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SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cenelec.eu.
Replace, in this clause modified by Amendment 1, under Addition, the reference to
IEC/PAS 61910-1:2014 with:
Publication Year Title EN/HD Year
IEC 61910-1 2014 Medical electrical equipment - Radiation EN 61910-1 2014
dose documentation - Part 1: Radiation dose
structured reports for radiography and
radioscopy
IEC 60601-2-63
Edition 1.0 2021-05
INTERNATIONAL
STANDARD
AMENDMENT 2
Medical electrical equipment –
Part 2-63: Particular requirements for the basic safety and essential
performance of dental extra-oral X-ray equipment
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.50 ISBN 978-2-8322-9629-5
– 2 – IEC 60601-2-63:2012/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/1232/FDIS 62B/1237/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.
_____________
201.1.1 Scope
Replace Note 1 with the following new note:
NOTE 1 An example of such equipment is an equipment designed to perform PANORAMIC, CEPHALOMETRIC and
DENTAL VOLUMETRIC RECONSTRUCTION (hereafter DVR) as defined in 201.3.203.
Add, under Replacement, before Note 5, the following new paragraph:
DENTAL EXTRA-ORAL X-RAY EQUIPMENT are X-RAY EQUIPMENT designed for EXTRA-ORAL
RADIOGRAPHY in which the geometrical relations between the X-RAY SOURCE, the anatomical
PATIENT, and the X-RAY IMAGE RECEPTOR, are preset in the design
object being imaged in the
and cannot be arbitrarily altered by the OPERATOR during INTENDED USE. In such equipment, the
X-RAY TUBE ASSEMBLY contains the HIGH-VOLTAGE TRANSFORMER ASSEMBLY.
Add, at the end of the existing fifth paragraph, between Note 8 and Note 9, "by entities other
than the manufacturer".
201.2 Normative references
Replace, in this clause modified by Amendment 1, under Addition, the reference to
IEC/PAS 61910-1:2007 with:
IEC 61910-1:2014, Medical electrical equipment – Radiation dose documentation – Part 1:
Radiation dose structured reports for radiography and radioscopy
IEC 60601-2-63:2012/AMD2:2021 – 3 –
© IEC 2021
201.3 Terminology and definitions
Add, after definition 201.3.213, the following new terms and definitions:
201.3.214
DENTAL CONE BEAM COMPUTED TOMOGRAPHY
DENTAL CBCT
3-dimensional imaging of DENTAL anatomical structures, performed by reconstruction of a
volume from a series of 2-dimensional projections produced by circular or rectangular
collimated X-RAY BEAM on an X-RAY IMAGE RECE
...