IEC 60601-2-65:2012

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

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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
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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 60601-2-65 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 DEVICE
Ropes, chains or bands running parallel to other ropes, chains or bands may be regarded as
a MECHANICAL PROTECTIVE DEVICE if they are not loaded during NORMAL USE.
Ropes, chains or bands used as a MECHANICAL PROTECTIVE DEVICE shall be accessible for
inspection and the ACCOMPANYING DOCUMENTS shall give appropriate instructions for
inspection.
Compliance is checked by functional test and inspection of ACCOMPANYING DOCUMENTS.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.
NOTE The collateral standard IEC 60601-1-3 is referenced in the general standard and is covered under clause
203 of this document.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
Additional subclause:
60601-2-65  IEC:2012 – 15 –
201.11.101 *Protection against excessive temperatures of X-RAY MONOBLOCK ASSEMBLIES
The limitations of temperatures do not apply inside the protective housing of the X-RAY
MONOBLOCK ASSEMBLY.
The temperature of the painted metal surface of an X-RAY MONOBLOCK ASSEMBLY which can be
touched during INTENDED USE by the OPERATOR, and occasionally also by the PATIENT, may
exceed the values in Table 23 of the general standard but shall not exceed 65 °C.
201.12 Accuracy of controls and instruments and protection against
hazardous outputs
Clause 12 of the general standard applies.
NOTE According to subclause 12.4.5.1 of the general standard, the dose-related aspects of this question are
addressed under 203.6.4.3 of this document.
201.13 HAZARDOUS SITUATIONS and fault conditions
Clause 13 of the general standard applies:
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
Clause 14 of the general standard applies:
201.15 Construction of ME EQUIPMENT
Clause 15 of the general standard applies.
201.16 ME SYSTEMS
Clause 16 of the general standard applies:
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
Clause 17 of the general standard applies.
202 Electromagnetic compatibility – Requirements and tests
IEC 60601-1-2:2007 applies, except as follows.
Additional subclause:
202.101 Immunity testing of ESSENTIAL PERFORMANCE
The MANUFACTURER may minimize the test requirements of the additional ESSENTIAL
PERFORMANCE listed in Table 201.101 to a practical level through the RISK MANAGEMENT
PROCESS.
When selecting the requirements to be tested, the MANUFACTURER needs to take into account
the sensitivity to the EMC environment, probability of EMC condition and severity, and
probability and contribution to unacceptable RISK through the RISK MANAGEMENT PROCESS.

– 16 – 60601-2-65  IEC:2012
The accuracy of the test instruments used to assess the immunity of the ME EQUIPMENT shall
not be affected by the electromagnetic conditions for the test.
The test instrument shall not have an influence on the immunity of the ME EQUIPMENT.
Only non-invasive measurements shall be performed.
Compliance is checked by the inspection of the RISK MANAGEMENT FILE.
203 Radiation protection in diagnostic X-ray equipment
IEC 60601-1-3:2008 applies, except as follows:
203.4 General requirements
203.4.1 Statement of compliance
Replacement:
If for ME EQUIPMENT, or a sub-assembly, compliance with this standard is to be stated, the
statement shall be made in the following form:
X-RAY EQUIPMENT for DENTAL INTRA-ORAL RADIOGRAPHY ++) IEC 60601-2-65:2012
++) MODEL OR TYPE REFERENCE
Additional subclause:
203.4.101 Qualifying conditions for defined terms
203.4.101.1 * IRRADIATION TIME
IRRADIATION TIME is measured as the time interval between the instant when the AIR KERMA
RATE has risen for the first time to a value of 50 % of the peak value, and the instant when it
finally drops below the same value.
NOTE 1 see also definition 3.32 of IEC 60601-1-3:2008
203.5 ME EQUIPMENT identification, marking and documents
203.5.2.4.5 Deterministic effects
Addition:
NOTE No deterministic effects are known at this date with DENTAL INTRA-ORAL X-RAY EQUIPMENT in NORMAL USE.
203.6 RADIATION management
203.6.2 Initiation and termination of the IRRADIATION
203.6.2.1 Normal initiation and termination of the IRRADIATION
Addition:
It shall not be possible to initiate any IRRADIATION event without releasing the control by which
IRRADIATION event was initiated.
the previous
Compliance is checked by inspection and by the appropriate functional tests.

60601-2-65  IEC:2012 – 17 –
203.6.2.1.101 Connections of external INTERLOCKS
ME EQUIPMENT, except MOBILE ME EQUIPMENT and HAND-HELD ME EQUIPMENT, should be
provided with connections for external electrical INTERLOCKS separate from the ME EQUIPMENT
that either:
• can prevent the ME EQUIPMENT from starting to emit X-RADIATION;
• can cause the ME EQUIPMENT to stop emitting X-RADIATION;
• or both.
If the state of the signals from these external electrical INTERLOCKS is not displayed on the
CONTROL PANE
...

IEC 60601-2-65 ®
Edition 1.2 2021-05
CONSOLIDATED VERSION
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
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IEC 60601-2-65 ®
Edition 1.2 2021-05
CONSOLIDATED VERSION
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
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-4311-4

IEC 60601-2-65 ®
Edition 1.2 2021-05
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
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
– 2 – IEC 60601-2-65:2012+AMD1:2017
+AMD2:2021 CSV  IEC 2021
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
INTRODUCTION TO AMENDMENT 1 . 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 . 15
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 16
201.10 Protection against unwanted and excessive radiation HAZARDS . 17
201.11 Protection against excessive temperatures and other HAZARDS . 17
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 17
201.13 HAZARDOUS SITUATIONS and fault conditions . 17
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 17
201.15 Construction of ME EQUIPMENT. 17
201.16 ME SYSTEMS . 17
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 18
202 Electromagnetic compatibility – Requirements and tests . 18
203 Radiation protection in diagnostic X-ray equipment . 18
Annexes . 31
Annex C (informative) Guide to marking and labeling requirements for ME EQUIPMENT
and ME SYSTEMS . 32
Annex AA (informative) Particular guidance and rationale . 33
Annex BB (informative) Identification of parts of dental X-RAY INTRA-ORAL SYSTEMS in
relation to defined terms in this standard . 40
Bibliography . 42
Index of defined terms used in this particular standard . 45

Figure AA.1 – AIR KERMA during IRRADIATION with direct current X-RAY GENERATOR . 34
Figure AA.2 – AIR KERMA during IRRADIATION with ONE-PEAK X-RAY GENERATOR. 36
Figure AA.3 – Waveform of long IRRADIATION TIME X-RADIATION from a
ONE-PEAK X-RAY GENERATOR . 37
Figure BB.1 – Structure of DENTAL INTRA-ORAL X-RAY EQUIPMENT . 40
Figure BB.2 – Parts of DENTAL INTRA-ORAL X-RAY EQUIPMENT . 41

Table 201.101 – List of potential ESSENTIAL PERFORMANCE to be considered by
MANUFACTURER in the RISK MANAGEMENT PROCESS . 12

+AMD2:2021 CSV  IEC 2021
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 – IEC 60601-2-65:2012+AMD1:2017
+AMD2:2021 CSV  IEC 2021
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
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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.
This consolidated version of the official IEC Standard and its amendments has been
prepared for user convenience.
IEC 60601-2-65 edition 1.2 contains the first edition (2012-09) [documents 62B/889/FDIS
and 62B/897/RVD], its amendment 1 (2017-05) [documents 62B/1006/CDV and
62B/1039/RVC] and its amendment 2 (2021-05) [documents 62B/1233/FDIS and
62B/1238/RVD].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendment 1. Additions are in green text, deletions are in strikethrough
red text. A separate Final version with all changes accepted is available in this
publication.
+AMD2:2021 CSV  IEC 2021
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.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
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.

– 6 – IEC 60601-2-65:2012+AMD1:2017
+AMD2:2021 CSV  IEC 2021
The committee has decided that the contents of the base publication and its amendments 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.
+AMD2:2021 CSV  IEC 2021
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.
INTRODUCTION TO AMENDMENT 1
The purpose of this first amendment to IEC 60601-2-65:2012 is to introduce changes to
reference the Amendment 1 (2012) to IEC 60601-1:2005. As neither IEC 60601-2-65:2012 nor
this amendment refers to specific elements of IEC 60601-1-2, the introduction of a dated
reference to the latter document has been removed.

– 8 – IEC 60601-2-65:2012+AMD1:2017
+AMD2:2021 CSV  IEC 2021
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 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance

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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.
3 4
IEC 60601-1-8, IEC 60601-1-10 , IEC 60601-1-11 and IEC 60601-1-12 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.
—————————
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
IEC 60601-1-12, Medical electrical equipment – Part 1-12: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical
systems intended for use in the emergency medical services environment

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“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 42.
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
IEC 60601-1-3:2008/AMD1:2013
Addition:
IEC 60336, Medical electrical equipment – X-ray tube assemblies for medical diagnosis –
Characteristics of focal spots
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
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

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201.3 Terms and definitions
Amendment:
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012, its applicable collateral standards, IEC/TR 60788:2004 and
the following apply:
NOTE An index of defined terms is found beginning on page 45.
Addition:
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]

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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
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 potential 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.

+AMD2:2021 CSV  IEC 2021
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:
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 item 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).
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.

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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.
If a test or a QUALITY CONTROL PROCEDURE recommended by the MANUFACTURER requires a
device-specific arrangement (including a tool, a phantom, a special software or a software
setting); that is only available from the MANUFACTURER, the MANUFACTURER shall provide this
arrangement for the RESPONSIBLE ORGANIZATION.
NOTE 102 The intention is to perform these QUALITY CONTROL PROCEDURES and tests using only the supplied
information.
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.

+AMD2:2021 CSV  IEC 2021
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;
TARGET ANGLE(s) with respect to the specified REFERENCE AXIS;
b)
c) position of the FOCAL SPOT;
NOMINAL FOCAL SPOT VALUE(s) determined according to IEC 60336 for the specified
d)
REFERENCE AXIS.
e) The EXIT FIELD SIZE(S) provided by the BEAM LIMITING DEVICE.
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
-RAY GENERATORS
X
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
and low-voltage circuits, or
VOLTAGE
– 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).

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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.
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:
MECHANICAL PROTECTIVE DEVICES
201.9.8.4 Systems with
Additional subclause:
ECHANICAL PROTECTIVE DEVICE
201.9.8.4.101 M
Ropes, chains or bands running parallel to other ropes, chains or bands may be regarded as
MECHANICAL PROTECTIVE DEVICE if they are not loaded during NORMAL USE.
a
+AMD2:2021 CSV  IEC 2021
Ropes, chains or bands used as a MECHANICAL PROTECTIVE DEVICE shall be accessible for
inspection and the ACCOMPANYING DOCUMENTS shall give appropriate instructions for
inspection.
Compliance is checked by functional test and inspection of ACCOMPANYING DOCUMENTS.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.
NOTE The collateral standard IEC 60601-1-3 is referenced in the general standard and is covered under clause
203 of this document.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
Additional subclause:
201.11.101 *Protection against excessive temperatures of X-RAY MONOBLOCK ASSEMBLIES
The limitations of temperatures do not apply inside the protective housing of the X-RAY
MONOBLOCK ASSEMBLY.
The temperature of the painted metal surface of an X-RAY MONOBLOCK ASSEMBLY which can be
touched during INTENDED USE by the OPERATOR, and occasionally also by the PATIENT, may
exceed the values in Table 23 of the general standard but shall not exceed 65 °C.
201.12 Accuracy of controls and instruments and protection against
hazardous outputs
Clause 12 of the general standard applies.
NOTE According to subclause 12.4.5.1 of the general standard, the dose-related aspects of this question are
addressed under 203.6.4.3 of this document.
201.13 HAZARDOUS SITUATIONS and fault conditions
Clause
...

IEC 60601-2-65 ®
Edition 1.1 2017-05
CONSOLIDATED VERSION
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

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IEC 60601-2-65 ®
Edition 1.1 2017-05
CONSOLIDATED VERSION
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
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-4396-1

IEC 60601-2-65 ®
Edition 1.1 2017-05
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
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

– 2 – IEC 60601-2-65:2012+AMD1:2017 CSV
 IEC 2017
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
INTRODUCTION TO AMENDMENT 1 . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 11
201.5 General requirements for testing of ME EQUIPMENT . 11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15
201.10 Protection against unwanted and excessive radiation HAZARDS . 15
201.11 Protection against excessive temperatures and other HAZARDS . 16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 16
201.13 HAZARDOUS SITUATIONS and fault conditions . 16
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 16
201.15 Construction of ME EQUIPMENT. 16
201.16 ME SYSTEMS . 16
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 16
202 Electromagnetic compatibility – Requirements and tests . 16
203 Radiation protection in diagnostic X-ray equipment . 17
Annexes . 27
Annex C (informative) Guide to marking and labeling requirements for ME EQUIPMENT
and ME SYSTEMS . 28
Annex AA (informative) Particular guidance and rationale . 29
Annex BB (informative) Identification of parts of dental X-RAY INTRA-ORAL SYSTEMS in
relation to defined terms in this standard . 36
Bibliography . 38
Index of defined terms used in this particular standard . 41

Figure AA.1 – AIR KERMA during IRRADIATION with direct current X-RAY GENERATOR . 30
Figure AA.2 – AIR KERMA during IRRADIATION with ONE-PEAK X-RAY GENERATOR. 32
Figure AA.3 – Waveform of long IRRADIATION TIME X-RADIATION from a
ONE-PEAK X-RAY GENERATOR . 33
Figure BB.1 – Structure of DENTAL INTRA-ORAL X-RAY EQUIPMENT . 36
Figure BB.2 – Parts of DENTAL INTRA-ORAL X-RAY EQUIPMENT . 37

Table 201.101 – List of potential ESSENTIAL PERFORMANCE to be considered by
MANUFACTURER in the RISK MANAGEMENT PROCESS . 11
Table 201.C.101 – Marking on the outside of ME EQUIPMENT or its parts . 28
Table 201.C.102 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 28

 IEC 2017
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,
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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
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4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
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5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
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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
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expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
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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.
This consolidated version of the official IEC Standard and its amendment has been prepared
for user convenience.
IEC 60601-2-65 edition 1.1 contains the first edition (2012-09) [documents 62B/889/FDIS and
62B/897/RVD] and its amendment 1 (2017-05) [documents 62B/1006/CDV and 62B/1039/RVC].
In this Redline version, a vertical line in the margin shows where the technical content is
modified by amendment 1. Additions are in green text, deletions are in strikethrough red text.
A separate Final version with all changes accepted is available in this publication.

– 4 – IEC 60601-2-65:2012+AMD1:2017 CSV
 IEC 2017
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.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
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.

 IEC 2017
The committee has decided that the contents of the base publication and its amendment 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.
– 6 – IEC 60601-2-65:2012+AMD1:2017 CSV
 IEC 2017
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.
INTRODUCTION TO AMENDMENT 1
The purpose of this first amendment to IEC 60601-2-65:2012 is to introduce changes to
reference the Amendment 1 (2012) to IEC 60601-1:2005. As neither IEC 60601-2-65:2012 nor
this amendment refers to specific elements of IEC 60601-1-2, the introduction of a dated
reference to the latter document has been removed.

 IEC 2017
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 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance

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 IEC 2017
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.
3 4
IEC 60601-1-8, IEC 60601-1-10 , IEC 60601-1-11 and IEC 60601-1-12 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.
—————————
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
IEC 60601-1-12, Medical electrical equipment – Part 1-12: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical
systems intended for use in the emergency medical services environment

 IEC 2017
“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 38.
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
IEC 60601-1-3:2008/AMD1:2013
Addition:
IEC 60336, Medical electrical equipment – X-ray tube assemblies for medical diagnosis –
Characteristics of focal spots
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
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:
– 10 – IEC 60601-2-65:2012+AMD1:2017 CSV
 IEC 2017
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012, its applicable collateral standards, IEC/TR 60788:2004 and
the following apply:
NOTE An index of defined terms is found beginning on page 41.
Addition:
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

 IEC 2017
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
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 potential 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.
ACCOMPANYING DOCUMENTS and by functional test.
Compliance is checked by inspection of the
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies.

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 IEC 2017
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:
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 item 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).
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:
 IEC 2017
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.
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;

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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.
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.

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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.
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 DEVICE
Ropes, chains or bands running parallel to other ropes, chains or bands may be regarded as
a MECHANICAL PROTECTIVE DEVICE if they are not loaded during NORMAL USE.
Ropes, chains or bands used as a MECHANICAL PROTECTIVE DEVICE shall be accessible for
inspection and the ACCOMPANYING DOCUMENTS shall give appropriate instructions for
inspection.
Compliance is checked by functional test and inspection of ACCOMPANYING DOCUMENTS.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.
NOTE The collateral standard IEC 60601-1-3 is referenced in the general standard and is covered under clause
203 of this document.
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201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
Additional subclause:
201.11.101 *Protection against excessive temperatures of X-RAY MONOBLOCK ASSEMBLIES
The limitations of temperatures do not apply inside the protective housing of the X-RAY
MONOBLOCK ASSEMBLY.
The temperature of the painted metal surface of an X-RAY MONOBLOCK ASSEMBLY which can be
touched during INTENDED USE by the OPERATOR, and occasionally also by the PATIENT, may
exceed the values in Table 23 of the general standard but shall not exceed 65 °C.
201.12 Accuracy of controls and instruments and protection against
hazardous outputs
Clause 12 of the general standard applies.
NOTE According to subclause 12.4.5.1 of the general standard, the dose-related aspects of this question are
addressed under 203.6.4.3 of this document.
201.13 HAZARDOUS SITUATIONS and fault conditions
Clause 1
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