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

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/AMD2:2021

Name:IEC 60601-2-63:2012/AMD2:2021   Standard name:Amendment 2 - Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
Standard number:IEC 60601-2-63:2012/AMD2:2021   language:English language
Release Date:11-May-2021   technical committee:SC 62B - Medical imaging equipment, software, and systems
Drafting committee:WG 39 - TC 62/SC 62B/WG 39   ICS number:11.040.50 - Radiographic equipment

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)





your local IEC member National Committee for further information.

IEC Central Office Tel.: +41 22 919 02 11
3, rue de
CH-1211 Geneva 20
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.

IEC publications search - webstore.iec.ch/advsearchform IEC online collection - oc.iec.ch
The advanced search enables to find IEC publications by a Discover our powerful search engine and read freely all the
variety of criteria (reference number, text, technical publications previews. With a subscription you will always have
committee, …). It also gives information on projects, replaced access to up to date content tailored to your needs.
and withdrawn publications.
Electropedia - www.electropedia.org
IEC Just Published - webstore.iec.ch/justpublished
The world's leading online dictionary on electrotechnology,
Stay up to date on all new IEC publications. Just Published
containing more than 22 000 terminological entries in English
details all new publications released. Available online and once
and French, with equivalent terms in 18 additional languages.
a month by email.
Also known as the International Electrotechnical Vocabulary

(IEV) online.
IEC Customer Service Centre - webstore.iec.ch/csc

If you wish to give us your feedback on this publication or need
further assistance, please contact the Customer Service
.
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
...

  • Relates Information
  • ISO 8130-9:1992

    ISO 8130-9:1992 - Coating powders
    09-28
  • EN 352-2:2020/FprA1

    EN 352-2:2021/oprA1:2023
    09-28
  • IEC TS 61158-4:1999

    IEC TS 61158-4:1999 - Digital data communications for measurement and control - Fieldbus for use in industrial control systems - Part 4: Data Link protocol specification Released:3/24/1999 Isbn:2831847656
    09-28
  • HD 566 S1:1990

    HD 566 S1:1998
    09-28
  • ISO 5131:1982/Amd 1:1992

    ISO 5131:1982/Amd 1:1992
    09-28
  • EN 60598-2-22:1990

    EN 60598-2-22:1996
    09-27
  • ISO 8504-2:1992

    ISO 8504-2:1992 - Preparation of steel substrates before application of paints and related products -- Surface preparation methods
    09-27
  • EN 12165:2024

    prEN 12165:2022
    09-27
  • IEC TS 61158-6:1999

    IEC TS 61158-6:1999 - Digital data communications for measurement and control - Fieldbus for use in industrial control systems - Part 6: Application Layer protocol specification Released:3/24/1999 Isbn:2831847613
    09-27
  • ISO 4252:1992

    ISO 4252:1992 - Agricultural tractors -- Operator's workplace, access and exit -- Dimensions
    09-27