table BB.2) . 52
Figure BB.1b – Positions of the ELECTRODES on the fetus for fetal ECG (see Table BB.2) . 52
Figure BB.2 – LEAD positions and colours for fetal scalp ECG (see Table BB.2) . 52
Figure FF.1 – Normal ELECTROCARDIOGRAM . 56
Figure FF.2 – Determination of global intervals (example) . 57
Figure FF.3 – Waveform durations, isoelectric segments . 58
Figure FF.4 – QRS complex with small R-wave(s) (see Figure FF.5, FF.6) . 59
Figure FF.5 – Detail of small accepted R-wave . 60
Figure FF.6 – Detail of small rejected R-wave . 60
Figure HH.1 – Nomenclature of calibration ECGS . 66
Figure HH.2 – Nomenclature of analytical ECGs . 69
Table 201.101 – ESSENTIAL PERFORMANCE requirements . 12
Table 201.102 – ELECTRODES, their position, identification and colour code . 14
Table 201.103 – Protection against the effect of defibrillation (test conditions) . 18
Table 201.104 – Acceptable mean differences and standard deviations for global
intervals and Q-, R-, S-durations on calibration and analytical ECGS . 23
Table 201.105 – Acceptable mean differences and standard deviations for global
durations and intervals for biological ECGs . 23
Table 201.106 – LEADS and their identification (nomenclature and definition) . 25
Table 201.107 – Frequency response . 31
Table 201.108 – PATIENT ELECTRODE connection for pacemaker pulse display test . 37
Table AA.1 – ELECTRODE positions and electrical strength requirements . 46
Table BB.1 – ELECTRODES, their positions, identifications and colour codes (other than
described in 201.7.4.101, Table 201.106) . 51
Table BB.2 – Other ELECTRODE-positions, identifications and colour codes not covered
by this particular standard . 51
Table DD.1 – ELECTRODE polarities . 54
Table EE.1 – Recommended identification and colour code for a 14-wire PATIENT CABLE . 55
Table GG.1 – CALIBRATION and analytical ECGS . 61
Table GG.2 – Data set for testing of measurement and wave recognition accuracy of
biological data – 100 selected ECGS of the CSE-study with their numbering in the CSE
database, to be used in 201.12.1.101.3.2 . 62
Table HH.1 – Naming of signals (calibration ECGS) . 67
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Table HH.2 – Naming of signals (analytical ECGs) . 68
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SIST EN 60601-2-25:2015
60601-2-25 IEC:2011 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-25: Particular requirements for the basic safety
and essential performance of electrocardiographs
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
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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 IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-25 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition cancels and replaces the first edition of IEC 60601-2-25, published in
1993 and the first edition of IEC 60601-2-51, published in 2003. This second edition of
IEC 60601-2-25 constitutes a technical revision of both those standards.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/944/FDIS 62D/957/RVD
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.
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SIST EN 60601-2-25:2015
– 6 – 60601-2-25 IEC:2011
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
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;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
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SIST EN 60601-2-25:2015
60601-2-25 IEC:2011 – 7 –
INTRODUCTION
This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of
ELECTROCARDIOGRAPHIC EQUIPMENT. It amends and supplements IEC 60601-1 (third edition,
2005): Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance, hereinafter referred to as the general standard.
This particular standard now includes the contents of the particular standard IEC 60601-2-51:
Medical electrical equipment – Part 2-51: Particular requirements for the safety, including
essential performance, of recording and analysing single channel and multichannel
electrocardiographs.
Updating the particular standards to refer to the third edition of the general standard provided
the opportunity to merge the first editions of IEC 60601-2-25 and IEC 60601-2-51 into one
standard. Reformatting and technical changes were both made.
The requirements of this particular standard take priority over those of the general standard.
A “General guidance and rationale” for the more important requirements of this particular
standard is included in Annex AA. Knowledge of the reasons for these requirements will not
only facilitate 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, Annex AA does not form part of the requirements of this standard.
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SIST EN 60601-2-25:2015
– 8 – 60601-2-25 IEC:2011
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-25: Particular requirements for the basic safety
and essential performance of electrocardiographs
201.1 Scope, object and related standards
1
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
ELECTROCARDIOGRAPHS as defined in 201.3.63 intended by themselves or as a part of an
ME SYSTEM, for the production of ECG REPORTS for diagnostic purposes, hereinafter referred to
as ME EQUIPMENT.
Not included within the scope of this particular standard are:
a) the part of ME EQUIPMENT that provides vectorcardiographic loops;
b) ambulatory electrocardiographic ME EQUIPMENT covered by IEC 60601-2-47 where not
intended for obtaining ECG REPORTS for diagnostic purposes;
c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining ECG
REPORTS for diagnostic purposes.
NOTE 1 For example. ME EQUIPMENT includes:
a) direct-writing ELECTROCARDIOGRAPHS;
b) other ME EQUIPMENT that produce ECG REPORTS for diagnostic purposes, e.g. patient monitors, defibrillators, exercise
testing devices;
c) ELECTROCARDIOGRAPHS having a display that is remote from the PATIENT (e.g. via phone lines, networks or storage media).
These ME EQUIPMENT or ME SYSTEMS are within the scope of this particular standard excluding transmission media.
NOTE 2 ME EQUIPMENT that provide selection between diagnostic and monitoring functions shall meet the
requirements of the appropriate standard when configured for that function.
ME EQUIPMENT intended for use under extreme or uncontrolled environmental conditions
outside the hospital environment or physician’s office, such as in ambulances and air
transport, shall comply with this particular standard. Additional standards may apply to
ME EQUIPMENT for those environments of use.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular requirements for BASIC SAFETY
and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHS as defined in 201.3.63.
201.1.3 Collateral standards
Addition:
—————————
1
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.
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SIST EN 60601-2-25:2015
60601-2-25 IEC:2011 – 9 –
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2 applies as modified in Clause 202. IEC 60601-1-3, IEC 60601-1-8 and
IEC 60601-1-10 do not apply. All other published collateral standards in the IEC 60601-1
series apply as published
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the gene
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