IEC 60601-2-65:2012/AMD2:2021

IEC 60601-2-65 ®
Edition 1.0 2021-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 2
AM ENDEMENT 2
Medical electrical equipment –
Part 2-65: Particular requirements for the basic safety and essential performance
of dental intra-oral X-ray equipment

Appareils électromédicaux –
Partie 2-65: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à rayonnement X dentaires intra-oraux

IEC 60601-2-65:2012-09/AMD2:2021-05(en-fr)

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IEC 60601-2-65 ®
Edition 1.0 2021-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 2
AM ENDEMENT 2
Medical electrical equipment –

Part 2-65: Particular requirements for the basic safety and essential performance

of dental intra-oral X-ray equipment

Appareils électromédicaux –
Partie 2-65: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils à rayonnement X dentaires intra-oraux

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-1014-1

– 2 – IEC 60601-2-65:2012/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/1233/FDIS 62B/1238/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• withdrawn,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.
_____________
201.7.9.1 General
Add, under Addition, after the existing second paragraph, the following new text and new note:
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 102 The intention is to perform these QUALITY CONTROL PROCEDURES and tests using only the supplied
information.
203.5.2.4.5 Deterministic effects
Add, after the note of this subclause, the following new subclause:
203.5.2.4.6 RISK to OPERATORS
Addition:
NOTE OPERATORS of HAND-HELD ME EQUIPMENT are assumed to be in the SIGNIFICANT ZONE OF OCCUPANCY when the
ME equipment is hand-held during LOADING.

203.6.2.1 Normal initiation and termination of the IRRADIATION
Add, under Addition, after the first paragraph, the following new paragraph and new note:

© IEC 2021
HAND-HELD ME EQUIPMENT shall have a means to prevent unauthorized initiation of IRRADIATION.
NOTE Example may be a physical key or password.

203.8.5.4 Positioning of the PATIENT and restriction of the irradiated area
Add, under Replacement, after the note, the following new text:
The MANUFACTURER of an INTRA-ORAL image receptor shall make available ACCESSORIES that
may be used to hold the INTRA-ORAL X-RAY IMAGE RECEPTOR and align the X-ray beam with the
INTRA-ORAL X-RAY IMAGE RECEPTOR during LOADING.

203.12.2 Mounting OF X-RAY SOURCE ASSEMBLIES and X-RAY IMAGING ARRANGEMENTS
Replace, under Replacement, the introductory paragraph of the list with the following:
For DENTAL INTRA-ORAL X-RAY SOURCE ASSEMBLIES intended to be HAND-HELD during LOADING in
NORMAL USE, the following information shall be provided with the ACCOMPANYING DOCUMENTS:

203.12.4 LEAKAGE RADIATION in the LOADING STATE
Add, under Replacement, before the first paragraph, the following new text:
1) DENTAL INTRA-ORAL X-RAY SOURCE ASSEMBLIES intended to be HAND-HELD during LOADING in
NORMAL USE
In the LOADING STATE, the AIR KERMA due to LEAKAGE RADIATION from X-RAY SOURCE ASSEMBLIES,
at any point on the outer surface of the equipment, when operated at the NOMINAL X-RAY TUBE
VOLTAGE under conditions of LOADING corresponding to the reference LOADING conditions, shall
not exceed 0,05 mGy in one hour.
Compliance is checked by the following test procedure:
a) block the RADIATION APERTURE sufficiently to ensure that measurements of LEAKAGE
RADIATION are not affected by RADIATION passing through it. Make and fit any cover used for
this purpose to be as close as practicable to the RADIATION APERTURE and not to overlap it
to an extent greater than is required for effective blocking;
b) for LOADING during the test
1) use the NOMINAL X-RAY TUBE VOLTAGE for the X-RAY SOURCE ASSEMBLY under test;
2) use a convenient value of CURRENT TIME PRODUCT;
3) do not use LOADINGS so as to cause any specified ratings to be exceeded during the test;
c) determine, if necessary by making measurements,
...