EN 60601-2-24:2015

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
• Withdrawal Date: 13-Apr-2018
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 22-May-2015
• Completion Date: 22-May-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-2-24:2015 - Medical electrical equipment - Part 2-24: Particular requirements for basic safety and essential performance of infusion pumps and controllers

Relations

• Replaces: EN 60601-2-24:1998 - Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers
• Effective Date: 28-Jan-2023

Standards Content (Sample)

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.

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SIST EN 60601-2-24:2015

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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

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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
...