IEC 60601-2-54:2022
(Main)Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
IEC 60601-2-54:2022 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and INDIRECT RADIOSCOPY. IEC 60601-2-43 applies to ME EQUIPMENT and ME SYSTEMS intended to be used for interventional applications and refers to applicable requirements in this document. ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption densitometry, computed tomography, mammography or dental or radiotherapy applications are excluded from the scope of this document. The scope of this document also excludes radiotherapy simulators. 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. IEC 60601-2-54:2022 edition cancels and replaces the first edition published in 2009, Amendment 1:2015 and Amendment 2:2018. This edition constitutes a technical revision. This edition includes editorial and technical changes to reflect the IEC 60601 1:2005/AMD2:2020. It also contains corrections and technical improvements. Significant technical changes with respect to the previous edition are as follows:
a) a new specific term DOSIMETER is introduced to replace the general term DOSEMETER;
b) terms and definitions taken exclusively from IEC TR 60788:2004 and which are specifically applicable in this document have been moved to 201.3;
c) the collateral standards IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020, IEC 60601-1-12:2014 and IEC 60601-1-12:2014/AMD1:2020 are applicable if MANUFACTURER so declares;
d) the subclause 201.11.101 “Protection against excessive temperatures of X-ray tube assemblies” has been removed from this document as its requirements are sufficiently and clearly covered by IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-28:2017;
e) to adopt changes which are introduced with respect to indicator lights in 7.8.1 of the IEC 60601-1:2005/AMD2:2020 clarification of requirements is provided to avoid conflicts with requirements of indicator lights stipulated for X-RAY EQUIPMENT;
f) explanation of the term ESSENTIAL PERFORMANCE is provided in Annex AA to emphasize the performance of the clinical function under NORMAL and SINGLE FAULT CONDITIONS. CONDITIONS.
Appareils électromédicaux - Partie 2-54: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X utilisés pour la radiographie et la radioscopie
L'IEC 60601-2-54:2022 s’applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS EM et des SYSTEMES EM destinés à la RADIOGRAPHIE de projection et à la RADIOSCOPIE INDIRECTE. L’IEC 60601-2-43 est applicable aux APPAREILS EM et aux SYSTEMES EM destinés à être utilisés lors de procédures d’interventions et se réfère aux exigences applicables du présent document. Les APPAREILS EM et SYSTEMES EM destinés à l’ostéodensitométrie par absorption, à la tomodensitométrie, à la mammographie ou aux applications dentaires ou de radiothérapie, sont exclus du domaine d’application du présent document. Le domaine d’application du présent document exclut également les simulateurs de radiothérapie. Lorsqu’un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, son titre et son contenu l’indiquent. Lorsque cela n’est pas le cas, l’article ou le paragraphe s’applique à la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas. L'IEC 60601-2-54:2022 nnule et remplace la première édition parue en 2009, l'Amendement 1:2015 et l'Amendement 2:2018. Cette édition constitue une révision technique. La présente édition comprend des modifications techniques et rédactionnelles destinées à représenter l’IEC 60601 1:2005/AMD2:2020. Elle contient également des corrections et des améliorations techniques. Les modifications techniques majeures par rapport à l’édition précédente sont les suivantes:
a) déplacement en 201.3 des termes issus exclusivement de l’IEC TR 60788:2004 et qui sont spécifiquement applicables dans le présent document;
b) si le FABRICANT le déclare, les normes collatérales IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020, IEC 60601-1-12:2014 et IEC 60601-1-12:2014/AMD1:2020 s'appliquent;
c) le paragraphe 201.11.101 “Protection contre les températures excessives des gaines équipées” a été supprimé du présent document, car ses exigences sont suffisamment et clairement traitées par l’IEC 60601-1:2005, l’IEC 60601-1:2005/AMD1:2012, l’IEC 60601-1:2005/AMD2:2020 et l’IEC 60601-2-28:2017;
d) clarification des exigences pour l’adoption des modifications introduites concernant les voyants lumineux au paragraphe 7.8.1 de l’IEC 60601-1:2005/AMD2:2020 afin d’éviter les conflits avec les exigences relatives aux voyants lumineux stipulées pour les APPAREILS A RAYONNEMENT X;
e) explication du terme PERFORMANCE ESSENTIELLE fournie dans l’Annexe AA afin de mettre l’accent sur la fonction clinique en CONDITION NORMALE ET DE PREMIER DEFAUT.
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IEC 60601-2-54 ®
Edition 2.0 2022-09
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-54: Particular requirements for the basic safety and essential
performance of X-ray equipment for radiography and radioscopy
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IEC 60601-2-54 ®
Edition 2.0 2022-09
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-54: Particular requirements for the basic safety and essential
performance of X-ray equipment for radiography and radioscopy
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.50 ISBN 978-2-8322-5784-5
– 2 – IEC 60601-2-54:2022 RLV © IEC 2022
CONTENTS
FOREWORD . 4
INTRODUCTION . 2
INTRODUCTION TO AMENDMENT 1 .
INTRODUCTION TO AMENDMENT 2 .
201.1 Scope, object and related standards . 9
201.2 Normative references . 11
201.3 Terms and definitions . 11
201.4 General requirements . 14
201.5 General requirements for testing ME EQUIPMENT . 15
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 15
201.7 ME EQUIPMENT identification, marking and documents . 15
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 19
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 22
201.10 Protection against unwanted and excessive radiation HAZARDS . 26
201.11 Protection against excessive temperatures and other HAZARDS . 26
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 27
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 27
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 27
201.15 Construction of ME EQUIPMENT . 28
201.16 ME SYSTEMS . 28
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 28
202 Electromagnetic compatibility disturbances – Requirements and tests . 28
202.101 * Immunity testing of ESSENTIAL PERFORMANCE . 28
203 RADIATION PROTECTION in diagnostic X-RAY EQUIPMENT. 29
203.4 General requirements . 29
203.5 ME EQUIPMENT identification, marking and documents . 30
203.6 RADIATION management . 33
203.7 RADIATION QUALITY . 48
203.8 Limitation of the extent of the X-RAY BEAM and relationship between X-RAY
FIELD and IMAGE RECEPTION AREA . 49
203.9 FOCAL SPOT TO SKIN DISTANCE . 57
203.10 ATTENUATION of the X-RAY BEAM between the PATIENT and the X-RAY IMAGE
RECEPTOR . 58
203.11 Protection against RESIDUAL RADIATION . 59
203.12 Protection against LEAKAGE RADIATION . 61
203.13 Protection against STRAY RADIATION . 61
Annexes . 67
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 68
Annex AA (informative) Particular guidance and rationale . 70
Bibliography . 75
Index of defined terms used in this document . 78
Figure 203.101 – Zone of EXTRA-FOCAL RADIATION . 50
Figure 203.102 – Discrepancies in covering the IMAGE RECEPTION AREA . 52
Figure 203.103 – Discrepancies in visual indication of the X-RAY FIELD . 56
Figure 203.104 – Testing for STRAY RADIATION (X-RAY BEAM horizontal with X-RAY
SOURCE ASSEMBLY below the PATIENT SUPPORT) . 64
Figure 203.105 – Testing for STRAY RADIATION (X-RAY BEAM vertical with X-RAY SOURCE
ASSEMBLY below the PATIENT SUPPORT) . 65
Figure 203.106 – Testing for STRAY RADIATION (X-RAY BEAM horizontal with X-RAY
SOURCE ASSEMBLY above the PATIENT SUPPORT) . 65
Figure 203.107 – Testing for STRAY RADIATION (X-RAY BEAM vertical with X-RAY SOURCE
ASSEMBLY above the PATIENT SUPPORT) . 66
Table 201.101 – Distributed potential ESSENTIAL PERFORMANCE requirements . 15
Table 203.101 – Tests for verifying reproducibility and linearity . 37
Table 203.102 – LOADINGS for testing automatic exposure controls . 38
Table 203.103 – ATTENUATION for the measurement of AIR KERMA. 40
Table 203.104 – ATTENUATION EQUIVALENT of items in the X-RAY BEAM . 58
Table 203.105 – Application categories. 60
Table 203.106 – Requirements for PRIMARY PROTECTIVE SHIELDING . 61
Table 203.107 – STRAY RADIATION in SIGNIFICANT ZONES OF OCCUPANCY . 63
Table 201.C.101 – Marking on the outside of ME EQUIPMENT or its parts . 68
Table 201.C.102 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 68
– 4 – IEC 60601-2-54:2022 RLV © IEC 2022
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-54: Particular requirements for the basic safety and essential
performance of X-ray equipment for radiography and radioscopy
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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rights. IEC shall not be held responsible for identifying any or all such patent rights.
This redline version of the official IEC Standard allows the user to identify the changes made to
the previous edition IEC 60601-2-54:2009+AMD1:2015+AMD2:2018 CSV. A vertical bar appears
in the margin wherever a change has been made. Additions are in green text, deletions are in
strikethrough red text.
IEC 60601-2-54 has been prepared by subcommittee 62B: Diagnostic imaging equipment, of
IEC technical committee 62: Electrical equipment in medical practice. It is an International
Standard.
This second edition cancels and replaces the first edition published in 2009, Amendment 1:2015
and Amendment 2:2018. This edition constitutes a technical revision.
This edition includes editorial and technical changes to reflect the
IEC 60601-1:2005/AMD2:2020. It also contains corrections and technical improvements.
Significant technical changes with respect to the previous edition are as follows:
a) a new specific term DOSIMETER is introduced to replace the general term DOSEMETER;
b) terms and definitions taken exclusively from IEC TR 60788:2004 and which are specifically
applicable in this document have been moved to 201.3;
c) the collateral standards IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020,
IEC 60601-1-12:2014 and IEC 60601-1-12:2014/AMD1:2020 are applicable if
MANUFACTURER so declares;
d) the subclause 201.11.101 “Protection against excessive temperatures of X-ray tube
assemblies” has been removed from this document as its requirements are sufficiently and
clearly covered by IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-
1:2005/AMD2:2020 and IEC 60601-2-28:2017;
e) to adopt changes which are introduced with respect to indicator lights in 7.8.1 of the
IEC 60601-1:2005/AMD2:2020 clarification of requirements is provided to avoid conflicts
with requirements of indicator lights stipulated for X-RAY EQUIPMENT;
ESSENTIAL PERFORMANCE is provided in Annex AA to emphasize the
f) explanation of the term
performance of the clinical function under NORMAL and SINGLE FAULT CONDITIONS.
The text of this document is based on the following documents:
Draft Report on voting
62B/1285/FDIS 62B/1293/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/standardsdev/publications.
In this document, 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 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 AND IEC
60601-1:2005/AMD2:2020, IN THIS DOCUMENT OR AS NOTED: SMALL CAPITALS.
In referring to the structure of this document, 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.);
– 6 – IEC 60601-2-54:2022 RLV © IEC 2022
– “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 document are preceded by the term “Clause” followed by the
clause number. References to subclauses within this document are by number only.
In this document, 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 document conform to usage described in Clause 7 of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance with
this document;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 and IEC 80601 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 document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
IMPORTANT – The "colour inside" logo on the cover page of this document indicates that it
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INTRODUCTION
This document has been prepared to provide, based on IEC 60601-1:2005 (third edition) and
its collaterals, a complete set of safety requirements for ME EQUIPMENT for RADIOGRAPHY and
RADIOSCOPY. The purpose of this second edition is to introduce changes to reference the second
amendment (2020) to IEC 60601-1:2005 and associated collateral standards. Moreover, in
Annex AA a clarification of the term for ESSENTIAL PERFORMANCE is provided. While the
previously existing standards for such equipment were dedicated to components and
subsystems, This document addresses the system level of X-RAY EQUIPMENT, which consists of
a combination of an X-RAY GENERATOR, ASSOCIATED EQUIPMENT and ACCESSORIES. Component
functions are addressed as far as necessary.
The minimum safety requirements specified in this document are considered to provide for a
practical degree of safety in the operation of ME EQUIPMENT for RADIOGRAPHY and RADIOSCOPY.
Requirements for additional provisions for ME EQUIPMENT for interventional applications are
covered by IEC 60601-2-43.
– 8 – IEC 60601-2-54:2022 RLV © IEC 2022
INTRODUCTION TO AMENDMENT 1
The purpose of this first amendment to IEC 60601-2-54:2009 is to introduce changes to
reference the first amendment (2012) to IEC 60601-1:2005. As neither IEC 60601-2-54:2009
nor this amendment refers to specific elements of IEC 60601-1-2, the introduction of a dated
reference to the latter document has been removed. In addition, a number of technical errors
have been corrected.
INTRODUCTION TO AMENDMENT 2
The purpose of this second amendment to IEC 60601-2-54:2009 is to introduce changes which
take the current state of the art into account. Therefore, X-RAY EQUIPMENT specified for DIRECT
RADIOSCOPY is no longer in the scope of this document. The normative references were also
updated in this amendment, and editorial clarifications and new terms and definitions were
added. Provisions for QUALITY CONTROL PROCEDURES to be recommended by the MANUFACTURER
are emphasized. Specific attention is paid to EXAMINATION PROTOCOLS in a new subclause which
differentiate between adult and paediatric applications, in particular for X-RAY EQUIPMENT
without an AUTOMATIC CONTROL SYSTEM. In addition, fixed periods for termination of LOADING
after release of the RADIATION control by the OPERATOR are stipulated for RADIOSCOPY.
A new subclause on electronic documentation of EXAMINATION PROTOCOLS is introduced. It
recommends providing access to electronic documentation containing relevant parameters of
the PRE-PROGRAMMED EXAMINATION PROTOCOL. In another new subclause, the creation of basic
documentation of the RADIATION DOSE STRUCTURED REPORT (RDSR) according to IEC 61910-1 is
recommended. Furthermore, the subclause describing the LAST IMAGE HOLD RADIOGRAM has
been revised and requires that the last image in RADIOSCOPY be displayed rather than provide
just a means to display it.
This amendment recommends providing a graphical DISPLAY of the position of the BEAM LIMITING
DEVICE blades on the IMAGE DISPLAY DEVICE in the subclause "Indication on the X-RAY
EQUIPMENT".
Finally, the requirement for providing means to limit the FOCAL SPOT TO SKIN DISTANCES for
radioscopic X-RAY EQUIPMENT differentiates between MOBILE and FIXED EQUIPMENT and extends,
in the latter case, the minimum distance in possible clinical applications.
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-54: Particular requirements for the basic safety and essential
performance of X-ray equipment for radiography and radioscopy
201.1 Scope, object and related standards
Clause 1 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.1.1 Scope
Replacement:
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and
ME SYSTEMS intended to be used for projection RADIOGRAPHY and INDIRECT RADIOSCOPY.
IEC 60601-2-43 applies to ME EQUIPMENT and ME SYSTEMS intended to be used for interventional
applications and refers to applicable requirements in this document.
ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption densitometry,
computed tomography, mammography or dental or radiotherapy applications are excluded from
the scope of this document. The scope of this document also excludes radiotherapy simulators.
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.
201.1.2 Object
Replacement:
BASIC SAFETY and ESSENTIAL PERFORMANCE
The object of this document is to establish particular
requirements for ME EQUIPMENT and ME SYSTEMS for RADIOGRAPHY and RADIOSCOPY.
201.1.3 Collateral standards
Addition:
This document refers to those applicable collateral standards that are listed in Clause 2 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 as
modified in 201.2.
IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-3:2008 and
IEC 60601-1-3:2008/AMD1:2013 and IEC 60601-1-3:2008/AMD2:2021 apply, as modified in
Clauses 202 and 203 respectively. If the MANUFACTURER declares that the ME EQUIPMENT or ME
SYSTEM is intended to be operated in a HOME HEALTHCARE ENVIRONMENT, then
IEC 60601-1-11:2015 and IEC 60601-1-11:2015/AMD1:2020 apply and if the MANUFACTURER
declares that the ME EQUIPMENT or ME SYSTEM is intended to be operated in an EMERGENCY
MEDICAL SERVICES ENVIRONMENT, then IEC 60601-1-12:2014 and
IEC 60601-1-12:2015/AMD1:2020 apply. IEC 60601-1-8, 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.
NOTE 1 OPERATORS of X-RAY EQUIPMENT are used to audible signals as required specified in this document rather
than to the concepts of IEC 60601-1-8. Therefore IEC 60601-1-8 does not apply.
– 10 – IEC 60601-2-54:2022 RLV © IEC 2022
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020 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 IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this document corresponds to that of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 with the
prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020) 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 document addresses the content of Clause 4 of
the IEC 60601-1-2 collateral standard, 203.4 in this document addresses the content of
Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text of the
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are
specified by the use of the following words:
“Replacement” means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or the applicable collateral
standard is replaced completely by the text of this document.
“Addition” means that the text of this document is additional to the requirements of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or the
applicable collateral standard.
“Amendment” means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or the applicable collateral
standard is amended as indicated by the text of this document.
Subclauses, figures or tables which are additional to those of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered starting from
201.101. However, due to the fact that definitions in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered 3.1 through
3.139154, additional definitions in this document 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 clause or subclause in this document, the clause or subclause
of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or the
applicable collateral standard, although possibly not relevant, applies without modification;
where it is intended that any part of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC
60601-1:2005/AMD2:2020 or the applicable collateral standard, although possibly relevant, is
not to be applied, a statement to that effect is given in this document.
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020 applies, except as follows:
Addition:
IEC 60336:2020, Medical electrical equipment – X-ray tube assemblies for medical diagnosis –
Characteristics of focal spots Focal spot dimensions and related characteristics
IEC 60580:20002019, Medical electrical equipment – Dose area product meters
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 60806, Determination of the maximum symmetrical radiation field from a rotating anode of
X-ray tube assemblies and X-ray source assemblies for medical diagnosis
IEC 62220-1-1:2015, Medical electrical equipment – Characteristics of digital X-ray imaging
devices – Part 1-1: Determination of the detective quantum efficiency – Detectors used in
radiographic imaging
IEC 61910-1:2014, Medical electrical equipment – Radiation dose documentation – Part 1:
Radiation dose structured reports for radiography and radioscopy
IEC 62494-1:2008, Medical electrical equipment – Exposure index of digital X-ray imaging
systems – Part 1: Definitions and requirements for general radiography
Amendment:
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
IEC 60601-1-3:2008/AMD1:2013
IEC 60601-1-3:2008/AMD2:2021
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012, applicable collateral standards and
IEC 60601-1:2005/AMD2:2020, IEC TR 60788:2004 and the following apply, except as follows.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
– 12 – IEC 60601-2-54:2022 RLV © IEC 2022
NOTE An Index of defined terms is found in the last part of this document.
Addition:
201.3.201
APPARENT RESISTANCE OF SUPPLY MAINS
for diagnostic X-RAY GENERATOR, resistance of the SUPPLY MAINS determined under specific load
conditions
201.3.202
AUTOMATIC INTENSITY CONTROL
in an X-RAY GENERATOR, mode of operation in which one or more LOADING FACTORS are controlled
automatically in order to obtain at a pre-selected location a desired rate of a RADIATION QUANTITY
201.3.203
DIRECT RADIOGRAPHY
RADIOGRAPHY in which the permanent recording is effected at an IMAGE RECEPTION AREA
Example: Film-screen or film RADIOGRAPHY.
201.3.204
DIRECT RADIOSCOPY
RADIOSCOPY in which the visible images are presented at the IMAGE RECEPTION AREA, or close to
it, in the RADIATION BEAM
201.3.205
DOSE AREA PRODUCT
product of the area of the cross-section of an X-RAY BEAM and the averaged AIR KERMA over that
cross-section. The unit is the gray square metre (Gy⋅m )
Note 1 to entry: This definition is equivalent to AIR KERMA area product.
201.3.206
DOSIMETER
EQUIPMENT which uses ionization chambers or semiconductor detectors for the measurement of
AIR KERMA or AIR KERMA RATE in the beam of an X-RAY EQUIPMENT used for diagnostic medical
RADIOLOGICAL examinations
201.3.207
ENTRANCE FIELD SIZE
dimensions of the field in the entrance plane of an X-RAY IMAGE RECEPTOR that can be used for
the transmission of an X-RAY PATTERN under specific conditions
201.3.208
EXAMINATION PROTOCOL
full set of any programmed technical factors, control functions and settings, including image
processing settings, designed to optimize the image acquisition and DISPLAY
201.3.209
EXAMINATION PROTOCOL SELECTION CONTROL
control to select a PRE-PROGRAMMED EXAMINATION PROTOCOL
201.3.210
HIGH-VOLTAGE GENERATOR
in an X-RAY GENERATOR, combination of all components for control and production of the
electrical energy to be supplied to an X-RAY TUBE, usually consisting of a high-voltage
transformer assembly and a control assembly
201.3.211
IMAGE RECEPTION PLANE
plane containing the greatest dimensions of the IMAGE RECEPTION AREA
201.3.212
INDIRECT RADIOGRAPHY
RADIOGRAPHY in which the permanent recording is effected after TRANSFER of the information
obtained at an IMAGE RECEPTION AREA
Examples: CR systems, digital detector systems, image intensifier systems.
201.3.213
INDIRECT RADIOSCOPY
RADIOSCOPY in which the images are presented at a location outside the RADIATION BEAM after
TRANSFER of the information
201.3.214
INTERLOCK
means preventing the start or the continued operation of ME EQUIPMENT unless certain
predetermined conditions prevail
201.3.215
ISOCENTRE
in RADIOLOGICAL equipment with several modes of movement of the REFERENCE AXIS around a
common centre, centre of the smallest sphere through which the X-RAY BEAM AXIS passes
201.3.216
LAST IMAGE HOLD RADIOGRAM
LIH RADIOGRAM
single image obtained by sampling or temporal processing of one or more images from the end
of a radioscopic IRRADIATION
Note 1 to entry: This note applies to the French language only.
201.3.217
NOMINAL ELECTRIC POWER
for a HIGH-VOLTAGE GENERATOR, highest constant electric power which can be delivered for a
single X-RAY TUBE load in a specific LOADING TIME
201.3.218
NOMINAL SHORTEST IRRADIATION TIME
shortest LOADING TIME for which a required constancy of the controlled radiation quantity is
maintained
Note 1 to entry: The IRRADIATION TIME is controlled by a HIGH-VOLTAGE GENERATOR with AUTOMATIC CONTROL
SYSTEMS.
201.3.219
PRE-PROGRAMMED EXAMINATION PROTOCOL
single hardware or software setting, or both, which is associated with an EXAMINATION PROTOCOL
201.3.220
QUALITY CONTROL
operational techniques and activities that are used to fulfil requirements for quality
201.3.221
RADIATION OUTPUT
AIR KERMA per CURRENT TIME PRODUCT (mGy/mAs) at a given distance from the FOCAL SPOT in
the primary X-RAY BEAM
– 14 – IEC 60601-2-54:2022 RLV © IEC 2022
201.3.222
RADIOSCOPY REPLAY IMAGE SEQUENCE
series of the most recent images of the most recent RADIOSCOPY IRRADIATION-EVENT
201.3.223
REGION OF INTEREST
localized part of an image, which is of particular interest at a given time
201.3.224
SERIAL RADIOGRAPHY
RADIOGRAPHY in which the information is obtained and recorded in a regular or irregular series
of LOADINGS with equal or unequal LOADING FACTORS
201.3.225
SIX-PEAK HIGH-VOLTAGE GENERATOR
HIGH-VOLTAGE GENERATOR for operation on a three-phase supply that delivers a rectified output
voltage with six peaks during each cycle of the supply
201.3.226
TIMING DEVICE
device integrating and/or presenting time elapsed during an equipment function and optionally
changing the state of operation at the end of a predetermined time interval
201.3.227
TWELVE-PEAK HIGH-VOLTAGE GENERATOR
HIGH-VOLTAGE GENERATOR for operation on a three-phase supply that delivers a rectified output
voltage with twelve peaks during each cycle of the supply
201.3.228
RAY BEAM AXIS
X-
for a symmetrical RADIATION BEAM, line through the centre of the RADIATION SOURCE and half way
between the effective edges of the BEAM LIMITING DEVICE
Note 1 to entry: Usually, the X-RAY BEAM AXIS coincides within required tolerances with the REFERENCE AXIS of the
RADIATION SOURCE.
201.4 General requirements
Clause 4 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020 applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Additional subclause:
201.4.3.101 * Additional potential ESSENTIAL PERFORMANCE requirements
Additional potential ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in
Table 201.101.
Table 201.101 – Distributed potential ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Accuracy of LOADING FACTORS 203.6.4.3.104
Reproducibility of the RADIATION output 203.6.3.2
AUTOMATIC CONTROL SYSTEM 203.6.5
Imaging performance 203.6.7
201.4.10.2 Supply mains for ME EQUIPMENT and ME SYSTEMS
Addition:
The internal impedance of a SUPPLY MAINS is to shall be considered sufficiently low for the
operation of X-RAY EQUIPMENT for RADIOGRAPHY and RADIOSCOPY 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 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.
A three-phase SUPPLY MAINS is considered to have a practical symmetry if it delivers symmetrical voltages and
produces, when loaded symmetrically, symmetrical currents.
The requirements of this document 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 can 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.
X-RAY EQUIPMENT is considered to comply with the requirements of this document 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 ME EQUIPMENT
Clause 5 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020 applies.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020 applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020 applies, except as follows:
– 16 – IEC 60601-2-54:2022 RLV © IEC 2022
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
SUPPLY MAINS
201.7.2.7 Electrical input power from the
Addition:
For ME EQUIPMENT that is specified to be PERMANENTLY INSTALLED, the information may be stated
in the ACCOMPANYING DOCUMENTS only.
The information on the input power shall be specified in terms of combinations of
a) the RATED MAINS VOLTAGE of the ME EQUIPMENT in volts; see 7.2.1 and 7.2.6 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
b) the number of phases; see 7.2.1 and 7.2.6 of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
c) the frequency, in hertz; see 7.2.1 and 7.2.6 of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
d) the maximum permissible value for APPARENT RESISTANCE OF SUPPLY MAINS, in ohms;
e) the characteristics of OVER-CURRENT RELEASES required in the SUPPLY MAINS.
NOTE These requirements are adapted from 6.1j) of IEC 60601-2-7:1998.
201.7.2.15 Cooling conditions
Addition:
If cooling is necessary for safe operation of ME EQUIPMENT, or a subassembly thereof, the cooling
requirements shall be indicated in the ACCOMPANYING DOCUMENT, including as appropriate:
– the maximum heat dissipation into the surrounding air, given separately for each
subassembly that dissipates more than 100 W and might be separately located on
installation;
– the maximum heat dissipation into forced air cooling devices, and the corresponding flow
rate and temperature rise of the forced air stream;
– the maximum heat dissipation into a cooling medium utility and the permissible input
temperature range, minimum flow rate and pressure requirements for the utility.
NOTE These requirements are adapted from 6.1t) of IEC 60601-2-7:1998.
Additional subclause:
201.7.2.101 Beam limiting device
BEAM LIMITING DEVICES shall be provided with the following markings:
– those required in 7.2.2 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC
60601-1:2005/AMD2:2020;
– serial designation or individual identification;
– QUALITY EQUIVALENT FILTRATION of all materials together that are permanently fixed and
intercept the X-RAY BEAM.
NOTE These requirements are adapted from 6.1 of IEC 60601-2-28:1993.
201.7.8.1 Colours of indicator lights
Addition:
The indication of X-RAY related states shall be excluded from 7.8 of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020. Subclauses 203.6.4.2 and
203.6.4.101 shall apply instead. Yellow and green colors of lights which are listed in Table 2 of
IEC 60601-1:2005 and IEC 60601-1:2005/AMD2:2020 should only be used if they are clearly
distinguishable from the indication of the X-ray related states as required in these subclauses.
If applicable, conflicts which can arise from using same or similar colors for indication of X-RAY
related states and other functions of the ME EQUIPMENT shall be evaluated by using the USABILITY
process.
ENGINEERING
Colors of indicator lights and alarm indicator lights for ME EQUIPMENT which are designated as
HIGH PRIORITY, MEDIUM PRIORITY, and LOW PRIORITY ALARM CONDITION listed in Table 2 of
IEC 60601-1:2005 and IEC 60601-1:2005/AMD2:2020 do not apply to X-RAY EQUIPMENT.
NOTE Even though 7.8 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020
mentions the collateral standard IEC 60601-1-8 which application is excluded in 201.1.3 of this document, the
selected specified references therein are considered informative and help to understand the requirements of 7.8 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.1 General
Addition:
The ACCOMPANYING DOCUMENTS shall contain instructions for MANUFACTURER-recommended
QUALITY CONTROL PROCEDURES and tests to be performed on the X-RAY EQUIPMENT by the
RESPONSIBLE ORGANIZATION. These shall include acceptance
...
IEC 60601-2-54 ®
Edition 2.0 2022-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-54: Particular requirements for the basic safety and essential
performance of X-ray equipment for radiography and radioscopy
Appareils électromédicaux –
Partie 2-54: Exigences particulières pour la sécurité de base et les
performances essentielles des appareils à rayonnement X utilisés pour la
radiographie et la radioscopie
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IEC 60601-2-54 ®
Edition 2.0 2022-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-54: Particular requirements for the basic safety and essential
performance of X-ray equipment for radiography and radioscopy
Appareils électromédicaux –
Partie 2-54: Exigences particulières pour la sécurité de base et les
performances essentielles des appareils à rayonnement X utilisés pour la
radiographie et la radioscopie
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-5592-6
– 2 – IEC 60601-2-54:2022 © IEC 2022
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 10
201.4 General requirements . 13
201.5 General requirements for testing ME EQUIPMENT . 14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 14
201.7 ME EQUIPMENT identification, marking and documents . 14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 18
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 20
201.10 Protection against unwanted and excessive radiation HAZARDS . 24
201.11 Protection against excessive temperatures and other HAZARDS . 24
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 25
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 25
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 25
201.15 Construction of ME EQUIPMENT . 25
201.16 ME SYSTEMS . 26
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 26
202 Electromagnetic disturbances – Requirements and tests . 26
202.101 * Immunity testing of ESSENTIAL PERFORMANCE . 26
203 RADIATION PROTECTION in diagnostic X-RAY EQUIPMENT. 26
203.4 General requirements . 27
203.5 ME EQUIPMENT identification, marking and documents . 28
203.6 RADIATION management . 31
203.7 RADIATION QUALITY . 46
203.8 Limitation of the extent of the X-RAY BEAM and relationship between X-RAY
FIELD and IMAGE RECEPTION AREA . 47
203.9 FOCAL SPOT TO SKIN DISTANCE . 54
203.10 ATTENUATION of the X-RAY BEAM between the PATIENT and the X-RAY IMAGE
RECEPTOR . 55
203.11 Protection against RESIDUAL RADIATION . 56
203.12 Protection against LEAKAGE RADIATION . 58
203.13 Protection against STRAY RADIATION . 58
Annexes . 64
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 65
Annex AA (informative) Particular guidance and rationale . 67
Bibliography . 72
Index of defined terms used in this document . 74
Figure 203.101 – Zone of EXTRA-FOCAL RADIATION . 47
Figure 203.102 – Discrepancies in covering the IMAGE RECEPTION AREA . 49
Figure 203.103 – Discrepancies in visual indication of the X-RAY FIELD . 53
Figure 203.104 – Testing for STRAY RADIATION (X-RAY BEAM horizontal with X-RAY
SOURCE ASSEMBLY below the PATIENT SUPPORT) . 61
Figure 203.105 – Testing for STRAY RADIATION (X-RAY BEAM vertical with X-RAY SOURCE
ASSEMBLY below the PATIENT SUPPORT) . 62
Figure 203.106 – Testing for STRAY RADIATION (X-RAY BEAM horizontal with X-RAY
SOURCE ASSEMBLY above the PATIENT SUPPORT) . 62
Figure 203.107 – Testing for STRAY RADIATION (X-RAY BEAM vertical with X-RAY SOURCE
ASSEMBLY above the PATIENT SUPPORT) . 63
Table 201.101 – Distributed potential ESSENTIAL PERFORMANCE requirements . 13
Table 203.101 – Tests for verifying reproducibility and linearity . 34
Table 203.102 – LOADINGS for testing automatic exposure controls . 36
Table 203.103 – ATTENUATION for the measurement of AIR KERMA. 38
Table 203.104 – ATTENUATION EQUIVALENT of items in the X-RAY BEAM . 55
Table 203.105 – Application categories. 57
Table 203.106 – Requirements for PRIMARY PROTECTIVE SHIELDING . 58
Table 203.107 – STRAY RADIATION in SIGNIFICANT ZONES OF OCCUPANCY . 60
Table 201.C.101 – Marking on the outside of ME EQUIPMENT or its parts . 65
Table 201.C.102 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 66
– 4 – IEC 60601-2-54:2022 © IEC 2022
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-54: Particular requirements for the basic safety and essential
performance of X-ray equipment for radiography and radioscopy
FOREWORD
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rights. IEC shall not be held responsible for identifying any or all such patent rights.
IEC 60601-2-54 has been prepared by subcommittee 62B: Diagnostic imaging equipment, of
IEC technical committee 62: Electrical equipment in medical practice. It is an International
Standard.
This second edition cancels and replaces the first edition published in 2009, Amendment 1:2015
and Amendment 2:2018. This edition constitutes a technical revision.
This edition includes editorial and technical changes to reflect the
IEC 60601-1:2005/AMD2:2020. It also contains corrections and technical improvements.
Significant technical changes with respect to the previous edition are as follows:
a) a new specific term DOSIMETER is introduced to replace the general term DOSEMETER;
b) terms and definitions taken exclusively from IEC TR 60788:2004 and which are specifically
applicable in this document have been moved to 201.3;
c) the collateral standards IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020,
IEC 60601-1-12:2014 and IEC 60601-1-12:2014/AMD1:2020 are applicable if
MANUFACTURER so declares;
d) the subclause 201.11.101 “Protection against excessive temperatures of X-ray tube
assemblies” has been removed from this document as its requirements are sufficiently and
clearly covered by IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-
1:2005/AMD2:2020 and IEC 60601-2-28:2017;
e) to adopt changes which are introduced with respect to indicator lights in 7.8.1 of the
IEC 60601-1:2005/AMD2:2020 clarification of requirements is provided to avoid conflicts
with requirements of indicator lights stipulated for X-RAY EQUIPMENT;
ESSENTIAL PERFORMANCE is provided in Annex AA to emphasize the
f) explanation of the term
performance of the clinical function under NORMAL and SINGLE FAULT CONDITIONS.
The text of this document is based on the following documents:
Draft Report on voting
62B/1285/FDIS 62B/1293/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/standardsdev/publications.
In this document, 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 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 AND IEC
60601-1:2005/AMD2:2020, IN THIS DOCUMENT OR AS NOTED: SMALL CAPITALS.
In referring to the structure of this document, 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 document are preceded by the term “Clause” followed by the
clause number. References to subclauses within this document are by number only.
In this document, 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 document conform to usage described in Clause 7 of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance with
this document;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
– 6 – IEC 60601-2-54:2022 © IEC 2022
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 and IEC 80601 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 document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
INTRODUCTION
This document has been prepared to provide, based on IEC 60601-1:2005 (third edition) and
its collaterals, a complete set of safety requirements for ME EQUIPMENT for RADIOGRAPHY and
RADIOSCOPY. The purpose of this second edition is to introduce changes to reference the second
amendment (2020) to IEC 60601-1:2005 and associated collateral standards. Moreover, in
Annex AA a clarification of the term for ESSENTIAL PERFORMANCE is provided. This document
addresses the system level of X-RAY EQUIPMENT, which consists of a combination of an X-RAY
GENERATOR, ASSOCIATED EQUIPMENT and ACCESSORIES. Component functions are addressed as
far as necessary.
The minimum safety requirements specified in this document are considered to provide for a
practical degree of safety in the operation of ME EQUIPMENT for RADIOGRAPHY and RADIOSCOPY.
Requirements for additional provisions for ME EQUIPMENT for interventional applications are
covered by IEC 60601-2-43.
– 8 – IEC 60601-2-54:2022 © IEC 2022
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-54: Particular requirements for the basic safety and essential
performance of X-ray equipment for radiography and radioscopy
201.1 Scope, object and related standards
Clause 1 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.1.1 Scope
Replacement:
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and
ME SYSTEMS intended to be used for projection RADIOGRAPHY and INDIRECT RADIOSCOPY.
IEC 60601-2-43 applies to ME EQUIPMENT and ME SYSTEMS intended to be used for interventional
applications and refers to applicable requirements in this document.
ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption densitometry,
computed tomography, mammography or dental or radiotherapy applications are excluded from
the scope of this document. The scope of this document also excludes radiotherapy simulators.
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.
201.1.2 Object
Replacement:
BASIC SAFETY and ESSENTIAL PERFORMANCE
The object of this document is to establish particular
requirements for ME EQUIPMENT and ME SYSTEMS for RADIOGRAPHY and RADIOSCOPY.
201.1.3 Collateral standards
Addition:
This document refers to those applicable collateral standards that are listed in Clause 2 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 as
modified in 201.2.
IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-3:2008 and
IEC 60601-1-3:2008/AMD1:2013 and IEC 60601-1-3:2008/AMD2:2021 apply, as modified in
Clauses 202 and 203 respectively. If the MANUFACTURER declares that the ME EQUIPMENT or ME
SYSTEM is intended to be operated in a HOME HEALTHCARE ENVIRONMENT, then
IEC 60601-1-11:2015 and IEC 60601-1-11:2015/AMD1:2020 apply and if the MANUFACTURER
declares that the ME EQUIPMENT or ME SYSTEM is intended to be operated in an EMERGENCY
MEDICAL SERVICES ENVIRONMENT, then IEC 60601-1-12:2014 and
IEC 60601-1-12:2015/AMD1:2020 apply. IEC 60601-1-8, IEC 60601-1-9, IEC 60601-1-10 do
not apply. All other published collateral standards in the IEC 60601-1 series apply as published.
NOTE 1 OPERATORS of X-RAY EQUIPMENT are used to audible signals as specified in this document rather than to
the concepts of IEC 60601-1-8. Therefore IEC 60601-1-8 does not apply.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020 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 IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
The numbering of clauses and subclauses of this document corresponds to that of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 with the
prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020) 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 document addresses the content of Clause 4 of
the IEC 60601-1-2 collateral standard, 203.4 in this document addresses the content of
Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text of the
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are
specified by the use of the following words:
“Replacement” means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or the applicable collateral
standard is replaced completely by the text of this document.
“Addition” means that the text of this document is additional to the requirements of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or the
applicable collateral standard.
“Amendment” means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or the applicable collateral
standard is amended as indicated by the text of this document.
Subclauses, figures or tables which are additional to those of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered starting from
201.101. However, due to the fact that definitions in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered 3.1 through
3.154, additional definitions in this document 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.
Where there is no corresponding clause or subclause in this document, the clause or subclause
of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or the
applicable collateral standard, although possibly not relevant, applies without modification;
where it is intended that any part of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC
60601-1:2005/AMD2:2020 or the applicable collateral standard, although possibly relevant, is
not to be applied, a statement to that effect is given in this document.
– 10 – IEC 60601-2-54:2022 © IEC 2022
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020 applies, except as follows:
Addition:
IEC 60336:2020, Medical electrical equipment – X-ray tube assemblies for medical diagnosis –
Focal spot dimensions and related characteristics
IEC 60580:2019, Medical electrical equipment – Dose area product meters
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 60806, Determination of the maximum symmetrical radiation field of X-ray tube assemblies
and X-ray source assemblies for medical diagnosis
IEC 61910-1:2014, Medical electrical equipment – Radiation dose documentation – Part 1:
Radiation dose structured reports for radiography and radioscopy
IEC 62494-1:2008, Medical electrical equipment – Exposure index of digital X-ray imaging
systems – Part 1: Definitions and requirements for general radiography
Amendment:
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
IEC 60601-1-3:2008/AMD1:2013
IEC 60601-1-3:2008/AMD2:2021
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020, IEC TR 60788:2004 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An Index of defined terms is found in the last part of this document.
Addition:
201.3.201
APPARENT RESISTANCE OF SUPPLY MAINS
for diagnostic X-RAY GENERATOR, resistance of the SUPPLY MAINS determined under specific load
conditions
201.3.202
AUTOMATIC INTENSITY CONTROL
in an X-RAY GENERATOR, mode of operation in which one or more LOADING FACTORS are controlled
automatically in order to obtain at a pre-selected location a desired rate of a RADIATION QUANTITY
201.3.203
DIRECT RADIOGRAPHY
RADIOGRAPHY in which the permanent recording is effected at an IMAGE RECEPTION AREA
Example: Film-screen or film RADIOGRAPHY.
201.3.204
DIRECT RADIOSCOPY
RADIOSCOPY in which the visible images are presented at the IMAGE RECEPTION AREA, or close to
it, in the RADIATION BEAM
201.3.205
DOSE AREA PRODUCT
product of the area of the cross-section of an X-RAY BEAM and the averaged AIR KERMA over that
cross-section. The unit is the gray square metre (Gy⋅m )
Note 1 to entry: This definition is equivalent to AIR KERMA area product.
201.3.206
DOSIMETER
EQUIPMENT which uses ionization chambers or semiconductor detectors for the measurement of
AIR KERMA or AIR KERMA RATE in the beam of an X-RAY EQUIPMENT used for diagnostic medical
RADIOLOGICAL examinations
201.3.207
ENTRANCE FIELD SIZE
dimensions of the field in the entrance plane of an X-RAY IMAGE RECEPTOR that can be used for
the transmission of an X-RAY PATTERN under specific conditions
201.3.208
EXAMINATION PROTOCOL
full set of any programmed technical factors, control functions and settings, including image
processing settings, designed to optimize the image acquisition and DISPLAY
201.3.209
EXAMINATION PROTOCOL SELECTION CONTROL
control to select a PRE-PROGRAMMED EXAMINATION PROTOCOL
201.3.210
HIGH-VOLTAGE GENERATOR
in an X-RAY GENERATOR, combination of all components for control and production of the
electrical energy to be supplied to an X-RAY TUBE, usually consisting of a high-voltage
transformer assembly and a control assembly
201.3.211
IMAGE RECEPTION PLANE
plane containing the greatest dimensions of the IMAGE RECEPTION AREA
– 12 – IEC 60601-2-54:2022 © IEC 2022
201.3.212
INDIRECT RADIOGRAPHY
RADIOGRAPHY in which the permanent recording is effected after TRANSFER of the information
obtained at an IMAGE RECEPTION AREA
Examples: CR systems, digital detector systems, image intensifier systems.
201.3.213
INDIRECT RADIOSCOPY
RADIOSCOPY in which the images are presented at a location outside the RADIATION BEAM after
TRANSFER of the information
201.3.214
INTERLOCK
means preventing the start or the continued operation of ME EQUIPMENT unless certain
predetermined conditions prevail
201.3.215
ISOCENTRE
in RADIOLOGICAL equipment with several modes of movement of the REFERENCE AXIS around a
common centre, centre of the smallest sphere through which the X-RAY BEAM AXIS passes
201.3.216
LAST IMAGE HOLD RADIOGRAM
LIH RADIOGRAM
single image obtained by sampling or temporal processing of one or more images from the end
of a radioscopic IRRADIATION
Note 1 to entry: This note applies to the French language only.
201.3.217
NOMINAL ELECTRIC POWER
for a HIGH-VOLTAGE GENERATOR, highest constant electric power which can be delivered for a
single X-RAY TUBE load in a specific LOADING TIME
201.3.218
NOMINAL SHORTEST IRRADIATION TIME
shortest LOADING TIME for which a required constancy of the controlled radiation quantity is
maintained
Note 1 to entry: The IRRADIATION TIME is controlled by a HIGH-VOLTAGE GENERATOR with AUTOMATIC CONTROL
SYSTEMS.
201.3.219
PRE-PROGRAMMED EXAMINATION PROTOCOL
single hardware or software setting, or both, which is associated with an EXAMINATION PROTOCOL
201.3.220
QUALITY CONTROL
operational techniques and activities that are used to fulfil requirements for quality
201.3.221
RADIATION OUTPUT
AIR KERMA per CURRENT TIME PRODUCT (mGy/mAs) at a given distance from the FOCAL SPOT in
the primary X-RAY BEAM
201.3.222
RADIOSCOPY REPLAY IMAGE SEQUENCE
series of the most recent images of the most recent RADIOSCOPY IRRADIATION-EVENT
201.3.223
REGION OF INTEREST
localized part of an image, which is of particular interest at a given time
201.3.224
SERIAL RADIOGRAPHY
RADIOGRAPHY in which the information is obtained and recorded in a regular or irregular series
of LOADINGS with equal or unequal LOADING FACTORS
201.3.225
SIX-PEAK HIGH-VOLTAGE GENERATOR
HIGH-VOLTAGE GENERATOR for operation on a three-phase supply that delivers a rectified output
voltage with six peaks during each cycle of the supply
201.3.226
TIMING DEVICE
device integrating and/or presenting time elapsed during an equipment function and optionally
changing the state of operation at the end of a predetermined time interval
201.3.227
TWELVE-PEAK HIGH-VOLTAGE GENERATOR
HIGH-VOLTAGE GENERATOR for operation on a three-phase supply that delivers a rectified output
voltage with twelve peaks during each cycle of the supply
201.3.228
X-RAY BEAM AXIS
for a symmetrical RADIATION BEAM, line through the centre of the RADIATION SOURCE and half way
between the effective edges of the BEAM LIMITING DEVICE
Note 1 to entry: Usually, the X-RAY BEAM AXIS coincides within required tolerances with the REFERENCE AXIS of the
RADIATION SOURCE.
201.4 General requirements
Clause 4 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020 applies, except as follows:
SSENTIAL PERFORMANCE
201.4.3 E
Additional subclause:
ESSENTIAL PERFORMANCE requirements
201.4.3.101 * Additional potential
Additional potential ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in
Table 201.101.
Table 201.101 – Distributed potential ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Accuracy of LOADING FACTORS 203.6.4.3.104
Reproducibility of the RADIATION output 203.6.3.2
AUTOMATIC CONTROL SYSTEM 203.6.5
Imaging performance 203.6.7
– 14 – IEC 60601-2-54:2022 © IEC 2022
201.4.10.2 Supply mains for ME EQUIPMENT and ME SYSTEMS
Addition:
The internal impedance of a SUPPLY MAINS shall be considered sufficiently low for the operation
of X-RAY EQUIPMENT for RADIOGRAPHY and RADIOSCOPY 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 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.
A three-phase SUPPLY MAINS is considered to have a practical symmetry if it delivers symmetrical voltages and
produces, when loaded symmetrically, symmetrical currents.
The requirements of this document are based upon the assumption that three-phase systems have a symmetrical
configuration of the MAINS VOLTAGE with respect to earth. Single-phase systems can 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.
X-RAY EQUIPMENT is considered to comply with the requirements of this document 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 ME EQUIPMENT
Clause 5 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020 applies.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020 applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020 applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.7 Electrical input power from the SUPPLY MAINS
Addition:
For ME EQUIPMENT that is specified to be PERMANENTLY INSTALLED, the information may be stated
in the ACCOMPANYING DOCUMENTS only.
The information on the input power shall be specified in terms of combinations of
a) the RATED MAINS VOLTAGE of the ME EQUIPMENT in volts; see 7.2.1 and 7.2.6 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
b) the number of phases; see 7.2.1 and 7.2.6 of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
c) the frequency, in hertz; see 7.2.1 and 7.2.6 of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
d) the maximum permissible value for APPARENT RESISTANCE OF SUPPLY MAINS, in ohms;
OVER-CURRENT RELEASES required in the SUPPLY MAINS.
e) the characteristics of
201.7.2.15 Cooling conditions
Addition:
If cooling is necessary for safe operation of ME EQUIPMENT, or a subassembly thereof, the cooling
ACCOMPANYING DOCUMENT, including as appropriate:
requirements shall be indicated in the
– the maximum heat dissipation into the surrounding air, given separately for each
subassembly that dissipates more than 100 W and might be separately located on
installation;
– the maximum heat dissipation into forced air cooling devices, and the corresponding flow
rate and temperature rise of the forced air stream;
– the maximum heat dissipation into a cooling medium utility and the permissible input
temperature range, minimum flow rate and pressure requirements for the utility.
Additional subclause:
201.7.2.101 Beam limiting device
BEAM LIMITING DEVICES shall be provided with the following markings:
– those required in 7.2.2 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC
60601-1:2005/AMD2:2020;
– serial designation or individual identification;
– QUALITY EQUIVALENT FILTRATION of all materials together that are permanently fixed and
intercept the X-RAY BEAM.
201.7.8.1 Colours of indicator lights
Addition:
The indication of X-RAY related states shall be excluded from 7.8 of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020. Subclauses 203.6.4.2 and
203.6.4.101 shall apply instead. Yellow and green colors of lights which are listed in Table 2 of
IEC 60601-1:2005 and IEC 60601-1:2005/AMD2:2020 should only be used if they are clearly
distinguishable from the indication of the X-ray related states as required in these subclauses.
If applicable, conflicts which can arise from using same or similar colors for indication of X-RAY
related states and other functions of the ME EQUIPMENT shall be evaluated by using the USABILITY
ENGINEERING process.
Colors of indicator lights and alarm indicator lights for ME EQUIPMENT which are designated as
HIGH PRIORITY, MEDIUM PRIORITY, and LOW PRIORITY ALARM CONDITION listed in Table 2 of
RAY EQUIPMENT.
IEC 60601-1:2005 and IEC 60601-1:2005/AMD2:2020 do not apply to X-
NOTE Even though 7.8 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020
mentions the collateral standard IEC 60601-1-8 which application is excluded in 201.1.3 of this document, the
selected specified references therein are considered informative and help to understand the requirements of 7.8 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
– 16 – IEC 60601-2-54:2022 © IEC 2022
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.1 General
Addition:
The ACCOMPANYING DOCUMENTS shall contain instructions for MANUFACTURER-recommended
QUALITY CONTROL PROCEDURES and tests to be performed on the X-RAY EQUIPMENT by the
RESPONSIBLE ORGANIZATION. These shall include acceptance criteria for each test and frequency
for each test.
NOTE The intention is to perform these QUALITY CONTROL PROCEDURES and tests using only the supplied information.
Additionally for X-RAY EQUIPMENT provided with an integrated digital X-RAY IMAGE RECEPTOR, the
ACCOMPANYING DOCUMENTS shall contain:
– an identification of adjustable or selectable image processing applied to ORIGINAL DATA
including the version number or how to determine it;
– a description of the file transfer format of the images acquired with this unit and of any data
associated with these images.
The performance of means required to present the images for diagnostic purpose shall be stated
according to the INTENDED USE.
If the test or PROCEDURE requires a device-specific TOOL that is only available from the
MANUFACTURER, the MANUFACTURER shall make this TOOL available to the RESPONSIBLE
ORGANIZATION.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
201.7.9.2 Instructions for use
201.7.9.2.1 General
Additional subclauses:
201.7.9.2.1.101 LOADING FACTORS
In the instructions for use the LOADING FACTORS shall be stated as described below. The
following combinations and data shall be stated:
a
...
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