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/A2:2021)

2019-05-29 IP: Link to legislation (MDD) removed following CLC/TC 62 decision 02/2019 decision (May 2019 plenary)

Medizinische elektrische Geräte - Teil 2-65: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von intraoralen zahnärztlichen Röntgeneinrichtungen (IEC 60601-2-65:2012/A2:2021)

Appareils élecromédicaux - 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/A2:2021)

Medicinska električna oprema - 2-65. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za intraoralni zobni rentgen - Dopolnilo A2 (IEC 60601-2-65:2012/A2:2021)

General Information

Status
Published
Publication Date
21-Jul-2021
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
01-Jul-2021
Due Date
05-Sep-2021
Completion Date
22-Jul-2021

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SLOVENSKI STANDARD
SIST EN 60601-2-65:2013/A2:2021
01-september-2021
Medicinska električna oprema - 2-65. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za intraoralni zobni rentgen - Dopolnilo A2 (IEC 60601-2-
65:2012/A2:2021)

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/A2:2021)

Medizinische elektrische Geräte - Teil 2-65: Besondere Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale von intraoralen zahnärztlichen
Röntgeneinrichtungen (IEC 60601-2-65:2012/A2:2021)

Appareils élecromédicaux - 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/A2:2021)
Ta slovenski standard je istoveten z: EN 60601-2-65:2013/A2:2021
ICS:
11.060.20 Zobotehnična oprema Dental equipment
13.280 Varstvo pred sevanjem Radiation protection
SIST EN 60601-2-65:2013/A2:2021 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 60601-2-65:2013/A2:2021
---------------------- Page: 2 ----------------------
SIST EN 60601-2-65:2013/A2:2021
EUROPEAN STANDARD EN 60601-2-65:2013/A2
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2021
ICS 11.040.50
English Version
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/A2:2021)

Appareils élecromédicaux - Partie 2-65: Exigences Medizinische elektrische Geräte - Teil 2-65: Besondere

particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der

essentielles des appareils à rayonnement X dentaires intra- wesentlichen Leistungsmerkmale von intraoralen

oraux zahnärztlichen Röntgeneinrichtungen
(IEC 60601-2-65:2012/A2:2021) (IEC 60601-2-65:2012/A2:2021)

This amendment A2 modifies the European Standard EN 60601-2-65:2013; it was approved by CENELEC on 2021-06-07. CENELEC

members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment the

status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC

Management Centre or to any CENELEC member.

This amendment exists in three official versions (English, French, German). A version in any other language made by translation under the

responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as

the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,

Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the

Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN 60601-2-65:2013/A2:2021 E
---------------------- Page: 3 ----------------------
SIST EN 60601-2-65:2013/A2:2021
EN 60601-2-65:2013/A2:2021 (E)
European foreword

The text of document 62B/1233/FDIS, future IEC 60601-2-65/A2, prepared by SC 62B "Diagnostic

imaging equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to the IEC-

CENELEC parallel vote and approved by CENELEC as EN 60601-2-65:2013/A2:2021.
The following dates are fixed:

• latest date by which the document has to be implemented at national (dop) 2022-03-07

level by publication of an identical national standard or by endorsement

• latest date by which the national standards conflicting with the (dow) 2024-06-07

document have to be withdrawn

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

Endorsement notice

The text of the International Standard IEC 60601-2-65:2012/A2:2021 was approved by CENELEC as

a European Standard without any modification.
---------------------- Page: 4 ----------------------
SIST EN 60601-2-65:2013/A2:2021
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: 5 ----------------------
SIST EN 60601-2-65:2013/A2:2021
– 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 unchan
...

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