IEC 60601-2-24:2012

Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers

IEC 60601-2-24:2012 applies to the basic safety and essential performance of infusion pumps and volumetric infusion controllers. This standard applies to administration sets insofar as their characteristics influence the basic safety or essential performance of infusion pumps and volumetric infusion controllers. However this standard does not specify requirements or tests for other aspects of administration sets. This particular standard specifies the requirements for enteral nutrition pumps, infusion pumps, infusion pumps for ambulatory use, syringe or container pumps, volumetric infusion controllers and volumetric infusion pumps. This particular standard does not apply to the following: devices specifically intended for diagnostic or similar use; devices for extracorporeal circulation of blood; implantable devices; equipment specifically intended for diagnostic use within urodynamics; equipment specifically intended for diagnostic use within male impotence testing; and devices covered by ISO 28620. This second edition cancels and replaces the first edition of IEC 60601-2-24. This edition constitutes a technical revision according to IEC 60601-1:2005+A1:2012 with new clause numbering, including usability and alarms.

Appareils électromédicaux - Partie 2-24: Exigences particulières pour la sécurité de base et les performances essentielles des pompes et régulateurs de perfusion

La CEI 60601-2-24:2012 s'applique à la sécurité de base et aux performances essentielles des pompes à perfusion et des régulateurs de perfusion volumétriques. La présente norme s'applique aux nécessaires de perfusion dans la mesure où leurs caractéristiques ont une influence sur la sécurité de base ou sur les performances essentielles des pompes à perfusion et des régulateurs de perfusion volumétriques. Toutefois, la présente norme n'indique pas d'exigences ou d'essais pour d'autres aspects des nécessaires de perfusion. La présente norme particulière spécifie les exigences applicables aux pompes de nutrition entérale, aux pompes à perfusion, aux pompes à perfusion à usage ambulatoire, aux pousse-seringues ou réservoirs, aux régulateurs de perfusion volumétriques et aux pompes à perfusion volumétriques. La présente norme particulière ne s'applique pas aux appareils suivants: les appareils spécifiquement destinés au diagnostic ou à un usage de même nature; les appareils de circulation extracorporelle de sang; les appareils implantables; les appareils spécifiquement destinés au diagnostic urodynamique; les appareils spécifiquement destinés au diagnostic de l'impuissance; et les appareils couverts par l'ISO 28620. Cette deuxième édition annule et remplace la première édition de la CEI 60601-2-24, dont elle constitue une révision technique conformément à la CEI 60601-1:2005+A1:2012, avec une nouvelle numérotation des articles, y compris l'aptitude à l'utilisation et les alarmes.

General Information

• Status: Published
• Publication Date: 18-Oct-2012
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: WG 23 - TC 62/SC 62D/WG 23
• Current Stage: PPUB - Publication issued
• Start Date: 19-Oct-2012
• Completion Date: 15-Nov-2012

Relations

• Revises: IEC 60601-2-24:1998 - Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers
• Effective Date: 05-Sep-2023

Overview

IEC 60601-2-24:2012 is an international standard issued by the International Electrotechnical Commission (IEC) that specifies the basic safety and essential performance requirements for medical electrical equipment, specifically focusing on infusion pumps and controllers. This standard applies to various types of infusion devices including volumetric infusion pumps, syringe or container pumps, enteral nutrition pumps, and ambulatory infusion pumps. It also covers related administration sets insofar as they influence the safety and performance of these devices.

The 2012 edition is a technical revision of the first edition published in 1998, aligning it with IEC 60601-1:2005+A1:2012 requirements and introducing updates related to usability and alarm systems. It excludes devices intended solely for diagnostic use, extracorporeal circulation, implantables, and other specific medical systems covered under different standards such as ISO 28620.

Key Topics

• Scope and Application
  Defines the range of infusion devices covered, emphasizing safety and performance aspects critical in medical environments. Notably, it concerns administration sets only when they impact infusion device operation.

• General Safety Requirements
  Covers electrical and mechanical hazard protections, ensuring that devices operate safely in clinical settings without causing harm to patients or operators.

• Performance Accuracy and Controls
  Details the accuracy required of dose control, flow rates, and delivered volume to ensure reliable and precise administration of fluids.

• Programmable Electrical Medical Systems (PEMS)
  Includes requirements for programmable functions, software safety, and error handling to reduce risks associated with automated infusion operations.

• Usability and Alarm Systems
  Enhances user interface design for safe operation and includes rigorous alarm conditions for fault detection, ensuring timely notification to healthcare providers.

• Electromagnetic Compatibility (EMC)
  Ensures devices are resistant to electromagnetic interference and do not contribute to disturbances within medical environments, preserving reliable function.

• Testing Procedures and Validation
  Specifies test apparatus configurations and protocols, including start-up curves, trumpet curves, occlusion alarm thresholds, and bolus volume verification to validate device compliance.

Applications

IEC 60601-2-24:2012 plays a crucial role in the development, manufacturing, and certification of infusion pumps and controllers widely used in hospitals, clinics, and home healthcare settings. Its practical applications include:

• Manufacturing Compliance
  Assists manufacturers in designing infusion pumps that meet internationally accepted safety and performance benchmarks, facilitating market access worldwide.

• Clinical Safety Assurance
  Assists healthcare providers by ensuring that infusion devices reliably deliver prescribed therapies with minimal risk of malfunction or medication errors.

• Regulatory Approval
  Supports regulatory bodies and certification agencies in assessing conformity of infusion pumps for medical device approvals, enhancing patient safety standards.

• Risk Management
  Guides risk assessments related to electrical, mechanical, and functional hazards inherent in infusion device operation, improving device reliability.

• User Training and Maintenance
  Defines clear marking and documentation standards, as well as operational usability features, ensuring end-users can safely and effectively manage infusion therapy.

Related Standards

• IEC 60601-1:2005+A1:2012 – General requirements for basic safety and essential performance of medical electrical equipment, to which IEC 60601-2-24 is a technical collateral standard.

• ISO 28620 – Specific standard applying to anesthesia and respiratory equipment, excluded from IEC 60601-2-24’s scope but related in terms of infusion control systems.

• Other IEC 60601 Part 2 Standards – Address particular safety and performance requirements for other types of medical electrical equipment.

• International Electrotechnical Vocabulary (IEV) – Provides essential definitions and terminology for consistent interpretation of technical terms used in IEC 60601-2-24.

Summary

IEC 60601-2-24:2012 ensures that infusion pumps and controllers adhere to stringent international safety and performance criteria, safeguarding patient health during fluid administration. Compliance with this standard enhances device reliability, usability, and alarms management-vital for modern medical electrical equipment relying on precise and error-resistant operation. Manufacturers, regulatory bodies, and healthcare professionals rely on this standard to maintain high-quality infusion therapy and promote safe clinical practice worldwide.

Keywords: infusion pumps, medical electrical equipment, IEC 60601-2-24, safety standards, performance requirements, volumetric infusion controllers, programmable medical systems, medical device compliance, healthcare safety, alarm systems, electromagnetic compatibility.

Standards Content (Sample)

IEC 60601-2-24 ®
Edition 2.0 2012-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-24: Particular requirements for the basic safety and essential performance
of infusion pumps and controllers

Appareils électromédicaux –
Partie 2-24: Exigences particulières pour la sécurité de base et les performances
essentielles des pompes et régulateurs de perfusion

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IEC 60601-2-24 ®
Edition 2.0 2012-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –

Part 2-24: Particular requirements for the basic safety and essential performance

of infusion pumps and controllers

Appareils électromédicaux –
Partie 2-24: Exigences particulières pour la sécurité de base et les performances

essentielles des pompes et régulateurs de perfusion

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XB
ICS 11.040.20 ISBN 978-2-83220-417-7

– 2 – 60601-2-24  IEC:2012
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 12
201.5 General requirements for testing of ME EQUIPMENT . 13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
201.7 ME EQUIPMENT identification, marking and documents. 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 15
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 16
201.10 Protection against unwanted and excessive radiation HAZARDS . 16
201.11 Protection against excessive temperatures and other HAZARDS . 16
201.12 *Accuracy of controls and instruments and protection against hazardous
outputs . 17
201.13 HAZARDOUS SITUATIONS and fault conditions . 35
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 35
201.15 Construction of ME EQUIPMENT . 35
201.16 ME SYSTEMS . 37
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 37
202 Electromagnetic compatibility – Requirements and tests . 37
206 Usability . 38
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 38
Annexes . 42
Annex AA (informative) Particular guidance and rationale . 43
Bibliography . 58
Index of defined terms used in this particular standard. 59

Figure 201.103 – Analysis periods . 22
Figure 201.104a – Test apparatus for VOLUMETRIC INFUSION PUMPS and VOLUMETRIC
INFUSION CONTROLLERS . 22
Figure 201.104b – Test apparatus for SYRINGE OR CONTAINER PUMPS . 23
Figure 201.104 – Test apparatuses for different types of INFUSION PUMPS . 23
Figure 201.105 – Start-up graph plotted from data gathered during the first 2 h of the
test period . 23
Figure 201.106 – Trumpet curve plotted from data gathered during the second hour of
the test period . 24
Figure 201.107 – Trumpet curve plotted from data gathered during the last hour of the
ADMINISTRATION SET CHANGE INTERVAL . 24
Figure 201.108 – Start-up graph over the stabilization period . 25
Figure 201.109 – Trumpet curve plotted from data at the end of the stabilization period . 25

60601-2-24  IEC:2012 – 3 –
Figure 201.110 – Start-up curve over the stabilization period for quasi-continuous
output pumps . 26
Figure 201.111 – Trumpet curve plotted from data at the end of the stabilization period
for quasi-continuous pumps . 26
Figure 201.112 – Test apparatus to determine the OCCLUSION ALARM THRESHOLD and
BOLUS volumes . 33
Figure AA.101 – Start-up graph . 49
Figure AA.102 – Trumpet curve . 49
Figure AA.103 – Calculation for E (max.) and E (min.) . 52
p p
Figure AA.104 – Sampling protocol . 53
Figure AA.105 – Observation windows . 54
Figure AA.106 – Distribution of parent variate X . 55
Figure AA.107 – Distribution of observation windows . 56
Figure AA.108 – The statistical trumpet graph . 56

Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 12
Table 201.102 – Set rates, BOLUS volumes and test apparatus for the accuracy tests of
12.1.102 to 12.1.107 . 31
Table 202.101 – Test levels . 37
Table 208.101 – ALARM CONDITION priorities and related situations . 39
Table 208.102 – * Characteristics of the PULSE of auditory ALARM SIGNALS . 40

– 4 – 60601-2-24  IEC:2012
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-24: Particular requirements for the basic safety and essential
performance of infusion pumps and controllers

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
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2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-24 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition cancels and replaces the first edition of IEC 60601-2-24 published in
1998. This edition constitutes a technical revision according to IEC 60601-1:2005+A1:2012
with new clause numbering, including usability and alarms.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/1026/FDIS 62D/1039/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.

60601-2-24  IEC:2012 – 5 –
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
– 6 – 60601-2-24  IEC:2012
INTRODUCTION
This particular standard deals with the safety of INFUSION PUMPS and INFUSION CONTROLLERS.
The relationship between this particular standard, IEC 60601-1:2005+A1:2012, 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 MEDICAL ELECTRICAL 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.

60601-2-24  IEC:2012 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-24: Particular requirements for the basic safety and essential
performance of infusion pumps and controllers

201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This Particular Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFUSION
PUMPS and VOLUMETRIC INFUSION CONTROLLERS, hereafter referred to as ME EQUIPMENT.
This standard applies to ADMINISTRATION SETS insofar as their characteristics influence the
BASIC SAFETY or ESSENTIAL PERFORMANCE of INFUSION PUMPS and VOLUMETRIC INFUSION
CONTROLLERS. However this standard does not specify requirements or tests for other aspects
of ADMINISTRATION SETS
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this standard are not covered by specific requirements in this standard
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This particular standard specifies the requirements for ENTERAL NUTRITION PUMPS, INFUSION
PUMPS, INFUSION PUMPS FOR AMBULATORY USE, SYRINGE OR CONTAINER PUMPS, VOLUMETRIC
INFUSION CONTROLLERS and VOLUMETRIC INFUSION PUMPS, as defined in 201.3.204, 201.3.206,
201.3.207, 201.3.220, 201.3.222 and 201.3.223.
These particular standard does not apply to the following:
a) devices specifically intended for diagnostic or similar use (e.g. angiography or other
pumps permanently controlled or supervised by the OPERATOR);
b) devices for extracorporeal circulation of blood;
c) implantable devices;
d) ME EQUIPMENT specifically intended for diagnostic use within urodynamics (measurement
of pressure-volume relationship of the urinary bladder when filled through a catheter with
water);
e) ME 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);
f) devices covered by ISO 28620.
—————————
The general standard is IEC 60601-1:2005+A1:2012, Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance.

– 8 – 60601-2-24  IEC:2012
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for ENTERAL NUTRITION PUMPS, INFUSION PUMPS, INFUSION PUMPS
FOR AMBULATORY USE, SYRINGE OR CONTAINER PUMPS, VOLUMETRIC INFUSION CONTROLLERS and
VOLUMETRIC INFUSION PUMPS, as defined in 201.3.204, 201.3.206, 201.3.207, 201.3.220,
201.3.222 and 201.3.223.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2:2007, IEC 60601-1-6:2010 and IEC 60601-1-8:2006 apply as modified in
Clauses 202, 206 and 208 respectively. IEC 60601-1-3 does not apply. All other published
collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard,
203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral
standard, etc.). 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 or applicable
collateral 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 or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.

60601-2-24  IEC:2012 – 9 –
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
Clause 2 of the general standard applies, except as follows:
Replacement:
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral standard: Usability
IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic
safety and essential performance – Collateral standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and medical electrical systems
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
Amendment 1:2012
ISO 3696:1987, Water for analytical laboratory use – Specification and test methods
ISO 7864, Sterile hypodermic needles for single use
ISO 8536-4, Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity
feed
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+A1:2012, apply, except as follows:
NOTE An index of defined terms is found beginning on page 57.
Replacement:
201.3.8
APPLIED PART
part of ME EQUIPMENT, including the infusion liquid pathway, that in NORMAL USE necessarily
comes into physical contact with the PATIENT for ME EQUIPMENT to perform its function

– 10 – 60601-2-24  IEC:2012
Addition:
201.3.201
ADMINISTRATION SET
accessory that convey(s) liquid from the supply via the ME EQUIPMENT to the PATIENT
201.3.202
ADMINISTRATION SET CHANGE INTERVAL
time recommended by the MANUFACTURER of the ME EQUIPMENT for using the ADMINISTRATION
SET
201.3.203
INTENDED BOLUS
discrete quantity of liquid which is intended to be delivered by the ME EQUIPMENT
201.3.204
ENTERAL NUTRITION PUMP
INFUSION PUMP where the liquid is used for enteral nutrition
201.3.205
FREE FLOW
unintended flow to a PATIENT through an ADMINISTRATION SET which is not controlled by the
INFUSION PUMP, for example, due to the unintended effects of gravity/pressure by the removal
of the ADMINISTRATION SET from the INFUSION PUMP
201.3.206
INFUSION PUMP
ME EQUIPMENT intended to regulate the flow of liquids into the PATIENT under pressure
generated by the pump
Note 1 to entry: The INFUSION PUMP may provide one or more of the following types of flow:
– type 1: continuous infusion;
– type 2: non-continuous infusion;
– type 3: discrete delivery of a bolus;
– type 4: PROFILE PUMP;
201.3.207
INFUSION PUMP FOR AMBULATORY USE
INFUSION PUMP intended to be carried continuously by the PATIENT
201.3.208
INTERMEDIATE RATE
test rate for the comparison of different kind of pumps

Note 1 to entry: The specific level of the rate differs for various types of equipment:
– for VOLUMETRIC INFUSION PUMP and VOLUMETRIC INFUSION CONTROLLER, set the rate to 25 ml/h;
– for SYRINGE OR CONTAINER PUMP, set the rate to 5 ml/h;
– for INFUSION PUMPS FOR AMBULATORY USE, set the rate specified by the MANUFACTURER as typical for the
ME EQUIPMENT.
201.3.209
KEEP OPEN RATE
KOR
low predetermined rate(s) to which the INFUSION PUMP reverts under specified conditions with
the object of keeping the PATIENT LINE open

60601-2-24  IEC:2012 – 11 –
Note 1 to entry: The abbreviation KVO (Keep-Vein-Open) is commonly used as a synonym of KOR.
201.3.210
MAXIMUM INFUSION PRESSURE
maximum pressure which can be generated by the INFUSION PUMP under conditions of total
occlusion at the end of the PATIENT LINE
201.3.211
MINIMUM RATE
lowest rate selectable by the OPERATOR, but not less than 1 ml/h
* 201.3.212
MAXIMUM SELECTABLE RATE
highest rate selectable by the OPERATOR if higher than the INTERMEDIATE RATE
* 201.3.213
MINIMUM SELECTABLE RATE
lowest rate selectable by the OPERATOR if lower than the MINIMUM RATE
201.3.214
OCCLUSION ALARM THRESHOLD
value of the physical quantity at which the occlusion alarm is activated
201.3.215
PATIENT END
that end of the PATIENT LINE where connection to the PATIENT takes place
201.3.216
PATIENT LINE
that part of the ADMINISTRATION SET between the ME EQUIPMENT and the PATIENT
201.3.217
REGION OF CONTROL
that part of the ME EQUIPMENT within which flow regulation, flow shut-off or air detection
occurs, within the body of the ME EQUIPMENT or remotely
201.3.218
PROFILE PUMP
INFUSION PUMP intended for controlled infusion of liquids into the PATIENT by means of a
programmed sequence of delivery rates
201.3.219
SUPPLY LINE
that part of the ADMINISTRATION SET between the liquid supply and the ME EQUIPMENT
201.3.220
SYRINGE OR CONTAINER PUMP
NFUSION PUMP intended for controlled infusion of liquids into the PATIENT by means of one or
I
more single action syringe(s) or similar container(s) (e.g. where the cartridge/bag is emptied
by positive pressure applied to the cartridge/bag) in which the delivery rate is indicated in
volume per unit of time or units related to drug dosage.
201.3.221
UNINTENDED BOLUS
unintended discrete quantity of liquid which is delivered after release of an occlusion

– 12 – 60601-2-24  IEC:2012
201.3.222
VOLUMETRIC INFUSION CONTROLLER
ME EQUIPMENT intended to regulate the flow of liquid into the PATIENT under positive pressure
generated by gravitational force in which the delivery rate is indicated by the ME EQUIPMENT in
volume per unit of time
201.3.223
VOLUMETRIC INFUSION PUMP
INFUSION PUMP in which the delivery rate is indicated in volume per unit of time or units related
to drug dosage, but excluding SYRINGE OR CONTAINER PUMPS
201.4 General requirements
Clause 4 of the general standard applies except as follows.
201.4.3 ESSENTIAL PERFORMANCE
Additional subclause:
201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements
Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in
Table 201.101.
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Accuracy tests for VOLUMETRIC INFUSION CONTROLLERS, 201.12.1.102
and SYRING OR CONTAINER PUMPS
VOLUMETRIC INFUSION PUMPS
Accuracy tests for INFUSION PUMPS FOR AMBULATORY USE type 1 201.12.1.103
Accuracy tests for INFUSION PUMP FOR AMBULATORY USE type 2 201.12.1.104
Accuracy tests for INFUSION PUMP type 3 201.12.1.105
Accuracy tests for INFUSION PUMP type 4 201.12.1.106
Accuracy tests for INFUSION PUMP type 5 201.12.1.107
Protection against UNINTENDED BOLUS volumes and occlusion 201.12.4.4.104
ALARM SIGNALS of HIGH PRIORITY according to Table 208.101 208.6.1.2.101
NOTE For ALARM CONDITIONS resulting from ME EQUIPMENT
failure no EMC and environmental testing is necessary.

201.4.7 * SINGLE FAULT CONDITION for ME EQUIPMENT
Addition:
SINGLE FAULT CONDITIONS occurring in those protective systems specified in 201.12.4.4.101,
201.12.4.4.102, 201.12.4.4.105 and 201.12.4.4.107 shall become obvious to the OPERATOR
within the ADMINISTRATION SET CHANGE INTERVAL.
NOTE Acceptable methods of complying with this requirement are, for example:
1) a safety system check initiated and controlled by the ME 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 ME EQUIPMENT within
the ADMINISTRATION SET CHANGE INTERVAL, with the OPERATOR initiating checks before or during the infusion;

60601-2-24  IEC:2012 – 13 –
3) a safety system check carried out by the OPERATOR at least once within the ADMINISTRATION SET CHANGE
st
INTERVAL (see the 21 dashed item of 201.7.9.2.101).
The following are not regarded as SINGLE FAULT CONDITIONS, but are regarded as NORMAL
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 drop chamber;
– air in the SUPPLY LINE or that part of the ME EQUIPMENT within which flow regulation, flow
shut-off or air detection occurs;
– pulling on the PATIENT LINE (see ISO 8536-4).
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.2 Number of samples
Addition:
MANUFACTURER shall define the number of samples of INFUSION PUMP / INFUSION
The
CONTROLLERS and ADMINISTRATION SET(S) with regard to accuracy in the technical
documentation.
Compliance is checked by review of the technical documentation
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
201.6.6 Mode of operation
Replacement
ME EQUIPMENT shall be classified for CONTINUOUS OPERATION.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2.1 Minimum requirements for marking on ME EQUIPMENT and on
interchangeable parts
Addition:
The ME EQUIPMENT shall be marked with an arrow or other appropriate symbol indicating the
correct direction of flow if the ADMINISTRATION SET can be incorrectly loaded;
Compliance is checked by inspection.
201.7.2.4 ACCESSORIES
Addition:
– 14 – 60601-2-24  IEC:2012
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
ME EQUIPMENT, then relevant markings shall be fixed or indicated in a prominent place on the
ME EQUIPMENT which either identify those conditions or provide location of such information.
Compliance is checked by inspection.
201.7.9.2 Instructions for use
Additional subclause:
201.7.9.2.101 Additional instructions for use
The instructions for use shall also include the following:
– the INTENDED USE including environment conditions;
– a warning of the consequences of the use of unsuitable ADMINISTRATION SET(S);
– permitted ME EQUIPMENT orientation and methods and precautions concerning its
mounting, for example, stability on a pole, if applicable;
– * instructions regarding ADMINISTRATION SET CHANGE INTERVAL to maintain the specified
performance;
– 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;
– where gravity is relevant to performance, the acceptable height range of the liquid
container above the PATIENT and/or pump;
– the means provided to protect the PATIENT from air infusion;
– a statement of the MAXIMUM INFUSION PRESSURE generated by the ME EQUIPMENT;
– a statement of the OCCLUSION ALARM THRESHOLD of the ME EQUIPMENT;
– a statement of the maximum time for activation of the occlusion alarm when the
ME EQUIPMENT is operating at the MINIMUM RATE, INTERMEDIATE RATE and the MINIMUM
SELECTABLE RATE and at the minimum and maximum selectable OCCLUSION ALARM
THRESHOLD (see 201.12.4.4.104). The MANUFACTURER shall also state that temperature and
l length of ADMINISTRATION SET affect the time, if applicable;
– a statement of the UNINTENDED BOLUS at the INTERMEDIATE RATE at the minimum and
maximum OCCLUSION ALARM THRESHOLDS (see also 201.12.4.4.104);
– a statement regarding management of the entrapped UNINTENDED BOLUS before occlusion
release;
– precautions required with drop detectors, for example with respect to placement, cleanli-
ness, liquid level, ambient light;
– *the typical operating time when the ME EQUIPMENT is operating from the INTERNAL
ELECTRICAL POWER SOURCE at the INTERMEDIATE RATE and, for VOLUMETRIC INFUSION PUMPS
and VOLUMETRIC INFUSION CONTROLLERS, also at the MAXIMUM SELECTABLE RATE with a new
and fully charged battery;
– a statement of KEEP OPEN RATE(S), and when initiated;
– a list of alarms and their operating conditions;
– *if applicable, a warning that under certain circumstances the specified accuracy may not
be maintained and details of those circumstances.
– *reference to a guide on the HAZARDS associated with the interconnection of other infusion
systems or ACCESSORIES to the PATIENT LINE;
– the rate obtained when the prime/purge or BOLUS control is operated, and a statement of
any alarm disabled;
– the selectable rate range and the increments of selection;

60601-2-24  IEC:2012 – 15 –
– if applicable, guidance on tests to permit the OPERATOR to check the correct functioning of
alarm(s) and the operational safety of the ME EQUIPMENT;
– data as evaluated by the test methods of 201.12.1.102 to 201.12.1.109 at the rates
indicated in Table 201.102, including an explanation for the OPERATOR of the data
presentation;
– *the maximum volume that may be infused under SINGLE FAULT CONDITIONS;
– a list of the allowed ADMINISTRATION SET(S) with their stated accuracy in accordance with
the test methods mentioned in 201.12.1;
– if changing between different allowed ADMINISTRATION SETS can result in an unacceptable
RISK if no changes are made to the ME EQUIPMENT, a statement regarding the procedure to
be followed to guarantee the stated accuracy shall be included;
– the range of infusion rates and the conditions (e.g. temperature) for which the stated
accuracy is valid;
– a list of ACCESSORIES (e.g. drop sensor) for use with the ME EQUIPMENT which are
necessary to maintain the accuracy stated in accordance with the test methods mentioned
in 201.12.1 and safe use;
– If applicable, description of how the ME EQUIPMENT operates if communication is lost with
the remote control device.
NOTE If the ME EQUIPMENT is part of a ME SYSTEM, the description can be part of the instruction for use of
the ME SYSTEM)
– *For PROFILE PUMPS the programmed sequence of delivery rates.
201.7.9.3 Technical description
Additional subclause:
201.7.9.3.101 Additional technical description
The technical description shall include the following:
– *the sensitivity of the air detector, if included to comply with 201.12.4.4.107, over the
specified range of rates for a single bubble. For INFUSION PUMP FOR AMBULATORY USE using
insulin, the sensitivity of the air detector could e.g. be expressed as the maximum
underinfusion until triggering of the air detector (or similar) if air detection is provided.
– if applicable, the PROCESS for calibration of the ME EQUIPMENT;
– a description of any battery charging system;
– a functional description of the means provided to protect the PATIENT from overinfusion
and, where applicable, underinfusion resulting from ME EQUIPMENT error or partial or total
blockage of the ADMINISTRATION SET;
– The MANUFACTURER shall disclose the identification of ADMINISTRATION SET(S) used for all
the tests in this standard,
– If the ME EQUIPMENT cannot be programmed in volume per unit time, and does not display
the rate in volume per unit time, the formula for calculating volume per unit time.
Compliance is checked by inspection of the technical description.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies except as follows:
201.8.3 Classification of APPLIED PARTS
Additional subclause:
– 16 – 60601-2-24  IEC:2012
201.8.3.101 Additional requirements for classification of APPLIED PARTS
APPLIED PARTS of an INFUSION PUMP shall be TYPE BF or TYPE CF APPLIED PARTS.
Check compliance by inspection.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and
ME SYSTEMS
Clause 9 of the general standard applies.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies except as follows:
201.11.6.3 * Spillage on ME EQUIPMENT and ME SYSTEMS
Replacement:
E EQUIPMENT and ME SYSTEMS requiring the handling of liquids in NORMAL USE shall be so
M
constructed that spillage does not wet parts that could result in a HAZARDOUS SITUATION.
Compliance is checked by the test according to IEC 60529 IPX1 or better:
After these PROCEDURES, the ME EQUIPMENT is to pass the appropriate dielectric strength and
LEAKAGE CURRENT tests and is to show no signs of wetting of uninsulated electrical parts or
electrical insulation of parts that could result in a HAZARDOUS SITUATION and is to maintain
BASIC SAFETY and ESSENTIAL PERFORMANCE
201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS
Addition:
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 ingress of liquids,
then the test is carried out with the ME EQUIPMENT in the carrying pouch. Where no such
specification exists then the carrying pouch is removed prior to the test.
E EQUIPMENT shall be appropriate to the environment of use and at least IPX2.
M
Replacement of compliance statement:
After these PROCEDURES, the ME EQUIPMENT is to show no signs of bridgin
...