IEC 60601-2-24:1998

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
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Numbering
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Terminology, graphical and letter
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For general terminology, readers are referred to IEC 60050: International Electrotechnical Vocabulary (IEV).
For graphical symbols, and letter symbols and signs approved by the IEC for general use, readers are referred to
publications IEC 60027: Letter symbols to be used in electrical technology, IEC 60417: Graphical symbols for use on
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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
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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, cl
...