EN 60601-2-25:1995

SLOVENSKI STANDARD
01-september-1998
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Medical electrical equipment - Part 2-25: Particular requirements for the safety of
electrocardiographs (IEC 60601-2-25:1993)
Medizinische elektrische Geräte - Teil 2-25: Besondere Festlegungen für die Sicherheit
von Elektrokardiographen (IEC 60601-2-25:1993)
Appareils électromédicaux - Partie 2-25: Règles particulières de sécurité des
électrocardiographes (CEI 60601-2-25:1993)
Ta slovenski standard je istoveten z: EN 60601-2-25:1995
ICS:
11.040.50 Radiografska oprema Radiographic equipment
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

NORME
CEI
INTERNATIONALE
IEC
601-2-25
INTERNATIONAL
Première édition
STANDARD
First edition
1993-03
Appareils électromédicaux
Partie 2:
Règles particulières de sécurité
des électrocardiographes
Medical electrical equipment
Part 2:
Particular requirements for the safety
of electrocardiographs
CEI 1993
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601-2-25 ©IEC: 1993 - 3 -
CONTENTS
Page
FOREWORD
INTRODUCTION
SECTION ONE: GENERAL
Clause
1 11
Scope and object
2 Terminology and definitions 13
4 General requirements for tests 15
5 Classification
6 Identification, marking and documents
SECTION TWO: ENVIRONMENTAL CONDITIONS
10 Environmental conditions 19
SECTION THREE: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
17 19
Separation
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
20 Dielectric strength
SECTION FOUR: PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE: PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
34 Ultraviolet radiation 23
SECTION SIX: PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN: PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 23
Excessive temperatures
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning,
sterilization and disinfection

601-2-25 ©IEC: 1993 – 5 –
SECTION EIGHT: ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
Clause Page
51 Protection against hazardous output 25
SECTION NINE: ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION TEN: CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly 31
57 MAINS PARTS, components and layout 33
Figures
101 Dynamic test for limitation of energy from different parts 35
102 Measuring circuit for the PATIENT LEAKAGE CURRENT from the APPLIED
PART to earth of CLASS I EQUIPMENT, caused by an external voltage on
a FUNCTIONAL EARTH TERMINAL 37
103 Measuring circuit for the PATIENT LEAKAGE CURRENT from the APPLIED
PART t0 earth of INTERNALLY POWERED EQUIPMENT, caused by an
external voltage on a FUNCTIONAL EARTH TERMINAL 39
104 Test of protection against the effects of defibrillation 41
105 Test of protection against the effects of defibrillation 41
106 Arrangements for ECG ELECTRODES on sponges 43
107 Test of the recovery time from the effects of cardiac defibrillator discharge 43
APPENDIX D Symbols on marking (Symbols to indicate protection against
the effects of the discharge of a cardiac defibrillator) 45
Annexe AA General guidance and rationale 47

- 7 -
601-2-25 © IEC: 1993
INTERNATIONAL ELECTROTECHNICAL COMMISSION
MEDICAL ELECTRICAL EQUIPMENT
Part 2: Particular requirements for the safety
of electrocardiographs
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization
comprising all national electrotechnical committees (IEC National Committees). The object of the IEC is to
promote international cooperation on all questions concerning standardization in the electrical and
electronic fields. To this end and in addition to other activities, the IEC publishes International Standards.
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. The IEC
collaborates closely with the International Organization for Standardization (ISO) in accordance with
conditions determined by agreement between the two organizations.
The formal decisions or agreements of the 1EC on technical matters, prepared by technical committees on
2)
which all the National Committees having a special interest therein are represented, express, as nearly as
possible, an international consensus of opinion on the subjects dealt with.
They have the form of recommendations for international use published in the form of standards, technical
3)
reports or guides and they are accepted by the National Committees in that sense.
In order to promote international unification, IEC National Committees undertake to apply IEC International
4)
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
International Standard IEC 601-2-25 has been prepared by subcommittee 62D: Electro-
medical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
The text of this Particular Standard is based on the following documents:
DIS Report on Voting
62D(CO)21
62D(CO)17
Full information on the voting for the approval of this Particular Standard can be found in
the repo rt on voting indicated in the above table.
Annex AA is for information only.
In this Particular Standard the following print types are used:
- requirements, compliance with which can be tested, and definitions: in roman type;
- notes, explanations, advice, instructions, general statements, exceptions and references, in smaller
type;
test specifications: in italic type;
-
– TERMS USED THROUGHOUT THIS PARTICULAR STANDARD WHICH HAVE BEEN DEFINED IN
CLAUSE 2 AND IN IEC 601-1: SMALL CAPITALS.

— 9 —
601-2-25 © IEC: 1993
INTRODUCTION
This Particular International Standard amends and supplements IEC 601-1 (second
rt 1: General requirements for safety,
edition, 1988): Medical electrical equipment – Pa
hereinafter referred to as the General Standard (see 1.3).
The requirements are followed by specifications for the relevant tests.
Following the decision taken by subcommittee 62D at the meeting in Washington in 1979,
a "General guidance and rationale" section giving some explanatory notes, where appropri-
ate, about the more important requirements is included in annex AA.
Clauses or subclauses for which there are explanatory notes in annex AA are marked with
an asterisk (*).
It is considered that a 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 tech-
of the requirements of this Standard.
nology. However, this annex does not form pa rt

601-2-25 ©IEC: 1993 - 11 -
MEDICAL ELECTRICAL EQUIPMENT
Part 2: Particular requirements for the safety
of electrocardiographs
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 International Standard specifies the particular safety requirements for
ELECTROCARDIOGRAPHS as defined in 2.102, intended for the production of detachable
for diagnostic purposes. It also applies to vector-cardiographs and
ELECTROCARDIOGRAMS
EQUIPMENT
for stress testing.
This Particular Standard covers minimum safety requirements.
Special requirements concerning use in ambulances, phono-cardiographs, cardiographic
monitors, polygraphs, telemetering, special tests (for example, His bundle electrocardio-
graphs), etc. are not covered by this Particular Standard.
with microelectrodes used directly in the fibres of the heart muscle is also
EQUIPMENT
excluded.
1.2
Object
Replacement:
The object of this Particular International Standard is to establish particular requirements
ELECTROCARDIOGRAPHS as defined in 2.102.
for the safety of
1.3 Particular Standards
Addition:
Medical electrical equipment- Part 1:
This Particular Standard refers to lEC 601-1 (1988):
General requirements for safety.
For brievity Part 1 is referred to in this Particular Standard either as the "General
Standard" or as the "General Requirement(s)".

601-2-25 ©IEC: 1993 –13 –
The numbering of sections, clauses and subclauses of this Particular Standard corre-
sponds to 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 or figures which are additional to those of the General Standard are numbered
starting from 101, additional appendices 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 Par-
ticular 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.
2 Terminology and definitions
This clause of the General Standard applies except as follows:
Additional definitions:
2.101 ELECTROCARDIOGRAM (ECG)
Visible record of heart action potentials.
2.102 ELECTROCARDIOGRAPH (ecg)
ELECTRODES intended for the production of
MEDICAL ELECTRICAL EQUIPMENT and associated
detachable ELECTROCARDIOGRAMS for diagnostic purposes.
2.103 LEAD(S)
ELECTRODE combination used for a certain ECG recording.
2.104 ELECTRODE
rt of the body to detect heart action voltages in
ELECTRODE attached to a specified pa
combination with another ELECTRODE Or ELECTRODES.

601-2-25 © IEC: 1993 - 15 -
2.105 LEAD SELECTOR
System to select certain LEADS and TEST.
2.106 MULTICHANNEL ELECTROCARDIOGRAPH
LEADS.
EQUIPMENT for the simultaneous recording of several ecg
This EQUIPMENT may also provide facilities for phonocardiography and pulse recording etc.
2.107 NEUTRAL ELECTRODE
Reference point for differential amplifiers and/or interference suppression circuits, not
ELECTROCARDIOGRAPH LEAD.
forming part of any
2.108 NORMAL SENSITIVITY
SENSITIVITY of 10 mm/mV.
2.109 PATIENT CABLE
ELECTRO-
Multiwire cable and associated connector(s) to connect the ELECTRODES to the
CARDIOGRAPH.
2.110 SENSITIVITY
Ratio of the amplitude of a recording to the amplitude of the signal producing it, expressed
in mm/mV.
2.111 SINGLE CHANNEL ELECTROCARDIOGRAPH
EQUIPMENT for the recording of one ecg LEAD at a time.
2.112 STANDARDIZATION VOLTAGE
Voltage step recorded for amplitude calibration purposes.
2.113 TEST
Facility enabling the STANDARDIZATION VOLTAGE or zero voltage to be recorded in place of
the ELECTROCARDIOGRAM.
4 General requirements for tests
This clause of the General Standard applies except as follows:
4.11* Sequence
601-2-25 ©IEC: 1993 - 17 -
Amendment:
Tests called for in 17.101 and 51.101 of this Particular Standard shall be carried out in
that order prior to the LEAKAGE CURRENT and dielectric strength tests of clauses C24 and
C25 of Appendix C of the General Standard.
5 Classification
This clause of the General Standard applies except as follows:
5.6 Amendment:
Delete all but CONTINUOUS OPERATION.
6 Identification, marking and documents
This clause of the General Standard applies except as follows:
6.1 Marking on the outside
I) Classification
Addition:
ELECTROCARDIOGRAPH and parts thereof that are specified as being protected
The
against the effects of defibrillation shall be marked with one of the symbols as appro-
priate, given in Appendix D of this Particular Standard. (See also 17.101 and 51.101.)
6.8.2 Instructions for use
Additional item:
aa) Advice shall be given on the following:
The procedures necessary for safe operation, drawing attention in the case of
1)
to the safety hazards which may occur as a result of
TYPE B ELECTROCARDIOGRAPHS
an inadequate electrical installation.
EQUIPMENT may be safety
2) The type of electrical installation to which the
connected, including the connection of any POTENTIAL EQUALIZATION CONDUCTOR.
TYPE BF or
3) That conductive parts of ELECTRODES and associated connectors for
including the NEUTRAL ELECTRODE, should not contact
CF ELECTROCARDIOGRAPHS,
other conductive parts including earth.
PATIENT CABLE which
4) The specification (and type number, if necessary) of the
needs to be used to provide protection against the effect of the discharge of a
cardiac defibrillator and against high-frequency burns.
is provided with protective means against burns of
5) If the ELECTROCARDIOGRAPH
when used with high-frequency (HF) surgical equipment, this shall be
the PATIENT
601-2-25 © I EC: 1993 - 19 -
drawn to the attention of the OPERATOR. If no such means are incorporated, advice
shall be given regarding the location of the ECG ELECTRODES to reduce the hazard of
burns in the event of a defect in the HF surgical neutral electrode connection.
6)
The choice and application of ELECTRODES.
7) The suitability of the ELECTROCARDIOGRAPH for DIRECT CARDIAC APPLICATION.
8)
The possible hazard caused by the summation of LEAKAGE CURRENTS when
several EQUIPMENTS are interconnected.
9)
Any safety hazard due to the operation of a cardiac pacemaker or other
electrical stimulators.
10)* Instructions for regular testing of the ELECTROCARDIOGRAPH and the PATIENT
CABLE.
11) The precautions to be taken when a defibrillator is used on a PATIENT.
12)
The means of indicating an inoperative ELECTROCARDIOGRAPH (see 51.103 of
this Particular Standard).
SECTION TWO - ENVIRONMENTAL CONDITIONS
The clauses and subclauses of this section of the General Standard apply except as
follows:
10 Environmental conditions
This clause of the General Standard applies except as follows:
10.2.1 b)*
Replacement:
Relative humidity between 25 % and 95 % (without condensation).
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
The clauses and subclauses of this section of the General Standard apply except as
follows:
17 Separation
This clause of the General Standard applies except as follows:
Addition:
17.101* Protection against the effects of a cardiac defibrillator discharge
Arrangements used to isolate any
ELECTRODES from parts a) to d) mentioned below shall
be so designed that during the discharge of a cardiac defibrillator to a
PATIENT connected
to the ELECTRODES,
hazardous electrical energies are excluded from the following:

601-2-25 ©IEC: 1993 - 21 -
a) the ENCLOSURE
any
b) SIGNAL INPUT PART
C) any SIGNAL OUTPUT PART
EQUIPMENT is placed and which has an area at least equal to
d) metal foil on which the
INTERNALLY POWERED EQUIPMENT.)
the base of the EQUIPMENT (CLASS I, II and
(see figure 101) the
The above-mentioned requirement is met when after operation of S 1
Y1 and Y2 does not exceed 1 V. The EQUIPMENT shall not
peak voltage between the points
be energized.
shall be tested while connected to protective earth.
CLASS I EQUIPMENT
SUPPLY MAINS, for example
CLASS I EQUIPMENT which is capable of operation without a
having an internal battery, shall also be tested without the protective earth connection.
Any connection to a functional earth shall be removed.
Repeat the test with the polarity of V 1 reversed.
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
This clause of the General Standard applies except as follows:
19.3 Allowable values
Item a) Addition:
the PATIENT
1)* For ELECTROCARDIOGRAPHS having a FUNCTIONAL EARTH TERMINAL,
APPLIED PART to earth shall comply with the values
LEAKAGE CURRENT flowing from the
RATED MAINS
given in table 101 below, when a voltage equal to 110 % of the highest
FUNCTIONAL EARTH TERMINAL and earth.
VOLTAGE is applied between the
FUNCTIONAL EARTH TERMINAL is connected
This test shall not be performed when the
EQUIPMENT.
direct to the PROTECTIVE EARTH TERMINAL inside the
PATIENT LEAKAGE CURRENT
Table 101 -
FUNCTIONAL EARTH TERMINAL)
(MAINS VOLTAGE on the
Type Of EQUIPMENT Or APPLIED PART Allowable values
mA
B, BF
0,05
CF
Compliance is checked by measurement according to figures 102 and 103.

601-2-25 © IEC: 1993 - 23 -
20 Dielectric strength
This clause of the General Standard applies except as follows:
20.2* Particular requirements for EQUIPMENT with an APPLIED PART
Amendment:
B-b Does not apply to ELECTROCARDIOGRAPHS.
20.3* Values of test voltages
Amendment:
B-d For ELECTROCARDIOGRAPHS, the test voltage shall be 1 500 V (CLASS I, CLASS II EQUIP-
MENT and INTERNALLY POWERED EQUIPMENT).
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
The clauses and subclauses of this section of the General Standard apply.
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
The clauses and subclauses of this section of the General Standard apply except as
follows:
34* Ultraviolet radiation
Replacement:
If the recorder is equipped with an ultraviolet lamp, the ELECTROCARDIOGRAPH should be so designed and con-
structed as to prevent ultraviolet emission of wavelength below 320 nm.
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
The clauses and subclauses of this section of the General Standard apply.
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
This section of the General Standard applies except as follows:

– 25 –
601-2-25 ©IEC: 1993
42 Excessive temperatures
This clause of the General Standard applies except as follows:
42.5* Guards
Amendment:
ELECTRO-
This subclause does not apply to any heated stylus or printing element of an
CARDIOGRAPH.
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning,
sterilization and disinfection
This clause of the General Standard applies except as follows:
44.3 Spillage
Does not apply.
SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
The clauses and subclauses of this section of the General Standard apply except as
follows:
51 Protection against hazardous output
This clause of the General Standard applies except as follows:
Additional subclauses:
Protection against the effects of defibrillation and unblocking after defibrillation
51.101*
ELECTRO-
51.101.1 Protection against the effects of defibrillation shall be provided for all
CARDIOGRAPHS.
Means shall be provided for enabling the test signal (see figure 104) to be readable within
after capacitor discharge.
5 s at NORMAL SENSITIVITY
Such means may be manual or automatic.

601-2-25 © IEC: 1993 - 27 -
Table 102 -Test conditions: Protection against the effect of defibrillation
Appropriate LEAD
setting
Pi P2 SELECTOR
to include
R, N, F, C I
Five ELECTRODE Cable L
II
R L,F,N,C
III
F L, R, N, C
V
C L,R,F
TEST position
N L, R, F, C
(if available)
All others 1l I
Ten ELECTRODE cable L
R " Il
Ill
F
V1, V2, V3
C1, C2, C3
C4, C5, C V4, V5, V6
TEST position
N L, R, F, Cl, C2
C3, C4, C5, C6 (if available)
Vx, Vz
VECTOR cable E, C All others . "
Vy, Vz
M, H
Vy
F
I " Vx
Vx
A
Vx, Vy, Vz
N
1) "All others" means all other ELECTRODES including the NEUTRAL ELECTRODE.
Compliance is checked by inspection and by carrying out the following tests, with the
as shown in table 102.
ELECTRODES connected to P1 and P2
ELECTROCARDIOGRAPH operating normally shall be connected as shown in figure 104.
The
S2 closed, S 1 is switched to position
With the capacitor charged to the source voltage and
B for a period of 200 ms ± 50 %, and then away from position B.
ELECTROCARDIOGRAPH
It is necessary to disconnect the capacitor in order to remove residual voltages from the
and to allow recovery to commence.
is opened. The test signal shall be
Immediately after the restoration of S 1 to position A, S2
recorded at not less than 80 % of normal amplitude within 5 s after the operation of S.
Repeat the tests with the polarity of the source voltage reversed.
the test voltage shall
51.101.2 In addition, in the case of CLASS I ELECTROCARDIOGRAPHS
NEUTRAL ELECTRODE, connected together
be applied between all ELECTRODES, including the
and the PROTECTIVE EARTH TERMINAL.
SUPPLY MAINS, for example
CLASS I EQUIPMENT which is capable of operation without a
having an internal battery, shall also be tested without the protective earth connection.
Any connection to a functional earth shall be removed.

601-2-25 © IEC: 1993 - 29 -
CLASS Ii and INTERNALLY POWERED ELECTROCARDIOGRAPHS, the test voltage
In the case of
including the NEUTRAL ELECTRODE, connected
shall be applied between all ELECTRODES,
and/or metal foil in close contact with the
FUNCTIONAL EARTH TERMINAL
together and the
ENCLOSURE.
INTERNAL ELECTRICAL POWER SOURCE which is recharge-
ELECTROCARDIOGRAPHS having an
SUPPLY MAINS connection,
shall be tested with and without the
able from the SUPPLY MAINS
SUPPLY MAINS.
if the ELECTROCARDIOGRAPH is capable of operating while connected to the
Compliance
...