SIST EN 60601-2-63:2015

SLOVENSKI STANDARD
01-september-2015
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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).
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.
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.
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

– 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

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

– 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
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
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:

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.

– 6 – 60601-2-63 © IEC:2012
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.
60601-2-63 © IEC:2012 – 7 –
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.
– 8 – 60601-2-63 © IEC:2012
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
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

60601-2-63 © IEC:2012 – 9 –
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) )
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”
—————————
)
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
)
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
– 10 – 60601-2-63 © IEC:2012
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 particular standard.
“Addition” means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
“Amendment” means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term “this standard” is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
NOTE Informative references are listed in the bibliography beginning on page 39.
Clause 2 of the general standard applies, except as follows:
Replacement:
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
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
Addition:
IEC 60336, Medical electrical equipment – X-ray tube assemblies for medical diagnosis –
Characteristics of focal spots
IEC 60601-2-29:2008, Medical electrical equipment – Part 2-29: Particular requirements for
the basic safety and essential performance of radiotherapy simulators

60601-2-63 © IEC:2012 – 11 –
IEC 60601-2-54:2009, Medical electrical equipment – 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
201.3 Terminology and definitions
Amendment:
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005, its
applicable collateral standards, IEC/TR 60788:2004 and the following apply:
NOTE An index of defined terms is found beginning on page 42.
Addition:
201.3.201
CEPHALOMETRIC
related to PROJECTION RADIOGRAPHY of the whole dento-maxillo-facial anatomy, whereas the
projection geometry is such to minimize geometrical image distortions
Note 1 to entry: This is usually achieved by setting a sufficiently large source-to-object-distance and source-to-
detector-distance.
Note 2 to entry: Another term often used for CEPHALOMETRIC RADIOGRAPHY is teleradiography.
201.3.202
DENTAL
related to structures in the dento-maxillo-facial district of the PATIENT, including dentition
201.3.203
*DENTAL VOLUMETRIC RECONSTRUCTION
DVR
reconstruction of the 3-dimensional attenuation distribution of the whole or part of the
irradiated volume from a series of 2-dimensional projections produced by an X-RAY BEAM on
an X-RAY IMAGE RECEPTOR moving around the head of the PATIENT
201.3.204
DOSE AREA PRODUCT
product of the area of the cross-section of an X-RAY BEAM and the averaged AIR KERMA over
that cross-section. The unit is the gray square metre (Gy⋅m ).
[SOURCE: IEC 60601-2-54:2009, 201.3.203]
201.3.205
ELECTRONIC X-RAY IMAGE RECEPTOR
X-RAY IMAGE RECEPTOR comprising an electrically-powered conversion method
201.3.206
EXTRA-ORAL
DENTAL RADIOGRAPHY where the X-RAY IMAGE RECEPTOR is located outside the oral
related to
cavity
– 12 – 60601-2-63 © IEC:2012
201.3.207
INTERLOCK
means preventing the start or the continued operation of ME EQUIPMENT unless certain
predetermined conditions prevail
[SOURCE:IEC 60601-2-54:2009, 201.3.207]
201.3.208
INTRA-ORAL
related to DENTAL RADIOGRAPHY where the X-RAY IMAGE RECEPTOR is located, wholly or
partially, inside the oral cavity
201.3.209
NOMINAL SHORTEST IRRADIATION TIME
shortest LOADING TIME for which a required constancy of the controlled RADIATION QUANTIY is
maintained
Note 1 to entry: The IRRADIATION TIME is controlled by a HIGH-VOLTAGE GENERATOR with AUTOMATIC CONTROL
SYSTEMS.
[SOURCE: IEC 60601-2-54:2009, 201.3.208]
201.3.210
ONE-PEAK HIGH-VOLTAGE GENERATOR
HIGH-VOLTAGE GENERATOR for operation on a single-phase supply that delivers an unrectified
output voltage, or rectified output voltage with one peak during each cycle of the supply
[SOURCE: IEC 60601-2-65:2012, 201.3.208
201.3.211
* PANORAMIC
related to DENTAL RADIOGRAPHY, produced by the coordinated motion of a scanning fan-shaped
X-RAY BEAM, oriented parallel to the cranio-caudal axis of the PATIENT, and an X-RAY IMAGE
RECEPTOR, both rotating around the head of the PATIENT
Note 1 to entry: A tomographic layer is produced with respect to the plane perpendicular to the rotational axis.
The resulting image is a focused projection on a surface parallel to the rotational axis.
Note 2 to entry: The scanning axis is usually vertical.
201.3.212
TWO-PEAK HIGH-VOLTAGE GENERATOR
HIGH-VOLTAGE GENERATOR for operation on a single-phase supply that delivers a rectified
output voltage with two peaks during each cycle of the supply
[SOURCE: IEC 60601-2-65:2012, 201.3.209]
201.3.213
X-RAY MONOBLOCK ASSEMBLY
X-RAY TUBE ASSEMBLY containing the HIGH-VOLTAGE TRANSFORMER ASSEMBLY
Note 1 to entry: The term X-RAY MONOBLOCK ASSEMBLY excludes the BEAM LIMITING DEVICE.
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Addition:
60601-2-63 © IEC:2012 – 13 –
201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements
The list in Table 201.101 is a list of potential ESSENTIAL PERFORMANCE to be considered by the
MANUFACTURER in the RISK MANAGEMENT PROCESS.
NOTE Subclause 203.6.4.3.102 (Accuracy of LOADING FACTORS) specifies a limitation in applying subclause
203.6.4.3.102.3 (Accuracy of X-RAY TUBE VOLTAGE) and 203.6.4.3.102.4 (Accuracy of X-RAY TUBE CURRENT). This
limitation is also valid for the ESSENTIAL PERFORMANCE list.
Table 201.101 – List of potential ESSENTIAL PERFORMANCE to be considered by
in the RISK MANAGEMENT PROCESS
MANUFACTURER
Requirement Subclause
Accuracy of LOADING FACTORS 203.6.4.3.102
Reproducibility of the RADIATION output 203.6.3.2

201.4.10.1 Source of power for ME EQUIPMENT
Addition:
201.4.10.1.101 Connection to SUPPLY MAINS
ME EQUIPMENT shall be PERMANENTLY INSTALLED unless the INTENDED USE requires it to be
MOBILE.
201.4.10.2 SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS
Addition:
The internal impedance of a SUPPLY MAINS is to be considered sufficiently low for the operation
of ME EQUIPMENT if the value of the APPARENT RESISTANCE OF SUPPLY MAINS does not exceed
the value specified in the ACCOMPANYING DOCUMENTS.
ME EQUIPMENT is considered to comply with the requirements of this standard only if its
specified NOMINAL ELECTRIC POWER can be demonstrated at a resistance of supply mains
having a value not less than the APPARENT RESISTANCE OF SUPPLY MAINS specified by the
MANUFACTURER in the ACCOMPANYING DOCUMENTS.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS and by functional test.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:

– 14 – 60601-2-63 © IEC:2012
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.7 Electrical input power from the SUPPLY MAINS
Addition:
Except for items a) to c) below, for ME EQUIPMENT that is specified to be PERMANENTLY
INSTALLED, the information may be stated in the ACCOMPANYING DOCUMENTS only.
The information on the input power shall be specified in terms of combinations of
a) the rated MAINS VOLTAGE of the ME EQUIPMENT in volts; see 7.2.1 and 7.2.6 of the general
standard;
b) the number of phases; see 7.2.1 and 7.2.6 of the general standard;
c) the frequency, in hertz; see 7.2.1 and 7.2.6 of the general standard;
d) the maximum permissible value for APPARENT RESISTANCE OF SUPPLY MAINS, in ohms;
e) the characteristics of OVER-CURRENT RELEASES required in the SUPPLY MAINS.
NOTE These requirements are adapted from IEC 60601-2-7 subclause 6.1j).
201.7.2.15 Cooling conditions
Addition:
If cooling is necessary for safe operation of ME EQUIPMENT, or a subassembly thereof, the
ACCOMPANYING DOCUMENTS, as identified in the
cooling requirements shall be indicated in the
RISK MANAGEMENT PROCESS.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS and the RISK
MANAGEMENT FILE.
Additional subclause:
201.7.2.101 BEAM LIMITING DEVICE
Where detachable in NORMAL USE, BEAM LIMITING DEVICES shall be provided with the following
markings:
– those required in subclause 7.2.2 of the general standard;
– serial designation or individual identification;
– ADDITIONAL FILTRATION, if the additional value is more than the equivalent of 0,2 mm Al.
Compliance is checked by inspection.
201.7.8.1 Colours of indicator lights
Addition:
The indication of X-ray related states shall be excluded from subclause 7.8 in the general
standard. 203.6.4.2 and 203.6.4.101 shall apply instead.
201.7.9 ACCOMPANYING DOCUMENTs
201.7.9.1 General
Addition:
NOTE 101 Annex C Table 201.C.102 lists the requirements of this particular standard that are additional to those
of the general standard for statements in the ACCOMPANYING DOCUMENTS.

60601-2-63 © IEC:2012 – 15 –
The ACCOMPANYING DOCUMENTS shall contain quality control PROCEDURES to be performed on
the ME EQUIPMENT by the RESPONSIBLE ORGANISATION. These shall include acceptance criteria
and frequency for the tests.
Additionally for ME EQUIPMENT provided with one or more integrated ELECTRONIC X-RAY IMAGE
RECEPTORs, the ACCOMPANYING DOCUMENTS shall contain a description of the minimum
performance required of the means, used to display the images for diagnostic purpose
according to the INTENDED USE for each ELECTRONIC X-RAY IMAGE RECEPTOR used.
NOTE 102 For instance, the minimum required number of pixels and number of discernible grey levels at the
DISPLAY.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
201.7.9.2 Instructions for use
201.7.9.2.1 General
Additional subclause:
201.7.9.2.1.101 LOADING FACTORS
In the instructions for use the LOADING FACTORS shall be stated as described below. The
following combinations and data shall be stated:
a) value(s) or range of X-RAY TUBE VOLTAGE settings;
b) value(s) or range of X-RAY TUBE CURRENT settings;
c) values or range of IRRADIATION TIME settings;
d) maximum X-RAY TUBE CURRENT at each X-RAY TUBE VOLTAGE setting, if different from (b);
e) maximum and minimum IRRADIATION TIME at each X-RAY TUBE VOLTAGE and X-RAY TUBE
CURRENT setting, if different from (c);
f) for ME EQUIPMENT indicating precalculated or measured CURRENT TIME PRODUCT, the lowest
CURRENT TIME PRODUCT or the combinations of LOADING FACTORS resulting in the lowest
CURRENT TIME PRODUCT;
g) if the value of the lowest CURRENT TIME PRODUCT depends upon the X-RAY TUBE VOLTAGE or
upon certain combinations of values of LOADING FACTORS, the lowest CURRENT TIME
PRODUCT may be given as a table or curve showing the dependence;
h) the NOMINAL SHORTEST IRRADIATION TIME used in AUTOMATIC EXPOSURE CONTROL systems of
ME EQUIPMENT;
i) if the NOMINAL SHORTEST IRRADIATION TIME depends upon LOADING FACTORS such as X-RAY
TUBE VOLTAGE and X-RAY TUBE CURRENT, the ranges of these LOADING FACTORS for which
the NOMINAL SHORTEST IRRADIATION TIME is valid;
j) the maximum possible range of the X-RAY TUBE VOLTAGE and/or the X-RAY TUBE CURRENT
during IRRADIATION, controlled with the AUTOMATIC CONTROL SYSTEM
NOTE these requirements are adapted from IEC 60601-2-7 subclause 6.8.2 a).
Compliance is checked by inspection of the instructions for use.
201.7.9.3 Technical description
Additional subclauses:
201.7.9.3.101 Technical description for DENTAL EXTRA-ORAL X-RAY EQUIPMENT
In addition to the data required to be marked according to subclause 7.2 of the general
standard, the technical description shall specify a description of the geometric relationship of

– 16 – 60601-2-63 © IEC:2012
the FOCAL SPOT, X-RAY BEAM dimensions, PATIENT position and IMAGE RECEPTION AREA, as well
as a method used to estimate the DOSE AREA PRODUCT.
Additional subclause:
201.7.9.3.102 X-RAY SOURCE ASSEMBLY
The technical description of the integrated X-RAY SOURCE ASSEMBLY shall specify the following,
in addition to the data required to be marked according to subclause 7.2 of the general
standard:
a) specification of the REFERENCE AXIS to which the TARGET ANGLE(s) and the FOCAL SPOT
characteristics of the X-RAY SOURCE ASSEMBLY refer:
b) TARGET ANGLE(s) with respect to the specified REFERENCE AXIS;
c) NOMINAL FOCAL SPOT VALUE(s) determined according to IEC 60336 for the specified
REFERENCE AXIS.
Compliance is checked by inspection of the technical description.
Additional subclause:
201.7.9.101 Requirements to the SUPPLY MAINS
The information on the RATED electrical input power for DENTAL EXTRA-ORAL X-RAY GENERATORS
shall also include:
• either the maximum permissible value for the APPARENT RESISTANCE OF SUPPLY MAINS or
SUPPLY MAINS specifications used in a facility, and
other appropriate
• the characteristics of OVER-CURRE
...