EN 60601-2-24:2015

SLOVENSKI STANDARD
01-september-2015
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SIST EN 60601-2-24:1998
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

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

of infusion pumps and controllers

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

essentielles des pompes et régulateurs de perfusion

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

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

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

60601-2-24  IEC:2012 – 3 –
Figure 201.110 – Start-up curve over the stabilization period for quasi-continuous
output pumps . 26
Figure 201.111 – Trumpet curve plotted from data at the end of the stabilization period
for quasi-continuous pumps . 26
Figure 201.112 – Test apparatus to determine the OCCLUSION ALARM THRESHOLD and
BOLUS volumes . 33
Figure AA.101 – Start-up graph . 49
Figure AA.102 – Trumpet curve .
...