IEC 60601-2-54:2009/AMD2:2018

Amendment 2 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

Amendment 2 - 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

General Information

• Status: Published
• Publication Date: 28-Jun-2018
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Drafting Committee: WG 37 - TC 62/SC 62B/WG 37
• Current Stage: DELPUB - Deleted Publication
• Start Date: 26-Sep-2022
• Completion Date: 26-Oct-2025

Relations

• Amends: IEC 60601-2-54:2009 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
• Effective Date: 05-Sep-2023
• Revised: IEC 60601-2-54:2022 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
• Effective Date: 05-Sep-2023

Overview

IEC 60601-2-54:2009/AMD2:2018 is an important international standard published by the International Electrotechnical Commission (IEC) that focuses on the basic safety and essential performance of medical electrical equipment used for X-ray radiography and radioscopy. This amendment updates the original 2009 standard to reflect the latest state-of-the-art technology and clinical practices in diagnostic imaging.

By detailing specific requirements for X-ray equipment, this amendment ensures enhanced protection against radiation hazards, improved quality control, and effective management of examination protocols. It promotes patient safety and supports healthcare providers in delivering reliable diagnostic imaging.

Key Topics

• Scope update: The amendment excludes X-ray equipment specified for direct radioscopy from its scope, focusing instead on projection radiography and indirect radioscopy systems.
• Examination protocols: Emphasis on differentiation between adult and pediatric applications, especially for devices without automatic control systems. Manufacturers are encouraged to preload and clearly label protocols for diverse patient populations.
• Quality control procedures: Manufacturers are required to supply recommended quality control protocols, including acceptance criteria, testing frequency, and device-specific tools for maintenance and safety verification.
• Radiation dose documentation: The standard recommends implementing Radiation Dose Structured Reports (RDSR) in line with IEC 61910-1 for effective dose tracking and management.
• Last Image Hold (LIH) radiogram: Requires the display of the last image in radioscopy rather than simply providing a means to view it, enhancing clinical usability and patient safety.
• Beam limiting and focal spot control: Introduction of graphical displays showing beam-limiting device blade positions and stricter minimum focal spot-to-skin distances, with distinctions between mobile and fixed equipment.
• Radiation loading termination: Specifies fixed time limits for terminating X-ray loading after operator control release, improving control over radiation exposure.
• Electronic documentation: Establishes requirements for electronic access to examination protocols and related imaging parameters to streamline clinical workflows.

Applications

IEC 60601-2-54:2009/AMD2:2018 applies mainly to medical electrical equipment used in:

• Projection radiography - including general diagnostic X-ray imaging of bones, tissues, and organs.
• Indirect radioscopy - fluoroscopic procedures where image intensifiers or flat panels convert the X-ray image for display.
• Pediatric and adult imaging - providing specific protocol management tailored for different patient sizes and age groups.
• Quality assurance programs - enabling hospitals and clinics to maintain consistent performance and safety of X-ray devices through standardized quality control tests.
• Radiation dose management - facilitating accurate recording and control of patient exposure during diagnostic procedures.

Healthcare facilities, medical device manufacturers, clinical engineers, and regulatory authorities utilize this standard to guarantee compliance with safety and performance requirements for diagnostic imaging X-ray devices.

Related Standards

This amendment integrates and references multiple related IEC publications to ensure harmonized requirements across medical electrical equipment including:

• IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
• IEC 60601-1-2: Electromagnetic compatibility requirements as modified for X-ray equipment.
• IEC 60601-1-3: Radiation protection in diagnostic X-ray equipment.
• IEC 61910-1: Radiation dose documentation and structured reporting for radiography and radioscopy.
• IEC 62220-1-1: Evaluation of digital X-ray detector performance including Detective Quantum Efficiency (DQE).
• IEC 62494-1: Exposure index definitions and requirements for digital X-ray imaging systems.

These standards work collectively to ensure comprehensive safety, performance, and documentation protocols for medical imaging devices.

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Keywords: IEC 60601-2-54 amendment 2, X-ray equipment safety, radiography standards, radioscopy performance, medical electrical equipment, radiation dose structured report, examination protocols, radiographic quality control, diagnostic imaging standards, pediatric radiography safety

Standards Content (Sample)

IEC 60601-2-54 ®
Edition 1.0 2018-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 2
AM ENDEMENT 2
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
IEC 60601-2-54:2009-06/AMD2:2018-06(en-fr)

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IEC 60601-2-54 ®
Edition 1.0 2018-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 2
AM ENDEMENT 2
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 978-2-8322-5758-6

– 2 – IEC 60601-2-54:2009/AMD2:2018
© IEC 2018
FOREWORD
This amendment has been prepared by subcommittee 62B: Diagnostic imaging equipment, of
IEC technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62B/1089/FDIS 62B/1097/RVD
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC website 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.
_____________
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".
© IEC 2018
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.
201.1.1 Scope
Replace, in the first paragraph, the first existing sentence by the following new sentence:
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.
Replace the second existing paragraph by the following new paragraph:
ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption
densitometry, computed tomography, mammography, dental or radiotherapy applications are
excluded from the scope of this International Standard.
Delete the note.
201.1.3 Collateral standards
Replace the second paragraph, modified by IEC 60601-2-54:2009/AMD1:2015, by the
following new paragraph:
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.
201.2 Normative references
Replace the existing reference to IEC 62220-1:2003 by the following new reference:
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
Add, to the existing list, the following new references:
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
Add, after the existing definition 201.3.209, the following new terms and definitions:
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

– 4 – IEC 60601-2-54:2009/AMD2:2018
© IEC 2018
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.
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
201.7.9.1 General
Replace the first paragraph after "Addition:" by the following new paragraph and note:
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.
Replace the first dash in the second paragraph by the following new dash:
– an identification of adjustable or selectable image processing settings applied to ORIGINAL
DATA including the version number or how to determine it;
Add, before the compliance statement at the end of this subclause, the following new
paragraph:
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.
201.7.9.3.101 X-RAY SOURCE ASSEMBLY
Replace, at the end of the item a), the colon by a semicolon.
201.9.8 HAZARDS associated with support systems
Replace the existing title of this subclause by the following new title:
201.9.8 MECHANICAL HAZARDS associated with support systems
201.9.8.3.3 Dynamic forces due to loading from persons
Replace the paragraph starting with "Where mechanical analysis…" by the following new
paragraph:
© IEC 2018
Where mechanical analysis proves that the following alternate static load test is more severe
than the dynamic load test specified in the general standard, it is possible to waive the
dynamic load test based on RISK MANAGEMENT. If the dynamic load test is passed, the static
test may not be necessary.
201.10 Protection against unwanted and excessive radiation HAZARDS
Replace the existing text of this clause by the following new text:
Clause 10 of the general standard applies, except Subclause 10.3 (Microwave radiation),
which does not apply.
201.11 Protection against excessive temperatures and other HAZARDS
Add, before the instruction "Additional subclauses", the following new subclauses:
201.11.1.1 Maximum temperature during NORMAL USE
Addition:
NOTE Restrictions on allowable maximum temperature in Table 22 of the general standard for parts in contact
with oil shall not apply to parts wholly immersed in oil.
201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT
Replacement of the first paragraph modified by IEC 60601-1:2005/AMD1:2012:
ME EQUIPMENT shall be so designed that an interruption and restoration of the power supply
shall not result in the loss of BASIC SAFETY and that restoration of the power shall not result in
the loss of ESSENTIAL PERFORMANCE.
201.12 Accuracy of controls and instruments and protection against
hazardous outputs
Replace the existing text of this clause by the following new text:
Clause 12 of the general standard applies, except as follows:
Addition:
NOTE According to subclause 12.4.5 of the general standard, the dose related aspects of this question are
addressed under 203.6.4.3 of this document.
201.16 ME SYSTEMS
Replace the existing text of this clause by the following new text:
Clause 16 of the general standard applies, except as follows:
201.16.8 Interruption of the power supply to parts of an ME SYSTEM
Replacement of the first paragraph modified by IEC 60601-1:2005/AMD1:2012:
An ME SYSTEM shall be so designed that an interruption and restoration of the power to the ME
SYSTEM as a whole, or any part of the ME SYSTEM, shall not result in the loss of BASIC SAFETY
and that restoration of the power shall not result in the loss of ESSENTIAL PERFORMANCE.

– 6 – IEC 60601-2-54:2009/AMD2:2018
© IEC 2018
202.101 Immunity testing of ESSENTIAL PERFORMANCE
Replace the existing title of this subclause by the following new title:
202.101 *Immunity testing of ESSENTIAL PERFORMANCE
E EQUIPMENT identification, marking and documents
203.5 M
Add, before the existing 203.5.2.4.5, the following new text:
203.5.2.1 References in subclauses
Amendment:
In Table 2 of IEC 60601-1-3:2008, the line about Clinical protocols, Subclause 5.2.4.4, does
not apply.
203.5.2.4 Instructions for use
203.5.2.4.4 Clinical protocols
Subclause 5.2.4.4 of IEC 60601-1-3:2008 does not apply.
Additional subclause:
203.5.2.4.101 EXAMINATION PROTOCOLS
When EXAMINATION PROTOCOLS are proposed by the MANUFACTURER, and preloaded on the
EQUIPMENT, the instructions for use shall state if they constitute recommendations to be
applied directly so as to allow optimized operation or if they are only examples/starting points,
to be replaced by more specific protocols developed by the RESPONSIBLE ORGANIZATION.
Compliance is checked by inspection of the instructions for use.
203.6 Radiation management
Add, after the existing title of 203.6, the following new subclauses:
203.6.1 General
Additional subclauses:
203.6.1.101 Management of RADIOSCOPY image storage
X-RAY EQUIPMENT specified for RADIOSCOPY should provide the capability to store
a RADIOSCOPY REPLAY IMAGE SEQUENCE for DISPLAY. This capability may be limited to storage of
images as follows:
• at pulse rates up to 10 pulses per second, the last 30 seconds of RADIOSCOPY;
• for pulse rates greater than 10 pulses per second, the last 300 images;
• for continuous RADIOSCOPY, the last 10 seconds of RADIOSCOPY.
Compliance is checked by functional test.

© IEC 2018
203.6.1.102 Management of EXAMINATION PROTOCOLS
EXAMINATION PROTOCOLS are preloaded and the INTENDED USE of the X-RAY EQUIPMENT covers
If
both adult and paediatric applications, the designation of these protocols shall clearly
distinguish between adult and paediatric applications.
For equipment without an automatic control system:
– at least three PATIENT size choices should be selectable by the OPERATOR for adult
PATIENTS;
INTENDED USE includes paediatric applications, at least three PATIENT size choices
– If the
should be selectable by the OPERATOR for paediatric PATIENTS.
Compliance is checked by inspection or by the appropriate functional tests.
203.6.2.1 Normal initiation and termination of the IRRADIATION
Add, at the end of the existing list, the following new item:
e) *For a RADIOSCOPY IRRADIATION-EVENT of more than 0,5 s, the X-RAY EQUIPMENT shall
LOADING within 0,1 s from the time the OPERATOR releases the control
terminate the
(e.g., by releasing pressure on a foot pedal).The shortest possible time is desirable.
For a RADIOSCOPY IRRADIATION-EVENT of 0,5 s or less, the X-RAY EQUIPMENT shall terminate
the LOADING within 0,5 s from the time the OPERATOR releases the control (e.g., by
releasing pressure on a foot pedal).
The instructions for use shall indicate the RADIOSCOPY IRRADIATION-EVENT times for which
RADIOSCOPY can continue after the control is released, as described in 203.6.2.1 e), and the
maximum amount of time that RADIOSCOPY can continue in each of the described cases.
203.6.3.2.102 Linearity and constancy in RADIOGRAPHY
Replace the existing item b) by the following new item b):
AUTOMATIC EXPOSURE CONTROLS for DIRECT RADIOGRAPHY
b) Reproducibility of
In the operation of an AUTOMATIC EXPOSURE CONTROL in RADIOGRAPHY to control
IRRADIATION for DIRECT RADIOGRAPHY, the reproducibility shall comply with the following
requirements, either
– the coefficient of variation of MEASURED VALUES of AIR KERMA shall be not greater than
0,05; or
RADIOGRAMS shall not exceed a value of
– the variation of optical density in the resultant
0,10 for unchanged X-RAY TUBE VOLTAGE and constant thickness of the irradiated
object.
Compliance is checked by the following test PROCEDURES:
I) Compliance of coefficient of variation of MEASURED VALUES OF AIR KERMA:
– Test conditions
Use the test conditions according to subclause 203.6.3.2.103 with an X-RAY TUBE
VOLTAGE representative of the specified INTENDED USE, or 80 kV if manually
adjustable.
Make 10 measurements of AIR KERMA in one hour. Calculate the coefficient of
variation of AIR KERMA.
II) Compliance of variation of optical density, see test PROCEDURE subclause c).

– 8 – IEC 60601-2-54:2009/AMD2:2018
© IEC 2018
Replace the existing item d) by the following new item d):
d) Reproducibility of AUTOMATIC EXPOSURE CONTROLS for INDIRECT RADIOGRAPHY
In the operation of an AUTOMATIC EXPOSURE CONTROL in RADIOGRAPHY to control
IRRADIATION for INDIRECT RADIOGRAPHY with DIGITAL X-RAY IMAGING DEVICES, the
reproducibility shall comply with one of the following requirements:
– either the ratio between the highest and the lowest MEASURED VALUES of AIR KERMA
shall be less than 1,2; or
DIGITAL X-RAY IMAGING DEVICES the ratio between the highest and the
– with integrated
lowest mean LINEARIZED DATA on a constant REGION OF INTEREST shall be less than 1,2
for constant X-RAY TUBE VOLTAGE and constant thickness of the irradiated object; or
– with integrated DIGITAL X-RAY IMAGING DEVICES and if the EXPOSURE INDEX according to
EXPOSURE
IEC 62494-1:2008 is displayed the ratio between the highest and the lowest
INDEX in the RELEVANT IMAGE REGION shall be less than 1,2 for constant X-RAY TUBE
VOLTAGE and constant thickness of the irradiated object.
Compliance is checked by the following test PROCEDURES:
I) Compliance of ratio of MEASURED VALUES of AIR KERMA:
– Test conditions
Use the test conditions according to 203.6.3.2.103 with an X-RAY TUBE VOLTAGE
representative of the specified INTENDED USE, or 80 kV if manually adjustable.
AIR KERMA in one hour. Calculate the ratio between the
Make 10 measurements of
highest and the lowest MEASURED VALUES of AIR KERMA.
II) Compliance of ratio in the mean LINEARIZED DATA or EXPOSURE INDEX:
– Test conditions
Use the X-RAY EQUIPMENT in conditions representative of the specified intended
use, in terms of geometric settings and selection of mode of operation, the PATIENT
being replaced by a phantom made of PMMA, the section and thickness of which
match this INTENDED USE.
As a minimum, a phantom with a thickness of 20 cm and a square area of
25 cm × 25 cm shall be used, with an X-RAY TUBE VOLTAGE representative of the
specified intended use, or 80 kV if manually adjustable.
Acquire 10 images per set of conditions. Calculate the ratio between the highest
and the lowest mean LINEARIZED DATA or EXPOSURE INDEX.
203.6.4.3 Indication of LOADING FACTORS and MODES OF OPERATION
203.6.4.3.101 General requirements for the indication of LOADING FACTORS
Add, after the last dash, the following new text:
If pulse rate or pulse width in pulsed RADIOSCOPY is selectable, then the units of indication
shall be as follows:
– for duration of X-RADIATION pulse, milliseconds;
– for X-RADIATION pulse repetition frequency, number of pulses per second.
203.6.4.3.104.3 Accuracy of X-RAY TUBE VOLTAGE
Replace the existing first paragraph by the following new paragraph:
For operation of a HIGH-VOLTAGE GENERATOR in any specified combination with subassemblies
and components of an X-RAY GENERATOR, the error in the indicated value of the X-RAY TUBE
VOLTAGE, in any combination of LOADING FACTORS, shall be not greater than 8 %.

© IEC 2018
Replace the first sentence of the existing third paragraph (without modifying items a) and b)
by the following new sentence:
Compliance is checked by the following test PROCEDURE, using a test instrument with
appropriate uncertainty:
Add, after the existing 203.6.4.3.105, the following new subclause:
203.6.4.3.106 *Electronic documentation of EXAMINATION PROTOCOLS
X-RAY EQUIPMENT that includes EXAMINATION PROTOCOL SELECTION CONTROL should provide
access to the electronic documentation of those parameters invoked by each available
PRE-PROGRAMMED EXAMINATION PROTOCOL in a defined format file (e.g., xml format, comma-
separated format, space-separated format) and export to an output device. This electronic
documentation should include the selected settings for each adjustable or selectable
parameter in each PRE-PROGRAMMED EXAMINATION PROTOCOL.
Data elements incorporated in the electronic documentation should also include the date of
configuration of the set of PRE-PROGRAMMED EXAMINATION PROTOCOLS.
PRE-PROGRAMMED EXAMINATION PROTOCOLS is provided, means shall be
If access to modify the
provided to track the date of the last change, and means shall be provided to enter an
identifier for the agent responsible for the change.
X-RAY EQUIPMENT that provides electronic documentation of EXAMINATION PROTOCOLS shall
provide either:
– access to a media output device; or
– access to a networked output device to transmit the electronic documentation through.
NOTE Additional equipment may be required (e.g. PC, CD/DVD drive, approved USB device, laptop wired by
Ethernet connection, etc.) to enable export.
If a PRE-PROGRAMMED EXAMINATION PROTOCOL contains adjustable or selectable parameters,
the MANUFACTURERS default value of each such parameter shall be provided.
Means should be recommended or provided to allow flagging differences between two or
more PRE-PROGRAMMED EXAMINATION PROTOCOLS to assist in the local review and clinical audit
process.
The means may be external to the X-RAY EQUIPMENT and, if so, it does not need to be
considered a medical device.
Compliance is checked by inspection and appropriate functional tests.
203.6.4.5 Dosimetric indications
Add, after the last dash of the existing third paragraph, the following new item:
– The displayed values of REFERENCE AIR KERMA RATE and cumulative REFERENCE AIR KERMA
may be measured or calculated.
Add, after the existing 203.6.4.5, the following new text:
Additional subclause:
– 10 – IEC 60601-2-54:2009/AMD2:2018
© IEC 2018
203.6.4.5.101 RADIATION DOSE STRUCTURED REPORTS
RAY EQUIPMENT specified for RADIOGRAPHY or RADIOSCOPY or RADIOGRAPHY and RADIOSCOPY
X-
should create RADIATION DOSE STRUCTURED REPORTS (RDSR) and have the ability to perform an
RDSR END OF PROCEDURE TRANSMISSION. The RDSR shall conform to at least the basic dose
documentation specified in IEC 61910-1. The relevant elements for the specified type of
X-RAY EQUIPMENT and for which data are available shall be populated with relevant data.
Compliance is checked by functional tests.
UTOMATIC CONTROL SYSTEM
203.6.5 A
Add, after the last paragraph, the following new paragraph:
RAY EQUIPMENT provided with AUTOMATIC INTENSITY CONTROL, a QUALITY CONTROL mode
For X-
shall be provided that enables selection of values, either by a manual control mode or by
selecting preset combination values, of X-RAY TUBE VOLTAGE, X-RAY TUBE CURRENT or X-RAY
CURRENT TIME PRODUCT, LOADING TIME, ADDITIONAL FILTRATION if any and FOCAL SPOT size if
selectable.
203.6.6 SCATTERED RADIATION reduction
Add, after the last sentence of the existing first paragraph, the following new sentence:
If the ANTI-SCATTER GRID is removable, it shall be possible to remove and replace it without the
TOOLS.
use of
Replace the existing second paragraph by the following new paragraph:
Means shall be provided for using X-RAY EQUIPMENT specified for paediatric applications
without an ANTI-SCATTER GRID.
203.6.7.101 DISPLAY of last image hold (LIH)
Replace the existing subclause, including its title, by the following new subclause:
203.6.7.101 DISPLAY of LAST IMAGE HOLD RADIOGRAM or RADIOSCOPY REPLAY IMAGE SEQUENCE
X-RAY EQUIPMENT specified for INDIRECT RADIOSCOPY shall display either a LIH RADIOGRAM or
a RADIOSCOPY REPLAY IMAGE SEQUENCE following termination of the radioscopic IRRADIATION,
and shall comply with the following:
1) The LIH RADIOGRAM or RADIOSCOPY REPLAY IMAGE SEQUENCE shall be displayed following
termination of the radioscopic IRRADIATION and shall remain visible until an action by the
OPERATOR.
2) Means shall be provided to clearly indicate to the OPERATOR whether a displayed image is:
LIH RADIOGRAM or RADIOSCOPY REPLAY IMAGE SEQUENCE, or
– an
– from ongoing RADIOSCOPY.
LIH RADIOGRAM or the RADIOSCOPY REPLAY IMAGE SEQUENCE shall be replaced
3) Display of the
by the RADIOSCOPY image concurrently with reinitiation of radioscopic IRRADIATION, unless
a separate DISPLAY is provided for the RADIOSCOPY images.
4) For a LIH RADIOGRAM obtained by retaining pre-termination RADIOSCOPY images, if the
OPERATOR, the
number of images and method of combining images are selectable by the
selection shall be indicated prior to initiation of the radioscopic IRRADIATION.
Compliance is checked by inspection and functional tests.

© IEC 2018
203.7.1.101 FILTRATION in X-RAY SOURCE ASSEMBLIES
Replace, in the existing first paragraph, first dash, the first sentence by the following new
sentence:
MOBILE X-RAY EQUIPMENT specified for RADIOSCOPY or for
– unless solely intended for use in
RADIOGRAPHY and RADIOSCOPY during surgery, X-RAY SOURCE ASSEMBLIES shall be provided
with means to mount, to dismount, or to select one or more ADDED FILTERS, without the use
of TOOLS.
203.8.102.2 Indication on the X-RAY EQUIPMENT
Add, after the existing last item c), the following new paragraph:
X-RAY EQUIPMENT specified for RADIOSCOPY should provide a graphical representation of the
boundaries of the X-RAY FIELD on the image DISPLAY while the BEAM LIMITING DEVICE is adjusted
when no IRRADIATION SWITCH is actuated. This representation shall be:
– provided at the working position of the OPERATOR, and
– updated during BEAM LIMITING DEVICE adjustment.
203.8.102.5 Indication by LIGHT FIELD-INDICATOR
Add, after the existing third paragraph, the following new paragraph:
The edge of a LIGHT FIELD is described by the locus of points at which the illumination is 25 %
of the maximum illumination.
203.8.103 Interception of the X-RAY BEAM in RADIOSCOPY
Delete, in the second paragraph, the existing second sentence, including items a) and b).
Add, after the second existing paragraph, the following new paragraphs and note:
For X-RAY EQUIPMENT with an adjustable BEAM LIMITING DEVICE, means shall be provided to
configure the boundaries of the X-RAY FIELD so that these boundaries are visible with the X-
RAY BEAM AXIS in a specified orientation. This orientation shall be described in the instructions
for use.
RESPONSIBLE ORGANISATION.
The means may be made available to the
NOTE This configuration enables boundaries of the BEAM LIMITING DEVICE to be seen on the image DISPLAY with
the X-RAY FIELD at its maximum size for each magnification mode.
203.9.1 General
Replace the existing text of this subclause by the following new text:
Addition:
Means shall be provided to prevent IRRADIATION with FOCAL SPOT TO SKIN DISTANCES less than
those specified in 203.9.101 and 203.9.102 for the INTENDED USE.
NOTE Means can include hardware, software, construction, or some other method.
203.9.101 X-RAY EQUIPMENT specified for RADIOSCOPY
Replace the existing text of this subclause by the following new text:

– 12 – IEC 60601-2-54:2009/AMD2:2018
© IEC 2018
FIXED X-RAY EQUIPMENT specified for RADIOSCOPY should be provided with means to prevent
the use, during radioscopic IRRADIATION, of FOCAL SPOT TO SKIN DISTANCES less than 38 cm.
FOCAL SPOT TO SKIN DISTANCE shall not be less than 30 cm.
MOBILE X-RAY EQUIPMENT specified for RADIOSCOPY shall be provided with means to prevent
the use, during radioscopic IRRADIATION, of FOCAL SPOT TO SKIN DISTANCES less than:
– 20 cm if the X-RAY EQUIPMENT is specified for RADIOSCOPY during surgery; or
– 30 cm for other specified applications.
Compliance is checked by inspection and measurement.
203.13.6 Test for STRAY RADIATION
Add, before "Addition:", the following new text:
Replacement of the existing item b) by the following new item:
RAY BEAM for the INTENDED
b) tests shall be done with representative orientations of the X-
USE. As far as possible, follow the arrangements and dimensions shown in
Figures 203.104 to 203.107;
Replace the existing item bb) of this subclause by the following new item:
bb) as far as possible, follow the arrangements and dimensions shown in
Figures 203.104 and 203.105;
Table 201.C.102 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS
Add, below the line starting with "Dosimetric information for X-RAY EQUIPMENT…", the following
new line:
EXAMINATION PROTOCOLS 203.5.2.4.101

Annex AA – Particular guidance and rationale
Add, after the existing "Subclause 201.8.7.3 – Allowable values", the following new item:
Subclause 202.101 – Immunity testing of ESSENTIAL PERFORMANCE
Immunity tests on X-RAY EQUIPMENT specified for RADIOGRAPHY and RADIOSCOPY may be
performed only in RADIOSCOPY mode if there is sufficient evidence that RADIOSCOPY covers the
same electrical sources and signalling paths leading to IRRADIATION.
Add, after the existing "Subclause 203.5.2.4.5.102 – Test for dosimetric information", the
following new item:
Subclause 203.6.2.1 e) – Normal initiation and termination of the IRRADIATION
The purpose of RADIOSCOPY is to observe objects or structures in real time [18][19]. A LAST
IMAGE HOLD RADIOGRAM is, in essence, a RADIOGRAPH intended for review for study,
consultation, or education instead of continuing RADIOSCOPY [18][19].

© IEC 2018
The intent is to limit the number of RADIOGRAPHY images to those necessary for diagnosis or
to document findings and device placement. Typical RADIOGRAPHY dose rates are at least 10
times greater than those for RADIOSCOPY [18]. If a LAST IMAGE HOLD RADIOGRAM demonstrates
the finding adequately, it can be studied instead of performing RADIOGRAPHY. When no
additional RADIOGRAPHY images are obtained, PATIENT RADIATION dose is reduced [18].
RADIOSCOPY equipment is designed so that the RADIOSCOPY IRRADIATION terminates
At present,
after the release of continuous pressure by the OPERATOR, regardless of the quality of the
resultant LAST IMAGE HOLD RADIOGRAM. For radioscopic IRRADIATIONS longer than 1 s or so,
this is of no consequence, as the image quality of the resultant LAST IMAGE HOLD RADIOGRAM
will be adequate. However, if the RADIOSCOPY IRRADIATION is too short, the LAST IMAGE HOLD
RADIOGRAM will not be usable, because image quality will not be adequate. Sufficient time is
AUTOMATIC INTENSITY CONTROL before terminating the radioscopic
necessary to stabilize the
IRRADIATION. The new requirement permits automatic creation of a LAST IMAGE HOLD
RADIOGRAM of adequate quality with a short tap on the RADIOSCOPY pedal and automatic
termination of the radioscopic IRRADIATION, rather than manual termination. This avoids an
IRRADIATION which is too short and results in an inadequate LAST IMAGE HOLD RADIOGRAM, or an
IRRADIATION that is longer than necessary to obtain a LAST IMAGE HOLD RADIOGRAM of adequate
LAST IMAGE HOLD RADIOGRAM to be obtained with the shortest possible
quality. It permits a
RADIOSCOPY IRRADIATION that will result in a usable image, and therefore with the lowest
possible PATIENT RADIATION dose.
Add, after the existing "Subclause 203.6.3.102 – High-level control (HLC)", the following new
item:
Subclause 203.6.4.3.106 – Electronic documentation of EXAMINATION PROTOCOLS
RAY EQUIPMENT includes one or more IMAGE DISPLAY DEVICES. The
At the system level, the X-
imaging performance characteristics of IMAGE DISPLAY SYSTEMS are provided by other
standards (e.g. IEC 62563-1 [21] and DICOM, Part 14 [22]). The IMAGE DISPLAY SYSTEM
settings selected under 203.6.4.3.106 are meaningful provided that the IMAGE DISPLAY DEVICE
conforms to the X-RAY EQUIPMENT's specifications and the IMAGE DISPLAY DEVICE performs in
accordance to its own standards.
A new addition is to provide a means (e.g. a comparison tool) to flag differences between two
(or more) PRE-PROGRAMMED EXAMINATION PROTOCOLS. The comparison tool can be used to
compare EXAMINATION PROTOCOLS for different examinations or different versions of the same
protocol.
EQUIPMENT may contain one or more PRE-PROGRAMMED EXAMINATION PROTOCOLS (PPEP). Each
PPEP usually contains settings controlling radiation production, image receptor performance,
and image processing for presentation. Incorrect or inappropriate settings may result in
inappropriate IRRADIATION of the PATIENT and/or in inappropriate clinical utility of the resulting
images.
Validating the contents of each PPEP is essential for both safety and performance. For this
reason, documentation of PPEPs over the life of the EQUIPMENT is useful for the RESPONSIBLE
ORGANIZATION. Routine audits by the RESPONSIBLE ORGANIZATION are often performed after
EQUIPMENT installation, commissioning, updates, and clinical configuration changes. Additional
audits are indicated if there are unexpected changes in radiation use or the clinical
acceptability of the resultant images.
Copies of the downloaded PPEP sets might be retained by the RESPONSIBLE ORGANIZATION to
document their status over the life of the EQUIPMENT.
Audits are facilitated by comparing currently installed PPEPs against a reference set of
MANUFACTURER'S
PPEPs and flagging the differences. Sources of reference PPEPs include
factory defaults or regional settings, as well as local settings for substantially similar
EQUIPMENT as defined by the RESPONSIBLE ORGANIZATION.

– 14 – IEC 60601-2-54:2009/AMD2:2018
© IEC 2018
This document does not require any specific content or format of a PPEP. It implies that all
controls and settings within a PPEP that affect either radiation production or the
characteristics of the resulting images be appropriately documented in a form that facilitates
comparisons between versions.
© IEC 2018
Bibliography
Add, at the end of the existing list, the following new references:
[18] ICRP 117:2010, Radiological Protection in Fluoroscopically Guided Procedures outside
the Imaging Department. ICRP Publication 117, Ann. ICRP 40(6)
[19] ICRP 121:2013, Radiological Protection in Paediatric Diagnostic and Interventional
Radiology. ICRP Publication 121, Ann. ICRP 42(2)
[20] IEC 62220-1-3:2008, Medical electrical equipment – Characteristics of digital X-ray
imaging devices – Part 1-3: Determination of the detective quantum efficiency –
Detectors used in dynamic imaging
[21] IEC 62563-1:2009, Medical electrical equipment – Medical image display systems –
Part 1: Evaluation methods
[22] DICOM, Part 14 (PS 3.14-2016e), Digital Imaging and Communications in Medicine –
Part 14: Grayscale Standard Display Function
[23] IEC 60601-1-9, Medical electrical equipment – Part 1-9: General requirements forbasic
safety and essential performance – Collateral Standard: Requirements for
environmentally conscious design

– 16 – IEC 60601-2-54:2009/AMD2:2018
© IEC 2018
Index of defined terms used in this particular standard
Replace the existing references to the following terms by the following new references:
DIGITAL X-RAY IMAGING DEVICE . IEC 62220-1-1:2015, 3.6
LINEARIZED DATA . IEC 62220-1-1:2015, 3.9
ORIGINAL DATA . IEC 62220-1-1:2015, 3.13
SPATIAL FREQUENCY . IEC 62220-1-1:2015, 3.17
Add the following new terms and references to the existing list:
DISPLAY . IEC TR 60788:2004, rm-84-01
EXAMINATION PROTOCOL . 201.3.210
EXAMINATION PROTOCOL SELECTION CONTROL . 201.3.211
EXPOSURE INDEX . IEC 62494-1:2008, 3.7
IMAGE DISPLAY DEVICE . IEC 62563-1:2009, 3.1.13
IMAGE DISPLAY SYSTEM . IEC 62563-1:2009, 3.1.14
IRRADIATION-EVENT . IEC 61910-1:2014, 3.1
LAST IMAGE HOLD RADIOGRAM (LIH RADIOGRAM) . 201.3.212
PRE-PROGRAMMED EXAMINATION PROTOCOL . 201.3.213
QUALITY CONTROL . IEC TR 60788:2004, rm-70-07
RADIATION DOSE STRUCTURED REPORT (RDSR) . IEC 61910-1:2014, 3.3
RADIOSCOPY REPLAY IMAGE SEQUENCE . 201.3.214
RDSR END OF PROCEDURE TRANSMISSION . IEC 61910-1:2014, 3.5

___________
– 18 – IEC 60601-2-54:2009/AMD2:2018
© IEC 2018
AVANT-PROPOS
Le présent amendement a été établi par le sous-comité 62B: Appareils d'imagerie de
diagnostic, du comité d'études 62 de l'IEC: Équipements électriques dans la pratique
médicale.
Le texte de cet amendement est issu des documents suivants:
FDIS Rapport de vote
62B/1089/FDIS 62B/1097/RVD
Le rapport de vote indiqué dans le tableau ci-dessus donne toute information sur le vote ayant
abouti à l'approbation de cet amendement.
Le comité a décidé que le contenu de cet amendement et de la publication de base ne sera
pas modifié avant la date de stabilité indiquée sur le site web de l'IEC sous
"http://webstore.iec.ch" dans les données relatives à la publication recherchée. À cette date,
la publication sera
• reconduite,
• supprimée,
• remplacée par une édition révisée, ou
• amendée.
_____________
INTRODUCTION À L'AMENDEMENT 2
Le présent deuxième amendement de l'IEC 60601-2-54:2009 a pour objet l'introduction de
modifications tenant compte de l'état actuel de la technique. Par conséquent, les APPAREILS A
RAYONNEMENT X spécifiés pour la RADIOSCOPIE DIRECTE ne relèvent plus du domaine
d'application du présent document. Les références normatives ont également été mises à jour
dans le présent amendement, et des éclaircissements rédactionnels ainsi que de nouveaux
termes et définitions ont été ajoutés. L'accent est mis sur les dispositions relatives aux
PROCEDURES DE CONTROLE DE LA QUALITE à recommander par le FABRICANT. Une attention
particulière est portée aux PROTOCOLES D'EXAMEN dans un nouveau paragraphe qui établit une
distinction entre les applications sur les personnes adultes et les applications pédiatriques,
notamment pour les APPAREILS A RAYONNEMENT X sans SYSTEME DE COMMANDE AUTOMATIQUE.
En outre, des périodes fixes de fin d'application d'une CHARGE par suite du déclenchement de
la commande des RAYONNEMENTS par l'OPERATEUR sont spécifiées pour la RADIOSCOPIE.
Un nouveau paragraphe relatif à la documentation électronique des PROTOCOLES D'EXAMEN est
introduit. Il recommande la mise à disposition d'un accès à la documentation électronique
comportant les paramètres pertinents du PROTOCOLE D
...