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

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
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.
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 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.
Annexes ZA and ZZ have been added by CENELEC.
__________
- 3 - EN 60601-2-44:2009
Endorsement notice
The text of the International Standard IEC 60601-2-44:2009 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60601-2-7 NOTE  Harmonized as EN 60601-2-7:1998 (not modified).
IEC 60601-2-32 NOTE  Harmonized as EN 60601-2-32:1994 (not modified).
IEC 60613 NOTE  Harmonized as EN 60613:1990 (not modified).
__________
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Annex ZA of EN 60601-1:2006 applies, except as follows:

Publication Year Title EN/HD Year

Replace the reference to IEC 60601-1-3 by:

IEC 60601-1-3 2008 Medical electrical equipment - EN 60601-1-3 2008
Part 1-3: General requirements for basic
safety and essential performance - Collateral
standard: Radiation protection in diagnostic
X-ray equipment
Addition:
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic safety
and essential performance
IEC 61223-3-5 2004 Evaluation and routine testing in medical EN 61223-3-5 2004
imaging departments -
Part 3-5: Acceptance tests - Imaging
performance of computed tomography X-ray
equipment
1)
ISO 12052 - Health informatics - Digital imaging and - -
communication in medicine (DICOM) including
workflow and data management
1)
Undated reference.
- 5 - EN 60601-2-44:2009
Annex ZZ
(informative)
Coverage of Essential Requirements of EC 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 as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
___________
IEC 60601-2-44 ®
Edition 3.0 2009-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-44: Particular requirements for the basic safety and essential
performance of X-ray equipment for computed tomography

Appareils électromédicaux –
Partie 2-44: Exigences particulières pour la sécurité de base et les
performances essentielles des équipements à rayonnement X de
tomodensitométrie
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
X
CODE PRIX
ICS 11.040.50 ISBN 2-8318-1032-8
– 2 – 60601-2-44 © IEC:2009
CONTENTS
FOREWORD.3
201.1 Scope, object and related standards.5
201.2 Normative references .7
201.3 Terms and definitions .7
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.14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT.16
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS .19
201.10 Protection against unwanted and excessive RADIATION HAZARDS .22
201.11 Protection against excessive temperatures and other HAZARDS.22
201.12 Accuracy of controls and instruments and protection against hazardous
outputs .22
201.13 Hazardous situations and fault conditions.23
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .23
201.15 Construction of ME EQUIPMENT .23
201.16 ME SYSTEMS.23
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS.24
203 General requirements for RADIATION protection in diagnostic X-ray equipment .24
Annexes .38
Annex A (informative) Choosing LOADING FACTORS for tests.39
Annex B (informative) Estimating CTDI for scan projection RADIOGRAPHY (SPR) .40
vol
Bibliography.41
Index of defined terms used in this particular standard.42

Figure 201.101 – Coordinate system.9
Figure 203.101 – Zone of extra-focal RADIATION .29
Figure 203.102 – Minimum dimensions for STRAY RADIATION measurement.32

Table 203.101 − Test pattern for CTDI .36
free air
60601-2-44 © IEC:2009 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

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

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 re
...