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

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• withdrawn,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 "Additiona
...