EN 60601-2-44:2009/A1:2012

Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of CT SCANNERS, hereafter also referred to as ME EQUIPMENT. 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. NOTE 1 See also 4.2 of the general standard. The scope of this document is limited to CT SCANNERS intended to be used for both head and body characterised by an ENCLOSURE of the X-ray source(s) and imaging detector(s) in a common protective cover in the shape of a toroid. It includes safety requirements for the XRAY GENERATORS used in CT SCANNERS, including those where HIGH-VOLTAGE GENERATORS are integrated with an X-RAY TUBE ASSEMBLY. NOTE 2 Requirements for X-RAY GENERATORS and for ASSOCIATED EQUIPMENT, which were previously specified in IEC 60601-2-7 and IEC 60601-2-32, have been included in either IEC 60601-1:2005 (Ed3) or this edition of IEC 60601-2-44. Therefore IEC 60601-2-7 and IEC 60601-2-32 are not part of the 3rd edition scheme for COMPUTED TOMOGRAPHY.

Medizinische elektrische Geräte - Teil 2-44: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für die Computertomographie

Appareils electromédicaux - Partie 2-44: Exigences particulières pour la sécurité de base et les performances essentielles des équipements à rayonnement X de tomodensitométrie

Medicinska električna oprema - 2-44. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenske opreme za računalniško tomografijo - Dopolnilo A1(IEC 60601-2-44:2009/A1:2012)

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI RENTGENOV ZA RAČUNALNIŠKO TOMOGRAFIJO, v nadaljevanju ME OPREMA. Če bo točka ali podtočka izrecno namenjena samo uporabi za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te točke ali podtočke to tudi navedla. Sicer točka in podtočka veljata za ustrezno ME OPREMO in ME SISTEME.  OPOMBA 1: Prav tako glej 4.2 splošnega standarda. Obseg tega dokumenta je omejen na RENTGENE ZA RAČUNALNIŠKO TOMOGRAFIJO, namenjene uporabi na glavi in telesu, za katere je značilno OHIŠJE rentgenskega vira(-ov) in slikovnega detektorja(-ev) v splošnem zaščitnem ohišju v obliki toroida. Vključuje varnostne zahteve RENTGENSKIH GENERATORJEV, ki se uporabljajo pri RENTGENIH ZA RAČUNALNIŠKO TOMOGRAFIJO, vključno s tistimi, kjer so VISOKONAPETOSTNI GENERATORJI vgrajeni v SESTAV RENTGENSKE CEVI. OPOMBA 2: Zahteve za rentgenske GENERATORJE in POVEZANO OPREMO, ki so bili predhodno določeni v IEC 60601-2-7 in IEC 60601-2-32, so bili vključeni v IEC 60601-1:2005 (Ed3) ali v to izdajo IEC 60601-2-44. Zato IEC 60601-2-7 in IEC 60601-2-32 nista del sheme 3. izdaje za RAČUNALNIŠKOTOMOGRAFIJO.

General Information

• Status: Published
• Publication Date: 18-Oct-2012
• Withdrawal Date: 03-Oct-2015
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 19-Oct-2012
• Completion Date: 19-Oct-2012
• 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 60601-2-44:2009/A1:2014 - Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

Relations

• Amends: EN 60601-2-44:2009 - Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-44:2009/A1:2014
01-februar-2014
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLUHQWJHQVNHRSUHPH]DUDþXQDOQLãNRWRPRJUDILMR'RSROQLOR$
,(&$
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and
essential performance of X-ray equipment for computed tomography
Medizinische elektrische Geräte - Teil 2-44: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für die
Computertomographie
Appareils electromédicaux - Partie 2-44: Exigences particulières pour la sécurité de base
et les performances essentielles des équipements à rayonnement X de
tomodensitométrie
Ta slovenski standard je istoveten z: EN 60601-2-44:2009/A1:2012
ICS:
11.040.50 Radiografska oprema Radiographic equipment
SIST EN 60601-2-44:2009/A1:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-44:2009/A1:2014

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SIST EN 60601-2-44:2009/A1:2014

EUROPEAN STANDARD
EN 60601-2-44/A1

NORME EUROPÉENNE
October 2012
EUROPÄISCHE NORM

ICS 11.040.50


English version


Medical electrical equipment -
Part 2-44: Particular requirements for the basic safety and essential
performance of X-ray equipment for computed tomography
(IEC 60601-2-44:2009/A1:2012)


Appareils electromédicaux -  Medizinische elektrische Geräte -
Partie 2-44: Exigences particulières Teil 2-44: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des équipements à rayonnement X von Röntgeneinrichtungen
de tomodensitométrie für die Computertomographie
(CEI 60601-2-44:2009/A1:2012) (IEC 60601-2-44:2009/A1:2012)




This amendment A1 modifies the European Standard EN 60601-2-44:2009; it was approved by CENELEC on
2012-10-04. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this amendment 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 amendment 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.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels


© 2012 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-44:2009/A1:2012 E

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SIST EN 60601-2-44:2009/A1:2014
EN 60601-2-44:2009/A1:2012 - 2 -
Foreword
The text of document 62B/869/FDIS, future amendment 1 to edition 3 of IEC 60601-2-44, prepared by
SC 62B "Diagnostic imaging equipment" of IEC TC 62 "Electrical equipment in medical practice" was
submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
EN 60601-2-44:2009/A1:2012.
The following dates are fixed:
(dop) 2013-07-04
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2015-10-04
standards conflicting with 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).

Endorsement notice
The text of the International Standard IEC 60601-2-44:2009/A1:2012 was approved by CENELEC as
a European Standard without any modification.

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