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

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

Medizinische elektrische Geräte - Teil 2-24: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Infusionspumpen und Infusionsreglern

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

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

Medicinska električna oprema - 2-24. del: Posebne zahteve za osnovno varnost in bistvene lastnosti infuzijskih črpalk in krmilnikov

Ta standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI INFUZIJSKIH ČRPALK in VOLUMETRIČNIH INFUZIJSKIH KRMILNIKOV, v nadaljevanju: ELEKTROMEDICINSKA OPREMA.
Ta standard velja za KOMPLETE ZA APLIKACIJO, v kolikor njihove lastnosti vplivajo na OSNOVNO VARNOST ali BISTVENE LASTNOSTI INFUZIJSKIH ČRPALK in VOLUMETRIČNIH INFUZIJSKIH KRMILNIKOV. Vendar ta standard ne navaja zahtev ali preskusov za druge vidike KOMPLETOV ZA APLIKACIJO. Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME.
Posebne zahteve tega standarda ne vključujejo temeljnih TVEGANJ pri nameravani fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo na področje tega standarda, razen v poglavjih 7.2.13 in 8.4.1 splošnega standarda.
OPOMBA: Glej tudi točko 4.2 splošnega standarda.
Ta standard navaja zahteve za ČRPALKE ZA ENTERALNO PREHRANO, INFUZIJSKE
ČRPALKE, INFUZIJSKE ČRPALKE ZA UPORABO V AMBULANTI, BRIZGE ALI ČRPALKE S POSODO, VOLUMETRIČNE INFUZIJSKE KRMILNIKE in VOLUMETRIČNE INFUZIJSKE ČRPALKE, kot so opredeljene v točkah 201.3.204, 201.3.206, 201.3.207, 201.3.220, 201.3.222 in 201.3.223.
Ta evropski standard se ne uporablja za:
a) naprave, ki so namenjene izključno za diagnostično ali podobno uporabo (npr. naprave za angiografijo ali črpalke, ki jih trajno upravlja ali nadzira OPERATER);
b) naprave za zunajtelesno kroženje krvi;
c) vsadljive naprave;
d) ELEKTROMEDICINSKA OPREMA, namenjene izključno za diagnostično uporabo znotraj urodinamike (merjenje
razmerja med tlakom in prostornino mehurja, ko se ga napolni z vodo prek katetra);
e) ELEKTROMEDICINSKA OPREMA, namenjena izključno za diagnostično uporabo v okviru preskusov moške impotence (merjenje količine infundirane tekočine, potrebne za obdržanje prednastavljenega nivoja tlaka za obdržanje penilne erekcije: kavernozometrija, kavernozografija);
f) naprave, obravnavane v standardu ISO 28620.

General Information

Status
Published
Publication Date
21-May-2015
Current Stage
6060 - Document made available
Due Date
22-May-2015
Completion Date
22-May-2015

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SLOVENSKI STANDARD
SIST EN 60601-2-24:2015
01-september-2015
1DGRPHãþD
SIST EN 60601-2-24:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLLQIX]LMVNLKþUSDONLQNUPLOQLNRY

Medical electrical equipment - Part 2-24: Particular requirements for basic safety and

essential performance of infusion pumps and controllers

Medizinische elektrische Geräte - Teil 2-24: Besondere Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale von Infusionspumpen und
Infusionsreglern

Appareils électromédicaux - Partie 2-24: Exigences particulières pour la sécurité de base

et les performances essentielles des pompes et régulateurs de perfusion
Ta slovenski standard je istoveten z: EN 60601-2-24:2015
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN 60601-2-24:2015 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 60601-2-24:2015
---------------------- Page: 2 ----------------------
SIST EN 60601-2-24:2015
EUROPEAN STANDARD EN 60601-2-24
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2015
ICS 11.040.20 Supersedes EN 60601-2-24:1998
English Version
Medical electrical equipment - Part 2-24: Particular requirements
for the basic safety and essential performance of infusion pumps
and controllers
(IEC 60601-2-24:2012)

Appareils électromédicaux - Partie 2-24: Exigences Medizinische elektrische Geräte - Teil 2-24: Besondere

particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der

essentielles des pompes et régulateurs de perfusion wesentlichen Leistungsmerkmale von Infusionspumpen und

(IEC 60601-2-24:2012) Infusionsreglern
(IEC 60601-2-24:2012)

This European Standard was approved by CENELEC on 2015-04-14. CENELEC members are bound to comply with the CEN/CENELEC

Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC

Management Centre or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation

under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the

same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,

Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,

Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN 60601-2-24:2015 E
---------------------- Page: 3 ----------------------
SIST EN 60601-2-24:2015
EN 60601-2-24:2015
Foreword

The text of document 62D/1026/FDIS, future edition 2 of IEC 60601-2-24, prepared by SC 62D

"Electromedical equipment", of IEC/TC 62 "Electrical equipment in medical practice" was submitted to

the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-24:2015.
The following dates are fixed:
(dop) 2016-01-14
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2018-04-14
• latest date by which the national standards conflicting with
the document have to be withdrawn
This document supersedes EN 60601-2-24:1998.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such

patent rights.

This document has been prepared under a mandate given to CENELEC by the European Commission

and the European Free Trade Association, and supports essential requirements of EU Directive(s).

For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part

of this document.
Endorsement notice

The text of the International Standard IEC 60601-2-24:2012 was approved by CENELEC as a

European Standard without any modification.

In the official version, for Bibliography, the following note has to be added for the standard indicated :

IEC 61000-4-2 NOTE Harmonized as EN 61000-4-2.
---------------------- Page: 4 ----------------------
SIST EN 60601-2-24:2015
EN 60601-2-24:2015
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod),

the relevant EN/HD applies.

NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is

available here: www.cenelec.eu.
Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Replacement in Annex ZA of EN 60601-1:2006:
IEC 60601-1-2 (mod) 2007 Medical electrical equipment - EN 60601-1-2 2007
Part 1-2: General requirements for basic
- - + corrigendum Mar. 2010
safety and essential performance -
Collateral standard: Electromagnetic
compatibility - Requirements and tests
IEC 60601-1-6 2010 Medical electrical equipment - EN 60601-1-6 2010
Part 1-6: General requirements for basic
safety and essential performance -
Collateral standard: Usability
IEC 60601-1-8 2006 Medical electrical equipment - EN 60601-1-8 2007
Part 1-8: General requirements for basic
- - + corrigendum Mar. 2010
safety and essential performance -
Collateral Standard: General
requirements, tests and guidance for
alarm systems in medical electrical
equipment and medical electrical
systems
Addition to Annex ZA of EN 60601-1:2006:
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic
- - + corrigendum Mar. 2010
safety and essential performance
+ A1 2012 + A1 2013
- - + A1/AC 2014
- - + A12 2014
ISO 3696 1987 Water for analytical laboratory use - EN ISO 3696 1995
Specification and test methods
ISO 7864 - Sterile hypodermic needles for single use EN ISO 7864 -
ISO 8536-4 - Infusion equipment for medical use - EN ISO 8536-4 -
Part 4: Infusion sets for single use,
gravity feed
---------------------- Page: 5 ----------------------
SIST EN 60601-2-24:2015
EN 60601-2-24:2015
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives

This European Standard has been prepared under a mandate given to CENELEC by the European

Commission and the European Free Trade Association, and within its scope the Standard covers all

relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993

concerning medical devices.

Compliance with this standard provides one means of conformity with the specified essential

requirements of the Directive concerned.

WARNING: Other requirements and other EU Directives can be applied to the products falling within

the scope of this standard.
---------------------- Page: 6 ----------------------
SIST EN 60601-2-24:2015
IEC 60601-2-24
Edition 2.0 2012-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –

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

of infusion pumps and controllers
Appareils électromédicaux –

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

essentielles des pompes et régulateurs de perfusion
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XB
ICS 11.040.20 ISBN 978-2-83220-417-7

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 7 ----------------------
SIST 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

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

201.5 General requirements for testing of ME EQUIPMENT ................................................... 13

201.6 Classification of ME EQUIPMENT and ME SYSTEMS ...................................................... 13

201.7 ME EQUIPMENT identification, marking and documents.............................................. 13

201.8 Protection against electrical HAZARDS from ME EQUIPMENT ........................................ 15

201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .............. 16

201.10 Protection against unwanted and excessive radiation HAZARDS ................................ 16

201.11 Protection against excessive temperatures and other HAZARDS ................................ 16

201.12 *Accuracy of controls and instruments and protection against hazardous

outputs .................................................................................................................... 17

201.13 HAZARDOUS SITUATIONS and fault conditions ............................................................. 35

201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ............................................... 35

201.15 Construction of ME EQUIPMENT ................................................................................. 35

201.16 ME SYSTEMS ............................................................................................................ 37

201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS ............................. 37

202 Electromagnetic compatibility – Requirements and tests ......................................... 37

206 Usability .................................................................................................................. 38

208 General requirements, tests and guidance for alarm systems in medical

electrical equipment and medical electrical systems ................................................ 38

Annexes ............................................................................................................................... 42

Annex AA (informative) Particular guidance and rationale .................................................... 43

Bibliography .......................................................................................................................... 58

Index of defined terms used in this particular standard.......................................................... 59

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

Figure 201.104a – Test apparatus for VOLUMETRIC INFUSION PUMPS and VOLUMETRIC

INFUSION CONTROLLERS .......................................................................................................... 22

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

Figure 201.104 – Test apparatuses for different types of INFUSION PUMPS .............................. 23

Figure 201.105 – Start-up graph plotted from data gathered during the first 2 h of the

test period ............................................................................................................................ 23

Figure 201.106 – Trumpet curve plotted from data gathered during the second hour of

the test period ....................................................................................................................... 24

Figure 201.107 – Trumpet curve plotted from data gathered during the last hour of the

ADMINISTRATION SET CHANGE INTERVAL .................................................................................... 24

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

Figure 201.109 – Trumpet curve plotted from data at the end of the stabilization period ....... 25

---------------------- Page: 8 ----------------------
SIST EN 60601-2-24:2015
60601-2-24  IEC:2012 – 3 –

Figure 201.110 – Start-up curve over the stabilization period for quasi-continuous

output pumps ........................................................................................................................ 26

Figure 201.111 – Trumpet curve plotted from data at the end of the stabilization period

for quasi-continuous pumps .................................................................................................. 26

Figure 201.112 – Test apparatus to determine the OCCLUSION ALARM THRESHOLD and

BOLUS volumes ...................................................................................................................... 33

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

Figure AA.102 – Trumpet curve ............................................................................................ 49

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

p p

Figure AA.104 – Sampling protocol ....................................................................................... 53

Figure AA.105 – Observation windows .................................................................................. 54

Figure AA.106 – Distribution of parent variate X .................................................................... 55

Figure AA.107 – Distribution of observation windows ............................................................ 56

Figure AA.108 – The statistical trumpet graph ....................................................................... 56

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

Table 201.102 – Set rates, BOLUS volumes and test apparatus for the accuracy tests of

12.1.102 to 12.1.107 ............................................................................................................. 31

Table 202.101 – Test levels .................................................................................................. 37

Table 208.101 – ALARM CONDITION priorities and related situations ........................................ 39

Table 208.102 – * Characteristics of the PULSE of auditory ALARM SIGNALS ............................. 40

---------------------- Page: 9 ----------------------
SIST EN 60601-2-24:2015
– 4 – 60601-2-24  IEC:2012
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-24: Particular requirements for the basic safety and essential
performance of infusion pumps and controllers
FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

international co-operation on all questions concerning standardization in the electrical and electronic fields. To

this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested

in the subject dealt with may participate in this preparatory work. International, governmental and non-

governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely

with the International Organization for Standardization (ISO) in accordance with conditions determined by

agreement between the two organizations.

2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

consensus of opinion on the relevant subjects since each technical committee has representation from all

interested IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

transparently to the maximum extent possible in their national and regional publications. Any divergence

between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

the latter.

5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity

assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

services carried out by independent certification bodies.

6) All users should ensure that they have the latest edition of this publication.

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

Publications.

8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International standard IEC 60601-2-24 has been prepared by IEC subcommittee 62D:

Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical

practice.

This second edition cancels and replaces the first edition of IEC 60601-2-24 published in

1998. This edition constitutes a technical revision according to IEC 60601-1:2005+A1:2012

with new clause numbering, including usability and alarms.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/1026/FDIS 62D/1039/RVD

Full information on the voting for the approval of this particular standard can be found in the

report on voting indicated in the above table.
---------------------- Page: 10 ----------------------
SIST EN 60601-2-24:2015
60601-2-24  IEC:2012 – 5 –

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.

– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.

Normative text of tables is also in a smaller type.

– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS

NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term

– “clause” means one of the seventeen numbered divisions within the table of contents,

inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);

– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all

subclauses of Clause 7).

References to clauses within this standard are preceded by the term “Clause” followed by the

clause number. References to subclauses within this particular standard are by number only.

In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any

combination of the conditions is true.

The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC

Directives, Part 2. For the purposes of this standard, the auxiliary verb:

– “shall” means that compliance with a requirement or a test is mandatory for compliance

with this standard;

– “should” means that compliance with a requirement or a test is recommended but is not

mandatory for compliance with this standard;

– “may” is used to describe a permissible way to achieve compliance with a requirement or

test.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title

indicates that there is guidance or rationale related to that item in Annex AA.

A list of all parts of the IEC 60601 series, published under the general title Medical electrical

equipment, can be found on the IEC website.

The committee has decided that the contents of this publication will remain unchanged until

the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data

related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
---------------------- Page: 11 ----------------------
SIST 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

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.
---------------------- Page: 12 ----------------------
SIST EN 60601-2-24:2015
60601-2-24  IEC:2012 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-24: Particular requirements for the basic safety and essential
performance of infusion pumps and controllers
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:

This Particular Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFUSION

PUMPS and VOLUMETRIC INFUSION CONTROLLERS, hereafter referred to as ME EQUIPMENT.

This standard applies to ADMINISTRATION SETS insofar as their characteristics influence the

BASIC SAFETY or ESSENTIAL PERFORMANCE of INFUSION PUMPS and VOLUMETRIC INFUSION

CONTROLLERS. However this standard does not specify requirements or tests for other aspects

of ADMINISTRATION SETS

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

ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the

case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS

within the scope of this standard are not covered by specific requirements in this standard

except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.

This particular standard specifies the requirements for ENTERAL NUTRITION PUMPS, INFUSION

PUMPS, INFUSION PUMPS FOR AMBULATORY USE, SYRINGE OR CONTAINER PUMPS, VOLUMETRIC

INFUSION CONTROLLERS and VOLUMETRIC INFUSION PUMPS, as defined in 201.3.204, 201.3.206,

201.3.207, 201.3.220, 201.3.222 and 201.3.223.
These particular standard does not apply to the following:

a) devices specifically intended for diagnostic or similar use (e.g. angiography or other

pumps permanently controlled or supervised by the OPERATOR);
b) devices for extracorporeal circulation of blood;
c) implantable devices;

d) ME EQUIPMENT specifically intended for diagnostic use within urodynamics (measurement

of pressure-volume relationship of the urinary bladder when filled through a catheter with

water);

e) ME EQUIPMENT specifically intended for diagnostic use within male impotence testing

(measurement of amount of liquid infused, necessary to maintain a preset pressure level

for maintaining penile erection: cavernosometry, cavernosography);
f) devices covered by ISO 28620.
—————————

The general standard is IEC 60601-1:2005+A1:2012, Medical electrical equipment – Part 1: General

requirements for basic safety and essential performance.
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SIST 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.
201.1.3 Collateral standards
Addition:

This particular standard refers to those applicable collateral standards that are listed in

Clause 2 of the general standard and Clause 201.2 of this particular standard.

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

Clauses 202, 206 and 208 respectively. IEC 60601-1-3 does not apply. All other published

collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:

In the IEC 60601 series, particular standards may modify, replace or delete requirements

contained in the general standard and collateral standards as appropriate for the particular

ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.

For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.

Collateral standards are referred to by their document number.

The numbering of clauses and subclauses of this particular standard corresponds to that of

the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content

of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”

where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this

particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard,

203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral

standard, etc.). The changes to the text of the general standard are specified by the use of

the following words:

"Replacement" means that the clause or subclause of the general standard or applicable

collateral standard is replaced completely by the text of this particular standard.

"Addition" means that the text of this particular standard is additional to the requirements of

the general standard or applicable collateral standard.

"Amendment" means that the clause or subclause of the general standard or applicable

collateral standard is amended as indicated by the text of this particular standard.

Subclauses, figures or tables which are additional to those of the general standard are

numbered starting from 201.101. However, due to the fact that definitions in the general

standard are numbered 3.1 through 3.139, additional definitions in this standard are

numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and

additional items aa), bb), etc.
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