Amendment 2 - Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
Amendement 2 - Appareils électromédicaux - Partie 2-63: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X dentaires extra-oraux
Standards Content (sample)
Edition 1.0 2021-05
Medical electrical equipment –
Part 2-63: Particular requirements for the basic safety and essential performanceof dental extra-oral X-ray equipment
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Edition 1.0 2021-05
Medical electrical equipment –
Part 2-63: Particular requirements for the basic safety and essential
performance of dental extra-oral X-ray equipment
ICS 11.040.50 ISBN 978-2-8322-9629-5
Warning! Make sure that you obtained this publication from an authorized distributor.® Registered trademark of the International Electrotechnical Commission
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– 2 – IEC 60601-2-63:2012/AMD2:2021
© IEC 2021
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
Full information on the voting for the approval of this amendment can be found in the report onvoting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication willremain 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, thepublication will be
• replaced by a revised edition, or
Replace Note 1 with the following new note:
NOTE 1 An example of such equipment is an equipment designed to perform PANORAMIC, CEPHALOMETRIC andDENTAL 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 anatomicalPATIENT, 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, theX-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 otherthan the manufacturer".
201.2 Normative references
Replace, in this clause modified by Amendment 1, under Addition, the reference toIEC/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
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IEC 60601-2-63:2012/AMD2:2021 – 3 –
© IEC 2021
201.3 Terminology and definitions
Add, after definition 201.3.213, the following new terms and definitions:
DENTAL CONE BEAM COMPUTED TOMOGRAPHY
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 PATIENT201.3.215
full set of programmed LOADING FACTORS, control functions and settings, including imageprocessing settings, designed to the image acquisition and DISPLAY
18.104.22.168 Source of power for ME EQUIPMENT
Delete the existing Addition and Subclause 22.214.171.124.101.
126.96.36.199 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 theformula:
U is the no-load MAINS VOLTAGE;
U is the MAINS VOLTAGE under load;
I is the mains current under load.
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 thisarrangement for the RESPONSIBLE ORGANIZATION.
NOTE 103 The intention is to perform these QUALITY CONTROL PROCEDURES and tests using only the ACCOMPANYINGDOCUMENTS.
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 theMANUFACTURER, the MANUFACTURER shall make this TOOL available to the RESPONSIBLE
NOTE 104 The MANUFACTURER can provide PHANTOM with the equipment, if specified in the local regulations.---------------------- Page: 5 ----------------------
– 4 – IEC 60601-2-63:2012/AMD2:2021
© IEC 2021
188.8.131.52.5 Deterministic effects
Add, under Addition, before the note, the