IEC 60601-2-49:2001

INTERNATIONAL IEC
STANDARD
60601-2-49
First edition
2001-07
Medical electrical equipment –
Part 2-49:
Particular requirements for the safety
of multifunction patient monitoring equipment
Appareils électromédicaux –
Partie 2-49:
Règles particulières de sécurité des appareils
de surveillance multifonction des patients
Reference number
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INTERNATIONAL IEC
STANDARD
60601-2-49
First edition
2001-07
Medical electrical equipment –
Part 2-49:
Particular requirements for the safety
of multifunction patient monitoring equipment
Appareils électromédicaux –
Partie 2-49:
Règles particulières de sécurité des appareils
de surveillance multifonction des patients
 IEC 2001  Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: +41 22 919 0300 e-mail: inmail@iec.ch IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
S
International Electrotechnical Commission
For price, see current catalogue

– 2 – 60601-2-49  IEC:2001(E)
CONTENTS
FOREWORD.3
INTRODUCTION.5
SECTION ONE – GENERAL
1 Scope and object .6
2 Terminology and definitions.7
5 Classification .9
6 Identification, marking and documents.9
SECTION TWO – ENVIRONMENTAL CONDITIONS
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 Requirements related to classification .10
17 Separation .10
19 Continuous leakage currents and patient auxiliary currents.12
20 Dielectric strength .14
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION
*36 Electromagnetic compatibility .15
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE
ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
49 Interruption of the power supply .16
SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data.16
51 Protection against hazardous output.16
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly.23
Appendix L – References – Publications mentioned in this standard .25
Annex AA (informative) Guidance and rationale .26
Annex BB (informative) Alarm diagrams of clause 51.33
Annex EE (informative) Survey of insulation paths and test circuit.36
Annex KK (informative) Examples of patient leakage current measurements.37
Index of defined terms .44

60601-2-49  IEC:2001(E) – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-49: Particular requirements for the safety
of multifunction patient monitoring equipment
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 co-operation 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.
2) The formal decisions or agreements of the 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 National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
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.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-49 has been prepared by subcommittee 62D: Electro-
medical equipment, of IEC technical committee 62: Electrical equipment in medical practice.
The text of this standard is based upon the following documents:
FDIS Report on voting
62D/409/FDIS 62D/412/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 3.
Annexes AA, BB, EE and KK are for information only.

– 4 – 60601-2-49  IEC:2001(E)
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, introductions, general statements, exceptions and references: in smaller type;
– test specifications, headings of subclauses and headings of items: in 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
2006. At this date, the publication will be:
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
A bilingual version of this publication may be issued at a later date.

60601-2-49  IEC:2001(E) – 5 –
INTRODUCTION
This Particular Standard concerns the safety of multifunction patient monitoring equipment. It
amends and supplements IEC 60601-1 (second edition 1988), hereinafter referred to as the
General Standard. The requirements of this Particular Standard take priority over those of the
General Standard, entitled “Medical electrical equipment – Part 1: General requirements for
safety”.
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, this annex
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 A of this Particular Standard.
At the time of the 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 medial electrical equipment”. It is intended to harmonize this standard
with the above-mentioned collateral standard after its publication.

– 6 – 60601-2-49  IEC:2001(E)
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-49: Particular requirements for the safety
of multifunction patient monitoring equipment
SECTION ONE – GENERAL
This section of the General Standard applies except as follows:
1 Scope and object
*1.1 Scope
This Particular Standard applies to the safety requirements of MULTIFUNCTION PATIENT
MONITORING EQUIPMENT as defined in subclause 2.2.101.
The scope of this standard is restricted to EQUIPMENT having either more than one APPLIED
PART or more than one SINGLE FUNCTION, intended for connection to a single PATIENT.
This standard does not specify requirements for individual monitoring functions.
1.2 Object
The object of this Particular Standard is to specify requirements for the safety of MULTIFUNCTION
PATIENT MONITORING EQUIPMENT.
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).
For brevity, Part 1 is referred to in this Particular Standard either as the “General Standard” or
as the “General Requirement(s)”.
The numbering of sections, clauses and subclauses of this Particular Standard corresponds to
that of the General Standard. 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.

60601-2-49  IEC:2001(E) – 7 –
Subclauses 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.
1.5 Collateral standards
Addition:
IEC 60601-1-2:1993, Medical electrical equipment – Part 1: General requirements for safety –
2. Collateral Standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-1-4:1996, Medical electrical equipment – Part 1: General requirements for safety –
4.Collateral standard: Programmable electric medical systems
Amendment 1 (1999)
2 Terminology and definitions
*2.1.5
APPLIED PART
Delete second dash.
Additional definitions:
2.2. EQUIPMENT types (classification)
2.2.101
MULTIFUNCTION PATIENT MONITORING EQUIPMENT (hereinafter referred to as EQUIPMENT)
modular or pre-configured device including more than one PHYSIOLOGICAL MONITORING UNIT
designed to collect information from a single PATIENT and process it for monitoring purposes
and to generate ALARMS
2.2.102
PHYSIOLOGICAL MONITORING UNIT
a part of the EQUIPMENT whose purpose is to collect information relating to (a) physiological
function(s) and to process it for monitoring and summary diagnostic purposes
2.5 Currents
2.5.101
MULTIPLE FUNCTION
measurement of more than one physiological parameter

– 8 – 60601-2-49  IEC:2001(E)
*2.5.102
PART LEAKAGE CURRENT
current flowing from a SINGLE FUNCTION through the PATIENT to the remaining SINGLE FUNCTION
(S) of the same APPLIED PART under NORMAL CONDITIONs
2.5.103
SINGLE FUNCTION
measurement of one physiological parameter
NOTE Examples of physiological functions are body temperature, ECG, invasive and non-invasive blood pressure
etc.
2.12 Miscellaneous
2.12.101
ALARM
a signal which indicates abnormal events occurring to the PATIENT or EQUIPMENT
2.12.102
INHIBITION
disabling or SILENCING and disabling an ALARM until revoked intentionally
2.12.103
LATCHED ALARM
an ALARM, the visual and auditory manifestation of which does not stop when the ALARM
condition no longer exists
2.12.104
NON-LATCHED ALARM
an ALARM, the auditory or visual and auditory manifestation of which stops when the ALARM
condition no longer exists
2.12.105
PHYSIOLOGICAL ALARM
a signal which either indicates that a monitored physiological function is out of specified limits
or indicates an abnormal PATIENT condition
2.12.106
SILENCE
the stopping of an auditory ALARM manifestation by OPERATOR action
*2.12.107
SILENCE/RESET
the stopping of an auditory or auditory and visual ALARM manifestation and re-enabling system
response to an ALARM condition
2.12.108
SUSPENSION
disabling or SILENCING and disabling an ALARM temporarily
2.12.109
TECHNICAL ALARM
a signal which indicates that the EQUIPMENT or part(s) of the EQUIPMENT is not capable of
accurately monitoring the PATIENT’S condition

60601-2-49  IEC:2001(E) – 9 –
5 Classification
*5.2 According to the degree of protection against electric shock:
Amendment:Delete TYPE B APPLIED PART.
5.6 According to the mode of operation:
Amendment:
Delete all but CONTINUOUS OPERATION.
6 Identification, marking and documents
6.1 Marking on the outside of the EQUIPMENT
Addition:
aa) When detachable, each PHYSIOLOGICAL MONITORING UNIT shall be identified by the
following markings and information:
1) manufacturer's name or mark;
2) designation of the model either by a name specific to the model or by reference
number or reference letters;
3) SERIAL NUMBER.
bb) Each PATIENT input connection on the APPLIED PART shall be marked for the function.
cc) Parts of an EQUIPMENT (for example, PATIENT CABLES or sensors) specified as not being
protected against the effects of defibrillation shall be marked with symbol 14 of table DI
in Appendix D of the General Standard.
6.8 ACCOMPANYING DOCUMENTS
6.8.2 Instructions for use
Addition:
aa) The instructions for use shall also include:
1) the intended use of the equipment;
2) that the use of the EQUIPMENT is restricted to one PATIENT at a time;
3) the instructions for connection of any POTENTIAL EQUALIZATION CONDUCTOR;
4) adequate information (and type number, if necessary) to identify the PATIENT CABLES
which need to be used to provide protection against the effect of the discharge of a
cardiac defibrillator and against burns;
5) precautions specific to the EQUIPMENT to be taken when a defibrillator is used on a
PATIENT, and effects on the EQUIPMENT of the discharge of a defibrillator;
6) safety hazard due to simultaneous use of other PATIENT-connected MEDICAL ELEC-
TRICAL EQUIPMENT, for example, a cardiac pacemaker or other electrical stimulators;

– 10 – 60601-2-49  IEC:2001(E)
7) if the EQUIPMENT is provided with protective means against burns to the PATIENT when
used with high-frequency (HF) surgical equipment, this shall be drawn to the attention
of the OPERATOR; if no such means are incorporated, advice shall be given regarding
the location of ELECTRODES and TRANSDUCERS to reduce the hazards of burns in the
event of a defect in the HF surgical equipment NEUTRAL ELECTRODE connection;
8) the choice and application of the specified ACCESSORIES;
9) the procedure(s) for regular checks on the correct function of the EQUIPMENT and
ACCESSORIES;
10) identification with which PHYSIOLOGICAL MONITORING UNIT/S the EQUIPMENT is intended
to be used;
11) methods by which the visual and auditory ALARMS may be tested by the OPERATOR;
12) the default settings (e.g. ALARM settings, modes, and filter);
13) simple fault finding methods by which the OPERATOR can locate problems if the
EQUIPMENT appears not to be functioning correctly;
NOTE This relates to simple OPERATOR difficulties, not to technical malfunctions.
14) the disclosure of the subsequent operation of the EQUIPMENT when the SUPPLY MAINS
to the EQUIPMENT is interrupted for more than 30 seconds;
15) the disclosure how ALARM manifestations of TECHNICAL ALARMS may be disabled if
sensors, probes, or modules are intentionally disconnected by the OPERATOR;
16) a statement indicating whether or not the EQUIPMENT is suitable for connection to
public mains as defined in CISPR 11;
17) adjustment ranges of all PHYSIOLOGICAL ALARM limits (see 51.102.3).
SECTION TWO – ENVIRONMENTAL CONDITIONS
This section of the General Standard applies.
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
This section of the General Standard applies except as follows:
14 Requirements related to classification
14.6 TYPES B, BF AND CF APPLIED PARTS
Addition:
EQUIPMENT shall have TYPE BF and/or CF APPLIED PARTS.
17 Separation
This clause of the general standard applies with the following addition:
aa) TYPE CF and TYPE BF APPLIED PARTS may consist of more than one SINGLE FUNCTION if the
requirements of 19.1 and 56.3 for such EQUIPMENT have been met.

60601-2-49  IEC:2001(E) – 11 –
*17 h) Addition:
1. DEFIBRILLATION-PROOF APPLIED PARTS 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 per cent relative to the energy delivered to this load with the EQUIPMENT
disconnected.
Compliance is checked by the following test:
The test circuit is shown in Fig. 101. The source generator shall have a minimum stored
voltage of 5 kV, and the energy delivered to the test assembly shall be 360 J. For this
test, the manufacturer's recommended ACCESSORIES such as cables, ELECTRODES and
TRANSDUCERS shall be used. The test is applied to one APPLIED PART or PATIENT
CONNECTION at a time). The procedure is as follows:
a. Connect the APPLIED PART/PATIENT CONNECTION to the test circuit. For connection
methods, follow the instructions for defibrillation tests described in particular
standards where available and applicable.
b. Charge the capacitor to 5 kV with switch S1 in position A.
c. Discharge the test circuit by actuating the switch S1 to position B, and measure the
energy E1 delivered to the defibrillator tester (i.e., 100 Ω load).
d. Remove the EQUIPMENT under test from the test circuit and measure the energy E2
delivered to the 100 Ω load.
e. Verify that the energy E1 is at least 90 per cent of E2.
nd
Replacement 2 dash:
– After defibrillation the EQUIPMENT shall return to the previous operating mode within 30 s
(unless otherwise specified in the relevant Particular Standards) without loss of any
OPERATOR settings or stored data, and shall continue to perform its intended function as
described in the ACCOMPANYING DOCUMENTS.
rd
Replacement 3 dash:
– (Common-mode test) The EQUIPMENT is connected to the test circuit shown in figure 50
of amendment 2 of the General Standard. The test voltage shall be applied to all
PATIENT CONNECTIONS of an APPLIED PART connected together and isolated from earth.
For EQUIPMENT having more than one APPLIED PART this test shall be repeated for the
PATIENT CONNECTIONS of each APPLIED PART while the PATIENT CONNECTIONS of the
remaining APPLIED PARTS are connected together and connected to earth.
th
Replacement 4 dash:
– (Differential-mode test) The EQUIPMENT is connected to the test circuit shown in figure
51 of amendment 2 of the General Standard. The test voltage is applied to each PATIENT
CONNECTION in turn with all the remaining PATIENT CONNECTIONS of all APPLIED PARTS
being connected to earth.
th
Replacement 6 dash:
– The EQUIPMENT shall be energized for this test.
Replacement last paragraph:
After 30 s recovery time, unless a shorter time is specified by an applicable particular standard,
the EQUIPMENT shall resume 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.

– 12 – 60601-2-49  IEC:2001(E)
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
The clause of the General Standard applies, except as follows:
19.1 General requirements
Replacement:
b) The specified values of the continuous earth leakage current, the enclosure leakage
current, the patient leakage current, the patient auxiliary current, the part leakage
current, and the total patient leakage current apply in any combination of the following
conditions:
Amendment:
e) The PATIENT LEAKAGE CURRENT shall be measured (see Annex KK):
Delete TYPE B APPLIED PARTS
*19.3 Allowable values
Addition
*aa) PATIENT LEAKAGE CURRENT of TYPE BF APPLIED PARTS
PATIENT LEAKAGE CURRENT shall not exceed the values given in Table IV of the General
Standard.
The PATIENT LEAKAGE CURRENT of a TYPE BF APPLIED PART shall be measured from and
to all PATIENT CONNECTIONS of an APPLIED PART connected together. The measurement
shall be carried out with all other PATIENT CONNECTIONS of the remaining APPLIED PARTS:
1) connected together, but not to earth, and
2) connected to earth
Compliance is checked by connecting the EQUIPMENT as shown in Annex KK
Figure KK.101 and verifying that the measured currents are below the limits given in
Table IV of the General Standard.
*bb) PATIENT LEAKAGE CURRENT of TYPE CF APPLIED PARTS
PATIENT LEAKAGE CURRENT shall not exceed the values given in Table IV of the General
Standard.
The PATIENT LEAKAGE CURRENT of TYPE CF APPLIED PARTS shall be measured from and to
each PATIENT CONNECTION in turn. The measurement shall be carried out with all other
PATIENT CONNECTIONS of the remaining APPLIED PARTS:
1) connected together, but not to earth, and
2) connected to earth
Compliance is checked by connecting the EQUIPMENT as shown in Annex KK
Figure KK.102 and verifying that the measured currents are below the limits given in
Table IV of the General Standard.
*cc) Total PATIENT LEAKAGE CURRENT of TYPE BF AND CF APPLIED PARTS
Total PATIENT LEAKAGE CURRENT shall not exceed the values given in table 101.

60601-2-49  IEC:2001(E) – 13 –
Table 101 – Maximum total PATIENT LEAKAGE CURRENT
TYPE BF TYPE CF
Current
APPLIED PARTS APPLIED PARTS
mA
N.C. S.F.C. N.C. S.F.C.
Total PATIENT LEAKAGE CURRENT (d.c.)
0,05 0,1 0,05 0,1
Total PATIENT LEAKAGE CURRENT (a.c.)
0,5 1 0,05 0,1
Total PATIENT LEAKAGE CURRENT
MAINS VOLTAGE APPLIED PART
( on the )
–5 – 0,1
(a.c.)
N.C.: normal condition
S.F.C.: single fault condition
Total PATIENT LEAKAGE CURRENT shall be measured by connecting all PATIENT
CONNECTIONS of all APPLIED PARTS of the same type (TYPE BF or TYPE CF) together and to
1) earth (NORMAL CONDITION), and to
2) MAINS VOLTAGE (SINGLE FAULT CONDITION).
SINGLE FAULT CONDITION other than compliance for cc) is checked according to 19.2 of
the General Standard.
NOTE Figure KK.103 illustrates the compliance test of EQUIPMENT having only APPLIED PARTS of the same
type (TYPE BF or TYPE CF). Figure KK.104 illustrates the compliance test of EQUIPMENT having TYPE BF and
TYPE CF APPLIED PARTS.
Compliance is checked by connecting the EQUIPMENT as shown in Annex KK
Figures KK.103 and KK.104 (TYPE BF/CF APPLIED PARTS) and verifying that the measured
current(s) is(are) below the limits given above.
*dd) PART LEAKAGE CURRENT of TYPE BF APPLIED PARTS
Total PART LEAKAGE CURRENT shall not exceed 0,01 mA d.c. or 0,1 mA a.c.
The PART LEAKAGE CURRENT of TYPE BF APPLIED PARTS shall be measured between any
SINGLE FUNCTION and the remaining SINGLE FUNCTIONS of the same APPLIED PART in turn.
The PATIENT CONNECTIONS shall be connected together.
Compliance is checked by connecting the EQUIPMENT as shown in Annex KK
Figure KK.105 and verifying that the measured currents are below the limits given
above.
*ee) PART LEAKAGE CURRENT of TYPE CF APPLIED PARTS
Total PART LEAKAGE CURRENT shall not exceed 0,01 mA d.c. or 0,01 mA a.c.
In TYPE CF APPLIED PARTS, the PART LEAKAGE CURRENT shall be measured in turn
between each PATIENT CONNECTION of the same SINGLE FUNCTION and the remaining
SINGLE FUNCTIONS connected together.
Compliance is checked by connecting the EQUIPMENT as shown in Annex KK
Figure KK.106 and verifying that the measured currents are below the limits given
above.
ff) Total PATIENT LEAKAGE CURRENT for patient connectors
Any connector in a LEAD having a conductive connection to the equipment, which does
not pass the test of 56.3 (aa) first dash shall meet the following requirements:
Total PATIENT LEAKAGE CURRENT for patient connectors shall not exceed the values given
in table 102.
– 14 – 60601-2-49  IEC:2001(E)
Table 102 – Maximum TOTAL PATIENT LEAKAGE CURRENTS for patient connectors
TYPE BF TYPE CF
Current
APPLIED PARTS APPLIED PARTS
mA
N.C. S.F.C. N.C. S.F.C.
Total PATIENT LEAKAGE CURRENT
(MAINS VOLTAGE on the APPLIED PART)
–5 – 0,1
N.C.: normal condition
S.F.C.: single fault condition
Total PATIENT LEAKAGE CURRENT shall be measured by applying the EQUIPMENT
connector(s) of the same APPLIED PART connected to earth and connecting all remaining
PATIENT CONNECTIONS of that APPLIED PART together and to mains voltage (SINGLE FAULT
CONDITION).
Compliance is checked by connecting the EQUIPMENT as shown in Figure KK.107 of
Annex KK and verifying that the measured current is below the limits given above.
20 Dielectric strength
The clause of the General Standard applies, except as follows,
*20.2 Requirements for EQUIPMENT with an APPLIED PART
Replacement:
B-b Insulation between the APPLIED PARTS shall be at least BASIC INSULATION. The reference
voltage shall be not less than the highest RATED supply voltage or for INTERNALLY
POWERED EQUIPMENT 250 V. If voltages exist within the APPLIED PARTS, the insulation shall
be in addition DOUBLE or REINFORCED INSULATION applicable to these voltages.
20.4 Tests
Replacement:
c) For EQUIPMENT having more than one APPLIED PART the dielectric strength between APPLIED
PARTS shall be tested as follows:
– the test voltage shall be applied between the PATIENT CONNECTIONS of one APPLIED PART
and all remaining APPLIED PARTs whose PATIENT CONNECTIONS are connected to earth.
– the test shall be repeated for each APPLIED PART.
See Figure EE.101 in Appendix EE for illustration.
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
This section of the General Standard applies.
SECTION FIVE – PROTECTION AGAINST HAZARDS
FROM UNWANTED OR EXCESSIVE RADIATION
This section of the General Standard applies except as follows:

60601-2-49  IEC:2001(E) – 15 –
*36 Electromagnetic compatibility
Addition:
Modular and preconfigured EQUIPMENT shall be tested configured with the maximum number of
PHYSIOLOGICAL MONITORING UNITS. All specified PHYSIOLOGICAL MONITORING UNITS shall be
tested. Representative samples from each family of PATIENT CABLES and/or TRANSDUCERS with
similar construction listed in the ACCOMPANYING DOCUMENTS shall be tested with the
corresponding PHYSIOLOGICAL MONITORING UNIT.
Replacement:
36.201.1.1 The EQUIPMENT shall comply with the requirements of CISPR 11, Group 1, Class A
or B depending on its intended use as specified by the manufacturer.
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES
This section of the General Standard applies.
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
This section of the General Standard applies except as follows:
44.3 Spillage
Replacement:
The EQUIPMENT shall be so constructed that, in the event of spillage of liquids (accidental
wetting), no safety hazard shall result.
The EQUIPMENT shall not be subjected to the following test, unless the EQUIPMENT is
PORTABLE/TRANSPORTABLE or part of the EQUIPMENT is separable while remaining functioning, in
which case the said EQUIPMENT, or parts of the EQUIPMENT, shall be subjected to the following
test.
Compliance is checked by the following test:
The EQUIPMENT shall be placed in the least favourable position of NORMAL USE. The EQUIPMENT
is then subjected for 30 seconds to an artificial rainfall of 3 mm/min falling vertically from a
height of 0,5 m above the top of the EQUIPMENT.
A test apparatus is shown in figure 3 of IEC 60529.
An intercepting device may be used to determine the duration of the test.
Immediately after 30 seconds exposure, visible moisture on the ENCLOSURE shall be removed.
Immediately after the above test, check that any water which may have entered the EQUIPMENT
cannot adversely affect the safety of the EQUIPMENT. In particular, the EQUIPMENT shall be
capable of meeting the relevant dielectric strength test.

– 16 – 60601-2-49  IEC:2001(E)
49 Interruption of the power supply
49.2
Addition:
a) When the SUPPLY MAINS to the EQUIPMENT is interrupted for less than 30 seconds, all
OPERATOR settings, including the mode of operation, and all stored PATIENT data shall not
be changed. However, the EQUIPMENT does not have to be operating during the interruption
of the SUPPLY MAINS.
Compliance is checked by observing the EQUIPMENT operating mode, OPERATOR settings,
and stored data and interrupting the SUPPLY MAINS for a period of between 25 and 30 seconds
by disconnecting the POWER SUPPLY CORD.
b) When the SUPPLY MAINS is interrupted for more than 30 seconds:
The subsequent operation shall be one of the following: reversion to the manufacturer’s
default settings, to a previous USER’s default settings or to the last settings used.
NOTE There may be provisions for the OPERATOR to select one or more than one of the above options.
Compliance shall be checked by inspection.
c) When the EQUIPMENT contains an INTERNAL ELECTRICAL POWER SOURCE and the SUPPLY
MAINS is interrupted the EQUIPMENT shall continue normal operation by switching
automatically to operation from its INTERNAL ELECTRICAL POWER SOURCE and the mode of
operation, all OPERATOR settings, and stored data shall not be changed.
EQUIPMENT shall be equipped with a device that visually indicates the operation from its
INTERNAL ELECTRICAL POWER SOURCE.
Compliance is checked by interrupting SUPPLY MAINS and observing that OPERATOR settings
and stored data are not changed. The ‘on-off’ switch shall remain in the ‘on’ position.
SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
This section of the General Standard applies except as follows:
50 Accuracy of operating data
Addition:
50.101 Software
Collateral Standard IEC 60601-1-4: Medical Electrical EQUIPMENT Incorporating Programmable
Electronic Systems, shall be applied.
NOTE While performing the HAZARD ANALYSIS, special emphasis should be given to the HAZARDS associated with
the ALARM system of the EQUIPMENT.
51 Protection against hazardous output
Addition:
51.101 ALARMS (see also ALARM diagrams in annex BB)

60601-2-49  IEC:2001(E) – 17 –
51.101.1 PHYSIOLOGICAL ALARM device
EQUIPMENT shall be provided with at least one auditory and one visual PHYSIOLOGICAL ALARM
device.
Compliance is checked by inspection.
51.101.2 TECHNICAL ALARM device
EQUIPMENT shall be provided with at least one auditory and one visual TECHNICAL ALARM device.
Compliance is checked by inspection.
*51.101.3 SUSPENSION or INHIBITION of all PHYSIOLOGICAL ALARMS and TECHNICAL ALARMS
a) EQUIPMENT may be provided with means to suspend or inhibit all PHYSIOLOGICAL ALARM(S)
and all TECHNICAL ALARM(S) in NORMAL USE. The said means shall inhibit or suspend
– the auditory
or
– the auditory and visual
manifestations of all PHYSIOLOGICAL ALARMS and the auditory manifestations of all
TECHNICAL ALARMS. The selection (configuration) of either SUSPENSION or INHIBITION function
shall be protected to prevent that the OPERATOR may change the configuration in NORMAL
USE. ACCOMPANYING DOCUMENTS (preferably in the technical documentation) shall describe
the selection procedure.
Compliance testing of INHIBITION: The PHYSIOLOGICAL ALARM(S) is/are simulated. As soon as
the visual and auditory ALARM devices indicate the ALARMS, the function INHIBITION is
activated. The function INHIBITION must disable the auditory or the auditory and visual
ALARM manifestations permanently depending on the configuration.
Compliance testing of SUSPENSION: The PHYSIOLOGICAL ALARM(S) is/are simulated. As soon
ALARM ALARMS SUSPENSION
as the visual and auditory devices indicate the , the function is
activated. The function SUSPENSION must disable the auditory or the auditory and visual
ALARM manifestations temporarily depending on the configuration. After exceeding the pre-
adjusted SUSPENSION time, the previously disabled auditory or visual and auditory ALARM
manifestations shall be restored automatically.
Both tests are repeated with simulated TECHNICAL ALARM(S). The functions SUSPENSION and
INHIBITION shall only disable the auditory ALARM manifestation.
ACCOMPANYING DOCUMENTS are checked by inspection.
b) If an EQUIPMENT is provided with means to suspend or inhibit the PHYSIOLOGICAL ALARM(S)
and TECHNICAL ALARM(S) only one of the functions SUSPENSION and INHIBITION shall be
selectable at a time.
Compliance is checked by inspection.
c) The duration of SUSPENSION may be adjustable. Said means shall not be adjustable by the
OPERATOR in NORMAL USE. The duration and/or the adjustment range of the duration shall be
specified in the ACCOMPANYING DOCUMENTS.
Compliance is checked by inspection.
d) If global SUSPENSION or INHIBITION of ALARM(S) is activated by the OPERATOR in NORMAL USE
it shall be visually indicated.
Compliance is checked by inspection.

– 18 – 60601-2-49  IEC:2001(E)
51.101.4 SILENCE/RESET of ALARMS
EQUIPMENT shall be equipped with means to SILENCE/RESET ALARMS.
Compliance is checked by inspection.
51.101.5 Selection of NON-LATCHED ALARM(S) and LATCHED ALARM(S)
EQUIPMENT shall be equipped with NON-LATCHED ALARM(S) and/or LATCHED ALARM(S). Only one
of the modes shall be selectable for PHYSIOLOGICAL ALARMS.
Compliance is checked by inspection.
51.101.6 NON-LATCHED ALARM(S)
If EQUIPMENT is equipped with NON-LATCHED ALARM(S), the ALARM shall be SILENCED and RESET
automatically (without any OPERATOR interaction) as soon as the monitored parameter(s)
come(s) back within the adjusted limits, or if the abnormal PATIENT condition does not exist any
longer.
Compliance is checked by the following test:
A PHYSIOLOGICAL ALARM is simulated. As soon as the visual and auditory ALARM devices
ALARM
indicate the , the simulator settings are changed to a value that does not exceed the
ALARM limit. When the monitored parameter returns to a value, that does not exceed the ALARM
limit, the auditory or the auditory and visual ALARM manifestations must cease without
activating the function SILENCE/RESET.
NOTE If EQUIPMENT guarantees minimum ALARM durations, the visual and auditory ALARM manifestations may
continue until the minimum ALARM duration is reached.
51.101.7 LATCHED ALARM(S)
If EQUIPMENT is equipped with LATCHED ALARM(S), the ALARM manifestations shall not cease
without activation of the function SILENCE/RESET.
Compliance is checked by the following test:
A PHYSIOLOGICAL ALARM is simulated. After the visual and auditory ALARM devices indicate the
ALARM, the simulator settings are changed to a value that no longer exceeds the ALARM limit.
The auditory or the auditory and visual ALARM manifestations must not cease without activating
the function SILENCE/RESET.
51.101.8 System ALARM delay time
The ACCOMPANYING DOCUMENTS shall specify the delay time of making ALARM(S) available from
the alarming EQUIPMENT to remote equipment at the SIGNAL OUTPUT PART.
Compliance is checked by inspection.
NOTE For guidance on this requirement, it is recommended that the delay time not exceed 0,5 s.

60601-2-49  IEC:2001(E) – 19 –
*51.101.9 Remote control of INHIBITION and SUSPENSION of ALARMS
Means may be provided to suspend or inhibit ALARMS remotely. The selection (configuration) of
remote SUSPENSION or INHIBITION shall be protected. The ACCOMPANYING DOCUMENTS shall
describe the selection procedure.
51.101.10 Remote control of SILENCE/RESET
Means may be provided to SILENCE/RESET ALARMS remotely. The selection (configuration) of
remote SILENCE/RESET shall be protected. The ACCOMPANYING DOCUMENTS shall describe the
selection procedure.
51.102 PHYSIOLOGICAL ALARMS
51.102.1 INHIBITION of individual PHYSIOLOGICAL ALARMS
EQUIPMENT may be equipped with means to inhibit its individual PHYSIOLOGICAL ALARMS. The
said means shall inhibit the auditory or the auditory and visual manifestations of individual
PHYSIOLOGICAL ALARMS.
Compliance is checked by the following test:
PHYSIOLOGICAL ALARM ALARM
A  is simulated. As soon as the visual and auditory devices
indicate the ALARM, the INHIBITION of the individual PHYSIOLOGICAL ALARM is activated. The
function INHIBITION must disable immediately the auditory or the auditory and visual ALARM
manifestations permanently, depending on the configuration.
*51.102.2 SILENCE/RESET of PHYSIOLOGICAL ALARMS
After SILENCE/RESET, the ALARM devices shall reset automatically to respond to a new ALARM
when the monitored parameter returns to a value within the adjusted limits, or if the abnormal
PATIENT condition does not exist any longer.
Compliance is checked by testing according to 51.102.
51.102.3 PHYSIOLOGICAL ALARM selection, ALARM limit range, and delay time of
PHYSIOLOGICAL ALARMS
The delay time of PHYSIOLOGICAL ALARMS after the parameter value has exceeded an ALARM
limit, may be adjustable.
NOTE The PHYSIOLOGICAL ALARM selection (e.g. systolic or diastolic pressure) and the ALARM limit range should be
described in particular standards.
Adjustment ranges of PHYSIOLOGICAL ALARMS shall be specified in the ACCOMPANYING
DOCUMENTS.
51.102.4 Auditory manifestation of PHYSIOLOGICAL ALARMS
The auditory manifestation shall be discontinuous.
Compliance is checked by inspection.
After SILENCE/RESET the auditory manifestation shall disappear.

– 20 – 60601-2-49  IEC:2001(E)
SILENCE/RESET shall apply for the PHYSIOLOGICAL ALARM(S) that are being annunciated. New
PHYSIOLOGICAL ALARM(S) that begin after the activation of SILENCE/RESET shall resume the
auditory and visual ALARM manifestations.
Compliance is checked by inspection.
*51.102.5 Visual manifestation of PHYSIOLOGICAL ALARMS
The visual manifestation shall be continuous or discontinuous.
Compliance is checked by inspection.
In addition to the visual ALARM manifestation, each PHYSIOLOGICAL ALARM-generating parameter
shall be continuously and legibly indicated.
NOTE As guidance on this requirement, it is recommended that manufacturers consider continuously indicating
each PHYSIOLOGICAL ALARM-generating parameter as well as the visual ALARM manifestation.
Compliance is checked by inspection.
If EQUIPMENT is provided with means to suspend the visual manifestation of PHYSIOLOGICAL
ALARMS, the SUSPENSION time shall be the same as for the auditory ALARM manifestation.
Compliance is checked by inspection.
SILENCE/RESET shall not stop the visual ALARM manifestation as long as the parameter is not
within the adjusted limits or if the abnormal PATIENT condition still exists.
If the EQUIPMENT provides means to inhibit or suspend visual PHYSIOLOGICAL ALARMS, the said
means shall also inhibit or suspend the auditory PHYSIOLOGICAL ALARMS.
LATCHED ALARMS:
After SILENCE/RESET, the visual ALARM device shall reset automatically if the monitored
parameter is within adjusted limits or if the abnormal PATIENT condition does not exist any
longer.
NON-LATCHED ALARMS:
The visual ALARM device shall reset automatically (with or without SILENCE/RESET) when the
monitored parameter returns to a value within the adjusted limits or if the abnormal PATIENT
condition does not exist any longer.
Compliance test of the function SILENCE/RESET with LATCHED ALARMS:
First, a PHYSIOLOGICAL ALARM is simulated. As soon as the visual and auditory ALARM devices
indicate the ALARM, the function SILENCE/RESET is activated by the OPERATOR, which must
disable the auditory ALARM manifestation immediately. Second, the simulator settings are
changed to a value that does not exceed the alarm limit. The visual ALARM manifestations must
cease without activating the function SILENCE/RESET again.

60601-2-49  IEC:2001(E) – 21 –
Compliance test of the function SILENCE/RESET with NON-LATCHED ALARMS:
a) SILENCE/RESET is activated by the OPERATOR before the ALARM condition ceases
First, a PHYSIOLOGICAL ALARM is simu
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