Professional Documents
Culture Documents
BS en 60601 2 24
BS en 60601 2 24
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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which will be withdrawn on 14 April 2018.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
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
English Version
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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.
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
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.
• latest date by which the national standards conflicting with (dow) 2018-04-14
the document have to be withdrawn
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 :
2
BS EN 60601-2-24:2015
EN 60601-2-24:2015
Annex ZA
(normative)
The following documents, in whole or in part, are normatively referenced in this document and are
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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.
3
BS EN 60601-2-24:2015
EN 60601-2-24:2015
Annex ZZ
(informative)
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
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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
BS EN 60601-2-24:2015
–2– 60601-2-24 IEC:2012
CONTENTS
FOREWORD ........................................................................................................................... 4
INTRODUCTION ..................................................................................................................... 6
201.1 Scope, object and related standards ......................................................................... 7
201.2 Normative references ................................................................................................ 9
201.3 Terms and definitions ................................................................................................ 9
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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
Part 2-24: Particular requirements for the basic safety and essential
performance of infusion pumps and controllers
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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.
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.
– “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.
BS EN 60601-2-24:2015
–6– 60601-2-24 IEC:2012
INTRODUCTION
This particular standard deals with the safety of INFUSION PUMPS and INFUSION CONTROLLERS .
The relationship between this particular standard, IEC 60601-1:2005+A1:2012, and the
collateral standards is explained in 1.3.
The safe use of INFUSION PUMPS and controllers is primarily the responsibility of the OPERATOR .
It is also recognized that OPERATORS should be trained in the operation of MEDICAL ELECTRICAL
EQUIPMENT and that safe use of the MEDICAL ELECTRICAL EQUIPMENT can only be achieved if it is
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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–
Part 2-24: Particular requirements for the basic safety and essential
performance of infusion pumps and controllers
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
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.
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.
BS EN 60601-2-24:2015
–8– 60601-2-24 IEC:2012
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for ENTERAL NUTRITION PUMPS , INFUSION PUMPS , INFUSION PUMPS
FOR AMBULATORY USE , SYRINGE OR CONTAINER PUMPS , VOLUMETRIC INFUSION CONTROLLERS and
VOLUMETRIC INFUSION PUMPS , as defined in 201.3.204, 201.3.206, 201.3.207, 201.3.220,
201.3.222 and 201.3.223.
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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.
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.
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.
BS EN 60601-2-24:2015
60601-2-24 IEC:2012 –9–
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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.
Replacement:
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral standard: Usability
IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic
safety and essential performance – Collateral standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and medical electrical systems
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
Amendment 1:2012
ISO 3696:1987, Water for analytical laboratory use – Specification and test methods
ISO 8536-4, Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity
feed
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+A1:2012, apply, except as follows:
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
BS EN 60601-2-24:2015
– 10 – 60601-2-24 IEC:2012
Addition:
201.3.201
ADMINISTRATION SET
accessory that convey(s) liquid from the supply via the ME EQUIPMENT to the PATIENT
201.3.202
ADMINISTRATION SET CHANGE INTERVAL
time recommended by the MANUFACTURER of the ME EQUIPMENT for using the ADMINISTRATION
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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:
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
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
* 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
BS EN 60601-2-24:2015
– 12 – 60601-2-24 IEC:2012
201.3.222
VOLUMETRIC INFUSION CONTROLLER
ME EQUIPMENT intended to regulate the flow of liquid into the PATIENT under positive pressure
generated by gravitational force in which the delivery rate is indicated by the ME EQUIPMENT in
volume per unit of time
201.3.223
VOLUMETRIC INFUSION PUMP
INFUSION PUMP in which the delivery rate is indicated in volume per unit of time or units related
to drug dosage, but excluding SYRINGE OR CONTAINER PUMPS
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
Additional subclause:
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
Accuracy tests for INFUSION PUMP type 4 201.12.1.106
Accuracy tests for INFUSION PUMP type 5 201.12.1.107
Protection against UNINTENDED BOLUS volumes and occlusion 201.12.4.4.104
A LARM SIGNALS of HIGH PRIORITY according to Table 208.101 208.6.1.2.101
Addition:
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;
BS EN 60601-2-24:2015
60601-2-24 IEC:2012 – 13 –
3) a safety system check carried out by the OPERATOR at least once within the ADMINISTRATION SET CHANGE
st
INTERVAL (see the 21 dashed item of 201.7.9.2.101).
The following are not regarded as SINGLE FAULT CONDITIONS , but are regarded as NORMAL
CONDITIONS :
– 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).
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.
Replacement
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;
201.7.2.4 ACCESSORIES
Addition:
BS EN 60601-2-24:2015
– 14 – 60601-2-24 IEC:2012
Additional subclause:
– 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;
BS EN 60601-2-24:2015
60601-2-24 IEC:2012 – 15 –
– if applicable, guidance on tests to permit the OPERATOR to check the correct functioning of
alarm(s) and the operational safety of the ME EQUIPMENT ;
– data as evaluated by the test methods of 201.12.1.102 to 201.12.1.109 at the rates
indicated in Table 201.102, including an explanation for the OPERATOR of the data
presentation;
– *the maximum volume that may be infused under SINGLE FAULT CONDITIONS ;
– a list of the allowed ADMINISTRATION SET ( S ) with their stated accuracy in accordance with
the test methods mentioned in 201.12.1;
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
Additional subclause:
– *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.
Additional subclause:
BS EN 60601-2-24:2015
– 16 – 60601-2-24 IEC:2012
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 .
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
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.
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.
BS EN 60601-2-24:2015
60601-2-24 IEC:2012 – 17 –
Addition:
Additional subclauses:
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.
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.
Additional subclauses:
The ME EQUIPMENT shall maintain the MANUFACTURER ' S stated accuracy or better over the
recommended ADMINISTRATION SET CHANGE INTERVAL .
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.
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)
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).
BS EN 60601-2-24:2015
60601-2-24 IEC:2012 – 19 –
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 .
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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):
maximum = 2 r
minimum = –0,2 r
scale increment = 0,2 r
time = 0 min to 120 min (10 min intervals)
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.
BS EN 60601-2-24:2015
– 20 – 60601-2-24 IEC:2012
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.
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
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).
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
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
BS EN 60601-2-24:2015
60601-2-24 IEC:2012 – 21 –
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)
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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);
S is the sample interval (min);
P is the observation window duration (min);
d is the density of water (0,998 g/ml at 20 °C).
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
r is the rate (ml/h);
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);
T1 is the analysis period (min);
d is the density of water (0,998 g/ml at 20 °C).
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
r is the rate (ml/h);
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);
T2 is the analysis period (min);
d is the density of water (0,998 g/ml at 20 °C).
BS EN 60601-2-24:2015
– 22 – 60601-2-24 IEC:2012
Flow
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
Analysis
period T0
Analysis Analysis
period T1 period T2
0 60 120 T – 60 T
Test time t (min)
Liquid level
Input
EUT
Output
0,000 0 g
Electronic
balance
Computer
IEC 1911/12
Needle
(18G, 1,2 mm, see ISO 7864)
ADMINISTRATION SET
Syringe
Same level
EUT
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
0,000 0 g
Electronic
balance
Computer
IEC 1912/12
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).
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
BS EN 60601-2-24:2015
– 24 – 60601-2-24 IEC:2012
Percentage
error of flow
10
Ep(max)
5
Set rate (r)
0
–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)
–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 .
BS EN 60601-2-24:2015
60601-2-24 IEC:2012 – 25 –
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.
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.
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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
Percentage
error of flow
15 30 45
IEC 1917/12
Figure 201.109 – Trumpet curve plotted from data at the end of the stabilization period
BS EN 60601-2-24:2015
– 26 – 60601-2-24 IEC:2012
Flow
(µl/h) Set rate
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
IEC 1918/12
Figure 201.110 – Start-up curve over the stabilization period for quasi-continuous
output pumps
Percentage
error of flow
(shot interval)
IEC 1919/12
Figure 201.111 – Trumpet curve plotted from data at the end of the stabilization period
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);
BS EN 60601-2-24:2015
60601-2-24 IEC:2012 – 27 –
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)
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
where
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
Ep (max.) =MAX ×
j =1 P
∑ 100 × i
r
(%) (15)
i= j
P
j + −1
m S S Qi − r
Ep (min.) =MIN ×
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);
S is the sample interval (min);
P is the observation window duration (min);
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
BS EN 60601-2-24:2015
– 28 – 60601-2-24 IEC:2012
201.12.1.104 *Accuracy tests for INFUSION PUMP FOR AMBULATORY USE type 2
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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).
S = kI (18)
where
S = kI (19)
where
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.
nS ≈ 30 (min) (20)
where
Calculate the mean flow from Equation (21) for every successive nS samples, over the
stabilization period T 1 .
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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);
d is the density of test liquid at the test temperature (g/ml).
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
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
(%) (23)
i= j
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
P
j + −1
m S S Qi − r
Ep (min.) =MIN ×
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);
r is the set rate (µl/h);
S is the sample interval (min);
P is the observation window duration (min);
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= (%) (25)
r
where
60 (Wj − Wk )
Q= (μl/h)
T2 d
r is the set rate (µl/h);
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);
T2 is the analysis period (min);
d is the density of test liquid at the test temperature (g/ml).
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
60601-2-24 IEC:2012 – 31 –
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.
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 .
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
Addition:
Additional subclauses:
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.
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
S INGLE FAULT CONDITIONS occurring in those protective systems specified shall become
obvious to the OPERATOR within the ADMINISTRATION SET CHANGE INTERVAL .
SINGLE FAULT CONDITIONS occurring in those protective systems specified shall become
obvious to the OPERATOR within the ADMINISTRATION SET CHANGE INTERVAL .
The ME EQUIPMENT shall not produce a MAXIMUM INFUSION PRESSURE capable of causing a
rupture or a leak in the ADMINISTRATION SET .
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.
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
60601-2-24 IEC:2012 – 33 –
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.
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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).
Pressure monitor
ADMINISTRATION SET
Rigid tubing
EUT Pressure
tranducer
D
Three-way tap Collecting vessel
IEC 1920/12
Any reverse flow shall not cause an unacceptable RISK in NORMAL USE and SINGLE FAULT
CONDITION .
This test applies only to INFUSION PUMPS with a particular ACCESSORY (drop sensor),
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.
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.
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.
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
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
60601-2-24 IEC:2012 – 35 –
Replacement:
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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.
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 .
201.15.4.4 Indicators
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 .
BS EN 60601-2-24:2015
– 36 – 60601-2-24 IEC:2012
Additional subclauses
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 .
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.
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 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.
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.
BS EN 60601-2-24:2015
60601-2-24 IEC:2012 – 37 –
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
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:
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
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
Additional subclause:
– 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
Additional subclause:
ME EQUIPMENT
All types of pumps H IGH PRIORITY Yes Yes
FAILURE
Repeating
Between
15 s and
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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
VOLUMETRIC INFUSION PUMP
P ROFILE PUMP ,
SYRINGE OR CONTAINER
PUMP ,
Occlusion alarm H IGH PRIORITY Yes Yes
VOLUMETRIC INFUSION
CONTROLLER
VOLUMETRIC INFUSION PUMP
P ROFILE PUMP ,
VOLUMETRIC INFUSION
Air in line alarm H IGH PRIORITY Yes Yes
CONTROLLER
VOLUMETRIC INFUSION PUMP
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
R EMINDER
SIGNAL .
BS EN 60601-2-24:2015
– 40 – 60601-2-24 IEC:2012
ME EQUIPMENT
All types of pumps H IGH PRIORITY Yes Yes
FAILURE
Repeating
Between 15s
and 30s
interburst
interval
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
R EMINDER
SIGNAL .
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.
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 .
Addition:
BS EN 60601-2-24:2015
60601-2-24 IEC:2012 – 41 –
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 .
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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.
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.
Annexes
The annexes of the general standard apply, with the following exception:
Addition:
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
BS EN 60601-2-24:2015
60601-2-24 IEC:2012 – 43 –
Annex AA
(informative)
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.
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 .
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.
th
201.7.9.2.101, 4 item (instruction and references)
The instructions can include references to ADMINISTRATION SET instruction for use.
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
th
201.7.9.2.101, 14 item
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
rd
Subclause 201.7.9.2.101, 23 item
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
Subclause 201.7.9.2.101, 29 item
Since there are many possible configurations for PROFILE PUMPS , the MANUFACTURER is
required to characterize a typical performance during transition intervals.
st
Subclause 201.7.9.3.101, 1 item
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 –
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.
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.
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.
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
– 46 – 60601-2-24 IEC:2012
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
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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 –
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.
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.
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.
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.
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 .
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
– 48 – 60601-2-24 IEC:2012
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
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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:
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
BS EN 60601-2-24:2015
60601-2-24 IEC:2012 – 49 –
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".
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
Flow
Set rate
Time
IEC 1921/12
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
Observation interval
IEC 1922/12
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
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.
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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);
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
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.
e + e + ... + eP / S
Ep (1) = 1 2 (AA.4)
P/S
BS EN 60601-2-24:2015
60601-2-24 IEC:2012 – 51 –
e + ... + eP / S +1
Ep (1) = 2 (AA.5)
P/S
e +e + ... + eP / S + eP / S +m−1
Ep (1) = m m+1 (AA.6)
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
P/S
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:
or
m
Ep ( max.) = MAX Ep ( j ) ( ) (AA.9)
j=1
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
mS 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
BS EN 60601-2-24:2015
– 52 – 60601-2-24 IEC:2012
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.
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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
IEC 1923/12
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.
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
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.
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
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
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
1 2 3 n–2 n–1 n
Window 1
Length l
Window 2 Window m
Analysis period
IEC 1925/12
These parameter definitions are well established for the calculation of maxima trumpet
curves.
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 –
µ –2σ µ µ +2σ
Flow rate
IEC 1926/12
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.
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.
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.
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
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
Window length 2
Window length 1
µ –2σ µ µ +2σ IEC 1927/12
Mean error
–2σ
Observation window
IEC 1928/12
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
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
Bibliography
IEC 61000-4-2, Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement
techniques – Electrostatic discharge immunity test
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
BS EN 60601-2-24:2015
60601-2-24 IEC:2012 – 59 –
_____________
Provided by BSI UK. Limited access during COVID-19 emergency. Personal use only.
About us Revisions
We bring together business, industry, government, consumers, innovators Our British Standards and other publications are updated by amendment or revision.
and others to shape their combined experience and expertise into standards We continually improve the quality of our products and services to benefit your
-based solutions. business. If you find an inaccuracy or ambiguity within a British Standard or other
The knowledge embodied in our standards has been carefully assembled in BSI publication please inform the Knowledge Centre.
a dependable format and refined through our open consultation process.
Organizations of all sizes and across all sectors choose standards to help Copyright
them achieve their goals. All the data, software and documentation set out in all British Standards and
other BSI publications are the property of and copyrighted by BSI, or some person
Information on standards or entity that owns copyright in the information used (such as the international
We can provide you with the knowledge that your organization needs standardization bodies) and has formally licensed such information to BSI for
to succeed. Find out more about British Standards by visiting our website at commercial publication and use. Except as permitted under the Copyright, Designs
bsigroup.com/standards or contacting our Customer Services team or and Patents Act 1988 no extract may be reproduced, stored in a retrieval system
Knowledge Centre. or transmitted in any form or by any means – electronic, photocopying, recording
or otherwise – without prior written permission from BSI. Details and advice can
Buying standards be obtained from the Copyright & Licensing Department.
You can buy and download PDF versions of BSI publications, including British
and adopted European and international standards, through our website at Useful Contacts:
bsigroup.com/shop, where hard copies can also be purchased. Customer Services
If you need international and foreign standards from other Standards Development Tel: +44 845 086 9001
Organizations, hard copies can be ordered from our Customer Services team. Email (orders): [email protected]
Email (enquiries): [email protected]
Subscriptions
Subscriptions
Our range of subscription services are designed to make using standards
Tel: +44 845 086 9001
easier for you. For further information on our subscription products go to
Email: [email protected]
bsigroup.com/subscriptions.
With British Standards Online (BSOL) you’ll have instant access to over 55,000 Knowledge Centre
British and adopted European and international standards from your desktop. Tel: +44 20 8996 7004
It’s available 24/7 and is refreshed daily so you’ll always be up to date. Email: [email protected]
You can keep in touch with standards developments and receive substantial
Copyright & Licensing
discounts on the purchase price of standards, both in single copy and subscription
format, by becoming a BSI Subscribing Member. Tel: +44 20 8996 7070
Email: [email protected]
PLUS is an updating service exclusive to BSI Subscribing Members. You will
automatically receive the latest hard copy of your standards when they’re
revised or replaced.
To find out more about becoming a BSI Subscribing Member and the benefits
of membership, please visit bsigroup.com/shop.
With a Multi-User Network Licence (MUNL) you are able to host standards
publications on your intranet. Licences can cover as few or as many users as you
wish. With updates supplied as soon as they’re available, you can be sure your
documentation is current. For further information, email [email protected].