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

IEC 60601-2-44:2009 applies to the basic safety and essential performance of CT scanners. The scope of IEC 60601-2-44:2009 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 X-ray generators used in CT scanners, including those where high-voltage generators are integrated with an X-ray tube assembly. This third edition cancels and replaces the second edition published in 2001 and its Amendment 1 (2002). This edition constitutes a technical revision primarily related to radiation protection and control.

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

La CEI 60601-2-44:2009 s'applique à la sécurité de base et aux performances essentielles des tomodensitomètres. Le domaine d'application de la CEI 60601-2-44:2009 est limité aux tomodensitomètres destinés à être utilisés pour les examens de la tête et du corps caractérisés par une enveloppe de la (des) source(s) de rayonnement X et du (des) détecteur(s) d'imagerie dans un couvercle de protection commun de forme toroïdale. Cette norme comprend les exigences de sécurité des générateurs radiologiques utilisés dans les tomodensitomètres, y compris celles pour les générateurs haute tension lorsqu'ils sont intégrés avec une gaine équipée. Cette troisième édition annule et remplace la deuxième édition parue en 2001 et son Amendement 1 (2002). La présente édition constitue une révision technique qui traite essentiellement de la protection contre les rayonnements et de leur contrôle.

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

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 RAČUNALNIŠKO
TOMOGRAFIJO.

General Information

• Status: Published
• Publication Date: 19-May-2009
• Withdrawal Date: 30-Apr-2012
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Parallel Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 20-May-2009
• Completion Date: 20-May-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-2-44:2009 - Medical electrical equipment - Part 2-44: Particular requirements for basic safety and essential performance of X-ray equipment for computed tomography (IEC 60601-2-44:2009)

Relations

• Replaces: EN 60601-2-44:2001/A1:2003 - Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography
• Effective Date: 29-Jan-2023
• Replaces: EN 60601-2-44:2001 - Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography
• Effective Date: 29-Jan-2023
• Amended By: 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
• Effective Date: 29-Jan-2023
• Amended By: EN 60601-2-44:2009/A11:2011 - Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
• Effective Date: 28-Jan-2023
• Amended By: EN 60601-2-44:2009/A2:2016 - Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
• Effective Date: 24-Mar-2015

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-44:2009
01-julij-2009
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLUHQWJHQVNHRSUHPH]DUDþXQDOQLãNRWRPRJUDILMR,(&

Medical electrical equipment - Part 2-44: Particular requirements for basic safety and
essential performance of X-ray equipment for computed tomography (IEC 60601-2-
44:2009)
Medizinische elektrische Geräte - Teil 2-44: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für die
Computertomographie (IEC 60601-2-44:2009)
Appareils electromédicaux - Partie 2-44: Exigences particulières pour la sécurité de base
et les performances essentielles des équipements à rayonnement X de
tomodensitométrie (CEI 60601-2-44:2009)
Ta slovenski standard je istoveten z: EN 60601-2-44:200X
ICS:
11.040.50 Radiografska oprema Radiographic equipment
SIST EN 60601-2-44:2009 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 60601-2-44:2009

---------------------- Page: 2 ----------------------

SIST EN 60601-2-44:2009

EUROPEAN STANDARD
EN 60601-2-44

NORME EUROPÉENNE
May 2009
EUROPÄISCHE NORM

ICS 11.040.50 Supersedes EN 60601-2-44:2001 + A1:2003


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)


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) (IEC 60601-2-44:2009)




This European Standard was approved by CENELEC on 2009-05-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

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

Central Secretariat: Avenue Marnix 17, B - 1000 Brussels


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

---------------------- Page: 3 ----------------------

SIST EN 60601-2-44:2009
EN 60601-2-44:2009 - 2 -
Foreword
The text of document 62B/727/FDIS, future 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 was approved by CENELEC as EN 60601-2-44 on 2009-05-01.
This European Standard supersedes EN 60601-2-44:2001 + A1:2003.
EN 60601-2-44:2009 constitutes a technical revision primarily related to RADIATION protection and control.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2010-02-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2012-05-01
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive MDD (93/42/EEC). See Annex ZZ.
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 PARTI
...