IEC 60601-2-54:2009

IEC 60601-2-54 ®
Edition 1.1 2015-04
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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

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 1.1 2015-04
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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

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 978-2-8322-2619-3

IEC 60601-2-54 ®
Edition 1.1 2015-04
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
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

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
– 2 – IEC 60601-2-54:2009
+AMD1:2015 CSV  IEC 2015
CONTENTS
FOREWORD . 4

INTRODUCTION . 7

INTRODUCTION TO AMENDMENT 1 . 7

201.1 Scope, object and related standards. 8

201.2 Normative references . 9

201.3 Terms and definitions . 10

201.4 General requirements . 11
201.5 General requirements for testing of ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 15
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 18
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 . 23
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
202 Electromagnetic compatibility – Requirements and tests . 24
203 Radiation protection in diagnostic X-ray equipment . 24
Annexes . 60
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 61
Annex AA (informative) Particular guidance and rationale . 63
Bibliography . 66
Index of defined terms used in this particular standard. 67

Figure 203.101 – Zone of EXTRA-FOCAL RADIATION . 43
Figure 203.102 – Discrepancies in covering the IMAGE RECEPTION AREA . 45
Figure 203.103 – Discrepancies in visual indication of the X-RAY FIELD . 49
Figure 203.104 – Testing for STRAY RADIATION (X-RAY BEAM horizontal with X-RAY
SOURCE ASSEMBLY below the PATIENT SUPPORT) . 57
Figure 203.105 – Testing for STRAY RADIATION (X-RAY BEAM vertical with X-RAY SOURCE
ASSEMBLY below the PATIENT SUPPORT) . 57
Figure 203.106 – Testing for STRAY RADIATION (X-RAY BEAM horizontal with X-RAY
SOURCE ASSEMBLY above the PATIENT SUPPORT) . 58
Figure 203.107 – Testing for STRAY RADIATION (X-RAY BEAM vertical with X-RAY SOURCE
ASSEMBLY above the PATIENT SUPPORT) . 59

Table 201.101 – Distributed potential ESSENTIAL PERFORMANCE requirements . 11

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Table 203.101 – Tests for verifying reproducibility and linearity . 31

Table 203.102 – Loadings for testing AUTOMATIC EXPOSURE CONTROLS . 33

Table 203.103 – ATTENUATION for the measurement of AIR KERMA . 35

Table 203.104 – ATTENUATION EQUIVALENT of items in the X-RAY BEAM . 51

Table 203.105 – Application categories . 53

Table 203.106 – Requirements for PRIMARY PROTECTIVE SHIELDING . 53

Table 203.107 – STRAY RADIATION in SIGNIFICANT ZONES OF OCCUPANCY . 55

Table 201.C.101 – Marking on the outside of ME EQUIPMENT or its parts . 61

Table 201.C.102 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 61

– 4 – IEC 60601-2-54:2009
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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
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,
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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.

This consolidated version of the official IEC Standard and its amendment has been prepared
for user convenience.
IEC 60601-2-54 edition 1.1 contains the first edition (2009-06) [documents 62B/735/FDIS and
62B/750/RVD] and its amendment 1 (2015-04) [documents 62B/929/CDV and 62B/956/RVC].
In this Redline version, a vertical line in the margin shows where the technical content is
modified by amendment 1. Additions and deletions are displayed in red, with deletions being
struck through. A separate Final version with all changes accepted is available in this
publication.
+AMD1:2015 CSV  IEC 2015
International standard IEC 60601-2-54 has been prepared by IEC subcommittee 62B:
Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical

practice.
IEC 60601-2-54 has been developed for use with the third edition of IEC 60601-1 (2005). It

replaces and supersedes IEC 60601-2-7 and IEC 60601-2-32, as well as parts of IEC 60601-

2-28:1993 (currently under revision), all of which were developed to amend earlier editions of

IEC 60601-1 and consequently no longer apply to this particular standard.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

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.
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 series, published under the general title Medical electrical
equipment, can be found on the IEC website.

– 6 – IEC 60601-2-54:2009
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The committee has decided that the contents of the base publication and its amendment will
remain unchanged until the stability date indicated on the IEC web site under

"http://webstore.iec.ch" in the data related to the specific publication. At this date, the

publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or

• amended.
The contents of the corrigenda of March 2010 and June 2011 have been included in this
copy.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
+AMD1:2015 CSV  IEC 2015
INTRODUCTION
This particular standard 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. While the previously existing standards for such equipment

were dedicated to components and subsystems, this particular standard 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 particular standard 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.

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.
– 8 – IEC 60601-2-54:2009
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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

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
ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and
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 particular
standard.
ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption
densitometry, computed tomography, mammography or dental applications are excluded from
the scope of this International Standard. The scope of this International Standard 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.
NOTE Taking into account economic and social factors, the scope of this particular standard includes
ME EQUIPMENT intended to be used for DIRECT RADIOSCOPY. In some countries examinations performed with
DIRECT RADIOSCOPY are prohibited.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for ME EQUIPMENT and ME SYSTEMS for RADIOGRAPHY and
RADIOSCOPY.
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 60601-1-2 and IEC 60601-1-3 apply as modified in Clauses 202 and 203 respectively.
IEC 60601-1-8, 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.
—————————
1)
The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance

+AMD1:2015 CSV  IEC 2015
NOTE OPERATORS of X-RAY EQUIPMENT are used to audible signals as required in this particular standard 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 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 number.
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:
“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 clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part 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 on page 66.

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Clause 2 of the general standard applies, except as follows:

Addition:
IEC 60336, Medical electrical equipment – X-ray tube assemblies for medical diagnosis –

Characteristics of focal spots

IEC 60580:2000, 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/TR 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 60806, Determination of the maximum symmetrical radiation field from a rotating anode
X-ray tube for medical diagnosis
IEC 62220-1:2003, Medical electrical equipment – Characteristics of digital X-ray imaging
devices – Part 1: Determination of the detective quantum efficiency
Amendment:
IEC 60601-1-2:2007 Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance– Collateral standard: Electromagnetic compatibility –
Requirements and tests
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
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012, applicable collateral standards and IEC 60788:2004 apply,
except as follows:
NOTE An index of defined terms is found beginning on page 66.

Addition:
201.3.201
DIRECT RADIOGRAPHY
RADIOGRAPHY in which the permanent recording is effected at an IMAGE RECEPTION AREA
Example: film-screen or film radiography.
201.3.202
DIRECT RADIOSCOPY
RADIOSCOPY in which the visible images are presented at the IMAGE RECEPTION AREA, or close
to it, in the RADIATION BEAM
201.3.203
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

+AMD1:2015 CSV  IEC 2015
201.3.204
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

201.3.205
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.

201.3.206
INDIRECT RADIOSCOPY
RADIOSCOPY in which the images are presented at a location outside the RADIATION BEAM after
TRANSFER of the information
201.3.207
INTERLOCK
means preventing the start or the continued operation of ME EQUIPMENT unless certain
predetermined conditions prevail
201.3.208
NOMINAL SHORTEST IRRADIATION TIME
shortest LOADING TIME for which a required constancy of the controlled RADIATION QUANTIY is
maintained
NOTE The IRRADIATION TIME is controlled by a HIGH-VOLTAGE GENERATOR with AUTOMATIC CONTROL SYSTEMS.
201.3.209
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
201.4 General requirements
Clause 4 of the general standard 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
– 12 – IEC 60601-2-54:2009
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201.4.10.2 Supply mains for ME EQUIPMENT and ME SYSTEMS

Addition:
The internal impedance of a SUPPLY MAINS is to be considered sufficiently low for the operation

of 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 standard are based upon the assumption that three-phase systems have a symmetrical
configuration of the MAINS VOLTAGE with respect to earth. Single-phase systems may be derived from such
three-phase systems. Where the supply system is not earthed at the source it is assumed that adequate measures
have been provided to detect, limit and remedy any disturbance of symmetry within a reasonably short time.
X-RAY EQUIPMENT is considered to comply with the requirements of this standard only if its specified NOMINAL
ELECTRIC POWER can be demonstrated at an APPARENT RESISTANCE OF SUPPLY MAINS having a value not less than
the APPARENT RESISTANCE OF SUPPLY MAINS specified by the MANUFACTURER in the ACCOMPANYING DOCUMENTS.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard 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 the general
standard,
b) the number of phases; see 7.2.1 and 7.2.6 of the general standard,
c) the frequency, in hertz; see 7.2.1 and 7.2.6 of the general standard,

+AMD1:2015 CSV  IEC 2015
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 subclause 7.2.2 of the general standard;
– serial designation or individual identification;
– TOTAL FILTRATION in terms of 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 subclause 7.8 in the general
standard. Subclauses 203.6.4.2 and 203.6.4.101 shall apply instead.
201.7.9 ACCOMPANYING DOCUMENTS

201.7.9.1 General
Addition:
The ACCOMPANYING DOCUMENTS shall contain quality control procedures to be performed on
the X-RAY EQUIPMENT by the RESPONSIBLE ORGANISATION. These shall include acceptance
criteria and frequency for the tests.
Additionally for X-RAY EQUIPMENT provided with an integrated digital X-RAY IMAGE RECEPTOR,
ACCOMPANYING DOCUMENTS shall contain:
the
– a description of image processing applied to ORIGINAL DATA including the revision number
or how to determine it and identification of the version if applicable;
– a description of the file transfer format of the images acquired with this unit and of any
data associated with these images;

– 14 – IEC 60601-2-54:2009
+AMD1:2015 CSV  IEC 2015
The performance of means required to present the images for diagnostic purpose shall be

stated according to the INTENDED USE.

Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.

201.7.9.2 Instructions for use

201.7.9.2.1 General
Addition:
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) The corresponding NOMINAL X-RAY TUBE VOLTAGE for RADIOSCOPY and RADIOGRAPHY
together with the highest X-RAY TUBE CURRENT obtainable from the ME EQUIPMENT when
operated at that X-RAY TUBE VOLTAGE.
b) The corresponding highest X-RAY TUBE CURRENT for RADIOSCOPY and RADIOGRAPHY
together with the highest X-RAY TUBE VOLTAGE obtainable from the ME EQUIPMENT when
operating at that X-RAY TUBE CURRENT.
c) The corresponding combination of X-RAY TUBE VOLTAGE for RADIOSCOPY and RADIOGRAPHY,
and X-RAY TUBE CURRENT which results in the highest electric power in the high-voltage
circuit (see 203.4.101).
d) The NOMINAL ELECTRIC POWER given as the highest constant electric power in kilowatts
which the ME EQUIPMENT can produce/generate, for a LOADING TIME of 0,1 s at an X-RAY
TUBE VOLTAGE of 100 kV or, if these values are not selectable, with nearest parameters
(see 203.4.101).
The NOMINAL ELECTRIC POWER shall be given together with the combination of X-RAY TUBE
VOLTAGE and X-RAY TUBE CURRENT and the LOADING TIME.
e) For ME EQUIPMENT indicating precalculated or measured CURRENT TIME PRODUCT, the
lowest CURRENT TIME PRODUCT or the combinations of LOADING FACTORS resulting in the
lowest CURRENT TIME PRODUCT.
If the value of the lowest CURRENT TIME PRODUCT depends upon the X-RAY TUBE VOLTAGE or
upon certain combinations of values of LOADING FACTORS, the lowest CURRENT TIME
PRODUCT may be given as a table or curve showing the dependence.
f) The NOMINAL SHORTEST IRRADIATION TIME used in AUTOMATIC EXPOSURE CONTROL systems of
ME EQUIPMENT.
If the NOMINAL SHORTEST IRRADIATION TIME depends upon LOADING FACTORS such as X-RAY

TUBE VOLTAGE and X-RAY TUBE CURRENT, the ranges of these LOADING FACTORS for which
the NOMINAL SHORTEST IRRADIATION TIME is valid shall be stated.
The maximum possible range of the X-RAY TUBE VOLTAGE and/or the X-RAY TUBE CURRENT
during IRRADIATIONS, controlled with the AUTOMATIC EXPOSURE CONTROL SYSTEMS, shall be
stated in the instructions for use.
NOTE These requirements are adapted from 6.8.2 a) of IEC 60601-2-7:1998.
201.7.9.2.1.102 X-RAY SOURCE ASSEMBLY
The instructions for use shall state the maximum symmetrical RADIATION FIELD of the
integrated X-RAY SOURCE ASSEMBLY determined according to IEC 60806.
NOTE This requirement is adapted from 6.8.2 (dd) of IEC 60601-2-28:1993.

+AMD1:2015 CSV  IEC 2015
201.7.9.2.1.103 Integrated X-RAY IMAGE RECEPTOR

For X-RAY EQUIPMENT provided with an integrated X-RAY IMAGE RECEPTOR, the instructions for

use shall contain a description of the particular handling and maintenance of the X-RAY IMAGE

RECEPTOR.
Compliance is checked by inspection of the instructions for use.

201.7.9.2.17 ME EQUIPMENT emitting radiation

Replacement:
For X-RAY EQUIPMENT the instructions for use shall provide information as required in 203.5.
201.7.9.3 Technical description
Additional subclause:
201.7.9.3.101 X-RAY SOURCE ASSEMBLY
The technical description of the integrated X-RAY SOURCE ASSEMBLIES shall specify the
following, in addition to the data required to be marked according to subclause 7.2 of the
general standard:
a) specification of the REFERENCE AXIS to which the TARGET ANGLE(s) and the FOCAL SPOT
characteristics of the X-RAY SOURCE ASSEMBLY refer:
b) TARGET ANGLE(s) with respect to the specified REFERENCE AXIS;
c) position of the FOCAL SPOT and its tolerances on the REFERENCE AXIS;
d) NOMINAL FOCAL SPOT VALUE(s) determined according to IEC 60336 for the specified
REFERENCE AXIS.
NOTE These requirements are adapted from 6.8.3 dd) of IEC 60601-2-28:1993.
Additional subclause:
201.7.9.101 Additional statements in ACCOMPANYING DOCUMENTS
Additional requirements for statements in ACCOMPANYING DOCUMENTS (which include
instructions for use and technical description) are found in the subclauses listed in Table
201.C.102 of Annex C.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:

201.8.4 Limitation of voltage, current or energy
201.8.4.3 ME EQUIPMENT intended to be connected to a power source by a plug
Addition:
201.8.4.3.101 HIGH-VOLTAGE CABLE CONNECTIONS
Detachable HIGH-VOLTAGE CABLE CONNECTIONS shall either be designed so that the use of
TOOLS is required to disconnect them or they shall be provided with INTERLOCKS so that at all
times when protective covers or HIGH-VOLTAGE CONNECTIONS are removed:
– the ME EQUIPMENT is disconnected from its power supply, and

– 16 – IEC 60601-2-54:2009
+AMD1:2015 CSV  IEC 2015
– capacitances in the high-voltage circuit are discharged within the minimum time necessary

to gain access to the high-voltage circuit, and

– the discharged state is maintained.

Compliance is checked by inspection and by measurement.

NOTE These requirements are adapted from Clause 15, item aa) of IEC 60601-2-7:1998.

Additional subclause:
201.8.4.101 Limitation of X-RAY TUBE VOLTAGE

ME EQUIPMENT shall be designed so as not to deliver in INTENDED USE, to any connected X-RAY
TUBE ASSEMBLY, a voltage greater than the NOMINAL X-RAY TUBE VOLTAGE for the X-RAY TUBE
concerned or greater than the NOMINAL X-RAY TUBE VOLTAGE the X-RAY TUBE ASSEMBLY is
designed for, whichever is the lower voltage.
NOTE This requirement is adapted from 3.1 of IEC 60601-2-7:1998.
201.8.5 Separation of parts
201.8.5.1 MEANS OF PROTECTION (MOP)
Additional subclause:
201.8.5.1.101 Additional limitation of voltage, current or energy
Provision shall be made to prevent the appearance of an unacceptably high voltage in the
MAINS PART or in any other low-voltage circuit.
NOTE This may be achieved for example
– by provision of a winding layer or a conductive screen connected to the PROTECTIVE EARTH TERMINAL between
high-voltage and low-voltage circuits;
– by provision of a voltage limiting dev
...

IEC 60601-2-54 ®
Edition 1.2 2018-06
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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

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 1.2 2018-06
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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

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 978-2-8322-5862-0

IEC 60601-2-54 ®
Edition 1.2 2018-06
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
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

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
– 2 – IEC 60601-2-54:2009+AMD1:2015

+AMD2:2018 CSV  IEC 2018
CONTENTS
FOREWORD. 4

INTRODUCTION . 7

INTRODUCTION TO AMENDMENT 1 . 7

INTRODUCTION TO AMENDMENT 2 . 7

201.1 Scope, object and related standards . 8

201.2 Normative references . 9

201.3 Terms and definitions . 10
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 . 13
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 . 23
201.11 Protection against excessive temperatures and other HAZARDS . 23
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 24
201.13 HAZARDOUS SITUATIONS and fault conditions . 24
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 24
201.15 Construction of ME EQUIPMENT . 24
201.16 ME SYSTEMS . 24
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 25
202 Electromagnetic compatibility – Requirements and tests . 25
203 Radiation protection in diagnostic X-ray equipment . 25
Annexes . 65
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 66
Annex AA (informative) Particular guidance and rationale . 68
Bibliography . 73

Index of defined terms used in this particular standard . 75

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) . 62
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) . 63
Figure 203.107 – Testing for STRAY RADIATION (X-RAY BEAM vertical with X-RAY SOURCE
ASSEMBLY above the PATIENT SUPPORT) . 64

+AMD2:2018 CSV  IEC 2018
Table 201.101 – Distributed potential ESSENTIAL PERFORMANCE requirements . 12

Table 203.101 – Tests for verifying reproducibility and linearity. 33

Table 203.102 – Loadings for testing AUTOMATIC EXPOSURE CONTROLS . 35

Table 203.103 – ATTENUATION for the measurement of AIR KERMA . 37

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 . 66
Table 201.C.102 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 66

– 4 – IEC 60601-2-54:2009+AMD1:2015

+AMD2:2018 CSV  IEC 2018
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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patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
This consolidated version of the official IEC Standard and its amendments has been prepared
for user convenience.
IEC 60601-2-54 edition 1.2 contains the first edition (2009-06) [documents 62B/735/FDIS and
62B/750/RVD], its amendment 1 (2015-04) [documents 62B/929/CDV and 62B/956/RVC],
its amendment 2 (2018-06) [documents 62B/1089/FDIS and 62B/1097/RVD] and its
corrigenda 1 (March 2010) and 2 (June 2011).
In this Redline version, a vertical line in the margin shows where the technical content is
modified by amendments 1 and 2. Additions and deletions are displayed in red, with deletions
being struck through. A separate Final version with all changes accepted is available in this
publication.
+AMD2:2018 CSV  IEC 2018
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendments 1 and 2. Additions and deletions are displayed in red, with
deletions being struck through. A separate Final version with all changes accepted is

available in this publication.

International standard IEC 60601-2-54 has been prepared by IEC subcommittee 62B:

Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical

practice.
IEC 60601-2-54 has been developed for use with the third edition of IEC 60601-1 (2005). It

replaces and supersedes IEC 60601-2-7 and IEC 60601-2-32, as well as parts of IEC 60601-

2-28:1993 (currently under revision), all of which were developed to amend earlier editions of
IEC 60601-1 and consequently no longer apply to this particular standard.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
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.
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 series, published under the general title Medical electrical
equipment, can be found on the IEC website.

– 6 – IEC 60601-2-54:2009+AMD1:2015

+AMD2:2018 CSV  IEC 2018
The committee has decided that the contents of the base publication and its amendments will
remain unchanged until the stability date indicated on the IEC web site under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the

publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or

• amended.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
+AMD2:2018 CSV  IEC 2018
INTRODUCTION
This particular standard 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. While the previously existing standards for such equipment

were dedicated to components and subsystems, this particular standard 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 particular standard 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.

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.

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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

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
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 particular
standard.
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 International Standard. The scope of this International
Standard 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.
NOTE Taking into account economic and social factors, the scope of this particular standard includes
ME EQUIPMENT intended to be used for DIRECT RADIOSCOPY. In some countries examinations performed with
DIRECT RADIOSCOPY are prohibited.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for ME EQUIPMENT and ME SYSTEMS for RADIOGRAPHY and

RADIOSCOPY.
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 60601-1-2 and IEC 60601-1-3 apply as modified in Clauses 202 and 203 respectively.
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.
—————————
1)
The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance

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NOTE OPERATORS of X-RAY EQUIPMENT are used to audible signals as required in this particular standard 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 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 number.
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:
“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 clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part 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 on page 73.

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Clause 2 of the general standard applies, except as follows:

Addition:
IEC 60336, Medical electrical equipment – X-ray tube assemblies for medical diagnosis –

Characteristics of focal spots

IEC 60580:2000, 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/TR 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 60806, Determination of the maximum symmetrical radiation field from a rotating anode
X-ray tube for medical diagnosis
IEC 62220-1-1:2003 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
Amendment:
IEC 60601-1-2:2007 Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance– Collateral standard: Electromagnetic compatibility –
Requirements and tests
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 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
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012, applicable collateral standards and IEC 60788:2004 apply,
except as follows:
NOTE An index of defined terms is found beginning on page 73.
Addition:
201.3.201
DIRECT RADIOGRAPHY
RADIOGRAPHY in which the permanent recording is effected at an IMAGE RECEPTION AREA
Example: film-screen or film radiography.

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201.3.202
DIRECT RADIOSCOPY
RADIOSCOPY in which the visible images are presented at the IMAGE RECEPTION AREA, or close

to it, in the RADIATION BEAM
201.3.203
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 )

201.3.204
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
201.3.205
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.
201.3.206
INDIRECT RADIOSCOPY
RADIOSCOPY in which the images are presented at a location outside the RADIATION BEAM after
TRANSFER of the information
201.3.207
INTERLOCK
means preventing the start or the continued operation of ME EQUIPMENT unless certain
predetermined conditions prevail
201.3.208
NOMINAL SHORTEST IRRADIATION TIME
shortest LOADING TIME for which a required constancy of the controlled RADIATION QUANTIY is
maintained
NOTE The IRRADIATION TIME is controlled by a HIGH-VOLTAGE GENERATOR with AUTOMATIC CONTROL SYSTEMS.
201.3.209
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

201.3.210
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
201.3.211
EXAMINATION PROTOCOL SELECTION CONTROL
control to select a PRE-PROGRAMMED EXAMINATION PROTOCOL
201.3.212
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.

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201.3.213
PRE-PROGRAMMED EXAMINATION PROTOCOL

single hardware or software setting, or both, which is associated with an EXAMINATION

PROTOCOL
201.3.214
RADIOSCOPY REPLAY IMAGE SEQUENCE

series of the most recent images of the most recent RADIOSCOPY IRRADIATION-EVENT

201.4 General requirements
Clause 4 of the general standard 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 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 standard are based upon the assumption that three-phase systems have a symmetrical
configuration of the MAINS VOLTAGE with respect to earth. Single-phase systems may be derived from such
three-phase systems. Where the supply system is not earthed at the source it is assumed that adequate measures
have been provided to detect, limit and remedy any disturbance of symmetry within a reasonably short time.

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X-RAY EQUIPMENT is considered to comply with the requirements of this standard only if its specified NOMINAL

ELECTRIC POWER can be demonstrated at an APPARENT RESISTANCE OF SUPPLY MAINS having a value not less than
the APPARENT RESISTANCE OF SUPPLY MAINS specified by the MANUFACTURER in the ACCOMPANYING DOCUMENTS.

Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.

201.5 General requirements for testing of ME EQUIPMENT

Clause 5 of the general standard applies.

201.6 Classification of ME EQUIPMENT and ME SYSTEMS

Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard 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 the general
standard,
b) the number of phases; see 7.2.1 and 7.2.6 of the general standard,
c) the frequency, in hertz; see 7.2.1 and 7.2.6 of the general standard,
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:
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201.7.2.101 Beam limiting device

EAM LIMITING DEVICES shall be provided with the following markings:
B
– those required in subclause 7.2.2 of the general standard;

– serial designation or individual identification;

– TOTAL FILTRATION in terms of 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 subclause 7.8 in the general
standard. Subclauses 203.6.4.2 and 203.6.4.101 shall apply instead.
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 the each tests.
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:
– a description an identification of adjustable or selectable image processing applied to
ORIGINAL DATA including the revision version number or how to determine it and
identification of the version if applicable;
– 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
Addition:
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:

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a) The corresponding NOMINAL X-RAY TUBE VOLTAGE for RADIOSCOPY and RADIOGRAPHY

together with the highest X-RAY TUBE CURRENT obtainable from the ME EQUIPMENT when

operated at that X-RAY TUBE VOLTAGE.

RAY TUBE CURRENT for RADIOSCOPY and RADIOGRAPHY
b) The corresponding highest X-

together with the highest X-RAY TUBE VOLTAGE obtainable from the ME EQUIPMENT when

operating at that X-RAY TUBE CURRENT.

c) The corresponding combination of X-RAY TUBE VOLTAGE for RADIOSCOPY and RADIOGRAPHY,

RAY TUBE CURRENT which results in the highest electric power in the high-voltage
and X-
circuit (see 203.4.101).
d) The NOMINAL ELECTRIC POWER given as the highest constant electric power in kilowatts
which the ME EQUIPMENT can produce/generate, for a LOADING TIME of 0,1 s at an X-RAY

TUBE VOLTAGE of 100 kV or, if these values are not selectable, with nearest parameters
(see 203.4.101).
The NOMINAL ELECTRIC POWER shall be given together with the combination of X-RAY TUBE
VOLTAGE and X-RAY TUBE CURRENT and the LOADING TIME.
e) For ME EQUIPMENT indicating precalculated or measured CURRENT TIME PRODUCT, the
lowest CURRENT TIME PRODUCT or the combinations of LOADING FACTORS resulting in the
lowest CURRENT TIME PRODUCT.
If the value of the lowest CURRENT TIME PRODUCT depends upon the X-RAY TUBE VOLTAGE or
upon certain combinations of values of LOADING FACTORS, the lowest CURRENT TIME
PRODUCT may be given as a table or curve showing the dependence.
NOMINAL SHORTEST IRRADIATION TIME used in AUTOMATIC EXPOSURE CONTROL systems of
f) The
ME EQUIPMENT.
If the NOMINAL SHORTEST IRRADIATION TIME depends upon LOADING FACTORS such as X-RAY
TUBE VOLTAGE and X-RAY TUBE CURRENT, the ranges of these LOADING FACTORS for which
NOMINAL SHORTEST IRRADIATION TIME is valid shall be stated.
the
The maximum possible range of the X-RAY TUBE VOLTAGE and/or the X-RAY TUB
...