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IEC 60601-2-63
Edition 1.0 2021-05
INTERNATIONAL
STANDARD
AMENDMENT 2
Medical electrical equipment –
Part 2-63: Particular requirements for the basic safety and essential performance
of dental extra-oral X-ray equipment
IEC 60601-2-63:2012-09/AMD2:2021-05(en)
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IEC 60601-2-63
Edition 1.0 2021-05
INTERNATIONAL
STANDARD
AMENDMENT 2
Medical electrical equipment –
Part 2-63: Particular requirements for the basic safety and essential
performance of dental extra-oral X-ray equipment
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.50 ISBN 978-2-8322-9629-5
– 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• withdrawn,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
PATIENT, and the X-RAY IMAGE RECEPTOR, are preset in the design
object being imaged in the
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
...