SIST EN 60601-2-63:2015

Medical electrical equipment - Part 2-63: Particular requirements for basic safety and essential performance of dental extra-oral x-ray equipment

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL EXTRA-ORAL X-RAY EQUIPMENT, hereafter also called ME EQUIPMENT. The scope includes ME SYSTEMS containing such ME EQUIPMENT.
NOTE 1 This includes PANORAMIC equipment, CEPHALOMETRIC equipment, and equipment for dental volumetric reconstruction (hereafter DVR) as defined in 201.3.203 below.
NOTE 2 DVR includes dental CBCT (cone beam computed tomography), which is also known with other names in certain parts of the world, e.g. DVT (digital volumetric tomography); DVR also includes tomosynthesis.
NOTE 3 This may include the imaging of other anatomical parts (e.g. the hand) as long as required for dental treatment (e.g. orthodontic treatment).
NOTE 4 This may include anatomical objects of interest to the ENT (ear, nose, and throat) specialist.
The scope of this standard is restricted to X-RAY EQUIPMENT where:
• the X-RAY TUBE ASSEMBLY contains the HIGH-VOLTAGE TRANSFORMER ASSEMBLY and
• the geometrical relations between the X-RAY SOURCE, the anatomical object being imaged
in the PATIENT, and the X-RAY IMAGE RECEPTOR, are preset in the design and cannot be arbitrarily altered by the OPERATOR during INTENDED USE.
NOTE 5 DENTAL INTRA-ORAL X-RAY EQUIPMENT is excluded from the scope of this standard.
NOTE 6 FOCAL SPOT TO IMAGE RECEPTOR DISTANCE and FOCAL SPOT to object distance are preset in the design of DENTAL EXTRA-ORAL X-RAY EQUIPMENT.
NOTE 7 For DENTAL X-RAY EQUIPMENT not in the scope of this document because of the restriction above, applicable clauses of IEC 60601-2-54 may be used with this document. ME EQUIPMENT and ME SYSTEMS in the scope of IEC 60601-2-44, IEC 60601-2-54, IEC 60601-2-45, IEC 60601-2-65 or IEC 60601-2-43 are excluded from the scope of this particular standard. The scope of this International Standard also excludes RADIOTHERAPY SIMULATORS and equipment for bone or tissue absorption densitometry. Excluded from the scope is also ME EQUIPMENT intended to be used for DENTAL RADIOSCOPY. Within its specific scope, the clauses of this particular standard supersede and replace those of IEC 60601-2-7, Medical electrical equipment – Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators and of IEC 60601-2-32, Medical electrical equipment – Particular requirements for the safety of associated equipment of X-ray equipment. IEC 60601-2-7 and IEC 60601-2-32, have been included in either IEC 60601-1:2005 (Ed3) or this particular standard. Therefore IEC 60601-2-7 and IEC 60601-2-32 are not part of the IEC 60601-1 3rd edition scheme for DENTAL EXTRA-ORAL X-RAY EQUIPMENT.
All requirements addressing integrated X-RAY TUBE ASSEMBLIES are covered by this particular standard. Therefore IEC 60601-2-28 does not apply to ME EQUIPMENT in the scope of this International Standard with the exception of X-RAY TUBE ASSEMBLIES that are replaceable in the field.
NOTE 9 Requirements particular to DENTAL X-RAY-EQUIPMENT which were included in previous editions of the collateral standard IEC 60601-1-3 or the particular standard IEC 60601-2-28 have been extracted and moved into this particular standard.
NOTE 10 For X-RAY EQUIPMENT in the scope of this particular standard X-RAY TUBE ASSEMBLIES are X-RAY MONOBLOCK ASSEMBLIES.

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

La CEI 60601-2-63:2012 s'applique à la sécurité de base et aux performances essentielles des appareils à rayonnement X dentaires extra-oraux, également désignés ci-après par appareils EM. Le domaine d'application inclut les systèmes EM contenant de tels appareils EM. La présente norme particulière a été préparée pour fournir, sur la base de la CEI 60601-1:2005 et de ses normes collatérales, un ensemble complet d'exigences de sécurité de base et de performances essentielles pour les appareils à rayonnement x dentaires extra-oraux. Alors que les normes antérieures pour de tels appareils étaient consacrées aux composants et aux sous-systèmes, la présente norme particulière concerne le niveau système des appareils à rayonnement x dentaires extra-oraux. Les composants et leurs fonctions sont mentionnés dans la mesure où cela est nécessaire. Le domaine d'application de la présente norme est limité aux appareils à rayonnement X dans lesquels:  - la gaine équipée contient l'ensemble transformateur haute tension; et  - les relations géométriques entre la source de rayonnement X, l'objet anatomique soumis à l'imagerie chez le patient et le récepteur radiologique sont préréglées au niveau de la conception et ne peuvent pas être modifiées de façon arbitraire par l'opérateur pendant l'utilisation prévue.

Medicinska električna oprema - 2-63. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za ekstraoralni zobni rentgen

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI EKSTRAORALNEGA ZOBNEGA RENTGENA, v nadaljevanju: ELEKTROMEDICINSKA OPREMA. Področje uporabe vključuje ELEKTROMEDICINSKE SISTEME, ki vključujejo tako ELEKTROMEDICINSKO OPREMO.
OPOMBA 1 Sem spada PANORAMSKA oprema, oprema za KEFALOMETRIJO in oprema za zobno volumetrično rekonstitucija (v nadaljevanju: DVR), kot je opredeljena v točki 201.3.203 spodaj.
OPOMBA 2 DVR vključuje zobni CBCT (računalniška tomografija s konusnim snopom), poznana tudi pod drugimi imeni v določenih delih sveta, npr. DVT (digitalna volumetrična tomografija); DVR vključuje tudi tomosintezo.
OPOMBA 3 Sem lahko spada slikanje drugih anatomskih delov (npr. roke), če je to potrebno za zobno zdravljenje.
OPOMBA 4 Sem lahko spadajo anatomski deli, ki so zanimivi za specialista ENT (uho, nos in grlo).
Področje uporabe tega standarda je omejeno na RENTGENSKO OPREMO, pri kateri:
• SESTAV RENTGENSKIH CEVI vsebuje VISOKONAPETOSTNI SESTAV TRANSFORMATORJEV in
• je geometrično razmerje med RENTGENSKIM VIROM, slikanim anatomskim delom
PACIENTA in RENTGENSKIM SLIKOVNIM SPREJEMNIKOM prednastavljeno v sami zasnovi in ga OPERATER ne more poljubno spremeniti med NAMERAVANO UPORABO.
OPOMBA 5 INTRAORALNI ZOBNI RENTGENI so izključeni s področja uporabe tega standarda.
OPOMBA 6 RAZDALJA MED GORIŠČEM IN SLIKOVNIM SPREJEMNIKOM ter GORIŠČEM in delom sta prednastavljeni v zasnovi EKSTRAORALNEGA ZOBNEGA RENTGENA.
OPOMBA 7 Za ZOBNI RENTGEN, ki ni v področju uporabe tega dokumenta zaradi zgornjih omejitev, se lahko s tem dokumentom uporabljajo ustrezne točke standarda IEC 60601-2-54. MEDICINSKA ELEKTRIČNA OPREMA in MEDICINSKI ELEKTRIČNI SISTEMI na področju uporabe standardov IEC 60601-2-44, IEC 60601-2-54, IEC 60601-2-45, IEC 60601-2-65 ali IEC 60601-2-43 so izključeni s področja uporabe tega standarda. Področje uporabe tega mednarodnega standarda izključuje tudi RADIOTERAPEVTSKE SIMULATORJE in opremo za denzitometrijo absorpcije kosti ali tkiva. Ta standard tudi ne vključuje MEDICINSKE ELEKTRIČNE OPREME, ki je namenjena ZOBNI RADIOSKOPIJI. Na določenem področju uporabe imajo točke tega standarda prednost in nadomeščajo tiste iz standarda IEC 60601-2-7, Medicinska električna oprema – Posebne zahteve za varnost visokonapetostnih generatorjev diagnostičnih rentgenskih generatorjev, in standarda IEC 60601-2-32, Medicinska električna oprema - Posebne zahteve za varnost opreme, ki je povezana z rentgensko opremo. Standarda IEC 60601-2-7 in IEC 60601-2-32 sta vključena ali v standard IEC 60601-1:2005 (3 različica) ali ta standard. Standarda IEC 60601-2-7 in IEC 60601-2-32 tako nista del sheme tretje različice standarda IEC 60601-1 za ZOBNI RENTGEN.
Vse zahteve glede integrirane SESTAVE RENTGENSKIH CEVI so opredeljene v okviru tega standarda. Standard IEC 60601-2-28 se tako ne uporablja za ELEKTROMEDICINSKO OPREMO, ki spada v področje uporabe tega mednarodnega standarda, razen SESTAVOV RENTGENSKIH CEVI, ki so zamenljive na kraju samem.
OPOMBA 9 Zahteve za ZOBNI RENTGEN, ki so bile vključene v prejšnje različice spremljevalnega standarda IEC 60601-1-3 ali standarda IEC 60601-2-28, so bile premaknjene v ta standard.
OPOMBA 10 SESTAVI RENTGENSKIH CEVI so RENTGENSKI SESTAVI MONOBLOKOV v okviru RENTGENA, ki spada v področje uporabe tega standarda.

General Information

• Status: Published
• Publication Date: 16-Aug-2015
• ICS: 11.040.50 - Radiographic equipment
• ICS: 11.060.20 - Dental equipment
• ICS: 13.280 - Radiation protection
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 15-Jun-2015
• Due Date: 20-Aug-2015
• Completion Date: 17-Aug-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN 60601-2-63:2015 - Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

Relations

• Amended By: SIST EN 60601-2-63:2015/A1:2019 - 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/A1:2017)
• Effective Date: 10-May-2016
• Amended By: SIST EN 60601-2-63:2015/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)
• Effective Date: 12-Mar-2019

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-63:2015
01-september-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL]DHNVWUDRUDOQL]REQLUHQWJHQ
Medical electrical equipment - Part 2-63: Particular requirements for basic safety and
essential performance of dental extra-oral x-ray equipment
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
Ta slovenski standard je istoveten z: EN 60601-2-63:2015
ICS:
11.040.50 Radiografska oprema Radiographic equipment
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
13.280 Varstvo pred sevanjem Radiation protection
SIST EN 60601-2-63:2015 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

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SIST EN 60601-2-63:2015


EUROPEAN STANDARD EN 60601-2-63

NORME EUROPÉENNE

EUROPÄISCHE NORM May 2015
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)
Appareils électromédicaux -  Medizinische elektrische Geräte - Teil 2-63: Besondere
Partie 2-63: Exigences particulières pour la sécurité Festlegungen für die Sicherheit einschließlich der
de base et les performances essentielles des appareils w esentlichen Leistungsmerkmale von extraoralen
à rayonnement X dentaires extra-oraux zahnärztlichen Röntgeneinrichtungen
(IEC 60601-2-63:2012) (IEC 60601-2-63:2012)
This European Standard w as approved by CENELEC on 2012-10-24. CENELEC members are bound to comply w ith the CEN/CENELEC
Internal Regulations w hich stipulate the conditions for giving this European Standard the status of a national standard w ithout 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 European Standard 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 ow n 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norw ay, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sw eden, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved w orldw ide for CENELEC Members.
 Ref. No. EN 60601-2-63:2015 E

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SIST EN 60601-2-63:2015
EN 60601-2-63:2015
Foreword
The text of document 62B/888/FDIS, future edition 1 of IEC 60601-2-63, 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.
The following dates are fixed:
• latest date by which the document has (dop) 2015-11-29
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-05-29
• latest date by which the national
standards conflicting with the
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 [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.

This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive.

For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standard IEC 60601-2-63:2012 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:

1)
IEC 60601-2-7:1998 NOTE Harm onised as EN 60601-2-7:1998 (not modified).
IEC 60601-2-28:2010 NOTE Harmonised as EN 60601-2-28:2010 (not modified).
1)
IEC 60601-2-32:1994 NOTE Harmonised as EN 60601-2-32:1994 (not modified).
IEC 60601-2-43:2010 NOTE Harmonised as EN 60601-2-43:2010 (not modified).
IEC 60601-2-44:2009 NOTE Harmonised as EN 60601-2-44:2009 (not modified).
IEC 60601-2-45:2011 NOTE Harmonised as EN 60601-2-45:2011 (not modified).
IEC 60601-2-65:2012 NOTE Harmonised as EN 60601-2-65:2013 (not modified).


1)
Superseded by EN 60601-2-54:2009 (IEC 60601-2-54:2009) and partially by EN 60601-2-65:2013
(IEC 60601-2-65:2012).
2

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SIST EN 60601-2-63:2015
EN 60601-2-63:2015
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications

The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.

NOTE 1 When 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

Publication Year Title EN/HD Year
Annex ZA of EN 60601-1:2006 applies except as follows:
Replacement:
1)
IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
1)
(mod) Part 1-2: General requirements for basic + corr. March 2010
safety and essential performance - Collateral
standard: Electromagnetic compatibility -
Requirements and tests


IEC 60601-1-3 2008 Medical electrical equipment - EN 60601-1-3 2008
Part 1-3: General requirements for basic + corr. March 2010
safety and essential performance - Collateral
Standard: Radiation protection in diagnostic
X-ray equipment

Addition:
IEC 60336 - Medical electrical equipment - X-ray tube EN 60336 -
assemblies for medical diagnosis -
Characteristics of focal spots

IEC 60601-2-29 2008 Medical electrical equipment - EN 60601-2-29 2008
Part 2-29: Particular requirements for the + A11 2011
basic safety and essential performance of
radiotherapy simulators


IEC 60601-2-54 2009 Medical electrical equipment - EN 60601-2-54 2009
Part 2-54: Particular requirements for the
basic safety and essential performance
of X-ray equipment for radiography and
radioscopy


IEC/TR 60788 2004 Medical electrical equipment - Glossary - -
of defined terms


IEC/PAS 61910-1 2007 Medical electrical equipment - Radiation - -
dose documentation -
Part 1: Equipment for radiography and
radioscopy



1)
Superseded by EN 60601-1-2:2014 (IEC 60601-1-2:2014): DOW = 2018-12-31.
3

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SIST EN 60601-2-63:2015
EN 60601-2-63:2015
Annex ZZ
(informative)

Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.

4

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SIST EN 60601-2-63:2015




IEC 60601-2-63

®

Edition 1.0 2012-09




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE
colour

inside










Medical electrical equipment –

Part 2-63: Particular requirements for the basic safety and essential performance

of dental extra-oral X-ray equipment




Appareils électromédicaux –

Partie 2-63: Exigences particulières pour la sécurité de base et les performances


essentielles des appareils à rayonnement X dentaires extra-oraux













INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE

PRICE CODE
INTERNATIONALE

X
CODE PRIX


ICS 11.040.50 ISBN 978-2-83220-382-8



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

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SIST EN 60601-2-63:2015
– 2 – 60601-2-63 © IEC:2012
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 11
201.4 General requirements . 12
201.5 General requirements for testing of ME EQUIPMENT . 13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 16
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 17
201.10 Protection against unwanted and excessive radiation HAZARDS . 18
201.11 Protection against excessive temperatures and other HAZARDS . 18
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 18
201.13 HAZARDOUS SITUATIONS and fault conditions . 18
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18
201.15 Construction of ME EQUIPMENT . 18
201.16 ME SYSTEMS . 18
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 19
202 Electromagnetic compatibility – Requirements and tests . 19
203 Radiation protection in diagnostic X-ray equipment . 19
Annexes . 31
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 32
Annex AA (informative) Particular guidance and rationale . 33
Bibliography . 39
Index of defined terms used in this particular standard . 42

Figure 203.101 – Zone of EXTRA-FOCAL RADIATION . 28
Figure AA.1 – PANORAMIC X-RAY EQUIPMENT . 33
Figure AA.2 – AIR KERMA during IRRADIATION with direct current X-RAY GENERATOR . 35
Figure AA.3 – AIR KERMA during IRRADIATION with ONE-PEAK X-RAY GENERATOR . 36
Figure AA.4 – Example – series of (numerous) pulsed IRRADIATIONS for a CBCT (cone
beam computed tomography) IRRADIATION event, with CONSTANT POTENTIAL HIGH-
VOLTAGE GENERATOR and time-width modulation . 37
Figure AA.5 – Example – series of two irradiations for PANORAMIC-like views of right
and left TMJ (temporo-mandibolar joint) in the same image, with ONE-PEAK HIGH-
VOLTAGE GENERATOR . 37

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SIST EN 60601-2-63:2015
60601-2-63 © IEC:2012 – 3 –
Table 201.101 – List of potential ESSENTIAL PERFORMANCE to be considered by
MANUFACTURER in the RISK MANAGEMENT PROCESS . 13
Table 201.C.101 – Marking on the outside of ME EQUIPMENT or its parts . 32
Table 201.C.102 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 32

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SIST EN 60601-2-63:2015
– 4 – 60601-2-63 © IEC:2012
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-63: Particular requirements for the basic safety
and essential performance of dental extra-oral X-ray equipment


FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-63 has been prepared by IEC subcommittee 62B:
Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62B/888/FDIS 62B/898/RVD

Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:

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SIST EN 60601-2-63:2015
60601-2-63 © IEC:2012 – 5 –
– Requirements and definitions: in roman type.
– Test specifications: in italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.

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The committee has decided that the contents of this publication will remain unchange-d until
the stability date indicated on the IEC web site 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.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.

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INTRODUCTION
This particular standard has been prepared to provide, based on IEC 60601-1:2005 (third
edition), and its collaterals, a complete set of BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for DENTAL EXTRA-ORAL X-RAY EQUIPMENT. While the previously existing standards
for such equipment were dedicated to components and subsystems, this particular standard
addresses the system level of DENTAL EXTRA-ORAL X-RAY EQUIPMENT. Components and their
functions are addressed as far as necessary.
The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of DENTAL EXTRA-ORAL
X-RAY EQUIPMENT
The minimum safety requirements for DENTAL INTRA-ORAL X-RAY EQUIPMENT are specified in a
separate particular standard IEC 60601-2-65 to simplify and improve the readability
Requirements particular to DENTAL X-RAY-EQUIPMENT which were included in previous editions
of the collateral standard IEC 60601-1-3, the particular standards IEC 60601-2-28
IEC 60601-2-7, or IEC 60601-2-32 have been extracted and moved into this particular
standard.
All requirements addressing integrated X-RAY TUBE ASSEMBLIES are covered by this particular
standard.

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MEDICAL ELECTRICAL EQUIPMENT –

Part 2-63: Particular requirements for the basic safety
and essential performance of dental extra-oral X-ray equipment



201.1 Scope, object and related standards
1
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
DENTAL EXTRA-ORAL X-RAY EQUIPMENT, hereafter also called ME EQUIPMENT. The scope includes
ME SYSTEMS containing such ME EQUIPMENT.
NOTE 1 This includes PANORAMIC equipment, CEPHALOMETRIC equipment, and equipment for dental volumetric
reconstruction (hereafter DVR) as defined in 201.3.203 below.
NOTE 2 DVR includes dental CBCT (cone beam computed tomography), which is also known with other names in
certain parts of the world, e.g. DVT (digital volumetric tomography); DVR also includes tomosynthesis.
NOTE 3 This may include the imaging of other anatomical parts (e.g. the hand) as long as required for dental
treatment (e.g. orthodontic treatment).
NOTE 4 This may include anatomical objects of interest to the ENT (ear, nose, and throat) specialist.
The scope of this standard is restricted to X-RAY EQUIPMENT where:
• the X-RAY TUBE ASSEMBLY contains the HIGH-VOLTAGE TRANSFORMER ASSEMBLY and
• the geometrical relations between the X-RAY SOURCE, the anatomical object being imaged
PATIENT, and the X-RAY IMAGE RECEPTOR, are preset in the design and cannot be
in the
arbitrarily altered by the OPERATOR during INTENDED USE.
NOTE 5 DENTAL INTRA-ORAL X-RAY EQUIPMENT is excluded from the scope of this standard.
NOTE 6 FOCAL SPOT TO IMAGE RECEPTOR DISTANCE and FOCAL SPOT to object distance are preset in the design of
DENTAL EXTRA-ORAL X-RAY EQUIPMENT.
NOTE 7 For DENTAL X-RAY EQUIPMENT not in the scope of this document because of the restriction above,
applicable clauses of IEC 60601-2-54 may be used with this document.
ME EQUIPMENT and ME SYSTEMS in the scope of IEC 60601-2-44, IEC 60601-2-54,
IEC 60601-2-45, IEC 60601-2-65 or IEC 60601-2-43 are excluded from the scope of this
RADIOTHERAPY
particular standard. The scope of this International Standard also excludes
SIMULATORS and equipment for bone or tissue absorption densitometry. Excluded from the
scope is also ME EQUIPMENT intended to be used for DENTAL RADIOSCOPY.
Within its specific scope, the clauses of this particular standard supersede and replace those
of IEC 60601-2-7, Medical electrical equipment – Particular requirements for the safety of
high-voltage generators of diagnostic X-ray generators and of IEC 60601-2-32, Medical
electrical equipment – Particular requirements for the safety of associated equipment of X-ray
equipment.
—————————
1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance

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NOTE 8 Requirements for X-RAY GENERATORS and for ASSOCIATED EQUIPMENT, which were previously specified in
IEC 60601-2-7 and IEC 60601-2-32, have been included in either IEC 60601-1:2005 (Ed3) or this particular
rd
standard. Therefore IEC 60601-2-7 and IEC 60601-2-32 are not part of the IEC 60601-1 3 edition scheme for
DENTAL EXTRA-ORAL X-RAY EQUIPMENT.
All requirements addressing integrated X-RAY TUBE ASSEMBLIES are covered by this particular
standard. Therefore IEC 60601-2-28 does not apply to ME EQUIPMENT in the scope of this
International Standard with the exception of X-RAY TUBE ASSEMBLIES that are replaceable in
the field.
NOTE 9 Requirements particular to DENTAL X-RAY-EQUIPMENT which were included in previous editions of the
collateral standard IEC 60601-1-3 or the particular standard IEC 60601-2-28 have been extracted and moved into
this particular standard.
NOTE 10 For X-RAY EQUIPMENT in the scope of this particular standard X-RAY TUBE ASSEMBLIES are X-RAY
MONOBLOCK ASSEMBLIES.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for ME EQUIPMENT for EXTRA-ORAL DENTAL RADIOGRAPHY.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2 and IEC 60601-1-3 apply as modified in Clause 202 and 203 respectively.
2) )
3
IEC 60601-1-8, IEC 60601-1-10 and IEC 60601-1-11 do not apply. All other published
collateral standards in the IEC 60601-1 series apply as published.
NOTE OPERATORS of DENTAL EXTRA-ORAL X-RAY EQUIPMENT are used to audible signals as required in this
particular standard rather than to the concepts of IEC 60601-1-8. Therefore IEC 60601-1-8 does not apply.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard or collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
—————————
)
2
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
)
3
 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

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where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard,
203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral
standard, etc.). The changes to the text of the general standard are specified by the use of
the following words:
“Replacement” means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this p
...