EN 60601-2-44:2009
(Main)Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2009
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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 relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-44 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
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.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62B/727/FDIS 62B/734/RVD
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
– 4 – 60601-2-44 © IEC:2009
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.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
The committee has decided that the contents of this particular standard will remain
unchanged until the maintenance result 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.
60601-2-44 © IEC:2009 – 5 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-44: Particular requirements for the basic safety and essential
performance of X-ray equipment for computed tomography
201.1 Scope, object and related standards
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
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 X-
RAY 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
rd
IEC 60601-2-44. Therefore IEC 60601-2-7 and IEC 60601-2-32 are not part of the 3 edition scheme for COMPUTED
TOMOGRAPHY.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for CT SCANNERS as defined in 201.3.201, to ensure safety, and to
specify methods for demonstrating compliance with those requirements, for CT SCANNERS.
NOTE 1 Requirements for reproducibility, linearity, constancy and accuracy are given because of their
relationship to the quality and quantity of the IONIZING RADIATION produced and are confined to those considered
necessary for safety.
NOTE 2 Both the levels for compliance and the tests prescribed to determine compliance reflect the fact that the
safety of HIGH-VOLTAGE GENERATORS is not sensitive to small differences in levels of performance. The
combinations of LOADING FACTORS specified for the tests are therefore limited in number but chosen from
experience as being appropriate in most cases. It is considered important to standardize the choice of
combinations of LOADING FACTORS so that comparison can be made between tests performed in different places on
different occasions. However, combinations other than those specified could be of equal technical validity.
NOTE 3 The safety philosophy on which this standard is based is described in the introduction to the general
standard and in IEC TR 60513.
—————————
1)
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance.
– 6 – 60601-2-44 © IEC:2009
NOTE 4 Concerning RADIOLOGICAL PROTECTION, it is assumed that MANUFACTURERS and RESPONSIBILE
ORGANIZATIONS accept the general principles of justification, optimisation, and application of dose limits of the
2)
International Commission on Radiological Protection as stated in ICRP 103, 2007, paragraph 203, [ 12] namely:
(a) “The principle of justification: Any decision that alters the RADIATION exposure situation should do more good
than harm.”
(b) “The principle of optimisation of protection: The likelihood of incurring exposures, the number of people
exposed, and the magnitude of their individual doses should all be kept as low as reasonably achievable, taking
into account economic and societal factors.”
(c) “The principle of application of dose limits: The total dose to any individual from regulated sources in planned
exposure situations other than medical exposure of PATIENTS should not exceed the appropriate limits
recommended by the Commission.”
(d) "Application of dose limits for the PATIENT dose might be to the PATIENT’S detriment. Therefore dose limits
should not be applied to medical exposures. However, considerations should be given to the use of dose
constraints or investigation levels for some common diagnostic procedures. This concept, now renamed as
diagnostic reference levels, has been introduced in a large number of countries."
NOTE 5 It is recognized that many of the judgements necessary to follow the ICRP general principles have to be
made by the RESPONSIBLE ORGANIZATIONS and not by the MANUFACTURER of the ME EQUIPMENT.
201.1.3 Collateral standards
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 60601-1-3 applies as modified in Clause 203. IEC 60601-1-8, IEC 60601-1-9 and
3)
IEC 60601-1-10 do not apply. All other published collateral standards in the IEC 60601-1
series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document numbers.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard,
203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral
standard, etc.). The changes to the text of the general standard are specified by the use of
the following words:
—————————
2)
Figures in square brackets refer to the Bibliography.
3)
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
60601-2-44 © IEC:2009 – 7 –
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding section, clause or subclause in this particular standard, the
section, clause or subclause of the general standard or applicable collateral standard,
although possibly not relevant, applies without modification; where it is intended that any
parts of the general standard or applicable collateral standard, although possibly relevant, is
not to be applied, a statement to that effect is given in this particular standard.
201.2 Normative references
NOTE Informative references are listed in the bibliography beginning on page 41.
Clause 2 of the general standard applies, except as follows:
Replacement:
IEC 60601-1-3:2008, Medical electrical equipment – 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 – Part 1: General requirements for basic
safety and essential performance
IEC 61223-3-5, Evaluation and routine testing in medical imaging departments – Part 3-5:
Acceptance tests – Imaging performance of computed tomography X-ray equipment
ISO 12052, Health informatics – Digital imaging and communication in medicine (DICOM)
including workflow and data management
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005, IEC
60601-1-3:2008 and IEC 60788:2004 apply, except as follows:
– 8 – 60601-2-44 © IEC:2009
NOTE 101 An index of defined terms is to be found at the end of this document.
NOTE 102 In accordance with the definitions in IEC 60601-1-3, in this standard unless otherwise indicated:
– values of X-RAY TUBE VOLTAGE refer to peak values, transients being disregarded;
– values of X-RAY TUBE CURRENT refer to average values.
Addition:
201.3.201
CT SCANNER
X-RAY EQUIPMENT intended to generate cross-sectional images of the body by computer
reconstruction of X-ray transmission data obtained at different angles, which may include
signal analysis and display equipment, PATIENT SUPPORT, support parts and ACCESSORIES
NOTE 1 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.
NOTE 2 Secondary imaging processing is not included in the scope of this standard.
201.3.202
CT CONDITIONS OF OPERATION
all selectable parameters governing the operation of a CT SCANNER
NOTE 1 Examples of such conditions include NOMINAL TOMOGRAPHIC SECTION THICKNESS, CT PITCH FACTOR,
FILTRATION, peak X-RAY TUBE VOLTAGE and either X-RAY TUBE CURRENT and LOADING TIME or CURRENT TIME PRODUCT.
NOTE 2 Some CT CONDITIONS OF OPERATION may vary during the exposure.
201.3.203
COMPUTED TOMOGRAPHY DOSE INDEX 100
CTDI
integral of the DOSE PROFILE produced in a single axial scan along a line perpendicular to
the TOMOGRAPHIC PLANE from –50 mm to +50 mm, divided by the product of the number of
TOMOGRAPHIC SECTIONS N and the NOMINAL TOMOGRAPHIC SECTION THICKNESS T, or divided by
100 mm, whichever is less:
+50 mm
D (z)
= dz
CTDI100
∫
min{N × T,100 mm}
−50 mm
where
D(z) is the DOSE PROFILE along a line z perpendicular to the TOMOGRAPHIC PLANE, where
dose is reported as ABSORBED DOSE in air and is evaluated within a
polymethylmethacrylate (PMMA) dosimetry PHANTOM (203.108);
N is the number of TOMOGRAPHIC SECTIONS produced in a single axial scan of the X-ray
source;
T is the NOMINAL TOMOGRAPHIC SECTION THICKNESS.
NOTE 1 The dose is reported as ABSORBED DOSE in air. Air is explicitly designated the reference medium for dose
in order to avoid potential confusion, since some MANUFACTURERS of CT SCANNERS express dose values calculated
as ABSORBED DOSE to air and others as ABSORBED DOSE to PMMA.
Although CTDI refers to ABSORBED DOSE in air, for practical purposes the evaluation of ABSORBED DOSE to air
within a PMMA dosimetry PHANTOM is well approximated by measurement of the AIR KERMA with an ionization
chamber in the PHANTOM. Generally there is traceability of ionization chambers to AIR KERMA.
NOTE 2 This definition assumes that the DOSE PROFILE is centred on z = 0.
NOTE 3 A single axial scan is typically a 360° rotation of the X-ray source.
NOTE 4 When the TOMOGRAPHIC SECTIONS overlap, e.g. in CT SCANNERS with “flying FOCAL SPOT”, the product
N × T needs to be adjusted for overlap.
60601-2-44 © IEC:2009 – 9 –
NOTE 5 Typically the z-axis is the axis of rotation.
NOTE 6 If N × T is greater than 100 mm, the physical meaning of CTDI changes from the average dose at the
centre of a 100 mm scan length to the average dose over the central 100 mm region for a single axial scan.
NOTE 7 The value of CTDI will be lower if the length of the dosimetry PHANTOM is less than N × T + 100 mm,
since the contribution from scattered RADIATION will be underestimated.
y
T
x
z
IEC 369/09
1 TOMOGRAPHIC PLANE
2 PHANTOM
Figure 201.101 – Coordinate system
201.3.204
CT PITCH FACTOR
in helical scanning the ratio of the PATIENT SUPPORT travel Δd along the z-direction per rotation
of the X-ray source divided by the product of the NOMINAL TOMOGRAPHIC SECTION THICKNESS T
and the number of TOMOGRAPHIC SECTIONS N:
Δd
CT pitch factor =
N ×T
where
Δd is the PATIENT SUPPORT travel along the z-direction per rotation of the X-RAY SOURCE;
T is the NOMINAL TOMOGRAPHIC SECTION THICKNESS;
N is the number of TOMOGRAPHIC SECTIONS produced in a single axial scan of the X-RAY
SOURCE.
NOTE 1 Although the CT PITCH FACTOR is associated with helical scanning, its definition refers to parameters T
and N that are defined only for axial scanning. Definition 201.3.204 presumes that these axial-scanning parameters
T and N correspond to the same collimation and active-detector configuration as that of the helical scanning for
which the CT PITCH FACTOR is being evaluated.
NOTE 2 When the TOMOGRAPHIC SECTIONS overlap, e.g. in CT SCANNERS with “flying FOCAL SPOT”, the product
N × T needs to be adjusted for overlap.
NOTE 3 CT PITCH FACTOR will be a function of time when Δd or N × T are variable during the exposure.
NOTE 4 The terms “helical” is used in this document as a synonym for the term “spiral”.
201.3.205
DOSE PROFILE
representation of the dose as a function of position along a line
– 10 – 60601-2-44 © IEC:2009
201.3.206
NOMINAL TOMOGRAPHIC SECTION THICKNESS
in CT SCANNERS the TOMOGRAPHIC SECTION THICKNESS which is selected and indicated on the
CONTROL PANEL
NOTE In helical scanning the thickness of a section associated with the reconstructed image depends on the
helical reconstruction algorithm and pitch. This thickness might or might not be equal to the NOMINAL TOMOGRAPHIC
SECTION THICKNESS.
201.3.207
SENSITIVITY PROFILE
relative response of a system for COMPUTED TOMOGRAPHY as a function of position along a line
perpendicular to the TOMOGRAPHIC PLANE
201.3.208
TOMOGRAPHIC PLANE
geometric plane perpendicular to the axis of rotation at the centre of the X-RAY FIELD in z (see
Figure 201.101)
201.3.209
TOMOGRAPHIC SECTION
for CT SCANNERS with a single detector row, the volume over which TRANSMISSION data of
X-RADIATION are collected in a single axial scan; for CT SCANNERS with multiple detector rows
along the z-axis, the volume over which data are collected by a single acquisition channel
representing a single row or a selected grouping of rows
201.3.210
TOMOGRAPHIC SECTION THICKNESS
FULL WIDTH AT HALF MAXIMUM of the SENSITIVITY PROFILE taken at the ISOCENTRE of a
TOMOGRAPHIC SECTION
201.3.211
WEIGHTED CTDI
CTDI
w
value defined as
1 2
CTDI = CTDI + CTDI
W 100(centre ) 100(peripheral)
3 3
where CTDI is the value of CTDI measured in the centre of a dosimetry PHANTOM,
100(centre) 100
and where CTDI is the average of the four values of CTDI measured around
100(peripheral) 100
the dosimetry PHANTOM periphery according to 203.109.1 a)2) and 3)
201.3.212
VOLUME CTDI
w
CTDI
vol
a) for axial scanning
N ×T
CTDI = CTDI
vol w
Δd
where
N is the number of TOMOGRAPHIC SECTIONS produced in a single axial scan of the X-
ray source;
T is the NOMINAL TOMOGRAPHIC SECTION THICKNESS;
Δd is the PATIENT SUPPORT travel in z-direction between consecutive scans.
NOTE 1 For axial scanning with a total table travel of less than N × T this definition may overestimate the dose.
60601-2-44 © IEC:2009 – 11 –
NOTE 2 For the selected CT CONDTIONS OF OPERATION, but irrespective of any scanning length that may be used
clinically, the VOLUME CTDI (CTDI ) is an index of dose based on a convention of 100 mm range of integration
w vol
along the z-axis. For axial scanning, CTDI corresponds to the average dose that would accrue in the PHANTOM
vol
central section of volume equal to the cross sectional area × Δd .
b) for helical scanning
CTDI
w
CTDI =
vol
CT pitch factor
NOTE 1 CT PITCH FACTOR will be a function of time when Δd or N × T are variable during the exposure.
NOTE 2 For helical scanning with a small number of rotations and a table travel per rotation of less than N × T
this definition may overestimate the dose.
NOTE 3 For the selected CT CONDTIONS OF OPERATION, but irrespective of any scanning length that may be used
clinically, the VOLUME CTDI (CTDI ) is an index of dose based on a convention of 100 mm range of integration
w vol
along the z-axis. For helical scanning, CTDI corresponds to the average dose that would accrue in the PHANTOM
vol
central section of volume equal to the cross sectional area × Δd.
c) for scanning without movement of the PATIENT SUPPORT
CTDI = n × CTDI
vol w
where n is equal to the number of rotations.
NOTE 1 c) includes situations where the PATIENT SUPPORT may be moved manually, for example, during an
interventional procedure.
NOTE 2 For scanning without movement of the PATIENT SUPPORT and for situations where the PATIENT SUPPORT
may be moved manually, this definition overestimates the dose as it includes assumed scatter contribution from
adjacent slices.
NOTE 3 For scanning without movement of the PATIENT SUPPORT, CTDI corresponds to the dose that would
vol
accrue in the PHANTOM central section of volume equal to the cross sectional area × N × T were there n congruent
sequences of contiguous scanning, each sequence of length 100 mm.
201.3.213
GEOMETRIC EFFICIENCY IN THE Z-DIRECTION
integral of the DOSE PROFILE determined at the ISOCENTRE without any object in the X-RAY BEAM,
over the acquisition range in the z-direction, expressed as percentage of the total integral of the
DOSE PROFILE in the z-direction, where the acquisition range is the length along the z-axis
spanned by the selected detector elements, or it is the z-axis length of the post-patient collimation,
whichever is less and where z-axis lengths are given as equivalent lengths at the ISOCENTRE
NOTE Detector ‘combs’ or grids will reduce geometric efficiency.
201.3.214
DOSE-LENGTH PRODUCT
DLP
index characterizing the product of the CTDI and the total length scanned
vol
a) For axial scanning
DLP = CTDI × Δd × n
vol
where
Δd is the PATIENT SUPPORT travel in z-direction between consecutive scans;
n is the number of scans in the series.
b) For helical scanning
DLP = CTDI × L
vol
where
L is the table travel during the entire LOADING.
– 12 – 60601-2-44 © IEC:2009
NOTE 1 L might be longer than the programmed scan length.
NOTE 2 The time weighted average of CTDI is to be used if CTDI is variable.
vol vol
c) For scanning without movement of the PATIENT SUPPORT
DLP = CTDI × N × T
vol
where
N is the number of TOMOGRAPHIC SECTIONS produced in a single axial scan of the X-ray
source;
T is the NOMINAL TOMOGRAPHIC SECTION THICKNESS.
201.3.215
COMPUTED TOMOGRAPHY DOSE INDEX FREE-IN-AIR
CTDI
FREE AIR
integral of the DOSE PROFILE produced in a single axial scan along a line perpendicular to
the TOMOGRAPHIC PLANE from –50 mm to +50 mm, divided by the product of the number of
TOMOGRAPHIC SECTIONS N and the NOMINAL TOMOGRAPHIC SECTION THICKNESS T, or divided by
100 mm, whichever is less
+50 mm
D (z)
= dz
CTDI FREE AIR
∫
min{N × T,100 mm}
−50 mm
where
D(z) is the DOSE PROFILE along a line z perpendicular to the TOMOGRAPHIC PLANE, where
dose is reported as ABSORBED DOSE in air and is evaluated free-in-air in the absence
of a PHANTOM and the PATIENT SUPPORT;
N is the number of TOMOGRAPHIC SECTIONS produced in a single axial scan of the X-ray
source;
T is the NOMINAL TOMOGRAPHIC SECTION THICKNESS.
NOTE 1 This definition assumes that the DOSE PROFILE is centred on z = 0.
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Addition:
For CT SCANNERS for which the INTENDED USE includes COMPUTED TOMOGRAPHY as the
principal means of guidance in invasive procedures (involving the introduction of a device,
such as a needle or a catheter into the body of the PATIENT), any ESSENTIAL PERFORMANCE
related to such use shall be identified.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
201.4.5 Equivalent Safety for ME EQUIPMENT or ME SYSTEMS
Addition:
NOTE Because state of the art technology changes for CT SCANNERS may result in the inability to strictly comply
with all clauses of this particular standard, alternate means of addressing risks via risk management are acceptable.
Alternate means are acceptable only when the residual risks resulting from application of the alternative are equal
to or less than the RESIDUAL RISKS that would ensue when the particular standards requirements are met.
60601-2-44 © IEC:2009 – 13 –
201.4.10.2 SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS
Addition:
The internal impedance of a SUPPLY MAINS is to be considered sufficiently low for the operation
of a CT SCANNER if the value of the APPARENT RESISTANCE OF SUPPLY MAINS does not exceed
the value specified in the ACCOMPANYING DOCUMENTS.
Either the APPARENT RESISTANCE OF SUPPLY MAINS or the proper gauge/length of supply cables
or other appropriate SUPPLY MAINS specifications used in a facility shall be specified in the
ACCOMPANYING DOCUMENTS.
NOTE If a NOMINAL voltage is claimed for a mains power supply system, it is assumed that there is no voltage of a
higher value between any of the conductors of the system or between any of these conductors and earth.
An alternating voltage is considered in practice to be sinusoidal if any instantaneous value of the waveform
concerned differs from the instantaneous value of the ideal waveform at the same moment by no more than ±2 % of
the peak value of the ideal waveform.
SUPPLY MAINS is considered to have a practical symmetry if it delivers symmetrical voltages and
A three-phase
produces, when loaded symmetrically, symmetrical currents.
The requirements of this standard are based upon the assumption that three-phase systems have a symmetrical
configuration of the MAINS VOLTAGE with respect to earth. Single-phase systems may be derived from such
three-phase systems. Where the supply system is not earthed at the source it is assumed that adequate measures
have been provided to detect, limit and remedy any disturbance of symmetry within a reasonably short time.
A CT SCANNER is considered to comply with the requirements of this standard only if its specified NOMINAL ELECTRIC
POWER can be demonstrated at an APPARENT RESISTANCE OF SUPPLY MAINS having a value not less than the
APPARENT RESISTANCE OF SUPPLY MAINS specified by the MANUFACTURER in the ACCOMPANYING DOCUMENTS.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.7 Humidity preconditioning treatment
Addition:
For those CT SCANNERS
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