Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (IEC 60601-2-27:2011)

This standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT as defined in 201.3.63 and hereinafter also referred to as ME EQUIPMENT. This particular standard applies to ME EQUIPMENT 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. ME EQUIPMENT 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 to ME EQUIPMENT 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.

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
25-May-2016
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
29-Aug-2014
Due Date
03-Nov-2014
Completion Date
26-May-2016

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SLOVENSKI STANDARD
SIST EN 60601-2-27:2016
01-julij-2016
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYHYNOMXþQR]
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
SIST EN 60601-2-27:2016 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 60601-2-27:2016
---------------------- Page: 2 ----------------------
SIST EN 60601-2-27:2016
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
---------------------- Page: 3 ----------------------
SIST EN 60601-2-27:2016
EN 60601-2-27:2014 - 2 -
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;
---------------------- Page: 4 ----------------------
SIST EN 60601-2-27:2016
- 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.
---------------------- Page: 5 ----------------------
SIST EN 60601-2-27:2016
EN 60601-2-27:2014 - 4 -
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
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.
---------------------- Page: 6 ----------------------
SIST EN 60601-2-27:2016
- 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.
---------------------- Page: 7 ----------------------
SIST EN 60601-2-27:2016
---------------------- Page: 8 ----------------------
SIST EN 60601-2-27:2016
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
CODE PRIX
ICS 11.040.50 ISBN 978-2-88912-430-5
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 9 ----------------------
SIST EN 60601-2-27:2016
– 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 ................................................... 33

Figure 201.108 – Baseline reset .......................................................................................... 34

Figure 201.109 – Pacemaker pulse ..................................................................................... 35

Figure 201.110 – Test waveforms for T-wave rejection ........................................................ 37

Figure 201.111 – Normal paced rhythm ............................................................................... 37

---------------------- Page: 10 ----------------------
SIST EN 60601-2-27:2016
60601-2-27  IEC:2011 – 3 –
Figure 201.112 – Ineffective pacing (heart rate at 30 1/min, pacemaker pulse at

80 1/min) ............................................................................................................................ 38

Figure 201.113 – Simulated QRS complex ........................................................................... 38

Figure 201.114 – Pacemaker test circuit .............................................................................. 38

Figure 202.101 – Test layout for radiated and conducted EMISSION test and radiated

immunity test ...................................................................................................................... 43

Figure 202.102 – Set-up for radiated IMMUNITY test .............................................................. 44

Figure 202.103 – Test circuit for HF surgery protection measurement .................................. 46

Figure 202.104 – Test setup for HF surgery protection measurement ................................... 47

Figure AA.1 – APPLIED PART with multiple PATIENT CONNECTIONS ........................................... 56

Figure BB.101 – NON-LATCHING ALARM SIGNALS without ALARM RESET .................................... 65

Figure BB.102 – NON-LATCHING ALARM SIGNALS with ALARM RESET ......................................... 65

Figure BB.103 – LATCHING ALARM SIGNALS with ALARM RESET ................................................ 66

Figure BB.104 – Two ALARM CONDITIONS with ALARM RESET ................................................... 66

Table 201.101 – ESSENTIAL PERFORMANCE requirements ....................................................... 11

Table 201.102 – ELECTRODES and NEUTRAL ELECTRODE, their position, identification and

colour ................................................................................................................................. 13

Table 201.103 – Protection against the effect of defibrillation (test conditions) ..................... 19

Table 208.101 – ALARM CONDITION priorities ......................................................................... 48

Table 208.102 – Characteristics of the BURST of auditory ALARM SIGNALS .............................. 49

Table AA.1 – Electrode positions and electrical strength requirements ................................. 55

---------------------- Page: 11 ----------------------
SIST EN 60601-2-27:2016
– 4 – 60601-2-27  IEC:2011
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-27: Particular requirements for the basic safety and 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-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

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. 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 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 60601-2-27 has been prepared by IEC subcommittee 62D:

Electromedical equipment of IEC technical committee 62: Electrical equipment in medical

practice.

This third edition cancels and replaces the second edition of IEC 60601-2-27 published in

2005. This edition constitutes a technical revision to the new structure of IEC 60601-1:2005

(third edition).
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/900/FDIS 62D/913/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.
---------------------- Page: 12 ----------------------
SIST EN 60601-2-27:2016
60601-2-27  IEC:2011 – 5 –

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.

A list of all parts of the IEC 60601 series, published under the general title Medical electrical

equipment, can be found on the IEC website.

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.
The contents of the corrigendum of May 2012 have been included in this copy.
---------------------- Page: 13 ----------------------
SIST EN 60601-2-27:2016
– 6 – 60601-2-27  IEC:2011
INTRODUCTION
This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of
ELECTROCARDIOGRAPHIC MONITORING 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.

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.

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. 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, Annex AA does not form part of the requirements of

this standard.
---------------------- Page: 14 ----------------------
SIST EN 60601-2-27:2016
60601-2-27  IEC:2011 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-27: Particular requirements for the basic safety and essential
performance of electrocardiographic monitoring equipment
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 *Scope
Replacement:
This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of

ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT as defined in 201.3.63 and hereinafter

also referred to as ME EQUIPMENT. This particular standard applies to ME EQUIPMENT 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.

ME EQUIPMENT 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 to ME EQUIPMENT 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.

201.1.2 Object
Replacement:

The object of this particular standard is to establish BASIC SAFETY and ESSENTIAL PERFORMANCE

requirements for ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT as defined in 201.3.63.

201.1.3 Collateral standards
Addition:

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 60601-1-2:2007 and IEC 60601-1-8:2006 apply as modified in Clauses 202 and 208

respectively. IEC 60601-1-3 does not apply. All other published collateral standards in the

IEC 60601-1 series apply as published.
—————————

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 60601-2-27:2016
– 8 – 60601-2-27  IEC:2011
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 general standard) or applicable collateral standard with the prefix “20x”

where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this

particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral

standard, 203.4 in this particular standard addresses the content of Clause 4 of the

IEC 60601-1-3 collateral standard, etc.). The 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 or applicable

collateral 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
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