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
01-februar-2014
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

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
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.

- 3 - EN 60601-2-44:2009/A1:2012
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  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year
In Annex ZA of EN 60601-2-44:2009, add under Replacement the following new
reference:
IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
(mod) Part 1-2: General requirements for basic + corr. March 2010
safety and essential performance - Collateral
standard: Electromagnetic compatibility -
Requirements and tests
In Annex ZA of EN 60601-2-44:2009, add under Addition the following new
reference:
IEC 60336 - Medical electrical equipment - X-ray tube EN 60336 -
assemblies for medical diagnosis -
Characteristics of focal spots

IEC 60601-2-44 ®
Edition 3.0 2012-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
AMENDMENT 1
AMENDEMENT 1
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
CODE PRIX U
ICS 11.040.50 ISBN 978-2-83220-304-0

– 2 – 60601-2-44 Amend.1 © IEC:2012
FOREWORD
This amendment has been prepared by subcommittee SC 62B: Diagnostic imaging equipment,
of IEC Technical Committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62B/879/FDIS 62B/890/RVD
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC web site under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
NOTE The attention of National Committees is drawn to the fact that equipment MANUFACTURERS and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests. It is the recommendation of the committee that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
_____________
60601-2-44 Amend.1 © IEC:2012 – 3 –
Introduction to Amendment 1
The main topic addressed in this amendment is an extended concept of CTDI to
accommodate CT SCANNERS with very large z-coverage. The other principal subject areas
include:
1) a dose-check feature associated with a pre-scanning alert if expected values of dose
DOSE NOTIFICATION VALUES or DOSE ALERT VALUES and
indices exceed user-configurable
2) requirements covering the use of CT data in radiotherapy treatment planning (RTP).
The CT dose metric in use has been based on the CTDI , i.e. measurement of dose in
PHANTOMs and limited integration of scattered radiation, and it is used in many countries’
legislation to define "dose reference values" (also called "diagnostic reference levels") for CT
examinations. Many people use these indices, CTDI and DLP, to derive estimates for
vol
is also part of CT acceptance and constancy
effective dose via conversion factors. CTDI
testing. The introduction of a new dose index would change all CT SCANNERS’ CTDI values.
Therefore the intention is to stay with the CTDI , i.e. the integration of primary radiation and
scatter over 100 mm, but adapt the way of measuring and reporting the dose index to
incorporate large collimations and to rate all collimations the same way, i.e. to reflect
approximately the same percentage of CTDI for all collimations.
∞
As defined in the amendment, CTDI is to be measured only for collimations up to 40 mm
with the current equipment, i.e. the PMMA PHANTOMs and a 100-mm chamber, or other
suitable methods that use a RADIATION DETECTOR. For these collimations there is no significant
change of the ratio CTDI / CTDI according to published data. For larger collimations at
100 ∞
the same CT CONDITIONS OF OPERATION, the z-efficiency may be different and must be
evaluated in the dose measurement. This can be accomplished by the measurement of dose
and the CTDI have been refined. Both
‘free air’. Based on these considerations CTDI
100 free air
types of measurement are combined now to determine the CTDI values for larger collimations
and they are explained in detail in informative Annexes CC and DD.
Some additional requirements and refinements related to dose have been added: CTDI and
vol
DLP are defined for a new type of scan mode (‘shuttle mode’). In body CT EXAMINATION it is
clarified that the CTDI and DLP always be reported for the 32-cm diameter PHANTOM. In the
vol
SCANNERS support user-configurable DOSE NOTIFICATION
amendment it is now required that CT
VALUES and DOSE ALERT VALUES.
A new subject area in this Amendment 1 covers requirements for CT SCANNERS providing
images for radiotherapy treatment planning. With this amendment begins the implementation
of this important CT application into the CT safety standard with a set of requirements that is
considered to be safety relevant. It mainly covers scanner hardware adjustments, accuracy of
CT image data, and the conversion of HU to electron and mass density.

– 4 – 60601-2-44 Amend.1 © IEC:2012
201.1.1 Scope
Add the following new sentence:
The scope of this International Standard excludes RADIOTHERAPY SIMULATORS and systems
where the image is created by a source other than an X-RAY TUBE.
201.1.3 Collateral standards
Replace the existing text of this subclause with the following:
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2 and IEC 60601-1-3 apply as modified in Clauses 202 and 203. IEC 60601-1-8,
1) 2) 3)
IEC 60601-1-9, IEC 60601-1-10 , IEC 60601-1-11 and IEC 60601-1-12 do not apply. All
other published collateral standards in the IEC 60601-1 series apply as published.
For collateral standards published after this particular standard, MANUFACTURERS need to
determine the applicability in accordance with the RISK MANAGEMENT PROCESS.
201.2 Normative references
Add, under "Replacement", the following new reference:
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
Add, under "Addition", the following new reference:
IEC 60336 Medical electric equipment – X-Ray Tube assemblies for medical diagnosis –
Characteristics of focal spots
201.3 Terms and definitions
201.3.202
CT CONDITIONS OF OPERATION
Add a note 3 to this definition:
NOTE 3 CT CONDITIONS OF OPERATION include parameters that are derived by the system from the user-selectable
parameters.
___________
1)
IEC 60601-1-10, Medical electrical equipment – Part 1-10: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers
2)
IEC 60601-1-11, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical
systems used in the home healthcare environment
3)
IEC 60601-1-12, Medical electrical equipment – Part 1-12: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical
systems intended to be used in the emergency medical services environment

60601-2-44 Amend.1 © I
...