SIST EN 60601-2-65:2013

SLOVENSKI STANDARD
01-marec-2013
1DGRPHãþD
SIST EN 60601-2-32:1995
SIST EN 60601-2-7:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQH]DKWHYH]DLQWUDRUDOQL]REQLUHQWJHQ
Medical electrical equipment - Part 2-65: Particular requirements for basic safety and
essential performance of dental intra-oral x-ray equipment
Medizinische elektrische Geräte - Teil 2-65: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von intraoralen zahnärztlichen
Röntgeneinrichtungen
Appareils électromédicaux - Partie 2-65: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils à rayonnement x dentaires intra-oraux
Ta slovenski standard je istoveten z: EN 60601-2-65:2013
ICS:
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 60601-2-65
NORME EUROPÉENNE
January 2013
EUROPÄISCHE NORM
ICS 11.040.50 Supersedes EN 60601-2-7:1998 (partially), EN 60601-2-32:1994 (partially)

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)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-65: Exigences particulières Teil 2-65: Besondere Festlegungen für die
pour la sécurité de base Sicherheit einschließlich der wesentlichen
et les performances essentielles Leistungsmerkmale von intraoralen
des appareils à rayonnement X dentaires zahnärztlichen Röntgeneinrichtungen
intra-oraux (IEC 60601-2-65:2012)
(CEI 60601-2-65:2012)
This European Standard was approved by CENELEC on 2012-10-24. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
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 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 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, Former Yugoslav Republic of Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2013 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-65:2013 E
Foreword
The text of document 62B/889/FDIS, future edition 1 of IEC 60601-2-65, prepared by IEC/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.
The following dates are fixed:
(dop) 2013-07-24
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2015-10-24
• latest date by which the national
standards conflicting with the
document have to be withdrawn
This document supersedes EN 60601-2-7:1998 (PART) and EN 60601-2-32:1994 (PART).

EN 60601-2-7:1998 and EN 60601-2-32:1994:
Within its specific scope, the clauses of EN 60601-2-65:2012 supersede and replace those of
EN 60601-2-7:1998 and EN 60601-2-32:1994.

This standard is to be read in conjunction with EN 60601-1:2006.

In this standard, the following print types are used:
- Requirements and definitions: roman type.
- Test specifications: 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.

- 3 - EN 60601-2-65:2013
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.

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.
Endorsement notice
The text of the International Standard IEC 60601-2-65:2012 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 Harmonised 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 60601-2-54:2009 NOTE Harmonised as EN 60601-2-54:2009 (not modified).
IEC 60601-2-63 NOTE Harmonised as EN 60601-2-63.

1)
Superseded by EN 60601-2-54:2009 (IEC 60601-2-54:2009, not modified).

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  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Annex ZA of EN 60601-1:2006 applies, except as follows:

Publication Year Title EN/HD Year
In Annex ZA of EN 60601-1:2006 replace IEC 60601-1-2 and IEC 60601-1-3 by:
IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
(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
Add to Annex ZA of EN 60601-1:2006 the following new references:
IEC 60336 - Medical electrical equipment - X-ray tube EN 60336 -
assemblies for medical diagnosis -
Characteristics of focal spots

IEC/TR 60788 2004 Medical electrical equipment - Glossary - -
of defined terms
IEC 62220-1 2003 Medical electrical equipment - EN 62220-1 2004
Characteristics of digital X-ray imaging
devices -
Part 1: Determination of the detective
quantum efficiency
IEC 60601-2-65 ®
Edition 1.0 2012-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 2-65: Particular requirements for the basic safety and essential performance

of dental intra-oral X-ray equipment

Appareils électromédicaux –
Partie 2-65: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils à rayonnement X dentaires intra-oraux

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX X
ICS 11.040.50 ISBN 978-2-83220-383-5

– 2 – 60601-2-65  IEC:2012
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 8
201.3 Terms and definitions . 8
201.4 General requirements . 10
201.5 General requirements for testing of ME EQUIPMENT . 10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 10
201.7 ME EQUIPMENT identification, marking and documents . 11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 13
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201.10 Protection against unwanted and excessive radiation HAZARDS . 14
201.11 Protection against excessive temperatures and other HAZARDS . 14
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 15
201.13 HAZARDOUS SITUATIONS and fault conditions . 15
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 15
201.15 Construction of ME EQUIPMENT . 15
201.16 ME SYSTEMS . 15
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 15
202 Electromagnetic compatibility – Requirements and tests . 15
203 Radiation protection in diagnostic X-ray equipment . 16
Annexes . 26
Annex C (informative) Guide to marking and labeling requirements for ME EQUIPMENT
and ME SYSTEMS . 27
Annex AA (informative) Particular guidance and rationale . 28
Annex BB (informative) Identification of parts of dental X-RAY INTRA-ORAL SYSTEMS in
relation to defined terms in this standard . 35
Bibliography . 37
Index of defined terms used in this particular standard . 40

Figure AA.1 – AIR KERMA during IRRADIATION with direct current X-RAY GENERATOR . 29
Figure AA.2 – AIR KERMA during IRRADIATION with ONE-PEAK X-RAY GENERATOR. 31
Figure AA.3 – Waveform of long IRRADIATION TIME X-RADIATION from a
ONE-PEAK X-RAY GENERATOR . 32
Figure BB.1 – Structure of DENTAL INTRA-ORAL X-RAY EQUIPMENT . 35
Figure BB.2 – Parts of DENTAL INTRA-ORAL X-RAY EQUIPMENT . 36

Table 201.101 – List of potential ESSENTIAL PERFORMANCE to be considered by
MANUFACTURER in the RISK MANAGEMENT PROCESS . 10
Table 201.C.101 – Marking on the outside of ME EQUIPMENT or its parts . 27
Table 201.C.102 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 27

60601-2-65  IEC:2012 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-65: Particular requirements for the basic safety
and essential performance of dental intra-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 60601-2-65 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/889/FDIS 62B/897/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.

– 4 – 60601-2-65  IEC:2012
In this standard, the following print types are used:
• Requirements and definitions: roman type.
• Test specifications: 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.
The committee has decided that the contents of this publication will remain unchanged 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.
60601-2-65  IEC:2012 – 5 –
INTRODUCTION
This particular standard has been prepared to provide, based on IEC 60601-1:2005 and its
collaterals, a complete set of BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for
DENTAL INTRA-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 INTRA-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 INTRA-ORAL X-RAY
EQUIPMENT.
The minimum safety requirements for DENTAL EXTRA-ORAL X-RAY EQUIPMENT are specified in a
separate particular standard IEC 60601-2-63 to simplify and improve the readability
This particular standard amends and supplements IEC 60601-1 (third edition, 2005): Medical
electrical equipment – Part 1: General requirements for safety and essential performance,
hereinafter referred to as the general standard.
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. 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, 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. Therefore IEC 60601-2-28 does not apply to equipment in the scope of this
International Standard.
– 6 – 60601-2-65  IEC:2012
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-65: Particular requirements for the basic safety
and essential performance of dental intra-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 INTRA-ORAL X-RAY EQUIPMENT and its main components, hereafter also called ME
EQUIPMENT.
The scope of this standard is restricted to X-RAY EQUIPMENT where the X-RAY TUBE ASSEMBLY
contains the HIGH-VOLTAGE TRANSFORMER ASSEMBLY.
DENTAL EXTRA-ORAL X-RAY EQUIPMENT is excluded from the scope of this standard
NOTE 1 The X-RAY GENERATOR in DENTAL INTRA-ORAL X-RAY EQUIPMENT always comprises an X-RAY MONOBLOCK
ASSEMBLY. Therefore in this particular standard the concept of X-RAY TUBE ASSEMBLY is replaced by that of X-RAY
MONOBLOCK ASSEMBLY.
NOTE 2 Main components may be for instance the X-RAY MONOBLOCK ASSEMBLY and an ELECTRONIC X-RAY IMAGE
RECEPTOR.
NOTE 3 Photostimulated phosphor plates and their readers (hardware and software) are excluded from the scope
of this particular standard, since they have no electrical APPLIED PARTS in the PATIENT ENVIRONMENT, and are not ME
EQUIPMENT.
ME EQUIPMENT and ME SYSTEMS in the scope of IEC 60601-2-63, IEC 60601-2-44,
IEC 60601-2-54, IEC 60601-2-45 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.
NOTE 4 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 in 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 INTRA-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.
—————————
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance

60601-2-65  IEC:2012 – 7 –
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 DENTAL INTRA-ORAL 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 Clauses 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 INTRA-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
requirements.
PERFORMANCE
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”
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.
—————————
)
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
)
IEC 60601-1-11, 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

– 8 – 60601-2-65  IEC:2012
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 37.
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/TR 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 62220-1:2003, Medical electrical equipment – Characteristics of digital X-ray imaging
devices – Part 1: Determination of the detective quantum efficiency
201.3 Terms 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 40.
Addition:
60601-2-65  IEC:2012 – 9 –
201.3.201
DENTAL
related to structures in the dento-maxillo-facial district of the PATIENT, including dentition
[SOURCE: IEC 60601-2-63:2012, 201.3.202]
201.3.202
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 meter (Gy·m ).
[SOURCE: IEC 60601-2-54:2009, 201.3.203]
201.3.203
ELECTRONIC X-RAY IMAGE RECEPTOR
X-RAY IMAGE RECEPTOR comprising an electrically-powered conversion method
[SOURCE: IEC 60601-2-63:2012, 201.3.205]
201.3.204
EXIT FIELD SIZE
dimensions of the RADIATION FIELD at the distal end of the dental cone as determined by the
BEAM LIMITING DEVICE
Note 1 to entry: The dental cone ensures the minimum focus to skin distance. Usually the BEAM LIMITING DEVICE is
part of the dental cone.
201.3.205
EXTRA-ORAL
related to DENTAL RADIOGRAPHY where the X-RAY IMAGE RECEPTOR is located outside the oral
cavity
[SOURCE: IEC 60601-2-63:2012, 201.3.206]
201.3.206
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]
201.3.207
INTRA-ORAL
related to DENTAL RADIOGRAPHY where the X-RAY IMAGE RECEPTOR is located, wholly or
partially, inside the oral cavity
[SOURCE: IEC 60601-2-63: 2012, 201.3.208]
201.3.208
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
201.3.209
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

– 10 – 60601-2-65  IEC:2012
201.3.210
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.
[SOURCE: IEC 60601-2-63:2012, 201.3.213]
201.4 General requirements
Clause 4 of the general standard applies, except as follows
201.4.3 ESSENTIAL PERFORMANCE
Addition:
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
203.6.4.3.102.2 (Accuracy of X-RAY TUBE VOLTAGE) and 203.6.4.3.102.3 (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 MANUFACTURER in the RISK MANAGEMENT PROCESS
Requirement Subclause
Accuracy of LOADING FACTORS 203.6.4.3.102
Reproducibility of the RADIATION output 203.6.3.2

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.

60601-2-65  IEC:2012 – 11 –
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
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:
ME EQUIPMENT that is specified to be PERMANENTLY
Except for item a) to c) below, for
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).
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;
• the EXIT FIELD SIZE in terms of dimension or graphical means. If the EXIT FIELD SIZE is
described by graphical means, such means shall be described in the instructions for use;
• 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.
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 the recommended minimum frequency for the tests.

– 12 – 60601-2-65  IEC:2012
Additionally for ELECTRONIC X-RAY IMAGE RECEPTORS, the ACCOMPANYING DOCUMENTS shall
contain
• a description of the performance of means, required to display the images for diagnostic
purpose according to the INTENDED USE;
NOTE For instance, the minimum required number of pixel and number of discernible grey levels of the
display screen.
• indication of the nominal IMAGE RECEPTOR AIR KERMA range needed for the INTENDED USE;
• recommendations for typical LOADING FACTORS and FOCAL SPOT TO SKIN DISTANCES to
achieve this AIR KERMA.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
201.7.9.2 Instructions for use
201.7.9.2.1 General
Additional subclauses:
201.7.9.2.1.101 LOADING FACTORS
In the instructions for use of ME EQUIPMENT, the LOADING FACTORS shall be stated as described
below. The following combinations and data shall be stated:
a) value(s) of X-RAY TUBE VOLTAGE settings;
b) value(s) of X-RAY TUBE CURRENT settings;
c) values or range of IRRADITION 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).
Compliance is checked by inspection of the instructions for use.
201.7.9.2.1.102 BEAM LIMITING DEVICES
The EXIT FIELD SIZE(S) provided by the BEAM LIMITING DEVICE shall be stated in the instructions
for use and technical description.
Compliance is checked by inspection of the instructions for use.
201.7.9.3 Technical description
Additional subclause:
201.7.9.3.101 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) position of the FOCAL SPOT;
d) NOMINAL FOCAL SPOT VALUE(s) determined according to IEC 60336 for the specified
REFERENCE AXIS.
e) The EXIT FIELD SIZE(S) provided by the BEAM LIMITING DEVICE.

60601-2-65  IEC:2012 – 13 –
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 INTRA-ORAL X-RAY GENERATORS
shall also include:
• either the maximum permissible value for the APPARENT RESISTANCE OF SUPPLY MAINS or
other appropriate SUPPLY MAINS specifications used in a facility; and
• the characteristics of OVER-CURRENT RELEASES eventually required in the SUPPLY MAINS.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:
201.8.5 Separation of parts
201.8.5.1 MEANS OF PROTECTION (MOP)
Additional subclause:
201.8.5.1.101 Additional limitation of voltage, current or energy for DENTAL INTRA-ORAL
X-RAY GENERATORS
Provision shall be made to prevent the appearance of an unacceptably HIGH VOLTAGE in the
MAINS PART or in any other low-voltage circuit.
NOTE This may be achieved for example by
– provision of a winding layer or a conductive screen connected to the PROTECTIVE EARTH TERMINAL between HIGH
VOLTAGE and low-voltage circuits, or
– provision of a voltage limiting device across terminals to which external devices are connected and between
which an excessive voltage might arise if the external path becomes open-circuited.
Compliance is checked by inspection of design data and construction.
NOTE these requirements are adapted from IEC 60601-2-7:1998, subclause 15bb).
201.8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
201.8.7.3 * Allowable values
Amendment:
Item c) is amended as follows:
For non-PERMANENTLY INSTALLED X-RAY GENERATORS the allowable value of TOUCH CURRENT in
SINGLE FAULT CONDITION is 2 mA.
NOTE This relaxation from the requirement of the general standard does not apply to PATIENT LEAKAGE CURRENT.
Item e) is amended as follows:
For PERMANENTLY INSTALLED X-RAY GENERATORS the allowable value of EARTH LEAKAGE
CURRENT is 20 mA r.m.s. in NORMAL CONDITION and SINGLE FAULT CONDITION.

– 14 – 60601-2-65  IEC:2012
201.8.8.3 * Dielectric strength
Addition:
Instead of subclause 8.8.3 of the general standard, the HIGH VOLTAGE circuit of X-RAY
MONOBLOCK ASSEMBLIES shall be tested as follows:
The test for the HIGH VOLTAGE circuit shall be made with a test voltage between 1,1 and 1,15
times the maximum NOMINAL X-RAY TUBE VOLTAGE of the X-RAY MONOBLOCK ASSEMBLY. If the
HIGH VOLTAGE circuit is not accessible, the voltage measurement may be indirect.
The HIGH VOLTAGE circuit of X-RAY MONOBLOCK ASSEMBLIES is tested by applying the test
voltage for a time equal to two times the maximum permissible IRRADIATION TIME for NORMAL
USE, as specified in the ACCOMPANYING DOCUMENTS. The test is repeated three times with a
minimum interval of two minutes between each test.
For ONE-PEAK HIGH-VOLTAGE GENERATORS, the test voltage for the HIGH VOLTAGE circuit shall be
referenced to the no-load half cycle if the X-RAY TUBE VOLTAGE for the no-load half cycle is
higher than in the on-load half cycle.
If during the dielectric strength test there is a risk of overheating a transformer under test, it is
permitted to carry out the test at a higher supply frequency.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME
SYSTEMS
Clause 9 of the general standard applies, except as follows:
201.9.8.4 Systems with MECHANICAL PROTECTIVE DEVICES
Additional subclause:
201.9.8.4.101 MECHANICAL PROTECTIVE DEV
...