Amendment 2 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment

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Status
Published
Publication Date
02-May-2021
Current Stage
PPUB - Publication issued
Completion Date
03-May-2021
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IEC 60601-2-65:2012/AMD2:2021 - Amendment 2 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
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IEC 60601-2-65
Edition 1.0 2021-05
INTERNATIONAL
STANDARD
AMENDMENT 2
Medical electrical equipment –

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

of dental intra-oral X-ray equipment
IEC 60601-2-65:2012-09/AMD2:2021-05(en)
---------------------- Page: 1 ----------------------
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IEC 60601-2-65
Edition 1.0 2021-05
INTERNATIONAL
STANDARD
AMENDMENT 2
Medical electrical equipment –
Part 2-65: Particular requirements for the basic safety and essential
performance of dental intra-oral X-ray equipment
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.50 ISBN 978-2-8322-9630-1

Warning! Make sure that you obtained this publication from an authorized distributor.

® Registered trademark of the International Electrotechnical Commission
---------------------- Page: 3 ----------------------
– 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• withdrawn,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:

QUALITY CONTROL PROCEDURE recommended by the MANUFACTURER requires a
If a test or 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 initiati
...

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