IEC 60601-2-65:2012/AMD2:2021
(Amendment)Amendment 2 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
Amendment 2 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
Amendement 2 - Appareils électromédicaux - Partie 2-65 : Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X dentaires intra-oraux.
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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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International Standards for all electrical, electronic and related technologies.
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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• withdrawn,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
Add
...
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)
---------------------- Page: 1 ----------------------
THIS PUBLICATION IS COPYRIGHT PROTECTED
Copyright © 2021 IEC, Geneva, Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
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questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
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
committee, …). It also gives information on projects, replaced have 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
and French, with equivalent terms in 18 additional languages.
once 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
Centre: sales@iec.ch.
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