BS en 60601 2 24

BS EN 60601-2-24:2015
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BSI Standards Publication
Medical electrical equipment

Part 2-24: Particular requirements for the
basic safety and essential performance of
infusion pumps and controllers
BS EN 60601-2-24:2015 BRITISH STANDARD
National foreword
This British Standard is the UK implementation of EN 60601-2-24:2015. It is
identical to IEC 60601-2-24:2012. It supersedes BS EN 60601-2-24:1998,
which will be withdrawn on 14 April 2018.
The UK participation in its preparation was entrusted by Technical
Committee CH/62, Electrical Equipment in Medical Practice, to
Subcommittee CH/62/4, Electromedical equipment.
A list of organizations represented on this committee can be obtained on
request to its secretary.

This publication does not purport to include all the necessary provisions of
a contract. Users are responsible for its correct application.
© The British Standards Institution 2015.
Published by BSI Standards Limited 2015
ISBN 978 0 580 62078 2
ICS 11.040.20
Compliance with a British Standard cannot confer immunity from
legal obligations.
This British Standard was published under the authority of the
Standards Policy and Strategy Committee on 30 June 2015.
Amendments/corrigenda issued since publication
Date Text affected

BS EN 60601-2-24:2015
EUROPEAN STANDARD EN 60601-2-24

NORME EUROPÉENNE
EUROPÄISCHE NORM May 2015
ICS 11.040.20 Supersedes EN 60601-2-24:1998
English Version
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)
Appareils électromédicaux - Partie 2-24: Exigences Medizinische elektrische Geräte - Teil 2-24: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des pompes et régulateurs de perfusion wesentlichen Leistungsmerkmale von Infusionspumpen und
(IEC 60601-2-24:2012) Infusionsreglern
(IEC 60601-2-24:2012)
This European Standard was approved by CENELEC on 2015-04-14. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization

Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-24:2015 E

BS EN 60601-2-24:2015
EN 60601-2-24:2015
Foreword
The text of document 62D/1026/FDIS, future edition 2 of IEC 60601-2-24, prepared by SC 62D
"Electromedical equipment", of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-24:2015.
The following dates are fixed:

• latest date by which the document has to be implemented at (dop) 2016-01-14

national level by publication of an identical national
standard or by endorsement
• latest date by which the national standards conflicting with (dow) 2018-04-14
the document have to be withdrawn
This document supersedes EN 60601-2-24:1998.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standard IEC 60601-2-24:2012 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated :
IEC 61000-4-2 NOTE Harmonized as EN 61000-4-2.
2
BS EN 60601-2-24:2015
EN 60601-2-24:2015
Annex ZA
(normative)
Normative references to international publications

with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is
available here: www.cenelec.eu.
Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year

Replacement in Annex ZA of EN 60601-1:2006:
IEC 60601-1-2 (mod) 2007 Medical electrical equipment - EN 60601-1-2 2007
Part 1-2: General requirements for basic
- - + corrigendum Mar. 2010
safety and essential performance -
Collateral standard: Electromagnetic
compatibility - Requirements and tests
IEC 60601-1-6 2010 Medical electrical equipment - EN 60601-1-6 2010
Collateral standard: Usability
IEC 60601-1-8 2006 Medical electrical equipment - EN 60601-1-8 2007
Collateral Standard: General
requirements, tests and guidance for
alarm systems in medical electrical
equipment and medical electrical
systems
Addition to Annex ZA of EN 60601-1:2006:
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic
safety and essential performance
+ A1 2012 + A1 2013
- - + A1/AC 2014
- - + A12 2014
ISO 3696 1987 Water for analytical laboratory use - EN ISO 3696 1995
Specification and test methods
ISO 7864 - Sterile hypodermic needles for single use EN ISO 7864 -
ISO 8536-4 - Infusion equipment for medical use - EN ISO 8536-4 -
Part 4: Infusion sets for single use,
gravity feed
3
BS EN 60601-2-24:2015
EN 60601-2-24:2015
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.
4
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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 M E 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 H AZARDOUS SITUATIONS and fault conditions ............................................................. 35
201.14 P ROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS ( PEMS ) ............................................... 35
201.15 Construction of ME EQUIPMENT ................................................................................. 35
201.16 M E 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
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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 p (max.) and E p (min.) ......................................................... 52

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 – A LARM CONDITION priorities and related situations ........................................ 39
Table 208.102 – * Characteristics of the PULSE of auditory ALARM SIGNALS ............................. 40
BS EN 60601-2-24:2015
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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
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). 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. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
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.
BS EN 60601-2-24:2015
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.
– T ERMS DEFINED IN C LAUSE 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.
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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.
BS EN 60601-2-24:2015
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 1 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.
H AZARDS 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.
—————————
1 The general standard is IEC 60601-1:2005+A1:2012, Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance.
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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.
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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
safety and essential performance – Collateral standard: Usability
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
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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
BS EN 60601-2-24:2015
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
intended for controlled infusion of liquids into the PATIENT by means of a
I NFUSION PUMP
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
I NFUSION PUMP 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/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
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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 E SSENTIAL 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
VOLUMETRIC INFUSION PUMPS and SYRING OR CONTAINER 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
Protection against UNINTENDED BOLUS volumes and occlusion 201.12.4.4.104
A LARM 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 * S INGLE FAULT CONDITION for ME EQUIPMENT
Addition:
S INGLE 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;
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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
201.5.2 Number of samples
Addition:
The MANUFACTURER shall define the number of samples of INFUSION PUMP / INFUSION
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
201.6.6 Mode of operation
Replacement
M E EQUIPMENT shall be classified for CONTINUOUS OPERATION .
201.7 M E EQUIPMENT identification, marking and documents
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:
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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

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;
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– 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
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
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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
201.11 Protection against excessive temperatures and other HAZARDS
201.11.6.3 * Spillage on ME EQUIPMENT and ME SYSTEMS
Replacement:
M E EQUIPMENT and ME SYSTEMS requiring the handling of liquids in NORMAL USE shall be so
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.
M E EQUIPMENT shall be appropriate to the environment of use and at least IPX2.
Replacement of compliance statement:
After these PROCEDURES , the ME EQUIPMENT is to show no signs of bridging of insulation (or
electrical components) that could result in a HAZARDOUS SITUATION in NORMAL CONDITION or in
combination with a SINGLE FAULT CONDITION (based on a visual inspection) followed by the
appropriate dielectric strength and LEAKAGE CURRENT tests.
Compliance is checked by inspection and by application of the tests of IEC 60529. Verify that
BASIC SAFETY and ESSENTIAL PERFORMANCE are maintained.
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201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT
Addition:
Additional subclauses:
201.11.8.101 Power supply/ SUPPLY MAINS interruption TECHNICAL ALARM CONDITIONS
201.11.8.101.1 SUPPLY MAINS interruption TECHNICAL ALARM CONDITION

For M E EQUIPMENT that is powered from the SUPPLY MAINS only, if the ME EQUIPMENT is in
operation and there is an accidental disconnection or failure of the SUPPLY MAINS the
ME EQUIPMENT shall give an ALARM SIGNAL of LOW PRIORITY . Under that condition, the ALARM
SIGNAL shall be maintained for at least 3 min or until power is restored, whichever is the less.
NOTE M E EQUIPMENT may stop infusion.
Compliance is checked by inspection and functional tests.
201.11.8.101.2 I NTERNAL ELECTRICAL POWER SOURCE depletion

TECHNICAL ALARM CONDITION
M E EQUIPMENT which utilizes an INTERNAL ELECTRICAL POWER SOURCE either as a primary or

standby supply shall give an ALARM SIGNAL of LOW PRIORITY at least 30 min before delivery
ceases due to battery exhaustion.
The visual ALARM SIGNAL indication does not apply to INFUSION PUMP FOR AMBULATORY USE e.g.
using insulin.
Compliance is checked by inspection and functional tests when the ME EQUIPMENT is operated
at the INTERMEDIATE RATE and with a new and fully charged battery.
If the SUPPLY MAINS and the INTERNAL ELECTRICAL POWER SOURCE both fail the ME EQUIPMENT
shall give an ALARM SIGNAL of HIGH PRIORITY and cease delivery. The alarm shall be
maintained for the duration of at least 3 min.
This requirement does not apply to INFUSION PUMP FOR AMBULATORY USE e.g. using insulin.
Compliance is checked by inspection and functional test.
201.12 *Accuracy of controls and instruments and protection against

hazardous outputs
201.12.1 Accuracy of controls and instruments
201.12.1.101 *General formula
The ME 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 201.12.1.102 to 201.12.1.108, to verify

the accuracy of the ME EQUIPMENT according to its defined type and the MANUFACTURER ' S
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disclosure of accuracy. If the ME EQUIPMENT does not fall into one of the defined categories
use the appropriate test from 201.12.1.102 to 201.12.1.108.
Definition of terms given in 201.12.1.102 to 201.12.1.108
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 0 designated as the first 2 h of the test period
analysis period T 1 designated as the second hour of test period
analysis period T 2 designated as the last hour of the test period
analysis period T x the analysis period specified as T 0 , T 1 or T 2
W the total mass
Wi the i th mass sample over a specified analysis period
Wj mass sample at the end of a specified analysis period or test period
Wk mass sample at the start of a specified analysis period
A overall mean percentage flow error measured over the analysis period T 1
B overall mean percentage flow error measured over the analysis period T 2
P observation window duration
E p (max.) maximum measured error in observation window of specified duration
E p (min.) minimum measured error in observation window of specified duration
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)
201.12.1.102 *Accuracy tests for VOLUMETRIC INFUSION CONTROLLERS , VOLUMETRIC

INFUSION PUMPS and SYRINGE OR CONTAINER PUMPS
The test apparatus shown in Figures 201.104a and 201.104b is used. Carry out the tests
using a test solution of ISO 3696:1987 Class III and installing an unused ADMINISTRATION SET .
Set up the ME EQUIPMENT with the test solution in accordance with the MANUFACTURER ' S
instructions for use.
Ensure that ME EQUIPMENT which has a non-delivery segment within its operating cycle has
this segment included in the test.
Set the required rate according to Table 201.102 Set the sample interval S. Begin the test
period simultaneously with starting the ME EQUIPMENT .
Determine the test period T. This test period shall equal the recommended ADMINISTRATION
SET CHANGE INTERVAL if there is sufficient fluid in the container. If not, calculate the duration of
the test period by dividing the total fluid volume by the rate. Allow the ME EQUIPMENT to run for
the test period T.
For VOLUMETRIC INFUSION PUMPS and SYRINGE OR CONTAINER PUMPS repeat the test at the
INTERMEDIATE RATE for a period of 120 min at back pressures of ±13,33 kPa (±100 mmHG).
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For VOLUMETRIC INFUSION CONTROLLERS repeat the test at the INTERMEDIATE RATE for a period
of 120 min at a back pressure of –13,33 kPa (–100 mmHG).
The MANUFACTURER shall disclose the maximum deviation between the results under normal
conditions and under back pressure conditions, if applicable.
For VOLUMETRIC INFUSION PUMPS repeat the test at the INTERMEDIATE RATE for a period of
120 min with the supply container below the pump mechanism at a distance of 0,5 m with the
same ADMINISTRATION SET .
The MANUFACTURER shall disclose the maximum deviation between the results under normal
condition and under condition if the supply container is below the pump mechanism, if
applicable.
If the ME EQUIPMENT incorporates a BOLUS facility carry out the tests specified in 201.12.1.106.
If the test of 201.12.1.102 cannot be applied because of design features within the
ME EQUIPMENT ,apply the most appropriate test from 201.12.1.103 to 201.12.1.108.
Calculate the actual flow Q i for each sample interval for the analysis period T 0 (min) from
Equation (1) (see Figure 201.103).
Calculate E p (max.) and E p (min.) for the 2 min, 5 min, 11 min, 19 min and 31 min observation
windows from Equations (3) and (4) over the analysis period T 1 (min) of the second hour of
the test period.
Except for SYRINGE OR CONTAINER PUMPS calculate E p (max.) and E p (min.) for the 2 min, 5 min,
11 min, 19 min and 31 min observation windows from Equations (3) and (4) over the analysis
period T 2 (min) of the last hour of the test period.
Plot the following graphs using a linear scale with scale ratios as follows (see rationale),
where r is the set rate (see Figures AA.3.1 and AA.3.3):
For start-up graph, flow axis is:
maximum = 2 r
minimum = –0,2 r
scale increment = 0,2 r
time = 0 min to 120 min (10 min intervals)
For trumpet graph, flow axis is:
maximum = 15 %
minimum = –15 %
scale increment = 5 %
time = 0 min to 31 min (1 min intervals)
Plot flow Q i (ml/h) against time T 0 (min) for the first 2 h of the test period, see example in
Figure 201.105. Indicate the rate by means of a broken line. Indicate flow Q i by means of a
solid line.
Plot percentage variation E p (max.) and E p (min.) against observation window duration P (min)
and the overall mean percentage error A (derived from Equation (5)) measured over the
analysis period T 1 (min) of the second hour of the test period. See example in Figure 201.106.
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Indicate E p (max.) and E p (min.) and the overall mean percentage error A by means of a solid
line. Indicate the zero error by means of a dotted line.
Plot percentage variation E p (max.) and E p (min.) against observation window duration P (min)
and the overall mean percentage error B (derived from Equation (6)) measured over the
analysis period T 2 (min) of the last hour of the test period.
See example in Figure 201.107.

Indicate E p (max.) and E p (min.) and the overall mean percentage error B by means of a solid
line. Indicate the zero error by means of a dotted line. This graph is not applicable to SYRINGE
OR CONTAINER PUMPS .
• Formulae
Calculate flow using the expression:
60 (Wi − Wi −1 )
Qi = (ml/h) (1)
Sd
i = 1, 2 .. T 0 /S
where
Wi is the i th mass sample from the analysis period T 0 (g) (corrected for evaporative loss);
T0 is the analysis period (min);
S is the sample interval (min);
d is the density of water (0,998 g/ml at 20 °C).
Calculate E p (max.) and E p (min.) using the trumpet algorithm as follows:
For observation windows of duration P = 2 min, 5 min, 11 min, 19 min and 31 min, within the
analysis period T x , there are a maximum of m observation windows, such that:
(Tx − P)
=m +1 (2)
S
where
m is the maximum number of observation windows;

P is the observation window duration;
Tx is the analysis period (min).
The maximum E p (max.) and minimum E p (min.) percentage variations within an observation
window of duration period P min are given by:
 P 
j + −1
m S S  Qi − r  
Ep (max.) =MAX  ×
j =1  P
∑ 100 × 
 r 
  (%) (3)
i= j
 
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 P 
j + −1
m S S  Qi − r  
Ep (min.) =MIN  ×
j =1  P
∑ 100 × 
 r 
  (%) (4)
i= j
 
where
60 (Wi − Wi−1 )
Qi = (ml/h)
Sd
Wi is the i th mass sample from the analysis period T x (g) (corrected for evaporative loss);
r is the rate (ml/h);
P is the observation window duration (min);
Calculate the overall mean percentage flow error A using the following expression where A is
measured over the analysis period T 1 (the second hour of the test period):
100 ( Q − r )
A= (%) (5)
r
where
60 (Wj − Wk )
Q= (ml/h)
T1d
Wj is the mass sample at the end of the analysis period T 1 (g) (j = 240);
Wk is the mass sample at the start of the analysis period T 1 (g) (k = 120);
Calculate the overall mean percentage flow error B using the following expression where B is
measured over the analysis period T 2 (the last hour of the test period):
100 ( Q − r )
B= (%) (6)
r
where
60 (Wj − Wk )
Q= (ml/h)
T2 d
Wj is the mass sample at the end of the test period T 2 (g) (corrected for evaporative loss);
Wk is the mass sample at the start of the analysis period T 2 (g) (corrected for evaporative
loss);
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Flow
Analysis
period T0
Analysis Analysis
period T1 period T2
0 60 120 T – 60 T
Test time t (min)
T = ADMINISTRATION SET CHANGE INTERVAL

IEC 1910/12
Figure 201.103 – Analysis periods
Liquid level
Liquid container (vented or collapsible bag)
Drip chamber (if included)
h1 ADMINISTRATION SET Needle

(18G, 1,2 mm, see ISO 7864)
Input
EUT
Output
0,000 0 g
Electronic
balance
Computer
IEC 1911/12
Figure 201.104a – Test apparatus for VOLUMETRIC INFUSION PUMPS

and VOLUMETRIC INFUSION CONTROLLERS
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Needle
(18G, 1,2 mm, see ISO 7864)
ADMINISTRATION SET
Syringe
Same level
EUT
0,000 0 g
Electronic
balance
Computer
IEC 1912/12
Figure 201.104b – Test apparatus for SYRINGE OR CONTAINER PUMPS
NOTE A balance accurate to five decimal places is required for pumps with low MINIMUM RATES .
Set height h 1 (collapsible bag, vented container) in accordance with the MANUFACTURER ’ S instructions for use. The
needle (18G, 1,2 mm, ISO 7864) shall be positioned below the liquid surface.
The mean centre line of the pumping chamber to be at the same height as the tip of the needle (18G, 1,2 mm,
ISO 7864).
The needle (ISO 7854) I.D. and length should be chosen to produce a pressure difference of 0.20 (±0.10) mmHg
based on the Hagen-Poiseuille formula (using a rate of 25 ml/h and viscosity of 0.01 poise).
Figure 201.104 – Test apparatuses for different types of INFUSION PUMPS
Flow
(µl/h) Set rate
1,5
1,0
0,5
0,0
–0,5
120
Time (min)
IEC 1913/12
Figure 201.105 – Start-up graph plotted from data gathered during the first 2 h
of the test period
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Percentage
error of flow
10
Ep(max)
5
Set rate (r)
0
–5 Overall percentage error (A)

–10 Ep(min)
2 5 11 19 31
Observation window (min)
IEC 1914/12
Figure 201.106 – Trumpet curve plotted from data gathered during the second hour
of the test period
Percentage
error of flow
10
Ep(max)
5
Set rate (r)
–5 Overall percentage error (A)
–10 Ep(min)
2 5 11 19 31
Observation window (min)
IEC 1915/12
Figure 201.107 – Trumpet curve plotted from data gathered during the last hour
of the ADMINISTRATION SET CHANGE INTERVAL
201.12.1.103 *Accuracy tests for INFUSION PUMPS FOR AMBULATORY USE type 1
The test apparatus shown in Figure 201.102b is used. Carry out the tests using a test solution
of ISO 3696:1987 class III or a liquid which can be expected to give similar test results and
installing an unused ADMINISTRATION SET . Set up the ME EQUIPMENT in accordance with the
MANUFACTURER ' S instructions for use. Prime the ADMINISTRATION SET and set the ME EQUIPMENT
for the INTERMEDIATE RATE . Start the ME EQUIPMENT . Set the sample interval S to 15 min. Allow
the ME EQUIPMENT to run for a time equivalent to half the container volume, or 24 h, whichever
is the shorter as a stabilization period T 1 (min). Continue the test without stopping the
ME EQUIPMENT for a further 25 h or until the liquid container is depleted. Measure the mass of
infusate W i delivered at each sample interval. Repeat the test at the MINIMUM RATE .
Calculate the mean flow from Equation (7) for every two successive samples over the
stabilization period T 1 .
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Calculate E p (max.) and E p (min.) for the 15 min, 60 min, 150 min, 330 min, 570 min and
930 min observation windows from Equations (9) and (10) over the analysis period T 2 (min)
starting from the end of the stabilization period to the end of the test.
Plot the following graphs:
a) Flow Q i (µl/h) against time (min) over the stabilization period T 1 at 30 min increments.
Indicate the rate r (µl/h) by means of a broken line. Indicate flow Q i by means of a solid
line. See Figure 201.108 as an example.
b) Percentage variation E p (max.) and E p (min.) against observation window duration over the
analysis period T 2 and the overall mean percentage error A (derived from Equation (11).
Indicate the zero error by means of a broken line. Indicate E p (max.) and E p (min.) and the
overall mean percentage error A by means of solid lines. See Figure 201.109 as an
example.
Flow
(µl/h) Set rate
45 90 (min) 24 (h)
IEC 1916/12
Figure 201.108 – Start-up graph over the stabilization period
Percentage
error of flow
Set rate (r)

0
Overall percentage error (A)
15 30 45
Observation window (min) Type 1 pump
IEC 1917/12
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Flow
(µl/h) Set rate
IEC 1918/12
Figure 201.110 – Start-up curve over the stabilization period for quasi-continuous
output pumps
Percentage
error of flow
Set rate (r)

0
Overall percentage error (A)
(shot interval)
Observation interval Type 2 pump
IEC 1919/12
for quasi-continuous pumps
• Formulae
60 (W2i − W2(i−1) )
Qi = (μl/h) (13)
2dS
where
i 1, 2.. T 1 /2S;
Wi is the i th mass sample from the stabilization period T 1 (mg) (corrected for evaporative
loss);
T1 is the stabilization period (min) (≈24 h);
S is the sample interval (min) (15 min);
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d is the density of test liquid at 20 °C (g/ml).
For observation windows of duration P = 15 min, 60 min, 150 min, 330 min, 570 min and
930 min, within the analysis period T 2 , there are a maximum of m observation windows, such
that:
(T2 − P )
m= +1 (14)
where

S is the sample interval (min) (15 min).
The maximum E p (max.) and minimum E p (min.) percentage variations, within an observation
window of duration period P (min), are given by;
 P 
j + −1
m S S  Q − r 
j =1  P
∑ 100 ×  i
 r 
  (%) (15)
i= j
 
 P 
j + −1
m S S  Qi − r  
j =1  P
∑ 100 × 
 r 
  (%) (16)
i= j
 
where
60 (Wi − Wi−1)
Qi = (ml/h)
Sd
Wi is the i th mass sample from the analysis period T 2 (mg) (corrected for evaporative
loss);
r is the set rate (µl/h);
d is the density of test liquid at the test temperature (g/ml).
Calculate the overall percentage flow error A using the following expression, where A is
measured over the analysis period T 2 :
100 ( Q − r )
A= (%) (17)
r
where
60 (Wj − Wk )
Q= (μl/h)
T2 d
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Wj is the mass sample at the end of the analysis period T 2 (mg);
Wk is the mass sample at the start of the analysis period T 2 (mg);
201.12.1.104 *Accuracy tests for INFUSION PUMP FOR AMBULATORY USE type 2
The test apparatus shown in Figure 201.104b is used. Carry out the tests using a test solution
of ISO 3696:1987 class III or a liquid which can be expected to give similar test results and
installing an unused ADMINISTRATION SET . Set up the ME EQUIPMENT in accordance with the
MANUFACTURER ' S instructions for use. Prime the ADMINISTRATION SET .
Determine the shot pattern of the pump output. Derive the shot cycle. Measure the time taken
(in minutes) for 20 successive shot cycles at the INTERMEDIATE RATE (and ensure that there is
sufficient liquid in the container for the subsequent 100 shots after the stabilization period).
Calculate the mean duration of the shot cycle I (min).
Derive sample interval S corresponding to the INTERMEDIATE RATE shot cycle I.
If the shot cycle I is greater than 0,5 min, then:
S = kI (18)
where
S is the sample interval;

I is the shot cycle;
k is the integer constant = 1.
If the shot cycle I is less than 0,5 min, then
S = kI (19)
where
S is the sample interval;

I is the shot cycle;
k is the minimum integer constant giving kI approximately equal to 0,5 min.
Synchronize the measuring equipment to measure the mass of infusate delivered in

successive sequences of k shot cycles.
Set the ME EQUIPMENT for the INTERMEDIATE RATE .
Start the ME EQUIPMENT . Allow the ME EQUIPMENT to run for a time equivalent to half the
container volume or 24 h, whichever is the shorter, as a stabilization period T 1 (min).
Continue the test without stopping the ME EQUIPMENT for a further 100 sample intervals.
Measure the mass of infusate W i delivered at each sample interval.
Choose any integer n so that:

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nS ≈ 30 (min) (20)
where
S is the sample interval (kI) (min);

n is the integer constant.
Calculate the mean flow from Equation (21) for every successive nS samples, over the
stabilization period T 1 .
Calculate E p (max.) and E p (min.) for P = S, 2S, 5S, 11S, 19S and 31S min observation windows
from Equations (23) and (24) over the analysis period T 2 starting from the end of the stabiliza-
tion period to the end of the test.
Plot flow as a function of elapsed time over the stabilization period T 1 defined above. Indicate
the rate on the graph by means of a broken line. See Figure 201.110 as an example.
Plot percentage variation E p (max.) and E p (min.) against observation window duration, over
the analysis period T 2 and the overall mean percentage error A (derived from Equation (25)).
Indicate the zero error by means of a broken line. Indicate E p (max.) and E p (min.) and the
overall mean percentage error A by means of solid lines. See Figure 201.111 as an example.
• Formulae
60 (Wni − Wn(i−1) )
Qi = (μl/h) (21)
ndS
where
i = 1, 2.. T 1 /nS;
Wi is the i th mass sample from the stabilization period T 1 (mg) (corrected for evaporative
loss);
T1 is the stabilization period (min) (≈24 h);
S is the sample interval (min) = (kImin);
n is the integer constant (nS ≈ 30 min);
For consecutive observation windows P = S, 2S, 5S, 11S, 19S and 31S min, within the analysis
period T 2 , there are a maximum of m successive samples such that:
(T2 − P )
m= +1 (22)
S
where

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S is the sample interval (min).
The maximum E p (max.) and minimum E p (min.) percentage variations, within an observation
window of duration period P (min), are given by:
 P 
j + −1
m S S  Qi − r  
j =1  P
∑ 100 × 
 r 
  (%) (23)
i= j
 
 P 
j + −1
m S S  Qi − r  
j =1  P
∑ 100 × 
 r 
  (%) (24)
i= j
 
where
60 (Wi − Wi−1)
Qi = (μl/h)
Sd
Wi is the i th mass sample from the analysis period T 2 (mg) (corrected for evaporative
loss);
Calculate the overall percentage flow error A using the following expression, where A is
measured over the analysis period T 2 :
100 ( Q − r )
A= (%) (25)
r
where
60 (Wj − Wk )
Q= (μl/h)
T2 d
W is the total mass (mg) (corrected for evaporative loss);
Wj is the mass sample at the end of the analysis period T 2 (mg);
Wk is the mass sample at the start of the analysis period T 2 (mg);
201.12.1.105 *Accuracy tests for INFUSION PUMP type 3
The test apparatus shown in figures 201.104a or 201.104b is used (as appropriate) using a
test solution of ISO 3696:1987 class III or a liquid which can be expected to give similar test
results and installing an unused ADMINISTRATION SET . Set up the ME EQUIPMENT with the
recommended ADMINISTRATION SET in accordance with the MANUFACTURER ' S instructions for
use. Set the ME EQUIPMENT to supply a BOLUS at the minimum setting. Start the ME EQUIPMENT
and weigh 25 successive BOLUS deliveries either demanded manually or by programme.
BS EN 60601-2-24:2015
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Calculate the mean and the percentage deviation from the set value. Select the deliveries with
the maximum positive and maximum negative deviations from the set value. Express these as
percentage deviations from the set value. Repeat the test with the ME EQUIPMENT at the
maximum BOLUS setting.
I NFUSION PUMP type 4 shall be tested according to 201.12.1.103, 201.12.1.104 and

201.12.1.105 as appropriate.
NOTE Correction factors may be applicable to INFUSIONPUMPS FOR AMBULATORY USE type 4 where a continuous or
quasi-continuous flow is maintained throughout the BOLUS delivery. These factors are disclosed in the
ACCOMPANYING DOCUMENTS .
I NFUSION PUMP type 5 shall be tested according to 201.12.1.102 to 201.12.1.105, as

appropriate.
Table 201.102 – Set rates, BOLUS volumes and test apparatus

for the accuracy tests of 12.1.102 to 12.1.107
Set rates B OLUS Test

M E EQUIPMENT Minimum Inter- Minimum Maximum Apparatus Subclause
mediate (figure)
VOLUMETRIC INFUSION CONTROLLER Used Used Not used Not used 201.104a), 201.12.1.102
201.104b)
VOLUMETRIC INFUSION PUMP Used Used Used Used 201.104a), 201.12.1.102,
201.104b) (201.12.1.105)
SYRINGE OR CONTAINER PUMP Used Used Used Used 201.104b) 201.12.1.102,
(201.12.1.105)
I NFUSION PUMPS FOR AMBULATORY Used Used Not used Not used 201.104b) 201.12.1.103
USE type 1
I NFUSION PUMPS FOR AMBULATORY Not used Used Not used Not used 201.104b) 201.12.1.104
USE Type 2
VOLUMETRIC , INFUSION PUMP , Not used Not used Used Used 201.104a), 201.12.1.105
or SYRINGE OR CONTAINER PUMP or 201.104b)
INFUSION PUMP FOR AMBULATORY USE
type 3
VOLUMETRIC , INFUSION PUMP , Used Used Used Used 201.104a), 201.12.1.103
or SYRINGE OR CONTAINER PUMP or 201.104b) and
INFUSION PUMP FOR AMBULATORY USE 201.12.1.105
type 4
VOLUMETRIC , INFUSION PUMP , Used Used Used Used 201.104a), 201.12.1.103
or SYRINGE OR CONTAINER PUMP or 201.104b) and
INFUSION PUMP FOR AMBULATORY USE 201.12.1.105
type 5
201.12.4.1 Intentional exceeding of safety limits
Addition:
An example would be the priming/purge control of the ME EQUIPMENT .

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201.12.4.4 Incorrect output
201.12.4.4.101 Protection against overinfusion
Means shall be provided in the ME EQUIPMENT to protect against overinfusion under SINGLE
FAULT CONDITIONS . An ALARM SIGNAL according to Table 208.101 shall be initiated in the event
of overinfusion and the ME EQUIPMENT shall either cease delivery of infusion liquid or reduce
the delivery rate to the KEEP OPEN RATE or less.
S INGLE FAULT CONDITIONS occurring in those protective systems specified shall become
obvious to the OPERATOR within the ADMINISTRATION SET CHANGE INTERVAL .
201.12.4.4.102 *Protection against overinfusion FREE FLOW conditions
Means shall be provided in the ME EQUIPMENT to protect against overinfusion as a result of

FREE FLOW conditions. This requirement applies as soon as the ADMINISTRATION SET is installed
in the ME EQUIPMENT in accordance with the MANUFACTURER ' S instructions for use.
SINGLE FAULT CONDITIONS occurring in those protective systems specified shall become
obvious to the OPERATOR within the ADMINISTRATION SET CHANGE INTERVAL .
Additional requirements are found in 201.15.102 and 201.15.103.
Compliance is checked by inspection and functional tests if applicable. As an example, a

functional test is to allow the flow to stabilize after momentarily lowering the collecting vessel
by 50 cm and checking for evidence of FREE FLOW .
201.12.4.4.103 M AXIMUM INFUSION PRESSURE
The ME EQUIPMENT shall not produce a MAXIMUM INFUSION PRESSURE capable of causing a
rupture or a leak in the ADMINISTRATION SET .
201.12.4.4.104 Protection against UNINTENDED BOLUS volumes and by occlusion
Means shall be provided in the ME EQUIPMENT to protect the PATIENT from underinfusion
resulting from occlusion.
NOTE An acceptable method of complying with this requirement is at OCCLUSION ALARM THRESHOLD to activate an
ALARM SIGNALof HIGH PRIORITY and terminate the infusion liquid flow.
Means shall be provided in the ME EQUIPMENT to protect the PATIENT from UNINTENDED BOLUS
following activation of the ALARM SIGNAL for occlusion.
Compliance is checked by the following test:
This test applies only to INFUSION PUMPS , VOLUMETRIC INFUSION PUMPS , INFUSION PUMPS FOR
AMBULATORY USE and SYRINGE OR CONTAINER PUMPS .
The test apparatus shown in Figure 201.112 is used. Carry out the tests using a test solution
of ISO 3696:1987 class III or using the existing drug in the INFUSION PUMP , if the drug is
prefilled by the MANUFACTURER . Perform the test under normal conditions (20 °C ± 2 °C, 65 %
± 5 % RH). Operate the ME EQUIPMENT in NORMAL USE according to the MANUFACTURER ' S
BS EN 60601-2-24:2015
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instructions for use. Prime the ADMINISTRATION SET and the tubing connected to the pressure
transducer.
Select the INTERMEDIATE RATE and the minimum OCCLUSION ALARM THRESHOLD . Connect the
PATIENT END of the PATIENT LINE to the stopcock. Open the stopcock to the collecting vessel.
Start the ME EQUIPMENT and allow the flow to become constant. Switch the stopcock and
measure the pressure at the OCCLUSION ALARM THRESHOLD . Measure the time taken from
switching the stopcock to activation of the occlusion alarm.
If an automatic bolus reduction feature is available, allow this function to complete.
Inspect the ADMINISTRATION SET for ruptures or leaks. Empty the collecting vessel. Switch the
stopcock and collect the UNINTENDED BOLUS volume generated as a result of the occlusion
until the pressure is reduced to atmospheric.
If the OCCLUSION ALARM THRESHOLD can be selected, repeat the test with it set to maximum.
If an automatic bolus reduction feature can be disabled repeat the test with this feature
disabled.
If any OPERATOR action is given for the eleventh dashed item of 201.7.9.2.101 a test shall also
be conducted of the means provided by the ME EQUIPMENT to release unreleased UNINTENDED
BOLUS . This consists of performing the release as described before measuring the amount of
the UNINTENDED BOLUS remaining.
Verify by volume or mass that the result of the test is in accordance with the requirements of
201.12.4.4.101 and 201.12.4.4.102 and the disclosure statement in the ACCOMPANYING
DOCUMENTS required by the eighth to eleventh dashed items of 201.7.9.2.101).
If length of ADMINISTRATION SET varies set length D to 1 m
Pressure monitor
ADMINISTRATION SET
Rigid tubing
EUT Pressure
tranducer
D
Three-way tap Collecting vessel
IEC 1920/12
Figure 201.112 – Test apparatus to determine the OCCLUSION ALARM THRESHOLD

and BOLUS volumes
201.12.4.4.105 Reverse delivery
Any reverse flow shall not cause an unacceptable RISK in NORMAL USE and SINGLE FAULT
CONDITION .
Compliance is checked by inspection of the RISK MANAGEMENT FILE .

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201.12.4.4.106 M E EQUIPMENT and drop sensor orientation
This test applies only to INFUSION PUMPS with a particular ACCESSORY (drop sensor),
Safe operation of the ME EQUIPMENT shall not be affected by:
– the mispositioning or removal of a drop sensor, and

– operating the ME EQUIPMENT with a tilted or incorrectly filled drop chamber.
Under these conditions the ME EQUIPMENT shall either:

– maintain the accuracy of delivery, or

– stop the flow and generate an ALARM SIGNAL according to Table 208.101.
Compliance is checked by the following functional test:
Operate the ME EQUIPMENT in NORMAL USE according to the MANUFACTURER ' S instructions for
use. Select any rate. Tilt the drop chamber from the vertical to a maximum of 20° in two
orthogonal planes. By inspection determine the result of the test. By inspection determine the
effects of mispositioning, removal or overfilling of a drop chamber.
201.12.4.4.107 *Protection against air infusion
This requirement does not apply to INFUSION PUMPS FOR AMBULATORY USE using a
subcutaneous access, ENTERAL NUTRITION PUMPS and SYRINGE OR CONTAINER PUMPS .
The ME EQUIPMENT shall protect the PATIENT from air infusion which can cause an
unacceptable RISK due to air embolism.
Compliance is checked by inspection and functional tests in accordance with the

MANUFACTURER ' S specification (see first dashed item of 201.7.9.3.101 ).
After the initiation of an ALARM SIGNAL for air detection alarm it shall not be possible to
recommence liquid delivery by a single action.
SINGLE FAULT CONDITIONS occurring in the protective system of the ME EQUIPMENT shall cause
the cessation of delivery and the generation of an ALARM SIGNAL according to Table 208.101
within a time interval less than the volume of the ADMINISTRATION SET between the air detector
and the venous cannula connected to it divided by the maximum flow rate of the pump.
201.12.4.4.108 ADMINISTRATION SETS – Operational characteristics
Should the MANUFACTURER allow the use of a range of ADMINISTRATION SETS with different
operational characteristics, then the ME EQUIPMENT shall not start infusion until
– either the type of ADMINISTRATION SET has been detected automatically, or

– the OPERATOR has identified the type of ADMINISTRATION SET
to prevent incorrect output.
201.12.4.4.109 Protection against underinfusion
The MANUFACTURER shall address in the RISK MANAGEMENT PROCESS RISKS associated with
underinfusion due to any cause including blockage of the ADMINISTRATION SET .
BS EN 60601-2-24:2015
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Compliance is checked by inspection of the risk management file
201.13 H AZARDOUS SITUATIONS and fault conditions
201.13.2.6 *Leakage of liquid
Replacement:
M E 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 ME 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 ME EQUIPMENT in the least favourable orientation of NORMAL USE and according to
the MANUFACTURER ' S instructions for use. By means of a pipette apply drops of the test
solution specified by the MANUFACTURER 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 201.12.1.102 to
201.12.1.107 according to the classification of the ME EQUIPMENT , at the INTERMEDIATE RATE
only. If the ME EQUIPMENT does not fall into one of the defined categories then use the
appropriate test from 201.12.1.102 to 201.12.1.107 ((see 201.12.1)). Carry out the tests of
201.12.4.4.106 and 201.12.4.4.107. Switch off the ME 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 worst case test solution which consists of a 50 % dextrose solution or
as indicated in the RISK MANAGEMENT FILE of the MANUFACTURER .
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS ( PEMS )
201.15 Construction of ME EQUIPMENT
201.15.4.4 Indicators
Addition at the end of the first paragraph:
An indicator light (or means other than marking) shall be provided to indicate that the SUPPLY
MAINS is on.
An indicator light (or means other than marking) shall be provided to indicate that the pump is
operated from an INTERNAL ELECTRICAL POWER SOURCE . This requirement does not apply if the
pump is powered only by an INTERNAL ELECTRICAL POWER SOURCE .
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M E EQUIPMENT powered by an INTERNAL ELECTRICAL POWER SOURCE shall incorporate means to

check the battery state at any time by the OPERATOR . Excluded are INFUSION PUMPS FOR
AMBULATORY use with a subcutaneous access.
Additional subclauses
201.15.101 Fitting of the syringe/container
If a syringe/container can be fitted by the OPERATOR , means shall be provided to ensure

correct clamping and location of a syringe/container and pumping mechanism to prevent FREE
FLOW .
In the event of incorrect location of a syringe/container the pump shall not start and an
ALARM SIGNAL according to Table 208.101 shall be activated.
Means shall be provided to prevent FREE FLOW under SINGLE FAULT CONDITIONS .
An ALARM SIGNAL according to Table 208.101 shall be activated, if an attempt is made to

remove the syringe/container while the INFUSION PUMP is running.
Compliance is checked by inspection and the following test
After the syringe/container is installed, it is disturbed just sufficiently to trigger the

ALARM SIGNAL according to Table 208.101. Confirm that FREE FLOW does not occur.
M E EQUIPMENT shall be so designed that no unacceptable RISK for the PATIENT can occur due
to pulling force on the PATIENT LINE .
Compliance is checked by inspection and by test with a force of 15 N and for 15 s in the worst
case condition. Confirm that FREE FLOW does not occur.
201.15.102 Fitting of the ADMINISTRATION SET
Where appropriate, means shall be provided to ensure correct fitting of the ADMINISTRATION
SET into the ME EQUIPMENT .
In the event of incorrect location of the ADMINISTRATION SET the INFUSION PUMP shall not start
and deliver fluid and an ALARM SIGNAL according to Table 208.101 shall be activated.
An ALARM SIGNAL according to Table 208.101 shall be activated, if an attempt is made to

remove the ADMINISTRATION SET while the INFUSION PUMP is delivering fluid.
An ME EQUIPMENT shall be so designed that there is no unacceptable RISK to the PATIENT due
to pulling force on the PATIENT LINE and the SUPPLY LINE , if applicable. The test is performed
with a force of 15 N and for 15 s in worst case condition.
Compliance is checked by functional testing. Specify that, after the ADMINISTRATION SET is
installed, it is disturbed just sufficiently to trigger the ALARM SIGNAL , and that FREE FLOW does
not occur until the ADMINISTRATION SET is moved further.
201.15.103 *Use errors
At least two distinctive and separate actions shall be required before FREE FLOW can occur in
NORMAL USE . The first action shall stop the flow and initiate an ALARM SIGNAL according to
Table 208.101.
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This requirement does not apply to SYRINGE OR CONTAINER PUMPS and INFUSION PUMPS FOR
AMBULATORY USE which use syringes or the pumping mechanism is combined with the
“container” (fluid displacement and container in the same part), (see 201.12.4.4.102).
M E EQUIPMENT shall be so designed that, if it is accidentally switched off and then switched on
again by means of a functional control, there shall be no unacceptable RISK to the PATIENT .

201.16 M E SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
202 Electromagnetic compatibility – Requirements and tests
IEC 60601-1-2:2007 applies except as follows:
202.6.2.1.3 Operating mode and configuration
Addition:
Protection against UNINTENDED BOLUS volumes and occlusion, and ALARM CONDITIONS regarded
as ESSENTIAL PERFORMANCE (see Table 208.101) are tested once after exposure to all relevant
immunity test levels.
202.6.2.2.1 Requirements
Replacement:
M E EQUIPMENT shall comply with the requirements of 6.2.1.10 (of IEC 60601-1-2:2007) as
modified below at IMMUNITY TEST LEVELS specified in Table 202.101 for air and contact
discharge. For this requirement, the following conditions if associated with BASIC SAFETY and
ESSENTIAL PERFORMANCE shall apply:
– no permanent DEGRADATION or loss of FUNCTION which is not recoverable or dataloss which

could cause an unacceptable RISK shall be observed at any IMMUNITY TEST LEVEL;
– no inappropriate delivery of fluids to the PATIENT shall occur at any IMMUNITY TEST LEVEL;
– at IMMUNITY TEST LEVELS 1,2 and 3, the ME EQUIPMENT shall maintain normal performance
within the specification limits;
– at IMMUNITY TEST LEVELS 4, the temporary degradation or loss of function or performance
which requires OPERATOR intervention is acceptable.
Table 202.101 – Test levels
Contact discharge Air discharge

Test voltage Test voltage
Level Level
kV kV
1 2 1 2
2 4 2 4
3 6 3 8
4 8 4 15
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NOTE Table 202.101 is taken from IEC 61000-4-2:2008 Table 1and modified
Check compliance by application of the tests in 6.2.2.2 [of IEC 60601-1-2:2007]. Evaluate the
response of the ME EQUIPMENT or ME SYSTEM during and after these tests in accordance with
6.2.1.10 [of IEC 60601-1-2:2007] as modified in above, considering each discharge
individually.
206 Usability
206.101 P RIMARY OPERATING FUNCTIONS
As a minimum, the following shall be considered.
– power on;
– load ADMINISTRATION SET or syringe/container;
– select infusion parameters;
– infusion start;
– alarm notification and operator action(s) to resolve the alarm situation;
– changing infusion parameters;
– infusion stop;
– remove ADMINISTRATION SET or syringe/container;
– power off.
The MANUFACTURER shall determine the complete list of PRIMARY OPERATING FUNCTIONS for the
ME EQUIPMENT .
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems
208.6.1.2 ALARM CONDITION priority
208.6.1.2.101 ALARM CONDITION priorities and related situations
M E EQUIPMENT shall comply with the requirements of Table 208.101.

BS EN 60601-2-24:2015
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Table 208.101 – ALARM CONDITION priorities and related situations
Situation For type of ME EQUIPMENT ALARM CONDITION priority Auditory Visual
ME EQUIPMENT
All types of pumps H IGH PRIORITY Yes Yes
FAILURE
Repeating
Between
15 s and
30 s
interburst
interval
Three tones
Prior end of infusion S YRINGE OR CONTAINER
L OW PRIORITY Acknowledge Yes
alarm PUMP , PROFILE PUMP
d by AUDIO
PAUSED by a
single action
of OPERATOR
R EMINDER
SIGNAL .
P ROFILE PUMP
SYRINGE OR CONTAINER
PUMP ,
End of infusion alarm H IGH PRIORITY Yes Yes
VOLUMETRIC INFUSION
CONTROLLER
P ROFILE PUMP ,
PUMP ,
Occlusion alarm H IGH PRIORITY Yes Yes
VOLUMETRIC INFUSION
CONTROLLER
P ROFILE PUMP ,
VOLUMETRIC INFUSION
Air in line alarm H IGH PRIORITY Yes Yes
CONTROLLER
Repeating
Between
15 s and
30 s
interburst
P ROFILE PUMP interval
SYRINGE OR CONTAINER Three tones
PUMP , L OW PRIORITY
Battery alarm VOLUMETRIC INFUSION Acknowledge Yes
CONTROLLER , d by AUDIO
VOLUMETRIC INFUSION PUMP PAUSED by
ENTERAL NUTRITION PUMP on single

action of
OPERATOR
R EMINDER
SIGNAL .
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– 40 – 60601-2-24  IEC:2012
Situation For type of ME EQUIPMENT ALARM CONDITION priority Auditory Visual
ME EQUIPMENT
All types of pumps H IGH PRIORITY Yes Yes
FAILURE
Repeating
Between 15s
and 30s
interburst
interval
P ROFILE PUMP , Three tones

No action with the PUMP , Acknowledge
L OW PRIORITY d by AUDIO Yes
pump VOLUMETRIC INFUSION
CONTROLLER , PAUSED by
VOLUMETRIC INFUSION PUMP on single

action of
OPERATOR
R EMINDER
SIGNAL .
Compliance is checked by inspection and functional tests
208.6.3.3.1 *Characteristics of auditory ALARM SIGNALS
Amendment:
Modification of the first and second rows of Table 4 of IEC 60601-1-8:2006 for INFUSION PUMPS
FOR AMBULATORY USE only, as shown in Table 208.102.
Table 208.102 – * Characteristics of the PULSE of auditory ALARM SIGNALS
Characteristic Value
P ULSE FREQUENCY (f o ) 150 Hz to 3 000 Hz
Number of harmonic components Minimum 1
in the range 300 Hz to 4 000 Hz
Effective PULSE duration (t d )
H IGH PRIORITY 75 ms to 200 ms
M EDIUM and LOW PRIORITY 125 ms to 250 ms
R ISE TIME (t r ) 10 % – 20 % of t d
a
F ALL TIME (t f ) tf ≤ ts − tr
NOTE The relative sound pressure level of the harmonic components should be within 15 dB above or below
amplitude at the PULSE FREQUENCY.
a
Prevents overlap of PULSES .
If a facility to select any alternative scheme of auditory ALARM SIGNAL characteristics is

provided, access shall be restricted to the RESPONSIBLE ORGANIZATION , 6.7 of IEC 60601-1-8
shall apply to this facility, and the technical description shall also include a warning to the
RESPONSIBLE ORGANIZATION to carry out a RISK assessment before selecting alternative ALARM
SIGNALS .
208.6.3.3.2 Volume of auditory ALARM SIGNALS and INFORMATION SIGNALS
Addition:
BS EN 60601-2-24:2015
60601-2-24  IEC:2012 – 41 –
208.6.3.3.2.101 Volume of auditory ALARM SIGNALS
For other than INFUSION PUMPS FOR AMBULATORY USE , unless the INFUSION PUMP is connected to
a DISTRIBUTED ALARM SYSTEM that is providing auditory ALARM SIGNALS , the volume of auditory
ALARM SIGNALS shall generate a sound-pressure level of at least 45 dBA at 1 m, and shall not
be adjustable by the OPERATOR without the use of a TOOL below 45 dBA at 1 m.
For INFUSION PUMPS FOR AMBULATORY USE , the volume of auditory ALARM SIGNALS shall
generate a sound-pressure level of at least 45 dBA at 1 m, and shall not be adjustable without
either the use of a TOOL or by special means by the OPERATOR .
EXAMPLE Special means consisting of pressing a sequence of keys.
Compliance is checked by inspection and functional testing. Utilize the test method specified
in IEC 60601-1-8:2006, 6.3.3.2, to measure the sound-pressure level.
208.6.3.3.2.102 * AUDIO PAUSED period
The duration of AUDIO PAUSED required by this standard shall not exceed 120 s without
OPERATOR intervention.. This requirement does not apply to INFUSION PUMPS FOR AMBULATORY
USE .
NOTE This permits an OPERATOR to extend deliberately the duration of AUDIO PAUSED by direct action.
F OR INFUSION PUMPS FOR AMBULATORY USE the maximum time for AUDIO PAUSED is specified
according to the RISK ASSESSMENT of the MANUFACTURER
The AUDIO PAUSED shall be indicated visually during the AUDIO PAUSED period.

BS EN 60601-2-24:2015
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Annexes
The annexes of the general standard apply, with the following exception:
Addition:
BS EN 60601-2-24:2015
60601-2-24  IEC:2012 – 43 –
Annex AA
(informative)
Particular guidance and rationale
AA.1 General guidance

A DMINISTRATION SETS are not fully tested by this particular standard, but it is recognized that
INFUSION PUMPS and INFUSION CONTROLLERS can comply with this particular standard only if
they are used together with compatible ADMINISTRATION SETS such as those recommended by
the MANUFACTURER . It is the responsibility of the OPERATOR to use such ADMINISTRATION SETS
in order to avoid a HAZARD resulting from the use of unsuitable ADMINISTRATION SETS . It is the
responsibility of the MANUFACTURER to recommend ADMINISTRATION SETS which comply with
functional safety aspects.
AA.2 Rationale for particular clauses and subclauses
The following are rationales for specific clauses and subclause in this particular standard, with
clause and subclause numbers parallel to those in the body of the document.
Subclause 2.3.212 and 201.3.213 – M AXIMUM SELECTABLE RATE and MINIMUM SELECTABLE
RATE
Rate definitions used in this standard are defined in a manner that utilizes the rate definitions
of MINIMUM RATE and INTERMEDIATE RATE from IEC 60601-2-24, and adds new definitions of
MAXIMUM SELECTABLE RATE and LOWEST SELECTABLE RATE . The new definitions were added to
include requirements for performance testing at rates lower than the MINIMUM RATE and higher
than the INTERMEDIATE RATE .
Subclause 201.4.7 – S INGLE FAULT CONDITION for ME EQUIPMENT
In order to protect the PATIENT from a HAZARD due to failure of the protective systems
specified in subclause 201.12.4, subclause 201.4.7 of this standard requires that SINGLE FAULT
CONDITIONS occurring in these protective systems become obvious to the OPERATOR while the
equipment is operational.
One method of implementing this would be for the ME EQUIPMENT to continuously carry out
self-check routines and alarm and stop infusing if a SINGLE FAULT CONDITION occurs (see
example 1 of 201.4.7). However, it is recognized that this method might require expensive
technology. Two other methods are, therefore, allowed. Example 2 allows the OPERATOR to
initiate an automatic self-check procedure at any time before, during or after the infusion.
Example 3 allows the OPERATOR to participate in an interactive procedure by following a safety
check list described in the ACCOMPANYING DOCUMENTS .
It is intended that, whichever method is employed, all primary sensors in the protective
system should be included so that a true functional check is carried out.
The following items are regarded as NORMAL CONDITION :
– 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;
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– pulling on the PATIENT LINE (see ISO 8536-4);

– because this will happen during usual infusion therapy.
Subclause 201.7.9.2.101 – Instruction for use
th
201.7.9.2.101, 4 item (instruction and references)
The instructions can include references to ADMINISTRATION SET instruction for use.
th
201.7.9.2.101, 14 item
Due to the power consumption of VOLUMETRIC INFUSION PUMPS or VOLUMETRIC INFUSION

CONTROLLERS the operating time may vary between different set rates. This information is
useful for the OPERATOR of the equipment during transport conditions.
th
201.7.9.2.101, 17 item
Examples of conditions under which the ME EQUIPMENT may fail to maintain the specified
accuracy include short time periods, unusual infusion liquid characteristics, the use of
excessively fine bore needles, inadequate protection against the extremes of environmental
conditions, occlusion of the ADMINISTRATION SET upstream of the ME EQUIPMENT . The
MANUFACTURER should specify the parameters in which the device cannot maintain the
specified accuracy; e.g., viscosity of liquids, back pressure, infusion rates, reaction time of
the safety system, scope of the risk analysis, etc.
th
Subclause 201.7.9.2.101, 18 item
Examples of a HAZARD associated with interconnection of the infusion system or ACCESSORIES

to the PATIENT line include the possible change in infusion rate due to such interconnections
and the increased possibility of air infusion to the PATIENT , especially with gravity feed
systems.
rd
The maximum infusion that may occur under SINGLE FAULT CONDITIONS may be declared as a
percentage of the set rate or the BOLUS volume delivered before the ME EQUIPMENT stops.
th
Since there are many possible configurations for PROFILE PUMPS , the MANUFACTURER is
required to characterize a typical performance during transition intervals.
st
For INFUSION PUMPS FOR AMBULATORY USE using insulin there is no direct HAZARD associated
with infusion of air. Infusion of air bubbles compromises dosing accuracy when insulin is
substituted by air causing an underinfusion that however is commonly detected/prevented by
e.g. blood glucose measurement, visual inspection of infusion sets and priming. Therefore it is
not required (see 201.12.4.4.107) to have an air detector in an insulin pump. If however an air
detector is provided, the MANUFACTURER may disclose in the technical description the
sensitivity of the air detector in terms relevant for the design. This could be done by e.g.
disclosing the possible amount of underinfusion until the air detector is triggered or a similar
description.
BS EN 60601-2-24:2015
60601-2-24  IEC:2012 – 45 –
Subclause 201.11.6.3 – Spillage on ME EQUIPMENT and ME SYSTEMS
If any liquid ingress occurs in the test, even if there is no sign of wetting of parts that could
result in a HAZARDOUS SITUATION , consideration should be given to the possibility that similar
liquid ingress on another occasion might reach other parts where it could cause incorrect
performance such as over- or underinfusion.
Subclause 201.12.1 – Accuracy of controls and instruments

201.12.1.101 General formula
The ability of the ME EQUIPMENT to maintain the MANUFACTURER ' S stated accuracy is the
essential safety component of this requirement. This requirement for the ME EQUIPMENT does
not take into account clinical criteria of the PATIENT , for example, age, weight, drugs used, etc.
Accuracy of these ME EQUIPMENT may be affected by extremes of back pressure.
Subclause 201.12.1.102 – Accuracy tests for VOLUMETRIC INFUSION CONTROLLERS ,

VOLUMETRIC INFUSION PUMPS and SYRINGE OR CONTAINER PUMPS
to
Subclause 201.12.1.107 – Accuracy tests for INFUSION PUMP type 5
Data on performance following the start of infusion is important and must be shown by an
unambiguous method so that the OPERATOR can select the appropriate ME EQUIPMENT to suit
the clinical application. Graphs of the type shown in Figures 201.105 and 201.110 should be
included in the instructions of use. These graphs also give a good indication of the nature of
the short-term flow fluctuations and are considered self-explanatory when studied with
201.12.1.102 to 201.12.1.104, as appropriate.
The type of presentation adopted enables OPERATORS to determine the start up performance
of the pump and the nature of its output, be it continuous, discontinuous, cyclical or otherwise.
It is a matter of safety whether delivery starts in a reasonable time. OPERATORS will wish to be
aware of likely delays in start up and whether there are long periods of zero flow (or even
reverse flow) during the pumping cycle.
Delays following start-up will vary greatly with:
a) correct priming;
b) backlash in the mechanism;
c) the point at which a lead screw is engaged (for SYRINGE OR CONTAINER PUMPS );
d) set delivery rate;
e) compliances within the syringe/container.
Following the attainment of the normal set delivery rate, it is important for OPERATORS to be
aware of the short term fluctuations in flow which may be expected from ME EQUIPMENT . Tests
for this are conducted as described in 201.12.1.102 to 201.12.1.104 ((see 201.12.1)) and
example graphs are shown in Figures 201.106, 201.107 and 201.109.
If these tests were carried out before delivery had stabilized, the results would normally be
completely dependent on the first few minutes after start up, and would give no useful
information on expected performance at other times.
In establishing the accuracy of various pumps, the flow over a given period of time is
measured. Parameters have been set to provide a safe standard to which the ME EQUIPMENT
should comply. However, when the time interval over which the accuracy is measured is
BS EN 60601-2-24:2015
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shortened, all pumps show considerable variations of flow pattern, for instance, on a minute-
to-minute basis. This applies to all currently available ME EQUIPMENT : rotary and linear
peristaltic, diaphragm and piston types, and even SYRINGE OR CONTAINER PUMPS . With certain
ME EQUIPMENT it is possible to show errors of flow of ±75 % over a 1 min cycle, and errors of
±30 % over a 5 min cycle are not uncommon.
At the present time, certain drugs infused by such ME EQUIPMENT have a pharmacological and
biological half-life of less than 5 min. For example, one of the agents commonly used to
support the cardiac output in a severely ill PATIENT has a half-life of approximately 2,5 min. It
is obvious that the use of such agents in concentrations which require low rates and where
such demonstrated fluctuations occur, may lead to alarming and potentially dangerous
responses by the PATIENT . It is therefore of vital importance that the OPERATOR is made aware
that such fluctuations can occur so that he can make the necessary adjustments in both
concentration and set delivery rate.
V OLUMETRIC INFUSION CONTROLLERS (drop controlled) are used only for intravenous infusions.
They operate because the pressure created by the height of the liquid level in the container
above the infusion site (usually about 90 cm H 2 = 8,83 kPa) is greater than the maximum
venous pressure likely to be encountered in clinical practice (approximately 2,67 kPa
(20 mmHG)).
The maximum drop rate available with these devices is usually 100 drops per minute which,
when using a 20 drops/ml set, is equivalent to a set rate of 300 ml/h. With an 18G, 1,2 mm
needle 40 mm long, the pressure drop across the needle at 300 ml/h using water is
approximately 0,33 kPa (2,5 mmHG). With higher viscosity liquids, such as dextrose (50 %),
these figures increase to 0,43 kPa (3,2 mmHG) (with an 18G, 1,2 mm needle 40 mm long)
and 2,86 kPa (21,4 mmHG) (with a 21G, 0,8 mm needle 40 mm long) respectively.
In clinical practice, it would be inadvisable to attempt to use higher viscosity liquids or smaller
gauge needles. Thus, the tests specified will allow realistic testing of the performance of the
ME EQUIPMENT .
V OLUMETRIC INFUSION CONTROLLERS use gravity to supply the required infusion pressure.
However, these VOLUMETRIC INFUSION CONTROLLERS are calibrated in volumetric units, for
example, milliliters per hour (ml/h) and, although they count drops, they attempt to convert
drops to volumes. This may be accomplished by the use of a special drop forming orifice in
the drop chamber and/or the use of liquid codes (programmed by the OPERATOR ) to take
account of the different characteristics of various solutions used in intravenous therapy. The
volume of a drop is dependent on a number of factors which include drop rate, temperature,
pressure, the material and condition of the drop forming orifice, viscosity and surface tension
of the liquid used. However, as the purpose of the test is to ensure that the infusion output is
consistent with the selected value, tests carried out using ISO 3696:1987 class III and at the
extremes of back pressure (negative back pressure only) are satisfactory.
V OLUMETRIC INFUSION PUMPS are designed to deliver precise volumes of liquids at medium and
high set rates and shall be capable of pumping intravenously and using various sizes of
needle and all types of liquids.
Variants of these pumps to cater for paediatric applications are designed to deliver precise
volumes at low set rates (between 1 ml/h and 10 ml/h) and are calibrated in 0,1 ml/h
increments. It is not considered necessary to test these VOLUMETRIC INFUSION PUMPS for
accuracy of delivery below 1 ml/h because clinical applications would call for the use of a
SYRINGE OR CONTAINER PUMP in these circumstances.
These ME EQUIPMENT are tested over the intermediate rate using water at a back pressure of
+39.9 kPa (+300 mm Hg) to simulate the back pressure that can be encountered during
arterial infusion or during infusion of viscous liquids. Testing at −13.3 kPa (−100 mm Hg) is to
simulate the negative back pressures that are sometimes encountered in clinical usage.
BS EN 60601-2-24:2015
60601-2-24  IEC:2012 – 47 –
Subclause 201.12.4.4.102 – Protection against overinfusion FREE FLOW conditions
P ATIENT movement has been known to cause FREE FLOW . During testing this may be
investigated by allowing the flow to stabilize, then quickly lowering the collecting vessel 50 cm
and checking for evidence of FREE FLOW . The above simulates PATIENT movement.
Subclause 201.12.4.4.107 – Protection against air infusion
S YRINGE OR CONTAINER PUMPS , INFUSION PUMPS FOR AMBULATORY USE and

ENTERAL NUTRITION PUMPS are excluded from the requirement of an air detector because no
vented containers can be used. The syringes or containers are prefilled, filled-up by the
operator. In some cases "air bubbles" can be seen in the container, but these bubbles come
from dissolved air from the liquid. With regard to the connection point to the patient (e.g.
venous) these little "air bubbles" have no influence to the patient. For ENTERAL NUTRITION
PUMPS no unacceptable RISK occurs, because the enteral nutrition will be pump into the
stomach.
Subclause 201.13.2.6 – Leakage of liquid
Attention is drawn to the fact that leakage may occur from liquid reservoirs, ADMINISTRATION
SETS and connectors above and in the ME EQUIPMENT , and that the liquid may be a viscous
50 % dextrose solution. Impairment of safety features due to leakage of this liquid may only
occurs after a period of time as the solution dries.
Subclause 201.15.103 – Use errors
Acceptable methods of maintaining PATIENT safety are either to maintain the previously
selected mode of operation and set rate, or to cease delivery and initiate an auditory alarm.
A functional control is one which is designed to either start or stop infusion, and may be
separate from or combined with the mains switch.
S YRINGE OR CONTAINER PUMPS and INFUSION PUMPS FOR AMBULATORY USE are excluded because
the pump level is equal or below the level of the PATIENT . Also the friction of the
syringe/container may prevent free flow conditions.
Subclause 208.6.3.3.1 – Characteristics of auditory ALARM SIGNALS
For INFUSION PUMPS FOR AMBULATORY use it is difficult to comply with the frequency and
harmonics requirement of the IEC 60601-1-8:2006 because of the technique is used for the
audible alarm source maybe piezoelectric for power consumption and ingress of water (e.g.
IPXX classification). These types of pumps are generally not used in the hospital
environment.
If OPERATORS are familiar with the auditory ALARM SIGNALS of existing INFUSION PUMPS or
VOLUMETRC INFUSION CONTROLLERS which are not in accordance with IEC 60601-1-8, it may be
better to retain similar auditory ALARM SIGNALS in new devices, subject to a RISK assessment
by the RESPONSIBLE ORGANIZATION .
Subclause 208.6.3.3.2.102 – AUDIO PAUSED period
This provision is intended to address the occurrence of failure to restart the ME EQUIPMENT
after a temporary suspension of operation such as changing an IV bag or adjustment of
delivery rate.
BS EN 60601-2-24:2015
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AA.3 Rationale for the algorithm for this particular standard
Accuracy tests for PUMPS FOR AMBULATORY USE
I NFUSION PUMPS for continuous drug infusion may be required to deliver at a mean set rate
which is adjustable over a range of 25-50 times, and with a minimum setting as low as
10 µl/h. The most practical method of controlling to such a limit is to operate
quasi-continuously by delivering a discrete small volume increment v ("shot") at
predetermined intervals t, to give a mean set rate of v/t. The shot frequency can be hundreds
of shots per hour, or only a few per 24 h. In some INFUSION PUMPS both the shot interval and
the shot volume are changed when a new set rate is selected.
For the subcutaneous delivery route, various pharmacokinetic delay mechanisms smooth the
effect of the discontinuous flow and the amplitude of consequential physiological excursions
may thereby be limited.
In the case of insulin where physiological considerations would predicate truly continuous
infusion, it has been shown that intermittent subcutaneous delivery with a period of 2 h has no
observable clinical disadvantage. Even at this low shot frequency, delivery may be defined as
quasi-continuous.
For luteinising hormone on the other hand, intermittent delivery of the hormone with a period
of around 90 min mimicking the normal pituitary release pattern, seems to be clinically
optimal. In this application delivery might be defined as programmed BOLUS , and the pump
might incorporate controls for BOLUS volume and for interval between BOLUSES . Insulin pumps
generally provide a variable continuous basal infusion, and a variable volume BOLUS on
demand. Certain pumps synthesize the BOLUS by an increase in infusion rate over a preset
time.
Each clinical application should be considered on its merits and it is the responsibility of the
OPERATOR to confirm the suitability of a pump for the intended application, taking into
consideration the performance and the required delivery protocol.
Types of pumps
Pumps for drug delivery may be categorized into four subgroups on the basis of the mode of
delivery:
– type 1: continuous infusion;

– type 2: non-continuous flow only;
– type 3: discrete delivery of a bolus;
– type 4: PROFILE PUMP .
Flow errors
The OPERATOR of an ambulatory pump will not normally consult the physician more than once
a day and therefore manual resetting of the set rate will not normally occur within a 24 h
period. Test protocols should operate on a similar cycle.
Ambulatory pumps are primed before use. Nevertheless, flow on start-up may remain erratic
for some time, and a stabilization period prior to testing for errors is therefore included in the
test protocol.
Flow testing
The test protocols are devised to characterize the steady-state flow and to identify errors both
in the mean and in variations about the mean. Flow is measured by weighing the infusate
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delivered in a defined observation period, which would ideally be specifically related to the
pharmacokinetics of the application for which the device is intended. This is clearly
impractical, not least because clinical data for many potential infusates are not available.
A graph of flow versus time (Figure AA.101) gives a clear and simple picture of the general
stability with time. This is generated during the stabilization period and produces the so-called
"start-up curve".
Flow
Set rate
Time
IEC 1921/12
Figure AA.101 – Start-up graph
After stabilization, data are processed to integrate flow over a range of time periods. The
maximum positive and negative errors occurring within these time periods are plotted, to give
the so-called 'trumpet' profile (Figure AA.102). The performance may thereby be compared
with the MANUFACTURER ' S data and the plot allows the clinician to match the device to the
pharmacokinetics of the application.
Percentage
error
Set rate (r)
Observation interval
IEC 1922/12
Figure AA.102 – Trumpet curve
For type 2 (quasi-continuous) pumps, with a fixed shot volume, the interrogation interval is a
simple multiple of the shot interval. In such pumps, the technique of flow measurement and
the characteristics of the pumps are such that the validity of tests is not dependent on the
setting of the pumps. Thus the curve derived at a convenient INTERMEDIATE RATE setting may
be applied to higher and lower rate settings by appropriate scaling of the ordinate.
B OLUS setting
BS EN 60601-2-24:2015
– 50 – 60601-2-24  IEC:2012
B OLUS delivery is measured by direct weighing of the infusate delivered.
Scaling of graphs (with reference to the tests of 201.12.1.102 to 201.12.1.107).
It may be necessary to produce different scales of percentage variation in flow or drop rate
depending on the type of ME EQUIPMENT tested. It is important that OPERATORS are able to
assess the accuracy characteristics of devices on a comparable basis and that the data
presented are easily understood.
Rationale for an algorithm to calculate E p (max.) and E p (min.)
The algorithm to calculate the maximum E p (max.) and minimum E p (min.) percentage
variations within the observation window of duration P (min) over an analysis period T, may be
divided into four component stages.
The first stage calculates the maximum number of observation windows of duration P (min)
over the analysis period T. There are a maximum number m of such observation windows.
Consider first, the smallest observation window of duration S (min), up to the largest observa-
tion window of duration T (min);
For the smallest observation window P=S m = T/S

For the second smallest observation window P = 2S m = T/S – 1
For the k th smallest observation window P = kS m = T/S – k + 1
For the largest observation window P=T m=1
Substituting k = P/S m = T/S – P/S + 1
Hence for any observation window of duration P, where P is a multiple of S, there are a
maximum of m observation windows given by the following equation;
(T − P)
=m +1 (AA.1)
S
The second stage calculates the flow error E i for each successive sample over the analysis
period T. Since E p (max.) and E p (min.) are expressed as a percentage, Q i shall also be
expressed as a percentage error from rate r. Figure AA.103 shows that for W 0 to W n mass
samples, there are Q 1 to Q n flows, and consequently e 1 to e n flow errors. Note that W i is the i th
mass sample of the analysis period T, not the i th mass sample of the test period. Any e i is
calculated from the following equation;
60 (Wi − Wi−1 )
Qi = (AA.2)
Sd
e i = 100 (Q i – r)/r (AA.3)
The third stage calculates the mean flow error over any observation window of duration P. An
average is achieved by summing the individual flow errors over each observation window and
dividing the result by their total number, see Figure AA.103.
This calculation is repeated for all m observation windows determined from Equation AA.1.
Equation AA.7 calculates the mean flow error E p for all observation windows of duration P.
For the first window
e + e + ... + eP / S
Ep (1) = 1 2 (AA.4)
P/S
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For the second window
e + ... + eP / S +1
Ep (1) = 2 (AA.5)
P/S
For the m th window
e +e + ... + eP / S + eP / S +m−1
Ep (1) = m m+1 (AA.6)
P/S
Hence for any window j from one to a maximum of m windows
P
j+ −1
S S
Ep ( j)=
P
× ∑ ei (AA.7
i= j
The final calculation stage is to determine the maximum E p (max.) and minimum E p (min.)
percentage variations within the observation window of duration P. These parameters are
simply the maxima of the E p (j) calculated from Equation AA.7. Hence:
For the maximum
E p (max.) = Maximum (E p (1), E p (2), .., E p (m)) (AA.8)
or
m
Ep ( max.) = MAX Ep ( j ) ( ) (AA.9)
j=1
Similarly, for the minimum
E p (min.) = Minimum (E p (1), E p (2), .., E p (m)) (AA.10)
or
m
Ep ( min.) = MIN Ep ( j ) ( ) (AA.11)
j=1
All four calculation stages may be combined into a single Equation for E p (max.) and E p (min.)
respectively:
 P 
j+ −1
mS S  Qi − r  
Ep (max.) =MAX  × ∑ 100 ×   (AA.12)
j=1  P i= j  r 
 
 P 
j+ −1
m S S  Qi − r  
Ep (min.) =MIN  × ∑ 100 ×   (AA.13)
j=1  P i= j  r 
 
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where
(T − P)
=m +1
S
In order to determine the maximum E p (max.) and minimum E p (min.) percentage variations
within each observation window of duration P, Equations AA.1 to AA.13 should be recalcu-
lated for each new value of P = 1, 2, 5, 11, 19 and 31 min.
W1 e1 W2 e2 W3 e3 W4 Wn–2 en–1 Wn–1 en Wn
1st window
P = 1 min
(e1 + e2)/2
2nd window
(e2 + e3)/2
mth window
(en–1 + en)/2
1st window
P = 31 min
(e1 + e2 + ... + e62)/62
mth window
(en–62 + ... + en)/62

S minutes
Analysis period minutes
IEC 1923/12
Figure AA.103 – Calculation for E p (max.) and E p (min.)
AA.4 Rationale for development of a 'statistical' trumpet graph
This rationale is not direct linked to the normative requirements if this standard. However for
further investigations for the next amendment of IEC 60601-2-24 and to reflect daily use of an
infusion technology it is a combination between different infusion pumps of the same model
and different administration sets of the same brand. Therefore it is interesting to know what
the overall variability of the accuracy is. This will help the medical staff for the medical
treatment.
The maxima trumpet graph is formulated to quantify the variations in mean flow accuracy over
specific observation periods or windows. The variations are presented only as maximum and
minimum deviations from the overall mean flow within the observation window.
When the quality of sampled flow data is good, then the maxima trumpet graph is an accurate
indicator of the INFUSION PUMP short-term performance. However, the sampled flow data can
be susceptible to measurement anomalies. Obvious anomalies may include the formation of
air bubbles from dissolved gas or environmental influences on the measurement system, but
more complicated interactions such as sampling aliasing or disposable batch performance
variations also reduce the quality of sampled data. When the quality of sampled data is
BS EN 60601-2-24:2015
60601-2-24  IEC:2012 – 53 –
reduced, the reliability and reproducibility of the 'maxima' trumpet performance is similarly
reduced. This is because the maxima trumpet methodology qualifies only the maximum and
minimum mean flow variations.
A methodology is required which can meet two primary objectives. Firstly, it should identify
the variation in the mean flow over a specific measurement interval. Secondly, it should be
able to produce data that is both reliable and reproducible. Both these primary objectives
shall be achieved when applied to the general case of any arbitrary infusion device.
The remainder of this proposal attempts to define a methodology for testing which meets the
stated primary objectives, based on statistical knowledge of the flow performance character-
istics of the infusion device.
• Statistical analysis on flow performance
Summary
Consider an arbitrary pump which has been infusing for a length of time sufficient to exclude
start-up anomalies from the analysis. The rate measured from such an infusion device is then
characterized only by the mean flow and variation about the mean flow. The probability
density function of the long-term flow is also characterized by these statistics of mean flow
and variance.
By determining the probability density function of each short-term observation window, the
short-term performance of the infusion device is characterized statistically. This may be
simplified since any observation window may be represented as a sequence of the mean of
successive individual data samples over the observation window length. Since the probability
density function of individual samples can be determined from the long-term flow statistics, a
method is required to determine the probability density function of successive sample means
also from the long-term flow statistics. This can be achieved with the application of the central
limit theorem.
Definition of parameters
Consider, once again, an arbitrary pump which has been infusing for a given length of time.
With reference to Figure AA.104, the flow is measured with a sample interval of T s (min) over
the total duration of the test. This yields a maximum of i data samples or interrogation points.
To eliminate the start-up anomalies, a continuous analysis period is selected from the i data
samples.
Flow rate
Analysis period Ta
2 3 4 i–1 i
1
Sample interval Ts
Time
IEC 1924/12
Figure AA.104 – Sampling protocol

BS EN 60601-2-24:2015
– 54 – 60601-2-24  IEC:2012
With reference to Figure AA.105, the analysis period is of duration T a (min) and contains n
data samples. The analysis period T a , may be subdivided into observation windows of lengths
1 to l (min), where the maximum window length l, may be arbitrarily assigned. The maximum
number of observation windows m, of length l, is not significant in the analysis.
Flow rate
1 2 3 n–2 n–1 n
Window 1
Length l
Window 2 Window m
Analysis period
IEC 1925/12
Figure AA.105 – Observation windows
These parameter definitions are well established for the calculation of maxima trumpet
curves.
Mathematical analysis of the flow
The flow output within the analysis period is considered as the parent variate X and will be
characterized by some probability density function, from which the n samples are taken. The
population sample mean and sample standard deviation of the parent variate X, can be
approximated from the n data samples, using the following formulae:
1 n
Sample mean x= × ∑ Xi (AA.4.1)
n i=1
1 n 2
Sample standard deviation s
= × ∑ ( Xi -X ) (AA.4.2)
n i=1
Providing the sampled data size n is large, then Equations AA.4.1 and AA.4.2 provide good
approximation to the population mean and population standard deviation of the parent distri-
bution (see Figure AA.106).
BS EN 60601-2-24:2015
60601-2-24  IEC:2012 – 55 –
Population For large n:

X→µ
s→σ
µ –2σ µ µ +2σ
Flow rate
IEC 1926/12
Figure AA.106 – Distribution of parent variate X
The probability distribution of the parent population defines the probability distribution of
individual samples. The probability density function of successive sample means may be
determined by the central limit theorem.
Definition: Central limit theorem
If variate X has mean µ and standard deviation σ , and successive

independent samples n are taken, the distribution of the sample
mean X tends, as n increases, to that of the normal variate
N( µ, σ 2/n).
So the theorem predicts that the distribution of the mean of successive samples will be
approximately normal, with mean equivalent to that of the parent distribution, and standard
deviation equivalent to the standard deviation of the parent distribution divided by the square
root of the successive sample size.
Application of the central limit theorem
The distribution of sample means for all observation windows can be calculated theoretically,
yielding probability density functions derived from the distribution of the parent variate X, and
the central limit theorem. Hence, the probability density function of each observation window
may be determined.
Observation window Mean Standard deviation

1 min µ σ × Ts
2 min µ σ × Ts / 2
l min µ σ × Ts / l
BS EN 60601-2-24:2015
– 56 – 60601-2-24  IEC:2012
Population
Window length l
Window length 2
Window length 1
µ –2σ µ µ +2σ IEC 1927/12
Figure AA.107 – Distribution of observation windows
Each probability density function is approximately normally distributed and by selecting a

nominal confidence limit of ±2 standard deviations the statistical trumpet profile can be
produced, and displayed in a form similar to the 'maxima' trumpet graph.
Flow rate error +2σ
Mean error
–2σ
Observation window
IEC 1928/12
Figure AA.108 – The statistical trumpet graph
Summary of the validation studies
Two studies were undertaken in order to attempt to validate the suitability of the statistical
trumpet proposal as a type test protocol for INFUSION PUMPS .
The first study examined the accuracy of the central limit theorem in predicting the probability
density function of each observation window, and compared this directly at ±3 standard
deviations with the results obtained from the maxima trumpet algorithm. This study concluded
that while the standard deviations of statistically predicted probability distributions compared
well on a qualitative basis, i.e. the characteristic trumpet curve profiles matched, on a
quantitative basis significant variations between the measured maxima and the predicted ±3σ
limits for each observation window existed. The uncertainty of the statistical independence of
each flow sample and the consequent effect on the central limit theorem are thought to
contribute to the errors observed.
The second study examined the ability of the central limit theorem to predict the probability
density function of each observation windows for a larger sample population of INFUSION
BS EN 60601-2-24:2015
60601-2-24  IEC:2012 – 57 –
PUMPS , based only on a type test of one INFUSION PUMP . Measurements were undertaken using
a sample population of ten identical SYRINGE OR CONTAINER PUMPS from varying batches.
Comparisons were made over each observation window, to determine whether the mean
maxima trumpet values averaged over all ten devices could be predicted by the statistical
trumpet ±3σ limits from one INFUSION PUMP . The study concluded that greater statistical
trumpet prediction accuracy could be attained if the population of devices used to obtain the
prediction increased, i.e. a type test of one sample is not appropriate.
The studies have demonstrated that the results of the statistical trumpet algorithm using the
central limit theorem yield a good approximation to the results from the maxima trumpet
algorithm. However, the approximation is not reliable enough.

BS EN 60601-2-24:2015
– 58 – 60601-2-24  IEC:2012
Bibliography
IEC 61000-4-2, Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement
techniques – Electrostatic discharge immunity test
BS EN 60601-2-24:2015
60601-2-24  IEC:2012 – 59 –
Index of defined terms used in this particular standard

ACCESSORY .............................................................................. IEC 60601-1:2005+A1:2012, 3.3
ACCOMPANYING DOCUMENT ....................................................... IEC 60601-1:2005+A1:2012, 3.4
ADMINISTRATION SET ................................................................................................... 201.3.201
ADMINISTRATION SET CHANGE INTERVAL ........................................................................ 201.3.202
ALARM CONDITION ................................................................................. IEC 60601-1-8:2006, 3.1
ALARM SIGNAL ........................................................................................ IEC 6060-1-8:2006, 3.9
APPLIED PART ........................................................................... IEC 60601-1:2005+A1:2012, 3.8

AUDIO PAUSED .................................................................................... IEC 60601-1-8:2006, 3.13
BASIC SAFETY ......................................................................... IEC 60601-1:2005+A1:2012, 3.10
BURST ................................................................................................. IEC 6060-1-8:2006, 3.14
CONTINUOUS OPERATION ......................................................... IEC 60601-1:2005+A1:2012, 3.18
ENTERAL NUTRITION PUMP ........................................................................................... 201.3.204
ESSENTIAL PERFORMANCE ....................................................... IEC 60601-1:2005+A1:2012, 3.27
FREE FLOW ................................................................................................................. 201.3.205
HARM ..................................................................................... IEC 60601-1:2005+A1:2012, 3.38
HAZARD ................................................................................. IEC 60601-1:2005+A1:2012, 3.39
HAZARDOUS SITUATION ............................................................ IEC 60601-1:2005+A1:2012, 3.40
HIGH PRIORITY .................................................................................... IEC 60601-1-8:2006, 3.22
IMMUNITY TEST LEVEL .......................................................................... IEC 60601-1-2:2007, 3.15
INFUSION PUMP ........................................................................................................... 201.3.206
INFUSION PUMP FOR AMBULATORY USE .......................................................................... 201.3.207
INTENDED BOLUS ........................................................................................................ 201.3.203
INTENDED USE / INTENDED PURPOSE ........................................... IEC 60601-1:2005+A1:2012, 3.44
INTERBURST INTERVAL (t b ) ................................................................... IEC 60601-1-8:2006, 3.25
INTERMEDIATE RATE .................................................................................................... 201.3.208
INTERNAL ELECTRICAL POWER SOURCE ..................................... IEC 60601-1:2005+A1:2012, 3.45
INTERNALLY POWERED ............................................................. IEC 60601-1:2005+A1:2012, 3.46
KEEP OPEN RATE ( KOR ) ............................................................................................... 201.3.209
LEAKAGE CURRENT .................................................................. IEC 60601-1:2005+A1:2012, 3.47
LIFE - SUPPORTING ME EQUIPMENT .......................................................... IEC 60601-1-2:2007, 3.18
LOW PRIORITY ..................................................................................... IEC 60601-1-8:2006, 3.27
MANUFACTURER ...................................................................... IEC 60601-1:2005+A1:2012, 3.55
MAXIMUM INFUSION PRESSURE ..................................................................................... 201.3.210
MAXIMUM SELECTABLE RATE ......................................................................................... 201.3.212
MECHANICAL HAZARD ............................................................... IEC 60601-1:2005+A1:2012, 3.61
MEDICAL ELECTRICAL EQUIPMENT ( ME EQUIPMENT ) ..................... IEC 60601-1:2005+A1:2012, 3.63
MEDICAL ELECTRICAL SYSTEM ( ME SYSTEM ) ............................... IEC 60601-1:2005+A1:2012, 3.64
MEDIUM PRIORITY ................................................................................ IEC 60601-1-8:2006, 3.28
MINIMUM RATE ............................................................................................................ 201.3.211
MINIMUM SELECTABLE RATE .......................................................................................... 201.3.213
NORMAL USE ........................................................................... IEC 60601-1:2005+A1:2012, 3.71
OCCLUSION ALARM THRESHOLD .................................................................................... 201.3.214
BS EN 60601-2-24:2015
– 60 – 60601-2-24  IEC:2012
OPERATOR ............................................................................. IEC 60601-1:2005+A1:2012, 3.73

PATIENT END .............................................................................................................. 201.3.215
PATIENT LINE .............................................................................................................. 201.3.216
PATIENT ................................................................................. IEC 60601-1:2005+A1:2012, 3.76
PROCESS ............................................................................... IEC 60601-1:2005+A1:2012, 3.89
PROFILE PUMP ............................................................................................................ 201.3.218
PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM .......................... IEC 60601-1:2005+A1:2012, 3.90
PULSE ................................................................................................ IEC 60601-1-8:2006, 3.32

REGION OF CONTROL ................................................................................................... 201.3.217
RISK ASSESSMENT ................................................................. IEC 60601-1:2005+A1:2012, 3.104
RISK MANAGEMENT FILE ......................................................... IEC 60601-1:2005+A1:2012, 3.108
RISK MANAGEMENT ................................................................ IEC 60601-1:2005+A1:2012, 3.107
RISK .................................................................................... IEC 60601-1:2005+A1:2012, 3.102
SINGLE FAULT CONDITION ....................................................... IEC 60601-1:2005+A1:2012, 3.116
SINGLE FAULT SAFE ............................................................... IEC 60601-1:2005+A1:2012, 3.117
SUPPLY LINE ............................................................................................................... 201.3.219
SUPPLY MAINS ...................................................................... IEC 60601-1:2005+A1:2012, 3.120
SYRINGE OR CONTAINER PUMP ...................................................................................... 201.3.220
TECHNICAL ALARM CONDITION .............................................................. IEC 60601-1-8:2006, 3.36
TOOL ................................................................................... IEC 60601-1:2005+A1:2012, 3.127
TYPE BF APPLIED PART .......................................................... IEC 60601-1:2005+A1:2012, 3.133
TYPE CF APPLIED PART .......................................................... IEC 60601-1:2005+A1:2012, 3.134
UNINTENDED BOLUS ..................................................................................................... 201.3.221
VOLUMETRIC INFUSION CONTROLLER ............................................................................. 201.3.222
VOLUMETRIC INFUSION PUMP ........................................................................................ 201.3.223
_____________
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BS EN 60601-2-24:2015

BSI Standards Publication

Medical electrical equipment

request to its secretary.

Amendments/corrigenda issued since publication

Date Text affected

EUROPEAN STANDARD EN 60601-2-24

ICS 11.040.20 Supersedes EN 60601-2-24:1998

Medical electrical equipment - Part 2-24: Particular requirements

European Committee for Electrotechnical Standardization

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

Ref. No. EN 60601-2-24:2015 E

The following dates are fixed:

• latest date by which the document has to be implemented at (dop) 2016-01-14

This document supersedes EN 60601-2-24:1998.

IEC 61000-4-2 NOTE Harmonized as EN 61000-4-2.

Normative references to international publications

Annex ZA of EN 60601-1:2006 applies, except as follows:

Publication Year Title EN/HD Year

Coverage of Essential Requirements of EU Directives

concerning medical devices.

201.4 General requirements .............................................................................................. 12

Figure 201.103 – Analysis periods ........................................................................................ 22

Figure 201.104b – Test apparatus for SYRINGE OR CONTAINER PUMPS ..................................... 23

Figure 201.108 – Start-up graph over the stabilization period ............................................... 25

Figure AA.101 – Start-up graph ............................................................................................ 49

Figure AA.103 – Calculation for E p (max.) and E p (min.) ......................................................... 52

Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements ...................................... 12

INTERNATIONAL ELECTROTECHNICAL COMMISSION

MEDICAL ELECTRICAL EQUIPMENT –

The text of this particular standard is based on the following documents:

FDIS Report on voting

In this standard, the following print types are used:

– Requirements and definitions: roman type.

NOTED : SMALL CAPITALS .

In referring to the structure of this standard, the term

MEDICAL ELECTRICAL EQUIPMENT –

201.1 Scope, object and related standards

Clause 1 of the general standard 1 applies, except as follows:

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to

H AZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS

NOTE See also 4.2 of the general standard.

These particular standard does not apply to the following:

201.1.3 Collateral standards

IEC 60601-1-2:2007, IEC 60601-1-6:2010 and IEC 60601-1-8:2006 apply as modified in

201.1.4 Particular standards

A requirement of a particular standard takes priority over the general standard.

201.2 Normative references

Clause 2 of the general standard applies, except as follows:

ISO 7864, Sterile hypodermic needles for single use

201.3 Terms and definitions

NOTE An index of defined terms is found beginning on page 57.

– type 1: continuous infusion;

– type 2: non-continuous infusion;

– type 3: discrete delivery of a bolus;

– type 4: PROFILE PUMP ;

201.4 General requirements

Clause 4 of the general standard applies except as follows.

201.4.3 E SSENTIAL PERFORMANCE

201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements

Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in

Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements

NOTE For ALARM CONDITIONS resulting from ME EQUIPMENT