EN 60601-2-24:1998

SLOVENSKI STANDARD
01-september-1998
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Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion
pumps and controllers (IEC 60601-2-24:1998)
Medizinische elektrische Geräte - Teil 2-24: Besondere Festlegungen für die Sicherheit
von Infusionspumpen und Infusionsreglern (IEC 60601-2-24:1998)
Appareils électromédicaux - Partie 2-24: Règles particulières de sécurité des pompes et
régulateurs de perfusion (CEI 60601-2-24:1998)
Ta slovenski standard je istoveten z: EN 60601-2-24:1998
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

INTERNATIONAL IEC
STANDARD 60601-2-24
First edition
1998-02
Medical electrical equipment –
Part 2-24:
Particular requirements for the safety of infusion
pumps and controllers
Appareils électromédicaux –
Partie 2-24:
Règles particulières de sécurité des pompes et régulateurs
de perfusion
 IEC 1998 Copyright - all rights reserved  Droits de reproduction réservés
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in
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For price, see current catalogue

– 2 – 60601-2-24 © IEC:1998(E)
CONTENTS
Page
FOREWORD . 4
INTRODUCTION . 5
Clause
SECTION ONE – GENERAL
1 Scope and object . 6
2 Terminology and definitions . 7
3 General requirements . 10
5 Classification . 11
6 Identification, marking and documents . 11
SECTION TWO – ENVIRONMENTAL CONDITIONS
10 Environmental conditions . 13
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 Requirements related to classification . 14
17 Separation. 14
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS. 14
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength. 16
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
36 Electromagnetic compatibility. 17
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,
disinfection and compatibility . 19
47 Electrostatic charges . 20
49 Interruption of the power supply . 20

60601-2-24 © IEC:1998(E) – 3 –
Clause Page
SECTION EIGHT – ACCURACY OF OPERATING DATA
AND PROTECTION AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data. 21
51 Protection against hazardous output . 38
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS:
ENVIRONMENTAL TESTS
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
54 General . 42
56 Components and general assembly. 44
Annexes
L References – Publications mentioned in this standard . 45
AA General guidance and rationale. 47

– 4 – 60601-2-24 © IEC:1998(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
–
MEDICAL ELECTRICAL EQUIPMENT
Part 2-24: Particular requirements for the safety
of infusion pumps and controllers
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 inter-
national 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 Standardi-
zation (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 inter-
national 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 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 60601-2-24 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:
FDIS Report on voting
62D/250/FDIS 62D/268/RVD
Full information on the voting for the approval of this Particular Standard can be found in the
report on voting indicated in the above table.
Annex L is an integral part of this standard.
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, introductions, general statements, exceptions and references: in
smaller type;
– test specifications: in italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD IEC 60601-1 OR THIS PARTICULAR
STANDARD: SMALL CAPITALS.
A bilingual version of this standard may be issued at a later date.

60601-2-24 © IEC:1998(E) – 5 –
INTRODUCTION
This Particular Standard deals with the safety of INFUSION PUMPS and CONTROLLERS. The
relationship between this Particular Standard, IEC 60601-1 (including amendments 1 and 2),
and the Collateral Standards is explained in 1.3.
The safe use of infusion pumps and controllers is primarily the responsibility of the OPERATOR.
It is also recognized that OPERATORS should be trained in the operation of MEDICAL ELECTRICAL
EQUIPMENT and that safe use of the EQUIPMENT can only be achieved if it is operated in
accordance with the manufacturer’s instructions for use. The minimum specified safety
requirements are considered to provide a practical degree of safety in operation. It is the
responsibility of the manufacturer to ensure that the requirements of this Particular Standard
are reliably implemented. This Particular Standard has been developed in accordance with
these principles.
Safe use can be ensured only if the associated disposable parts, especially lines and syringes
are consistent with the system. ISO 7886-2:1996, Sterile hypodermic syringes for single use –
Part 2: Syringes for use with power-driven syringe pumps should be taken into account.

– 6 – 60601-2-24 © IEC:1998(E)
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-24: Particular requirements for the safety
of infusion pumps and controllers
SECTION ONE – GENERAL
The clauses and subclauses of this section of the General Standard and of this section of the
Collateral Standard IEC 60601-1-2 apply, except as follows:
1 Scope and object
This clause of the General Standard and this clause of the Collateral Standard IEC 60601-1-2
apply, except as follows:
1.1* Scope
Addition:
This Particular Standard specifies the requirement for INFUSION PUMPS, INFUSION CONTROLLERS,
SYRINGE PUMPS and PUMPS FOR AMBULATORY USE, as defined in 2.101 to 2.110. These devices
are intended for use by medical staff and home PATIENTS as prescribed and medically
indicated. These particular requirements do not apply to devices:
1) specifically intended for diagnostic or similar use (e.g. angiography or other pumps
permanently controlled or supervised by the OPERATOR),
2) enteral infusion,
3) extracorporeal circulation of blood,
4) implantable or disposable devices,
5) EQUIPMENT specifically intended for diagnostic use within urodynamics (measurement of
pressure-volume relationship of the urinary bladder when filled through a catheter with
water);
6) EQUIPMENT specifically intended for diagnostic use within male impotence testing
(measurement of amount of liquid infused, necessary to maintain a preset pressure level
for maintaining penile erection: cavernosometry, cavernosography).
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) and to the Collateral Standard IEC 60601-1-2:1993, Medical electrical equipment –
Part 1: General requirements for safety – 2. Collateral Standard: Electromagnetic compatibility
– Requirements and tests.
For brevity, Part 1 is referred to in this Particular Standard either as the General Standard or as
the General Requirement(s) and IEC 60601-1-2 as the Collateral Standard.
The numbering of sections, clauses and subclauses of this Particular Standard corresponds to
that of the General Standard. The changes to the text of the General Standard are specified by
the use of the following words:

60601-2-24 © IEC:1998(E) – 7 –
“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 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, the Collateral
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.
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 appropriate,
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 neces-
sitated 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.
1.5 Collateral Standards
Addition:
This Particular Standard also refers to IEC 60601-1-2, which is applicable unless otherwise
stated in a particular clause or subclause.
2 Terminology and definitions
This clause of the General Standard and of the Collateral Standard IEC 60601-1-2 apply,
except as follows:
2.1.3
ACCESSORY
Addition:
Separate programmers are regarded as accessories and therefore a component part of the
EQUIPMENT
– 8 – 60601-2-24 © IEC:1998(E)
2.1.5
APPLIED PART
Replacement:
entirety of all parts of the EQUIPMENT including the infusion liquid pathway that is intentionally in
contact with the PATIENT being treated in NORMAL USE
2.2.18
PORTABLE EQUIPMENT
Replacement:
TRANSPORTABLE EQUIPMENT intended to be moved from one location to another while in use or
between periods of use, by one or more persons or by other means
Additional definitions:
2.101
INFUSION PUMP
EQUIPMENT intended to regulate the flow of liquids into the PATIENT under positive pressure
generated by the pump
The INFUSION PUMP may be of:
– type 1: continuous infusion flow only,
– type 2: non-continuous flow only,
BOLUS
– type 3: discrete delivery of a ,
– type 4: type 1 combined with type 3 and/or type 2 in the same EQUIPMENT,
– type 5: PROFILE PUMP.
2.102
VOLUMETRIC INFUSION PUMP
INFUSION PUMP OPERATOR
in which the delivery rate is set by the and indicated by the
EQUIPMENT in volume per unit of time, but excluding SYRINGE PUMPS
2.103
DRIP-RATE INFUSION PUMP
INFUSION PUMP in which the delivery rate is set by the OPERATOR and indicated by the
EQUIPMENT as a number of drops per unit of time
2.104
INFUSION CONTROLLER
EQUIPMENT intended to regulate the flow of liquid into the PATIENT under positive pressure
generated by gravitational force
2.105
VOLUMETRIC INFUSION CONTROLLER
INFUSION CONTROLLER in which the delivery rate is set by the OPERATOR and indicated by the
EQUIPMENT in volume per unit of time
2.106
DRIP-RATE INFUSION CONTROLLER
INFUSION CONTROLLER in which the delivery rate is set by the OPERATOR and indicated by the
EQUIPMENT as a number of drops per unit of time

60601-2-24 © IEC:1998(E) – 9 –
2.107
SPECIAL USE EQUIPMENT
EQUIPMENT in which the delivery rate is set by the OPERATOR and indicated by the EQUIPMENT in
units other than those defined in 2.101 to 2.106
2.108
SYRINGE PUMP
EQUIPMENT intended for controlled infusion of liquids into the PATIENT by means of one or more
single action syringe(s) or similar container(s) (e.g. where the cartridge is emptied by pushing
on its plunger)) and in which the delivery rate is set by the OPERATOR and indicated by the
EQUIPMENT in volume per unit of time
2.109
INFUSION PUMP FOR AMBULATORY USE
EQUIPMENT intended for the controlled infusion of liquids into the PATIENT and intended to be
carried continuously by the PATIENT
2.110
PROFILE PUMP
EQUIPMENT intended for controlled infusion of liquids into the PATIENT by means of a
programmed sequence of delivery rates
2.111
REGION OF CONTROL
that part of the EQUIPMENT within which flow regulation, flow shut-off or air detection occurs,
within the body of the EQUIPMENT or remotely
2.112
ADMINISTRATION SET
device(s) that convey(s) liquid from the supply via the EQUIPMENT to the PATIENT
2.113
PATIENT LINE
that part of the ADMINISTRATION SET between the EQUIPMENT and the PATIENT
2.114
SUPPLY LINE
that part of the ADMINISTRATION SET between the liquid supply and the EQUIPMENT
2.115
OCCLUSION ALARM THRESHOLD (PRESSURE)
value of the physical quantity at which the occlusion alarm is activated
2.116
KEEP OPEN RATE (KOR)
low predetermined rate(s) to which the EQUIPMENT reverts under specified conditions with the
object of keeping the PATIENT LINE open
NOTE – The abbreviation KVO (Keep-Vein-Open Rate) is commonly used as a synonym of KOR.
2.117
FREE FLOW
flow in an ADMINISTRATION SET which is not controlled by the EQUIPMENT, for example, due to the
unintended effects of gravity by the removal of the ADMINISTRATION SET from the EQUIPMENT
2.118
ADMINISTRATION SET CHANGE INTERVAL
time recommended by the manufacturer of the EQUIPMENT for using the ADMINISTRATION SET

– 10 – 60601-2-24 © IEC:1998(E)
2.119
BOLUS
discrete quantity of liquid which is delivered in a short time
2.120
INTERMEDIATE RATE defined as follows:
– for volumetric infusion pumps and volumetric infusion controllers, set the rate to 25 ml/h;
– for drip-rate infusion pumps and drip-rate infusion controllers, set the rate to
20 drops/minute;
– for syringe pumps, set the rate to 5 ml/h;
– for special use equipment and infusion pumps for ambulatory use, set the rate specified by
the manufacturer as typical for the equipment.
2.121
MINIMUM RATE
lowest rate selectable by the OPERATOR, but not less than 1 ml/h
NOTE – For INFUSION PUMPS FOR AMBULATORY USE it is the lowest selectable rate.
2.122
MAXIMUM INFUSION PRESSURE
maximum pressure which can be generated by the EQUIPMENT under conditions of total
occlusion at the end of the PATIENT LINE
2.123
PATIENT END
that end of the PATIENT LINE where connection to the PATIENT takes place
3 General requirements
This clause of the General Standard applies, except as follows:
3.6* Addition
SINGLE FAULT CONDITIONS occurring in those protective systems specified in 51.5 and 51.102
shall become obvious to the OPERATOR within the ADMINISTRATION SET CHANGE INTERVAL. SINGLE
FAULT CONDITIONS occurring in the protective system specified in clause 51.103 shall cause the
cessation of delivery and the generation of an alarm within a time interval less than the volume
ADMINISTRATION SET
of the between the air detector and the venous cannula connected to it
divided by the maximum flow rate of the pump.
NOTE – Acceptable methods of complying with this requirement are, for example:
1) a safety system check initiated and controlled by the EQUIPMENT, first at the beginning of the
ADMINISTRATION SET CHANGE INTERVAL, and then repeated continuously as warranted;
2) one or more protective systems checks initiated by the OPERATOR and controlled by the EQUIPMENT within
the ADMINISTRATION SET CHANGE INTERVAL, with the OPERATOR initiating checks before or during the
infusion;
3) a safety system check carried out by the OPERATOR at least once within the ADMINISTRATION SET CHANGE
INTERVAL (see 6.8.2 a) 24)).
The following are not regarded as SINGLE FAULT CONDITIONS, but are regarded as NORMAL USE
CONDITIONS:
– leakage from the ADMINISTRATION SET and/or the liquid supply;
– depletion of the INTERNAL ELECTRICAL POWER SOURCE;
– mispositioning and/or incorrect filling of a drip chamber;

60601-2-24 © IEC:1998(E) – 11 –
– air in the SUPPLY LINE or the REGION OF CONTROL;
– pulling on the PATIENT LINE (see ISO 8536-4).
5 Classification
This clause of the General Standard applies, except as follows:
5.2 Amendment:
Delete TYPE B APPLIED PART;
5.6 Amendment:
CONTINUOUS OPERATION
Delete all except for .
6 Identification, marking and documents
This clause of the General Standard and this clause of the Collateral Standard IEC 60601-1-2
apply, except as follows:
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
Addition:
aa)If detachable liquid reservoirs or PATIENT LINE(S) of specific sizes or brands, or containing
specific concentrations of drugs need to be used to maintain safe NORMAL USE of the
EQUIPMENT then relevant markings shall be fixed or indicated in a prominent place on the
EQUIPMENT which either identify those conditions or provide location of such information.
Compliance is checked by inspection.
6.1 q) Physiological effects
Replacement:
The body of the EQUIPMENT shall be marked with the following:
1) symbol No. 14 of appendix D of the General Standard or a statement to refer the OPERATOR
to the ACCOMPANYING DOCUMENTS;
2) an arrow or other appropriate symbol indicating the correct direction of flow if the
ADMINISTRATION SET can be incorrectly loaded;
3) EQUIPMENT as defined in 2.103 and 2.106 shall additionally be marked as follows:
"Caution: this equipment controls the drip rate not the volume delivered."
Additional items:
6.1.201 of the Collateral Standard, IEC 60601-1-2
Addition:
Compliance is checked by inspection.
6.8 ACCOMPANYING DOCUMENTS
– 12 – 60601-2-24 © IEC:1998(E)
6.8.2 Instructions for use
a) Addition:
The instructions for use shall also include the following:
1) a list of the recommended ADMINISTRATION SET(S) to be used;
2) a warning of the consequences of the use of unsuitable ADMINISTRATION SET(S);
ACCESSORIES
3) a list of particular recommended by the manufacturer for use with the
EQUIPMENT;
4) permitted EQUIPMENT orientation and methods and precautions concerning its mounting, for
example, stability on a pole;
5) instructions regarding loading, priming, changing and reloading the ADMINISTRATION SET(S),
and the ADMINISTRATION SET CHANGE INTERVAL to maintain the specified performance;
6) instructions regarding the use of clamps on an ADMINISTRATION SET, the avoidance of FREE
FLOW conditions and the procedure to be followed when changing liquid containers;
7) where gravity is relevant to performance, the acceptable height range of the liquid
container above the PATIENT's heart;
8) the means provided to protect the PATIENT from air infusion;
9) a statement of the MAXIMUM INFUSION PRESSURE generated and the OCCLUSION ALARM
THRESHOLD (PRESSURE)(S) of the EQUIPMENT;
10) a statement of the maximum time for activation of the occlusion alarm when the
EQUIPMENT is operating at the MINIMUM RATE and the INTERMEDIATE RATE and at the
minimum and maximum selectable OCCLUSION ALARM THRESHOLD (PRESSURE)(S);
11) a statement of the BOLUS volume generated as a result of the EQUIPMENT operating at the
INTERMEDIATE RATE and reaching the minimum and maximum OCCLUSION ALARM THRESHOLD
(PRESSURE) (see also 51.5 b));
12) a statement of the means provided (if any) to manage the BOLUS before occlusion release;
13) a statement to indicate to the OPERATOR if the EQUIPMENT cannot be used as PORTABLE
EQUIPMENT;
14) precautions required with drop detectors, for example with respect to placement, cleanli-
ness, liquid level, ambient light;
15) recommendations on any specific method of cleaning and maintaining the EQUIPMENT;
16) the typical operating time when the EQUIPMENT is operating from the INTERNAL ELECTRICAL
POWER SOURCE at the INTERMEDIATE RATE;
17) a statement of KEEP OPEN RATE(S), and when initiated;
18) a list of alarms and their operating conditions;
19)* a warning that under certain circumstances the specified accuracy may not be maintained.
NOTE – The manufacturer must specify the parameters in which the device cannot maintain the specified accuracy;
e.g. minimum/maximum viscosity of liquids, reaction time of the safety system, scope of the risk analysis, etc.
20)*reference to a guide on the SAFETY HAZARDS associated with the interconnection of other
infusion systems or ACCESSORIES to the PATIENT LINE;
21) the rate obtained when the prime/purge or BOLUS control is operated, and a statement of
any alarm disabled;
22) a warning statement on the possible SAFETY HAZARDS associated with external radio-
frequency interference (RFI) or electromagnetic radiation which may affect the safe
operation of the EQUIPMENT. This statement should include examples of typical EQUIPMENT
which may generate such radiation;
23) the selectable rate range and the increments of selection;
24) guidance on tests to permit the OPERATOR to check the correct functioning of alarm(s) and
the operational safety of the EQUIPMENT;

60601-2-24 © IEC:1998(E) – 13 –
25) data as evaluated by the test methods of 50.101 to 50.108 at the rates indicated in table
102, including an explanation for the OPERATOR of the data presentation;
26) the time for which the electronic memory is retained following switch-off;
27) for SPECIAL USE EQUIPMENT, the conversion factor(s) for volume divided by unit of time;
28)* the maximum volume that may be infused under SINGLE FAULT CONDITIONS;
29) guidance on the safe operation of the EQUIPMENT if it is connected operationally to a
remote control device;
30) information concerning type(s) of battery to be used and where available;
31) a statement of the meaning of claimed IP-classification.
6.8.201 of IEC 60601-1-2
Addition:
6.8.3 Technical description
Addition:
The technical description shall also include the following:
aa) the sensitivity of the air detector, if included to comply with 51.9, over the specified range
of rates for a single bubble;
bb) the units of measurement used for calibration of the EQUIPMENT;
cc) a description of any battery charging system;
dd) a functional description of the means provided to protect the PATIENT from EQUIPMENT error
resulting in overinfusion and, where applicable, in underinfusion;
ee) the manufacturer shall disclose the ADMINISTRATION SET(S) used for all the tests in this
standard.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
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:
Replacement:
10.2.1 a) An ambient temperature between +5 °C and +40 °C.
10.2.1 b) A relative humidity between 20 % and 90 %.

– 14 – 60601-2-24 © IEC:1998(E)
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
The clauses and subclauses of the General Standard apply, except as follows:
14 Requirements related to classification
This clause of the General Standard applies, except as follows:
Replacement:
14.6 b) EQUIPMENT shall be of Type BF or CF.
14.6 d) EQUIPMENT intended for DIRECT CARDIAC APPLICATION having one or more APPLIED
PARTs of TYPE CF may have one or more additional APPLIED PARTS of TYPE BF which may be
applied simultaneously if the requirements of 6.1 l) and 19.3 for such EQUIPMENT have been
met.
17 Separation
This clause of the General Standard applies, except as follows:
Item c) is not applicable.
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
This clause of the General Standard applies, except as follows:
19.4 Tests:
d) Measuring arrangement
Addition:
3) Measurement of the PATIENT LEAKAGE CURRENT shall be made from the APPLIED PART with
the PATIENT LINE filled with saline solution (0,9 % NaCl), and with the PATIENT connection
immersed in a container of saline solution (0,9 % NaCl) as indicated in figures 101 and 102.

60601-2-24 © IEC:1998(E) – 15 –
Saline solution
(0,9 % NaCl)
Measurement in
EUT
accordance with
IEC 60601-1,
MD
figures 10 to 14,
21, 22, 24 and 25,
if applicable
Saline solution
(0,9 % NaCl)
IEC  253/98
Figure 101 – PATIENT LEAKAGE CURRENT external power supply
(MD = Measuring device, EUT = EQUIPMENT under test)
Saline solution
(0,9 % NaCl)
MD
EUT
Saline solution
(0,9 % NaCl)
IEC  254/98
Figure 102 – PATIENT LEAKAGE CURRENT – INTERNAL ELECTRICAL POWER SOURCE

– 16 – 60601-2-24 © IEC:1998(E)
h) Measure of PATIENT LEAKAGE CURRENT
Addition:
h) Measurement of PATIENT LEAKAGE CURRENT in a SINGLE FAULT CONDITION shall be performed
utilizing the method described in 19.4 d) 3) of this Particular Standard.
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
The clauses and subclauses of this section of the General Standard apply, except as follows:
21 Mechanical strength
This clause of the General Standard applies, except as follows:
21.1 Replacement:
EQUIPMENT shall not present a safety hazard to the PATIENT as a result of external vibration.
This requirement applies only to PORTABLE EQUIPMENT.
Compliance is checked by inspection and the following test:
Fit the EQUIPMENT with the manufacturer's recommended ADMINISTRATION SET and ACCES-
SORIES. Apply vibrations in a vertical direction and consecutively in two other directions
perpendicular to each other in a horizontal plane and in accordance with the values given in
table 101.
Table 101 – Vibration value
Frequency range Displacement or acceleration Number of sweep cycles in
Hz (peak value) each direction
3 to 8 7,5 mm 4
8 to 300 2 g 4
Applied with a sweep rate of 1 octave/min.
21.4 Replacement:
Remote parts including MAINS OPERATED adapters and parts not specified in 21.5 shall not
present a safety hazard as a result of a free fall from a height of 1 m onto a hard surface.
Subsequent to the fall of the remote part, when the EQUIPMENT is turned on for use, it shall
either:
– function normally, or
– cease delivery and activate an alarm.
Compliance is checked by the following test:
The sample to be tested is allowed to fall freely once from each of three different starting
attitudes from a height of 1 m onto a 50 mm thick hardwood board (e.g. hardwood with a
density greater than 700 kg/m ) which lies flat on a rigid base (concrete block). After this test,
LIVE
no parts shall become accessible. Cracks not visible to the naked eye and surface cracks
in fibre reinforced mouldings and the like shall be ignored. If the EQUIPMENT is operational after
LEAKAGE CURRENT
the test a dielectric strength test and tests according to clauses 19 and 20
and FUNCTIONAL TESTS at the INTERMEDIATE RATE shall be carried out.

60601-2-24 © IEC:1998(E) – 17 –
21.6 Addition:
INFUSION PUMPS FOR AMBULATORY USE shall not present a SAFETY HAZARD as a result of a free
fall from a height of 1 m onto a hard surface.
Compliance is checked by the test of 21.4.
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
The clauses and subclauses of this section of the General Standard and of this section of the
Collateral Standard IEC 60601-1-2 apply, except as follows:
36* Electromagnetic compatibility
This clause of the Collateral Standard IEC 60601-1-2 applies, except as follows:
36.201* EMISSIONS
36.201.1 Radio frequency (RF) EMISSIONS
36.201.1.3* This subclause of the Collateral Standard IEC 60601-1-2 does not apply.
36.201.1.4* This subclause of the Collateral Standard IEC 60601-1-2 applies, except as
follows:
Amendment:
Only paragraph 2 of the Collateral Standard IEC 60601-1-2 applies.
36.201.1.5* This subclause of the Collateral Standard IEC 60601-1-2 does not apply.
36.201.1.6 High-frequency surgical equipment
This subclause of the Collateral Standard IEC 60601-1-2 does not apply.
36.201.1.7*
36.201.2.1* VOLTAGE FLUCTUATIONS and harmonic distorsion
36.201.2.2* Magnetic field EMISSIONS
36.202* IMMUNITY
Addition:
The safe functioning of the EQUIPMENT as specified by the manufacturer shall not be impaired
by one or more of the immunity tests, or the EQUIPMENT shall fail without creating a SAFETY
HAZARD by these tests. In the latter case, the (non-hazardous) failure mode and the failure level
to worst case shall be specified by the manufacturer.
Compliance is checked by the following test:

– 18 – 60601-2-24 © IEC:1998(E)
Set up the EQUIPMENT in NORMAL USE according to the manufacturer's instructions for use.
Switch on the EQUIPMENT and select the INTERMEDIATE RATE. Carry out the test as described in
this Particular Standard according to the test conditions described in this Particular Standard.
By inspection and functional tests determine compliance with the additional requirement
formulated in the previous paragraph. (In case of doubt and if the EQUIPMENT still continues to
infuse liquid, carry out a functional test without changing any of the previously selected
parameters, for a period of 1 h). Switch the EQUIPMENT off and then on again. Select the
INTERMEDIATE RATE
and carry out another functional test for a period of 1 h.
36.202.1* ELECTROSTATIC DISCHARGE
This subclause of the Collateral Standard IEC 60601-1-2 applies, except as follows (see annex
AA also):
Amendment:
A level of 8 kV shall apply for contact discharge and a level of 15 kV shall apply for air
discharge.
36.202.2 Radiated radiofrequency electromagnetic field
This subclause of the Collateral Standard IEC 60601-1-2 applies, except as follows:
Amendment:
36.202.2.1 Requirements
a)* This item applies except as follows:
The applicable level is not 3 V/m but 10 V/m.
b)* This item does not apply
c)* This item does not apply
d)*
36.202.2.2* Test conditions
c) This item does not apply
e)* This item does not apply
36.202.4* VOLTAGE DIPS, short interruptions and voltage variations on power supply input
lines
36.202.5* Conducted disturbances, induced by radio-frequency fields above 9 kHz
36.202.6* Magnetic fields
This subclause of the Collateral Standard IEC 60601-1-2 applies, except as follows:

60601-2-24 © IEC:1998(E) – 19 –
Amendment:
Level: 400 A/m
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
The clauses and subclauses of this section of the General Standard apply, except as follows:
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning,
sterilization, disinfection and compatibility
This clause of the General Standard applies, except as follows:
44.3 Spillage
Replacement:
If an IPX1-classification or better is not claimed:
Replacement:
The EQUIPMENT shall be so designed that, taking into consideration ageing and rough handling
EQUIPMENT
of the , in the event of spillage (accidental wetting) no liquid is retained within the
EQUIPMENT ENCLOSURE and the EQUIPMENT shall either continue to function normally or cease
delivery and activate an alarm.
Compliance is checked by the following test:
Use the test in accordance with IEC 60529 with a test apparatus for DRIP-PROOF EQUIPMENT.
Place the EQUIPMENT in the position of NORMAL USE. Subject the EQUIPMENT to an artificial
rainfall of 3 mm/min for 30 s, falling vertically from a height of 0,5 m above the top of the
EQUIPMENT. Carry out the test using tap water. Covers and other parts, for example battery
compartment covers, which can be removed without the aid of a TOOL are left in position during
the test. Where carrying pouches are specified by the manufacturer as forming part of the
protection against spillage then the test is carried out with the EQUIPMENT in the carrying pouch.
Where no such specification exists then the carrying pouch is removed prior to the start of the
test. Immediately after the 30 s exposure, remove visible moisture from the body of the
EQUIPMENT. Immediately after the above test, determine by inspection that the water has not
entered the EQUIPMENT. If water has entered the EQUIPMENT, repeat the test using saline
solution (0,9 % NaCl). Carry out a functional test at the INTERMEDIATE RATE for a period of 1 h.
Carry out the dielectric strength tests specified in 20.4.

– 20 – 60601-2-24 © IEC:1998(E)
44.4* Leakage
Replacement:
EQUIPMENT shall be so constructed that liquid which might leak from containers, tubing,
couplings and the like does not impair the safe functioning of the EQUIPMENT nor wet
uninsulated LIVE parts or electrical insulation which is liable to be adversely affected by such a
liquid.
Compliance is checked by the following test:
Set up the EQUIPMENT in NORMAL USE and according to the manufacturer's instructions for use.
By means of a pipette apply drops of the test solution to couplings, tubing connectors, seals
and to parts of the ADMINISTRATION SET which might rupture. Moving parts are in operation or at
rest whichever is the most unfavourable.
Immediately after application of the test solution, carry out the test(s) from 50.102 to 50.108
according to the classification of the EQUIPMENT, at the INTERMEDIATE RATE only. If the
EQUIPMENT
does not fall into one of the defined categories then use the appropriate test from
50.102 to 50.108. Carry out the tests of 51.103 and 51.104. Switch off the EQUIPMENT and allow
it to stand for a minimum of 12 h under normal conditions (20 °C ± 2 °C, 65 % ± 5 % RH). By
means of functional tests determine that FREE FLOW does not occur. By inspection, check the
function of controls and other parts which may have been adversely affected by the test
solution.
Carry out the test with a test solution consisting of a 50 % dextrose solution.
44.6 Ingress of liquids
Addition:
If an IPX1-classification is claimed:
Covers and other parts, for example, battery compartment covers, which can be removed with-
out the aid of a TOOL are left in position during the test. Where carrying pouches are specified
by the manufacturer as forming part of the protection against ingress of liquids, then the test is
carried out with the EQUIPMENT in the carrying pouch. Where no such specification exists then
the carrying pouch is removed prior to the test.
47 Electrostatic charges
Not used. Transferred to clause 36.
49 Interruption of the power supply
This clause of the General Standard applies, except as follows:
49.2
Additions:
EQUIPMENT powered from the SUPPLY MAINS only shall give an audible alarm in the event of an
accidental disconnection or a SUPPLY MAINS failure. Under such conditions, the audible alarm
shall be maintained for at least 3 min or until power is restored, whichever is the less.
Compliance is checked by inspection and functional tests.

60601-2-24 © IEC:1998(E) – 21 –
EQUIPMENT which utilizes an INTERNAL ELECTRICAL POWER SOURCE either as a primary or standby
supply shall give an audible and visible warning 30 min before delivery ceases due to battery
exhaustion. During this period, the EQUIPMENT shall give a continuous visible and an intermit-
tent audible warning.
At least 3 min before the end of the battery life the EQUIPMENT shall give an audible and visible
alarm and cease delivery. The alarm shall be maintained for the duration of the remaining
battery lifetime.
Compliance is checked by inspection and functional tests when the EQUIPMENT is operated at
the INTERMEDIATE RATE and with a fully charged battery.
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:
50 Accuracy of operating data
This clause of the General Standard applies except as follows:
Additions:
50.101* The EQUIPMENT shall maintain the manufacturer's stated accuracy or better over the
recommended ADMINISTRATION SET CHANGE INTERVAL.
Compliance is checked, using the tests prescribed in 50.102 to 50.108, to verify the accuracy
of the EQUIPMENT according to its defined type and the manufacturer's disclosure of accuracy. If
the EQUIPMENT does not fall into one of the defined categories use the appropriate test from
50.102 to 50.108.
Definition of terms given in 50.102 to 50.108
rate r the delivery rate selected by the operator
flow the measured output in volume per unit of time
bolus a discrete quantity of liquid which is delivered in a short time as an
infusion but not part of a priming routine
sample interval S the time between successive mass readings or drop counts
test period T the total duration of the test from start to finish
analysis period T designated as the first 2 h of the test period
analysis period T designated as the second hour of test period
analysis period T designated as the last hour of the test period
analysis period T the analysis period specified as T , T or T
X 0 1 2
W the total mass
th
W the i mass sample over a specified analysis period
i
W mass sample at the end of a specified analysis period or test period
j
W mass sample at the start of a specified analysis period
k
A overall mean percentage flow error measured over the analysis period T
B overall mean percentage flow error measured over the analysis period T
P observation window duration
E (max.) maximum measured error in observation window of specified duration
p
– 22 – 60601-2-24 © IEC:1998(E)
E (min.) minimum measured error in observation window of specified duration
p
shot pattern a sequence of bolus deliveries which may occur at regular or irregular
intervals
shot cycle I the minimum time between successive repetitions of the shot or the shot
pattern (from the start of the first shot pattern to the start of the second
shot pattern)
density d density of water (0,998 g/ml at 20 °C)
50.102* Accuracy tests for VOLUMETRIC INFUSION CONTROLLERS, VOLUMETRIC INFUSION
PUMPS and SYRINGE PUMPS
The test apparatus shown in figures 104a and 104b is used. Carry out the tests using a test
solution of ISO Class III water for medical use and installing an unused ADMINISTRATION SET.
Set up the EQUIPMENT with the test solution in accordance with the manufacturer's instructions
for use.
Ensure
...