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SIST EN 60601-2-44:2009
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
SIST EN 60601-2-44:2009 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 60601-2-44:2009
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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
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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 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.
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SIST EN 60601-2-44:2009
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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).
__________
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SIST EN 60601-2-44:2009
EN 60601-2-44:2009 - 4 -
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.
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SIST EN 60601-2-44:2009
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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.
___________
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SIST EN 60601-2-44:2009
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SIST EN 60601-2-44:2009
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
Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
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SIST EN 60601-2-44:2009
– 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
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SIST EN 60601-2-44:2009
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.
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SIST EN 60601-2-44:2009
– 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.
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SIST EN 60601-2-44:2009
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.
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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
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SIST EN 60601-2-44:2009
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, exc
...