Amendment 1 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment

Specifies the requirements for testing items of equipment intended for use on railway vehicles which are subsequently subjected to vibrations and chock owing to the nature of railway operational environment.

Amendement 1 - Appareils électromédicaux - Partie 2-65: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X dentaires intra-oraux

Spécifie les prescriptions d'essai des matériels destinés à être utilisés sur les véhicules ferroviaires soumis à des vibrations et à des chocs dus à la nature de l'environnement d'exploitation ferroviaire.

General Information

Status
Published
Publication Date
16-May-2017
Current Stage
PPUB - Publication issued
Start Date
17-May-2017
Completion Date
17-May-2017
Ref Project

Buy Standard

Standard
IEC 60601-2-65:2012/AMD1:2017 - Amendment 1 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
English and French language
9 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (sample)

IEC 60601-2-65
Edition 1.0 2017-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
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/AMD1:2017-05(en-fr)
---------------------- Page: 1 ----------------------
THIS PUBLICATION IS COPYRIGHT PROTECTED
Copyright © 2017 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.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite

ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie

et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des

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 Fax: +41 22 919 03 00
CH-1211 Geneva 20 info@iec.ch
Switzerland www.iec.ch
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 corrigenda or an amendment might have been published.
IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org

The stand-alone application for consulting the entire The world's leading online dictionary of electronic and

bibliographical information on IEC International Standards, electrical terms containing 20 000 terms and definitions in

Technical Specifications, Technical Reports and other English and French, with equivalent terms in 16 additional

documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical

iPad. Vocabulary (IEV) online.

IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary

The advanced search enables to find IEC publications by a 65 000 electrotechnical terminology entries in English and

variety of criteria (reference number, text, technical French extracted from the Terms and Definitions clause of

committee,…). It also gives information on projects, replaced IEC publications issued since 2002. Some entries have been

and withdrawn publications. collected from earlier publications of IEC TC 37, 77, 86 and

CISPR.
IEC Just Published - webstore.iec.ch/justpublished

Stay up to date on all new IEC publications. Just Published IEC Customer Service Centre - webstore.iec.ch/csc

details all new publications released. Available online and If you wish to give us your feedback on this publication or

also once a month by email. need further assistance, please contact the Customer Service

Centre: csc@iec.ch.
A propos de l'IEC

La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des

Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications IEC

Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la

plus récente, un corrigendum ou amendement peut avoir été publié.
Catalogue IEC - webstore.iec.ch/catalogue Electropedia - www.electropedia.org

Application autonome pour consulter tous les renseignements Le premier dictionnaire en ligne de termes électroniques et

bibliographiques sur les Normes internationales, électriques. Il contient 20 000 termes et définitions en anglais

Spécifications techniques, Rapports techniques et autres et en français, ainsi que les termes équivalents dans 16

documents de l'IEC. Disponible pour PC, Mac OS, tablettes langues additionnelles. Egalement appelé Vocabulaire

Android et iPad. Electrotechnique International (IEV) en ligne.

Recherche de publications IEC - www.iec.ch/searchpub Glossaire IEC - std.iec.ch/glossary

La recherche avancée permet de trouver des publications IEC 65 000 entrées terminologiques électrotechniques, en anglais

en utilisant différents critères (numéro de référence, texte, et en français, extraites des articles Termes et Définitions des

comité d’études,…). Elle donne aussi des informations sur les publications IEC parues depuis 2002. Plus certaines entrées

projets et les publications remplacées ou retirées. antérieures extraites des publications des CE 37, 77, 86 et

CISPR de l'IEC.
IEC Just Published - webstore.iec.ch/justpublished

Restez informé sur les nouvelles publications IEC. Just Service Clients - webstore.iec.ch/csc

Published détaille les nouvelles publications parues. Si vous désirez nous donner des commentaires sur cette

Disponible en ligne et aussi une fois par mois par email. publication ou si vous avez des questions contactez-nous:

csc@iec.ch.
---------------------- Page: 2 ----------------------
IEC 60601-2-65
Edition 1.0 2017-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
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 978-2-8322-4260-5

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

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 3 ----------------------
– 2 – IEC 60601-2-65:2012/AMD1:2017
© IEC 2017
FOREWORD

This 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:
CDV Report on voting
62B/1006/CDV 62B/1039/RVC

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.
_____________
INTRODUCTION TO AMENDMENT 1

The purpose of this first amendment to IEC 60601-2-65:2012 is to introduce changes to

reference the Amendment 1 (2012) to IEC 60601-1:2005. As neither IEC 60601-2-65:2012 nor

this amendment refers to specific elements of IEC 60601-1-2, the introduction of a dated

reference to the latter document has been removed.
_____________
201.1 Scope, object and related standards
Replace the text of the existing footnote by the following:

The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –

Part 1: General requirements for basic safety and essential performance
---------------------- Page: 4 ----------------------
IEC 60601-2-65:2012/AMD1:2017 – 3 –
© IEC 2017
201.1.3 Collateral standards
Replace the existing second sentence of the second paragraph by the following:
2 3
IEC 60601-1-8, IEC 60601-1-10 , IEC 60601-1-11 and IEC 60601-1-12 do not apply
201.2 Normative references
Delete, under "Replacement", the existing reference to IEC 60601-1-2:2007.

Replace, under "Replacement", the existing reference to IEC 60601-1-3 by the following:

IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic

safety and essential performance – Collateral Standard: Radiation protection in diagnostic

X-ray equipment
IEC 60601-1-3:2008/AMD1:2013
Add, under "Addition", the following new reference:

IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic

safety and essential performance
IEC 60601-1:2005/AMD1:2012
201.3 Terms and definitions

Replace, under "Amendment", "IEC 60601-1:2005" by "IEC 60601-1:2005 and IEC 60601-

1:2005/AMD1:2012".
201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements
Replace the existing title of this subclause by the following:
201.4.3.101 Additional potential ESSENTIAL PERFORMANCE requirements
202 Electromagnetic compatibility – Requirements and tests
Replace the first sentence of this subclause by the following:
IEC 60601-1-2 applies, except as follows.
__________

IEC 60601-1-10, Medical electrical equipment – Part 1-10: General requirements for basic safety and essential

performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers

IEC 60601-1-11, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential

performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical

systems used in the home healthcare environment

IEC 60601-1-12, Medical electrical equipment – Part 1-12: General requirements for basic safety and essential

performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical

systems intended for use in the emergency medical services environment
---------------------- Page: 5 ----------------------
– 4 – IEC 60601-2-65:2012/AMD1:2017
© IEC 2017
202.101 Immunity testing of ESSENTIAL PERFORMANCE
Replace the existing first paragraph by the following new paragraph:

The MANUFACTURER may minimize the test requirements of the additional potential ESSENTIAL

PERFORMANCE requirements listed in Table 201.101 to a practical level through the RISK

...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.