EN 60601-2-27:2006

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
 IEC 2005 Droits de reproduction réservés  Copyright - all rights reserved
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Pour prix, voir catalogue en vigueur
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-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 provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
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 sub-committee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition cancels and replaces the first edition published in 1994. It constitutes a
technical revision that introduces essential performance to electrocardiographic monitoring
equipment such as defibrillator protection, performance requirements and alarming.

60601-2-27  IEC:2005 – 11 –
The text of this Particular Standard is based upon the following documents:
FDIS Report on Voting
62D/529/FDIS 62D/533/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this Particular 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: smaller type;
– test specifications: italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL
CAPITALS.
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result 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.
60601-2-27  IEC:2005 – 13 –
INTRODUCTION
This Particular Standard concerns the safety of electrocardiographic monitoring equipment
including essential performance. It amends and supplements IEC 60601-1 (second edition
1988): Medical electrical equipment – Part 1: General requirements for safety) and its
Amendment 1 (1991) and Amendment 2 (1995), hereinafter referred to as the General
Standard. The requirements of this Particular Standard take priority over those of the General
Standard.
A “General guidance and rationale” for the 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.
An asterisk (*) by a clause or subclause number indicates that some explanatory notes are
given in Annex AA.
At the time of publication of this Particular Standard work was in progress to create a joint
ISO/IEC collateral standard addressing “General requirements and guidelines for the
application of alarms in medical electrical equipment”. It is intended to harmonize this
standard with the above-mentioned collateral standard following its publication.

60601-2-27  IEC:2005 – 15 –
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-27: Particular requirements for the safety, including essential
performance, of electrocardiographic monitoring equipment

SECTION ONE – GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:
1 Scope and object
This clause of the General Standard applies except as follows:
*1.1 Scope
Addition:
This Particular Standard specifies the particular safety requirements, including essential
performance, for ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT as defined in 2.101
and hereinafter also referred to as 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.
NOTE Additional standards apply to the EQUIPMENT covering specifically use outside the hospital environment.
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.
ECG telemetry systems, ambulatory ("Holter") monitors and other ECG recording devices are
outside the scope of this Particular Standard.
1.2 Object
Replacement:
The object of this Particular Standard is to specify particular requirements for the safety,
including essential performance, of EQUIPMENT as defined in 2.101.
1.3 Particular standards
Addition:
This Particular Standard refers to IEC 60601-1:1988, Medical electrical equipment – Part 1:
General requirements for safety as amended by its Amendment 1 (1991) and Amendment 2
(1995). The General Standard takes into account IEC 60601-1-1:2000, Medical electrical
equipment – Part 1-1: General requirements for safety – Collateral standard: Safety
requirements for medical electrical systems, IEC 60601-1-2:2001, Medical electrical

60601-2-27  IEC:2005 – 17 –
equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic
compatibility – Requirements and tests and IEC 60601-1-4:1996, Medical electrical equipment
– Part 1: General requirements for safety – 4. Collateral standard: Programmable electric
medical systems and its Amendment 1 (1999).
For brevity, Part 1 is referred to in this Particular Standard either as the “General Standard” or
as the “General Requirement(s)”, and IEC 60601-1-1, IEC 60601-1-2 and IEC 60601-1-4 as
the “Collateral Standards”.
The numbering of sections, clauses and subclauses of this Particular Standard corresponds
with that of the General Standard. 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 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.
“Amendment” means that the clause or subclause of the General Standard is amended as
indicated by the text of this Particular Standard.
Subclauses, tables or figures which are additional to those of the General Standard are
numbered starting from 101, additional annexes are lettered AA, BB, etc., and additional
items aa), bb), etc.
The term “this Standard” is used to make reference to the General Standard and this
Particular Standard taken together.
Where there is no corresponding section, clause or subclause in this Particular Standard, the
section, clause or subclause of the General Standard, although possibly not relevant, applies
without modification; where it is intended that any part of the General Standard, although
possibly relevant, is not to be applied, a statement to that effect is given in this Particular
Standard.
The requirements of this Particular Standard take priority over those of the General Standard
and Collateral Standard mentioned above.
2 Terminology and definitions
This clause of the General Standard applies, except as follows:
Addition:
2.101
ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT (EQUIPMENT)
device and associated LEAD WIRES and ELECTRODES for the monitoring and/or recording of
heart action potentials and displaying the resultant data of one PATIENT
2.102
LEAD WIRE(S)
cable(s) connected between ELECTRODE(S) and the device

60601-2-27  IEC:2005 – 19 –
2.103
LEAD(S)
combination(s) of ELECTRODES and LEAD WIRES used for a certain ECG recording
2.104
ELECTRODE(S)
means (typically, an electrical sensor) in contact with a specified part of the body to detect
heart action voltage in combination with another means
2.105
LEAD SELECTOR
system to select certain LEADS and CALIBRATION (CAL)
2.106
NEUTRAL ELECTRODE
reference point for differential amplifiers and/or interference suppression circuits, not forming
part of any electrocardiographic LEAD
2.107
SENSITIVITY
ratio of the amplitude of a recorded signal to the amplitude of the signal producing it,
expressed in mm/mV
2.108
ALARM
signal, which indicates abnormal events occurring to the PATIENT or EQUIPMENT
2.109
INHIBITION
disabling or SILENCING and disabling an ALARM until revoked intentionally
2.110
LATCHED ALARM
ALARM, the visual and auditory manifestations of which do not stop when the ALARM condition
no longer exists
2.111
NON-LATCHED ALARM
ALARM, the auditory or visual and auditory manifestation of which stop when ALARM condition
no longer exists
2.112
PHYSIOLOGICAL ALARM
signal which either indicates that a monitored physiological function is out of specified limits
or indicates an abnormal PATIENT condition
2.113
SILENCE
stopping of an auditory ALARM manifestation by OPERATOR action
*2.114
SILENCE/RESET
stopping of an auditory or auditory and visual ALARM manifestation and re-enabling system
response to an ALARM condition

60601-2-27  IEC:2005 – 21 –
2.115
SUSPENSION
disabling or SILENCING and disabling an ALARM temporarily
2.116
TECHNICAL ALARM
signal, which indicates that the EQUIPMENT or part(s) of the EQUIPMENT is not capable of
accurately monitoring the PATIENT’S condition
4 General requirements for tests
This clause of the General Standard applies except as follows:
4.6 Other conditions
Amendment:
Unless otherwise stated, tests shall be carried out with the accessories and the recording
materials specified by the manufacturer.
For EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE, if the test result is affected by the
INTERNAL ELECTRICAL POWER SOURCE voltage, then the test shall be performed using the least
favourable INTERNAL ELECTRICAL POWER SOURCE voltage specified by the manufacturer. If
necessary for the purpose of conducting the test, an external battery or d.c. power supply may
be used to provide the necessary test voltage.
The values used in test circuits, unless otherwise specified, shall have at least an accuracy as
given below:
– resistors: ±2 %;
– capacitors: ±10 %;
– inductors: ±10 %;
– test voltages: ±1 %
*4.11 Sequence
Amendment:
Tests called for in 17 h) and 17.101 of this Particular Standard shall be carried out prior to the
LEAKAGE CURRENT and dielectric strength tests described in Clauses C.24 and C.25 of
Appendix C of the General Standard and prior to the tests specified in Clause 50.
5 Classification
This clause of the General Standard applies except as follows:
5.2 According to the degree of protection against electric shock:
Amendment: Delete TYPE B and TYPE BF APPLIED PARTS.

60601-2-27  IEC:2005 – 23 –
5.6 According to the mode of operation:
Replacement:
Delete all items but CONTINUOUS OPERATION.
6 Identification, marking and documents
6.1 Marking on the outside of the EQUIPMENT or EQUIPMENT parts
Addition:
In order to minimize the possibility of incorrect connections the PATIENT CABLE shall be
permanently marked with one of the identifiers (ELECTRODE identifier and/or colour code)
specified in Table 101.
Table 101 – ELECTRODES and NEUTRAL ELECTRODE,
their position, identification and colour
Code 1 Code 2
(usually European) (usually American)
ELECTRODES ELECTRODES
System Identifier Colour code Identifier Colour code Position on body surface
R Red RA White Right arm
Limb
L Yellow LA Black Left arm
F Green LL Red Left leg
C White V Brown Single movable chest electrode
C1 White/red V1 Brown/Red Fourth intercostal space at right border
of sternum
C2 White/yellow V2 Brown/Yellow Fourth intercostal space at left border
of sternum
Chest
accor- C3 White/green V3 Brown/Green Fifth rib between C2 and C4
ding to
C4 White/brown V4 Brown/Blue Fifth intercostal space on left
Wilson
midclavicular line
C5 White/black V5 Brown/Orange Left anterior axillary line at the
horizontal level of C4
C6 White/violet V6 Brown/Violet Left midaxillary line at the horizontal
level of C4
a
I Light blue/red I Orange/Red At the right midaxillary line
a
E Light blue/yellow E Orange/Yellow At the front midline
C Light blue/green C Orange/Green Between the front midline and left
Position
midaxillary line of 45 degrees
accor-
a
ding to A Light blue/black A Orange/Brown At the left midaxillary line
Frank
a
M Light blue/brown M Orange/Black At the back midline
H Light blue/violet H Orange/Violet On the back of the neck
F Green F Red On the left leg
N Black RL Green Right leg (NEUTRAL ELECTRODE)
a
Located at the transverse level of the ventricles, if known, or otherwise at the fifth intercostal space

60601-2-27  IEC:2005 – 25 –
6.8 Accompanying documents
6.8.2 Instructions for use
Addition:
aa) Advice shall be given on the following:
1) That conductive parts of ELECTRODES and associated connectors for APPLIED PARTS,
including the NEUTRAL ELECTRODE, should not contact other conductive parts
including earth.
2) The type of electrical installation to which the EQUIPMENT may be safely connected,
including the connection of any POTENTIAL EQUALIZATION CONDUCTOR.
3) A warning that only PATIENT-related ACCESSORIES including LEAD WIRES as specified
by the manufacturer shall be used to guarantee defibrillator protection. The
specification (or type-number) of such ACCESSORIES (see 17.101) shall be disclosed.
4) If parts of the EQUIPMENT are provided with protections against burning of the PATIENT
when used with high frequency (HF) surgical equipment, this shall be drawn to the
attention of the OPERATOR. Advice shall be given regarding the location of the
electrodes and LEAD WIRES etc, to reduce the hazard of burns in the event of a defect
in the HF surgical neutral electrode connection.
5) The choice and application of ELECTRODES.
6) Any possible hazard caused by the summation of LEAKAGE CURRENTS when several
items of EQUIPMENT are interconnected.
7) Any safety hazard due to the simultaneous use of other PATIENT-connected
EQUIPMENT, for example, a cardiac pacemaker or other electrical stimulators.
*8) The need for regular testing of the EQUIPMENT and ACCESSORIES.
9) The means of indicating an inoperative EQUIPMENT (see 51.101).
10) If indication of the heart-rate may be adversely affected by the operation of cardiac
pacemaker pulses or by cardiac arrhythmias.
11) The delay time of making ALARMS available from the ALARMING EQUIPMENT to remote
equipment at the SIGNAL OUTPUT PART (see 51.102.7)
12) The selection procedure for suspending or inhibiting ALARMS remotely (see 51.102.8)
13) The selection procedure provided to SILENCE/RESET ALARMS remotely (see 51.102.9)
14) The intended environment of use.
15) The amplitude, pulse width and overshoot of pacemaker pulses that are rejected by
the EQUIPMENT.
16) The operation of the EQUIPMENT after interruption of supply mains exceeding 30 s
(see 49.2.bb)).
bb) The following performance specification shall be disclosed:
1) Respiration, leads-off sensing, and active noise suppression. For EQUIPMENT
designed to intentionally apply a current to the PATIENT for the purpose of respiration
sensing, leads-off sensing or active noise suppression, the manufacturer shall
disclose the waveforms (in the form of voltage, current, frequency, or other
appropriate electrical parameters) which are applied to the PATIENT.

60601-2-27  IEC:2005 – 27 –
2) Tall T-wave rejection capability. Disclosure shall be made of the maximum T-wave
amplitude according to clause 50.102.17.
3) Heart rate averaging. The type of averaging done to compute the minute heart rate
and, if applicable, the updating rate of the display shall be disclosed.
4) Heart rate meter accuracy and response to irregular rhythm. Disclosure shall be
made of the indicated heart rate, after a 20 s EQUIPMENT stabilization period, for the
four types of alternating ECG complexes A1 to A4 described in Figure 101.
5) Response time of heart rate meter to change in heart rate. Disclosure shall be
made of the maximum time, to the nearest second and including the update time of
the EQUIPMENT, required for the heart rate meter to indicate a new heart rate for a step
increase from 80 1/min to 120 1/min and a step decrease from 80 1/min to 40 1/min.
The response time is measured from the time of the first QRS complex of the new
rate to the time the heart rate meter first reads 37 % of the heart rate indication at
80 1/min plus (a) for the step increase, 63 % of the steady state indication at
120 1/min or greater, and (b) for the step decrease, 63 % of the steady state
indication at 40 1/min or less.
6) Time to ALARM for tachycardia. Disclosure shall be made of the time to ALARM for
the two ventricular tachycardia waveforms B1 and B2 shown in Figure 101, following
a normal 80 1/min rate with the upper ALARM limit set closest to 100 1/min and the
lower ALARM limit set closest to 60 1/min. Disclosure shall also be made of EQUIPMENT
failure to ALARM on either of these waveforms. In addition, the time to ALARM shall be
disclosed for these waveforms when their amplitudes are one-half and twice the
indicated amplitudes.
7) Pacemaker pulse rejection warning label. The following or a similar warning shall
be displayed in the operator manual: “WARNING — PACEMAKER PATIENTS. Rate
meters may continue to count the pacemaker rate during occurrences of cardiac
arrest or some arrhythmias. Do not rely entirely upon rate meter ALARMS. Keep
pacemaker patients under close surveillance. See this manual for disclosure of the
pacemaker pulse rejection capability of this instrument” (see 50.102.13 m).
8) Visual and auditory ALARM disclosure. The manufacturer shall disclose the ALARM'S
location (i.e., central station, bedside, or both), colour, size, and modulation
(flashing), and the frequency or other descriptive characteristics of the sounds.
9) For INTERNALLY POWERED EQUIPMENT, the minimum operating time of the EQUIPMENT
shall be disclosed, provided that the battery is new and fully charged. If rechargeable
batteries are used, the manufacturer shall disclose the battery charge time from
depletion to 90 % charge. In addition, the function of the indicator of clause 56.8 c)
and the battery charging cycle or charging procedure shall also be clearly stated.
10) Auxiliary output. Disclosure shall be made regarding proper connection of other
devices to the auxiliary ECG signal output, if provided. In addition, the manufacturer
shall disclose the bandwidth, gain and propagation delay time of all auxiliary outputs.
Manufacturers also shall disclose how internal pacemaker pulses are represented in
the auxiliary output (their inclusion or absence, and whether enhanced pace pulses
are summed with the ECG signal).

60601-2-27  IEC:2005 – 29 –
11) Pacer pulse detection disabling. If OPERATOR accessible controls are provided that
disable the pace pulse detection capability of the EQUIPMENT, the mode selection
shall be disclosed.
12) The inputs and their minimum input impedance that are also used for other
measurements (e.g. respiration) shall be disclosed (see 50.102.3).
13) The available time bases of permanent and non-permanent displays of the
equipment shall be disclosed.
SECTION TWO – ENVIRONMENTAL CONDITIONS
The clauses and subclauses of this section of the General Standard apply.
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
The clauses and subclauses of this section of the General Standard apply except as follows:
14 Requirements related to classification
*14.6 TYPES B, BF and CF APPLIED PARTS
Replacement:
EQUIPMENT shall have TYPE CF APPLIED PARTS.
17 Separation
This clause of the general standard applies with the following addition:
Addition :
*17h) 101 Protection against the effects of defibrillation and blocking after
defibrillation
Protection against the effects of defibrillation shall be provided for all EQUIPMENT.
For defibrillator testing the EQUIPMENT is operated using the PATIENT CABLES as specified by
the manufacturer.
– Warning –
The following tests are hazardous and precautions must be enforced for protection of
test personnel. It is recommended that an enclosed test fixture be used such that
defibrillator voltages will not reach test personnel!
17h) 101.1 Defibrillator energy delivered to the patient
The EQUIPMENT and/or PATIENT CONNECTIONS shall incorporate a means so that the defibrillator
energy delivered to a 100 Ω load is reduced by a maximum of 10 % relative to the energy
delivered to this load with the EQUIPMENT disconnected.

60601-2-27  IEC:2005 – 31 –
Compliance is checked by the following test:
The test circuit is shown in Figure 106. For this test, the manufacturer's recommended
accessories such as PATIENT CABLES and LEAD WIRES shall be used. The test is applied
between a single LEAD WIRE and all other LEAD WIRES connected together. The EQUIPMENT shall
be energized for this test. The procedure is as follows:
a) Connect a single LEAD WIRE to point C of the test circuit. Connect the remaining LEAD
WIRES to point D of the test circuit.
b) Charge the capacitor to 5 kV with switch S in position A.
c) Discharge the test circuit by moving the switch S to position B, and measure the energy
E1 delivered to the 100 Ω load across points E and F.
d) Remove the EQUIPMENT under test from the test circuit (disconnect points C and D.)
e) Charge the capacitor to 5 kV with switch S in position A.
f) Discharge the test circuit by moving the switch S to position B, and measure the energy
E2 delivered to the 100 Ω load across points E and F.
g) Verify that the energy E1 is at least 90 % of E2.
h) Repeat the test for each available LEAD WIRE, with the test voltage applied between the
LEAD WIRE being tested and all other LEAD WIRES connected together.
17h) 101.2 Differential mode test of EQUIPMENT
After exposure to the defibrillation voltage, the EQUIPMENT shall resume within 5 s normal
operation in the previous operating mode, without loss of any OPERATOR settings or stored
data, and shall continue to perform its intended function as described in the ACCOMPANYING
DOCUMENTS.
The EQUIPMENT is connected to the test circuit shown in Figure 107. The test voltage is
applied to each LEAD WIRE in turn with all the remaining LEAD WIRES being connected to earth.
Initially, the test is conducted applying the test voltage between the R (RA) LEAD WIRE and all
remaining LEAD WIRES connected to the N (RL) LEAD WIRE. The EQUIPMENT shall be energized
for these tests.
EQUIPMENT having an INTERNAL ELECTRICAL POWER SOURCE which is rechargeable from the
SUPPLY MAINS shall be tested with and without the SUPPLY MAINS connection if the EQUIPMENT is
capable of operating while connected to the SUPPLY MAINS.
Compliance is checked by the following test:
Set the SENSITIVITY of the EQUIPMENT such that a 5 mV signal produces a maximum display
deflection without clipping the signal. With S2 open, adjust the 10 Hz sine wave generator to
produce a 5 mV peak-to-valley output signal. Close switch S2.
Connect S1 to position A and charge the capacitor C. After about 10 s, connect S1 to position
B. Leave in position B for at least 200 ms ± 50 %.
Open S1 in order to remove residual voltages from the EQUIPMENT and allow recovery to
begin.
S2 is then immediately opened. The test signal shall be recorded at not less than 4 mV peak-
to-valley referred to the input within 5 s.

60601-2-27  IEC:2005 – 33 –
Repeat the test for any other LEAD WIRE according to Table 102 with all remaining LEAD WIRES
connected to the N (RL) LEAD WIRE.
Table 102 – Protection against the effect of defibrillation (test conditions)
P1 P2 Lead setting Number of
tests
L (LA) R, F, N, C (RA, LL, RL, V) I 1
R (RA) F, L, N, C (LL, LA, RL, V) II 1
5 electrode
F (LL) L, R, N, C (LA, RA, RL, V) III 1
cables
N (RL) L, R, F, C (LA, RA, LL, V) Standby  1
C (V) L, R, F, N (LA, RA, LL, RL) V 1
L (LA) R, F, or N (RA, LL or RL) I 2
3 electrode
R (RA) L, F, or N (LA, LL or RL) I 2
cables
F (LL) or N (RL) R, L (RA, LA) II or standby 2
2 electrode L (LA) R (RA) I 1
cables
17h) 101.3 Common mode test of EQUIPMENT
After exposure to the defibrillation voltage, the EQUIPMENT shall resume within 5 s normal
operation in the previous operating mode, without loss of any OPERATOR settings or stored
data, and shall continue to perform its intended function as specified in the ACCOMPANYING
DOCUMENTS.
Compliance is checked according to Figure 108. The test voltage shall be applied between all
LEAD WIRES, including the NEUTRAL ELECTRODE, connected together and the FUNCTIONAL EARTH
TERMINAL. The EQUIPMENT shall be energized for these tests.
In the case of CLASS II EQUIPMENT and EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE,
the test voltage shall be applied between all LEAD WIRES, including the NEUTRAL ELECTRODE,
connected together and the FUNCTIONAL EARTH TERMINAL and/or metal foil in close contact with
the ENCLOSURE.
EGG MONITORING EQUIPMENT having an INTERNAL ELECTRICAL POWER SOURCE, which is
rechargeable from the SUPPLY MAINS, shall be tested with and without the SUPPLY MAINS
connection if the EQUIPMENT is capable of operating while connected to SUPPLY MAINS.
Connect S1 to position A and charge the capacitor C. After about 10 s, connect S1 to position
B. Leave in position B for at least 200 ms ± 50 %.
Open S1 in order to remove residual voltages from the EQUIPMENT and allow recovery to
begin.
Repeat the above test with the polarity of the high voltage source reversed. The tests with
positive and negative polarities shall be repeated 5 times.

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The EQUIPMENT shall resume normal operation in the previous operating mode, without loss of
any OPERATOR settings or stored data within 5 s and shall continue to perform its intended
function as specified in the ACCOMPANYING DOCUMENTS.
17h) 101.4 Recovery time of EQUIPMENT from electrode polarization after defibrillation
After defibrillation discharge when the EQUIPMENT is operated using PATIENT CABLE and
ELECTRODES as specified by the manufacturer, the ECG signal sha
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