IEC 60601-2-63:2012/AMD2:2021

IEC 60601-2-63 ®
Edition 1.0 2021-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 2
AM ENDEMENT 2
Medical electrical equipment –
Part 2-63: Particular requirements for the basic safety and essential performance
of dental extra-oral X-ray equipment

Appareils électromédicaux –
Partie 2-63: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à rayonnement X dentaires extra-oraux

IEC 60601-2-63:2012-09/AMD2:2021-05(en-fr)

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IEC 60601-2-63 ®
Edition 1.0 2021-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 2
AM ENDEMENT 2
Medical electrical equipment –

Part 2-63: Particular requirements for the basic safety and essential performance

of dental extra-oral X-ray equipment

Appareils électromédicaux –
Partie 2-63: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils à rayonnement X dentaires extra-oraux

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-1033-4

– 2 – IEC 60601-2-63:2012/AMD2:2021
© IEC 2021
FOREWORD
This second 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/1232/FDIS 62B/1237/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• withdrawn,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.
_____________
201.1.1 Scope
Replace Note 1 with the following new note:
NOTE 1 An example of such equipment is an equipment designed to perform PANORAMIC, CEPHALOMETRIC and
DENTAL VOLUMETRIC RECONSTRUCTION (hereafter DVR) as defined in 201.3.203.
Add, under Replacement, before Note 5, the following new paragraph:
DENTAL EXTRA-ORAL X-RAY EQUIPMENT are X-RAY EQUIPMENT designed for EXTRA-ORAL
RADIOGRAPHY in which the geometrical relations between the X-RAY SOURCE, the anatomical
object being imaged in the PATIENT, and the X-RAY IMAGE RECEPTOR, are preset in the design
and cannot be arbitrarily altered by the OPERATOR during INTENDED USE. In such equipment, the
X-RAY TUBE ASSEMBLY contains the HIGH-VOLTAGE TRANSFORMER ASSEMBLY.
Add, at the end of the existing fifth paragraph, between Note 8 and Note 9, "by entities other
than the manufacturer".
201.2 Normative references
Replace, in this clause modified by Amendment 1, under Addition, the reference to
IEC/PAS 61910-1:2007 with:
IEC 61910-1:2014, Medical electrical equipment – Radiation dose documentation – Part 1:
Radiation dose structured reports for radiography and radioscopy

© IEC 2021
201.3 Terminology and definitions
Add, after definition 201.3.213, the following new terms and definitions:
201.3.214
DENTAL CONE BEAM COMPUTED TOMOGRAPHY
DENTAL CBCT
3-dimensional imaging of DENTAL anatomical structures, performed by reconstruction of a
volume from a series of 2-dimensional projections produced by circular or rectangular
collimated X-RAY BEAM on an X-RAY IMAGE RECEPTOR rotating around the head of the PATIENT
201.3.215
EXAMINATION PROTOCOL
full set of programmed LOADING FACTORS, control functions and settings, including image
processing settings, designed to the image acquisition and DISPLAY
201.4.10.1 Source of power for ME EQUIPMENT
Delete the existing Addition and Subclause 201.4.10.1.101.
201.4.10.2 SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS
Add, under Addition, after the first paragraph, the following new text:
For this purpose, the APPARENT RESISTANCE of SUPPLY MAINs R is determined according to the
formula:
UU−
R=
I
where
U is the no-load MAINS VOLTAGE;
U is the MAINS VOLTAGE under load;
I is the mains current under load.
201.7.9.1 General
Add, under Addition, after the second paragraph, the following new text:
If a test or a QUALITY CONTROL PROCEDURE recommended by the MANUFACTURER requires a
device-specific arrangement (including a TOOL, a PHANTOM, a special software or a software
setting); that is only available from the MANUFACTURER, the MANUFACTURER shall provide this
arrangement for the RESPONSIBLE ORGANIZATION.
NOTE 103 The intention is to perform these QUALITY CONTROL PROCEDURES and tests using only the ACCOMPANYING
DOCUMENTS.
Add, after Note 102, the following new text and new note:
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.
NOTE 104 The MANUFACTURER can provide PHANTOM with the equipment, if specified in the local regulations.

– 4 – IEC 60601-2-63:2012/AMD2:2021
© IEC 2021
203.5.2.4.5 Deterministic effects
Add, under Addition, before the note, the following new subclause:
203.5.2.4.101 EXAMINATION PROTOCOLS
EXAMINATION PROTOCOLS are proposed by the MANUFACTURER, and preloaded on the
When
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 user.
Compliance is checked by inspection of the INSTRUCTIONS FOR USE.
203.6 Radiation management
Add, before 203.6.2, the following new instruction and subclause:
Addition:
203.6.1.102 *Management of EXAMINATION PROTOCOLS
If EXAMINATION PROTOCOLS are preloaded and the INTENDED USE of the X-RAY EQUIPMENT covers
both adult and paediatric applications, the designation of these protocols shall clearly
distinguish between adult and paediatric applications.
For DVR (DENTAL CBCT, DVT) if EXAMINATION PROTOCOLS are preloaded and multiple
EXAMINATION PROTOCOLS are intended for both the same clinical task and, if applicable, the same
PATIENT size, then those EXAMINATION PROTOCOLS will be differentiated by qualitative indication
of their effect on image resolution and dose.
Compliance is checked by inspection or by the appropriate functional tests.
203.6.4.3.102.4 *Accuracy of IRRADIATION TIME
Add, after the second paragraph, the following new text and new note:
For ME EQUIPMENT in which the RADIATION dose is using time-width modulation during the
IRRADIATION EVENT, the MANUFACTURER shall provide in the ACCOMPANYING DOCUMENTS a
description of the modulation pattern, including the NOMINAL duration(s) of single pulses, which
are generated during the IRRADIATION EVENT.
NOTE These pulses are synchronized with the RADIATION cycle used for a single projection image within the DVT
or DENTAL CBCT image acquisition sequence and are generated from CONSTANT POTENTIAL HIGH-VOLTAGE GENERATOR.
Replace the compliance statement with the following:
Compliance is checked based on calculation of the IRRADIATION TIME using the examination of
typical pulse pattern according to the description provided in the ACCOMPANYING DOCUMENTS on
data acquired by the test according to 203.6.4.3.102.2.
203.6.4.3.102.5 Accuracy of CURRENT TIME PRODUCT
Replace the second paragraph with the following note:
NOTE This requirement also applies in cases when the CURRENT TIME PRODUCT is derived by calculation (eg X-RAY
TUBE CURRENT and X-RAY TUBE IRRADIATION TIME).

© IEC 2021
203.6.4.101 READY STATE
Add, after the conformance assessment, the following new subclause:
203.6.4.5.101 RADIATION DOSE STRUCTURED REPORTS
E EQUIPMENT intended for DENTAL CBCT applications shall be capable of creating RADIATION
M
DOSE STRUCTURED REPORTS (RDSR) and have the ability to perform an RDSR END OF PROCEDURE
TRANSMISSION. 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.
203.8.5.3 Correspondence between X-RAY FIELD and EFFECTIVE IMAGE RECEPTION AREA
Replace the hyphenated list, including items a) to d), after in DVR, with the following:
The X-RAY FIELD shall not extend beyond the EFFECTIVE IMAGE RECEPTION AREA at the surface of
RAY iMAGE RECEPTOR more than 2 % of the FOCAL SPOT TO IMAGE RECEPTOR DISTANCE in
the X-
one direction or at most 3 % in both directions. In the case of the X-RAY IMAGE RECEPTOR having
an active surface side length below 8 cm, the over-RADIATION shall not be larger than 1 % of the
FOCAL SPOT TO IMAGE RECEPTOR DISTANCE in one direction or at most 2 % in two directions.
The dimensions of a rectangular X-RAY FIELD are described in terms of the length of its intercepts
on each of two orthogonal major axes in the plane of interest.
RAY FIELD, the dimensions are described accordingly, replacing the lengths of the
For circular X-
intercepts with the diameter.
203.9 FOCAL SPOT TO SKIN DISTANCE
Replace the existing paragraph under Replacement with the following new paragraph:
The FOCAL SPOT TO SKIN DISTANCE shall be nominally 15 cm or greater.

– 6 – IEC 60601-2-63:2012/AMD2:2021
© IEC 2021
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