EN 60601-2-63:2015/A2:2021
(Amendment)Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
No scope available
Medizinische elektrische Geräte - Teil 2-63: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von extraoralen zahnärztlichen Röntgeneinrichtungen
Appareils électromédicaux - Partie 2-63: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X dentaires extra-oraux
Medicinska električna oprema - 2-63. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za ekstraoralni zobni rentgen - Dopolnilo A2 (IEC 60601-2-63:2012/A2:2021)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 60601-2-63:2015/A2:2021
01-september-2021
Medicinska električna oprema - 2-63. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za ekstraoralni zobni rentgen - Dopolnilo A2 (IEC 60601-2-
63:2012/A2:2021)
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and
essential performance of dental extra-oral X-ray equipment (IEC 60601-2-
63:2012/A2:2021)
Medizinische elektrische Geräte - Teil 2-63: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von extraoralen zahnärztlichen
Röntgeneinrichtungen (IEC 60601-2-63:2012/A2:2021)
Appareils électromédicaux - Partie 2-63: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils à rayonnement X dentaires extra-oraux
(IEC 60601-2-63:2012/A2:2021)
Ta slovenski standard je istoveten z: EN 60601-2-63:2015/A2:2021
ICS:
11.040.50 Radiografska oprema Radiographic equipment
11.060.20 Zobotehnična oprema Dental equipment
13.280 Varstvo pred sevanjem Radiation protection
SIST EN 60601-2-63:2015/A2:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 60601-2-63:2015/A2:2021
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SIST EN 60601-2-63:2015/A2:2021
EUROPEAN STANDARD EN 60601-2-63:2015/A2
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2021
ICS 11.040.50
English Version
Medical electrical equipment - Part 2-63: Particular requirements
for the basic safety and essential performance of dental extra-
oral X-ray equipment
(IEC 60601-2-63:2012/A2:2021)
Appareils électromédicaux - Partie 2-63: Exigences Medizinische elektrische Geräte - Teil 2-63: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils à rayonnement X dentaires extra- wesentlichen Leistungsmerkmale von extraoralen
oraux zahnärztlichen Röntgeneinrichtungen
(IEC 60601-2-63:2012/A2:2021) (IEC 60601-2-63:2012/A2:2021)
This amendment A2 modifies the European Standard EN 60601-2-63:2015; it was approved by CENELEC on 2021-06-16. 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 60601-2-63:2015/A2:2021 E
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SIST EN 60601-2-63:2015/A2:2021
EN 60601-2-63:2015/A2:2021 (E)
European foreword
The text of document 62B/1232/FDIS, future IEC 60601-2-63/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 60601-2-63:2015/A2:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022-03-16
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-06-16
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 60601-2-63:2012/A2:2021 was approved by CENELEC as
a European Standard without any modification.
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SIST EN 60601-2-63:2015/A2:2021
EN 60601-2-63:2015/A2:2021 (E)
Annex ZA
(normative)
Normative re
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