IEC 60601-2-64:2025

IEC 60601-2-64 ®
Edition 2.0 2025-12
INTERNATIONAL
STANDARD
REDLINE VERSION
Medical electrical equipment -
Part 2-64: Particular requirements for the basic safety and essential performance
of light ion beam medical electrical equipment
ICS 11.040.60 ISBN 978-2-8327-0929-0
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CONTENTS
FOREWORD . 2
INTRODUCTION . 1
201.1 Scope, object and related standards . 6
201.2 Normative references . 8
201.3 Terms and definitions . 8
201.4 General requirements . 16
201.5 General requirements for testing ME EQUIPMENT . 16
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 17
201.7 ME EQUIPMENT identification, marking and documents . 18
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 21
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 21
201.10 Protection against unwanted and excessive radiation HAZARDS . 27
201.11 Protection against excessive temperatures and other HAZARDS . 49
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 49
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 49
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 50
201.15 Construction of ME EQUIPMENT . 50
201.16 ME SYSTEMS. 50
201.17 ELECTROMAGNETIC DISTURBANCES of ME EQUIPMENT and ME SYSTEMS . 52
201.101 ELECTRONIC IMAGING DEVICES (EID) . 53
201.102 Operation of ME EQUIPMENT parts from outside the facility . 53
206 Usability . 53
Annexes . 57
Annex B (informative) Sequence of testing . 57
Annex I (informative) ME SYSTEMS aspects . 57
Bibliography . 58
Index of defined terms used in this document . 59

Figure 201.101 – PATIENT SUPPORT POSITIONER movements . 54
Figure 201.102 – Diagram illustrating example RADIATION HEAD components and
possible PATIENT position for NON-PRIMARY RADIATION REQUIREMENTS . 55
Figure 201.103 – Diagram illustrating distance along PATIENT plane to measure
NON-PRIMARY RADIATION ABSORBED DOSE . 56

Table 201.101 – Data required in the technical description to support Clause 201.10
SITE TEST compliance . 19

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
Medical electrical equipment -
Part 2-64: Particular requirements for the basic safety and essential
performance of light ion beam medical electrical 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
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6) All users should ensure that they have the latest edition of this publication.
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
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9) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
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shall not be held responsible for identifying any or all such patent rights.
This redline version of the official IEC Standard allows the user to identify the changes made
to the previous edition IEC 60601-2-64:2014. A vertical bar appears in the margin wherever a
change has been made. Additions are in green text, deletions are in strikethrough red text.

IEC 60601-2-64 has been prepared by subcommittee 62C: Equipment for radiotherapy, nuclear
medicine and radiation dosimetry, of IEC technical committee 62: Medical equipment, software,
and systems. It is an International Standard.
This second edition cancels and replaces the first edition published in 2014. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) harmonization with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2011 and
IEC 60601-1:2005/AMD2:2020;
b) harmonization with IEC 62667:2017 for defined terms and definitions;
c) address revision to neutrons outside the field of irradiation.
The text of this International Standard is based on the following documents:
Draft Report on voting
62C/954/FDIS 62C/964/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
In this document, 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 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 AND
IEC 60601-1:2005/AMD2:2020, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
– "clause" means one of the 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 document are preceded by the term "Clause" followed by the
clause number. References to subclauses within this particular standard are by number only.
In this document, 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 document conform to usage described in Clause 7 of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance with
this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
– reconfirmed,
– withdrawn, or
– revised.
INTRODUCTION
The use of LIGHT ION BEAM ME EQUIPMENT for RADIOTHERAPY purposes may can expose PATIENTS
to danger if the ME EQUIPMENT fails to deliver the required dose to the PATIENT, or if the ME
EQUIPMENT design does not satisfy standards of electrical and mechanical safety. The ME
EQUIPMENT may can also cause danger to persons in the vicinity if the ME EQUIPMENT itself fails
to contain the RADIATION adequately or if there are inadequacies in the design of the TREATMENT
ROOM.
This particular standard establishes requirements to be complied with by MANUFACTURERS in the
design and construction of LIGHT ION BEAM ME EQUIPMENT for use in RADIOTHERAPY; it does not
attempt to define their optimum performance requirements. Its purpose is to identify those
features of design that are regarded, at the present time, as essential for the safe operation of
ME EQUIPMENT; it places limits on the degradation of ME EQUIPMENT performance beyond
such
which it can be presumed that a fault condition exists and where an INTERLOCK then operates
to prevent continued operation of the ME EQUIPMENT.
Clause 201.10 contains limits beyond which INTERLOCKS prevent, INTERRUPT or TERMINATE
IRRADIATION, cause INTERRUPTION OF IRRADIATION or cause TERMINATION OF IRRADIATION in order
to insure that ESSENTIAL PERFORMANCE is maintained and to avoid an unsafe condition. TYPE
that are performed by the MANUFACTURER, or SITE TESTS, which are not necessarily
TESTS
performed by the MANUFACTURER, are SPECIFIED for each requirement. It should be understood
that, before installation, a MANUFACTURER can provide a compliance certificate relating only to
TYPE TESTS. Data available from SITE TESTS should be incorporated in the ACCOMPANYING
DOCUMENTS DOCUMENTATION, in the form of a SITE TEST report, by those who test the ME
EQUIPMENT at installation.
Closely related to this document is IEC 62667 which is currently being developed. It specifies
test methods and reporting formats for performance tests of LIGHT ION BEAM ME EQUIPMENT for
use in RADIOTHERAPY, with the aim of providing uniform methods of doing so. The annex Annex
A of IEC 62667:2017 provides forms for presenting performance values, measured per the
methods SPECIFIED.
201.1 Scope, object and related standards
Clause 1 of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.1.1 Scope
Replacement:
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LIGHT ION BEAM ME
EQUIPMENT, hereafter referred to as ME EQUIPMENT, used for treatment of PATIENTS.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME
SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case,
the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
This document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the
manufacture MANUFACTURER and some SPECIFIED installation aspects of LIGHT ION BEAM ME
EQUIPMENT
– intended for RADIOTHERAPY in human medical practice, including those in which the selection
and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE
ELECTRONIC SUBSYSTEMS (PESS),
– that, in NORMAL USE, deliver a RADIATION BEAM of LIGHT IONS having ENERGY PER NUCLEON in
the range 10 MeV/n to 500 MeV/n,
and
– intended to be
• for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED
PERSONS by OPERATORS having the required skills for a particular medical application, for
particular SPECIFIED clinical purposes maintained in accordance with the
recommendations given in the INSTRUCTIONS FOR USE,
• subject to regular quality assurance performance and calibration checks by a QUALIFIED
PERSON.
NOTE 1 In this document, all references to installation refer to installation in the RESPONSIBLE ORGANIZATION's
premises.
NOTE 2 In this document, all references to ABSORBED DOSE refer to ABSORBED DOSE in water.
NOTE 3 Information regarding x-ray image guidance can be found in IEC 60601-2-68 (under development).
NOTE 4 IEC 61217 gives guidance on the designation of ME EQUIPMENT movements, the marking of scales, their
zero positions and the direction of movement with increasing value (see 201.7.4.101).
201.1.2 Object
Replacement:
___________
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
The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for LIGHT ION BEAM ME EQUIPMENT in the range 10 MeV/n to 500 MeV/n and to
SPECIFY tests to check compliance to those requirements.
NOTE The adoption of this document helps to ensure that the ME EQUIPMENT
− maintains PATIENT safety during ME EQUIPMENT movements and failure of the SUPPLY MAINS;
− delivers the pre-selected RADIATION TYPE, ENERGY PER NUCLEON, LIGHT ION species, and ABSORBED DOSE;
− delivers pre-selected LIGHT ION BEAMS to the PATIENT, by utilizing LIGHT ION BEAM modifying devices, etc.,
without causing unnecessary risk to the PATIENT, the OPERATOR, other persons or the environment.
201.1.3 Collateral standards
Addition:
Collateral standards published after the date of publication of this standard shall only apply
subject to further amendment to this standard.
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 and Clause 201.2 of this document.
IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020
applies as modified in Clause 206. IEC 60601-1-3, IEC 60601-1-8, IEC 60601-1-9 [1] and
3 4
IEC 60601-1-10 [2] do not apply. All other published collateral standards in the IEC 60601-
1 series apply as published.
NOTE Collateral standards published after the date of publication of this document will only apply subject to further
amendment to this document.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 or and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard IEC 60601-
1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
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 document corresponds to that of the general
standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 with the prefix "201" (e.g. 201.1 in this document addresses the
content of Clause 1 of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012
and IEC 60601-1:2005/AMD2:2020) 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 addresses the
content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 addresses the content of
___________
IEC 60601-1-9, Medical electrical equipment – Part 1-9: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for environmentally conscious design
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
Numbers in square brackets refer to the Bibliography.
Clause 4 of the 60601-1-3 collateral standard, etc.). The changes to the text of the general
standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 are specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is replaced completely by the text in this document.
"Addition" means that the text of this document is additional to the requirements of the general
standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020 or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is amended as indicated by the text of this document.
Subclauses, figures or tables which are additional to those of the general standard IEC 60601-
1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered
starting from 201.101. However, due to the fact that definitions in the general standard
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are
numbered 3.1 through 3.139154, additional definitions in this document 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 document, the clause or subclause
of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 or applicable collateral standard, although possibly not relevant,
applies without modification; where it is intended that any part of the general standard
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard, although possibly relevant, is not to be applied, a statement to
that effect is given in this document.
201.2 Normative references
NOTE Informative references are listed in the bibliography.
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, Clause
2 of the general standard applies, except as follows:
Replacement:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic compatibility –
Requirements and tests
Addition:
IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC 60601-2-1:20092020, Medical electrical equipment - Part 2-1: Particular requirements for
the basic safety and essential performance of electron accelerators in the range 1 MeV to 50
MeV
IEC 60601-2-11:2013, Medical electrical equipment – Part 2-11: Particular requirements for the
basic safety and essential performance of gamma beam therapy equipment
IEC 60601-2-68:2014, Medical electrical equipment - Part 2-68: Particular requirements for the
basic safety and essential performance of x-ray-based image guided radiotherapy equipment
for use with electron accelerators, light ion beam therapy equipment and radionuclide beam
therapy equipment
IEC TR 60788:2004, Medical electrical equipment - Glossary of defined terms
IEC 61217:2011, Radiotherapy equipment - Coordinates, movements and scales
ISO/IEC 14165-321:2009, Information technology – Fibre channel – Part 321: Audio video (FC-
AV)
CISPR 11, Industrial, scientific and medical equipment - Radio-frequency disturbance
characteristics - Limits and methods of measurement
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005+A1:
2012 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
IEC 60601-2-1: 20092020, and IEC TR 60788:2004 apply, except as follows:
NOTE An index of defined terms is given after the Bibliography.
Additional terms and definitions:
201.3.201
APPLICATOR CARRIAGE
most distal part of the RADIATION HEAD that cannot be removed without using tools to which
interchangeable LIGHT ION BEAM APPLICATORS are attached and which may extend toward and
retract away from the ISOCENTRE or ERP
Note 1 to entry: Colloquially the APPLICATOR CARRIAGE has sometimes been called a snout.
201.3.202
BEAM FLUENCE DISTRIBUTION MONITOR
system to monitor directly or indirectly the FLUENCE distribution of the beam to provide beam
steering or lateral spreading information
Note 1 to entry: This monitor may be used as a surrogate monitor for the DOSE distribution delivered to the patient.
Note 2 to entry: Examples of BEAM FLUENCE DISTRIBUTION MONITORS include quadrant foil ionization chambers,
concentric ring ionization chambers, multi-strip ionization chambers, scintillator plates, and scanning magnet field
probes.
201.3.203
BEAM FLUX MONITOR
system to monitor the FLUX of the beam
___________
A newer edition of IEC 60601-2-68 was published in 2025.
Note 1 to entry: This monitor may be used as a surrogate monitor for the ABSORBED DOSE RATE delivered to the
patient.
201.3.204
BEAM GATING
allowance or inhibition of IRRADIATION and related equipment movements according to the status
provided by a BEAM GATING SIGNAL
201.3.205
BEAM GATING SIGNAL
signal generated for the purpose of BEAM GATING
EXAMPLE Examples include a respiratory spirometer, electrocardiogram, optical sensor, etc.
201.3.206
CONTROLLING TIMER
device to measure the time during which IRRADIATION occurs and, if a predetermined time is
reached, to TERMINATE cause TERMINATION OF IRRADIATION
[SOURCE: IEC 60601-2-1: 20092020, 201.3.202210]
201.3.207
DOSE MONITOR UNIT
parameter, reported by the DOSE MONITORING SYSTEM, from which, through a calibration
procedure and with additional information, the ABSORBED DOSE delivered can be calculated
201.3.208
DOSE MONITOR UNIT RATE
DOSE MONITOR UNIT per unit time
201.3.209
DOSE MONITOR UNIT RATE MONITORING SYSTEM
system of devices for the measurement and DISPLAY of a radiation quantity related to DOSE
MONITOR UNIT RATE
201.3.210
DOSE MONITORING SYSTEM
system of devices for the measurement and DISPLAY of a radiation quantity related to the
ABSORBED DOSE
201.3.211
ENERGY PER NUCLEON
total kinetic energy of the ion divided by the number of nucleons in the nucleus at the point
where the ion enters the RADIATION HEAD before passing through any beam modifiers
201.3.212
EQUIPMENT REFERENCE POINT
ERP
point in space used for referencing dimensions of equipment and performing dosimetry
measurements
Note 1 to entry: Typically, the reference point is coincident with the ISOCENTRE. If the beam delivery equipment is
not ISOCENTRIC, then the centre of the PATIENT alignment systems may be used.
Note 2 to entry: The corresponding note to entry in the French text indicates that the abbreviation "ERP" stands for
"EQUIPMENT REFERENCE POINT" in English.
201.3.213
FLUENCE
particles per unit area
quotient of dN by dA, where dN is the number of particles incident on a sphere of cross-sectional
area dA, thus
Φ = dN/dA
Note 1 to entry: See ICRU 33, ICRU 85a. Definition from ICRU 85a:2011, 3.1.3.
201.3.214
FLUX
particles per unit time
quotient of dN by dt, where dN is the increment of the particle number in the time interval dt,
thus
.
N = dN/dt
Note 1 to entry: See ICRU 33, ICRU 85a. Definition from ICRU 85a:2011, 3.1.2.
201.3.215
HARD-WIRED
term used condition of a system where the its features of a system can be modified only by
physically removing and re-routing linked wires
[SOURCE: IEC 60601-2-1: 20092020, 201.3.208224]
201.3.216
INTERRUPTION OF IRRADIATION
TO INTERRUPT IRRADIATION
stopping of/to stop IRRADIATION and movements with the possibility of continuing without
reselecting operating conditions
[SOURCE: IEC 60601-2-1: 20092020, 201.3.210227]
201.3.217
LATERAL SPREADING DEVICE
LSD
device used to increase the lateral (x , y Xg, Yg) dimensions of a small diameter LIGHT ION BEAM
b b
produced by an accelerator
EXAMPLE Examples of spreading devices include a thin metal foil for scattering the ions or a magnet to defocus
the beam or to scan the beam laterally across the intended TARGET VOLUME.
Note 1 to entry: X Xg and y Yg are defined in IEC 61217:2011.
b b
201.3.218
LIGHT ION
species of ion with an atomic number less than or equal to that of neon (Z ≤ 10) and SPECIFIED
by its number of protons, number of nucleons and ionization state
201.3.219
LIGHT ION BEAM
collection of LIGHT IONS travelling in the same general direction
201.3.220
LIGHT ION BEAM APPLICATOR
device for holding a BEAM LIMITING DEVICE or ACCESSORY close to the PATIENT's skin during
delivery of LIGHT ION BEAM
Note 1 to entry: Several LIGHT ION BEAM APPLICATORS may be available to reduce the weight of APERTURES lifted by
therapists the OPERATOR, decrease the aperture/bolus to skin distance from the skin to ACCESSORIES and reduce
leakage radiation.
201.3.221
LIGHT ION BEAM DISTRIBUTION SYSTEM
system of components and a control system used to transport the RADIATION from a RADIATION
SOURCE to several TREATMENT stations, experimental stations or beam dumps
EXAMPLE Examples of components include vacuum pipes, magnets, and steering coils.
201.3.222
LIGHT ION RANGE
PHANTOM most distant from its surface at which the ABSORBED DOSE is a SPECIFIED
depth in a
value, given in the ACCOMPANYING DOCUMENTS DOCUMENTATION, of the dose at the nominal
centre-of-modulation depth or of the dose maximum for a non-range-modulated beam, which is
measured on the RADIATION BEAM AXIS in a SPECIFIED RADIATION FIELD and with the surface of the
PHANTOM at a SPECIFIED distance from the ERP without RANGE SHIFTERS or ACCESSORIES installed
in the RADIATION HEAD downstream of the ENERGY PER NUCLEON or range monitoring system
201.3.223
MODULATED SCANNING
SCANNING MODE wherein a small diameter LIGHT ION BEAM is scanned across a target to create
a field large enough to cover the target such that the intended FLUENCE delivered to the PATIENT
is different at different lateral locations
Note 1 to entry: Various spatial and temporal scanning patterns may be used to generate the modulated FLUENCE
distribution.
201.3.224
NON-PRIMARY RADIATION
RADIATION emitted from the LIGHT ION BEAM ME EQUIPMENT that is not intended to treat the PATIENT
201.3.225
NORMAL USE
operation, including routine inspection and adjustments by the OPERATOR, and STAND-BY,
according to the instructions for use
Note 1 to entry: NORMAL USE includes PATIENT TREATMENT, equipment calibration, quality assurance procedures,
maintenance, and other procedures performed by the OPERATOR required in preparation for PATIENT TREATMENTS.
[SOURCE: IEC TR 60788:2004, NG, 10.08, modified – A note to entry has been added.]
201.3.226
OPERATOR
person utilizing an EQUIPMENT individually with or without the aid of an assistant, who controls
some or all functions of the EQUIPMENT in his presence
[SOURCE: IEC TR 60788:2004, rm-85-02]
201.3.227
PATIENT SUPPORT
assembly of ME EQUIPMENT that supports the PATIENT
[SOURCE: IEC TR 60601-2-1:2009, 201.3.215]
201.3.225
PATIENT POSITIONER
assembly of equipment upon which the PATIENT is placed and positioned for
RADIOTHERAPY ME EQUIPMENT
[SOURCE: IEC 60601-2-1:2020, 201.3.235, modified – Addition of “ME EQUIPMENT”.]
201.3.226
PATIENT POSITIONER TOP
component of the PATIENT POSITIONER to which registration and immobilization devices are
attached and upon which PATIENT is placed
Note 1 to entry: PATIENT POSITIONER TOPS are often exchangeable to hold PATIENTS or equipment in different
orientations, for instance, a flat board or seat.
[SOURCE: IEC 60601-2-1:2020, 201.3.254, modified – Main term “table top” replaced with
“patient positioner top”; beginning of the definition “device attached to the table top support”
replaced with “component of the PATIENT POSITIONER”; Note 1 replaced.]
201.3.228227
PORTAL
collection of one or more pre-programmed TREATMENT segments treated automatically with a
single PATIENT set-up
Note 1 to entry: Segments may consist of treatment beam IRRADIATION, motion of devices, or imaging.
201.3.229228
PRE-PROGRAMMED MOVEMENT
movement of ME EQUIPMENT parts that takes place according to a previously planned programme
without intervention by the OPERATOR during a PATIENT treatment or imaging
201.3.230229
PRIMARY/SECONDARY DOSE MONITORING COMBINATION
utilization of two DOSE MONITORING SYSTEMS where one is arranged to be the PRIMARY DOSE
MONITORING SYSTEM and the other the SECONDARY DOSE MONITORING SYSTEM
201.3.231230
PROGRAMMABLE RANGE MODULATED PORTAL
PRMP
LIGHT ION PORTAL in which a program is used, with or without a RANGE MODULATION DEVICE (RMD)
or program is used, to tailor the DEPTH DOSE distribution by varying the penetration and
weighting factors of several component segments
Note 1 to entry: Typically the DEPTH DOSE distribution is tailored to give a uniform dose distribution over the depths
where the TARGET (tumour) VOLUME resides.
Note 2 to entry: The corresponding note to entry in the French text indicates that the abbreviation "PRMP" stands
for "PROGRAMMABLE RANGE MODULATED PORTAL" in English.
201.3.231
QUALITY FACTOR
Q
QUALITY FACTOR at a point in tissue given by:
∞
Q = Q L D dL
( )
∫ L
L=0
D
where D is the ABSORBED DOSE at that point, D is the distribution of D in unrestricted linear
L
energy transfer L at the point of interest, and Q(L) is the QUALITY FACTOR as a function of L
Note 1 to entry: The integration is to be performed over D , due to all charged particles, excluding their secondary
L
electrons.
Note 2 to entry: The QUALITY FACTOR Q at a point in tissue relates the DOSE EQUIVALENT H at that point to the
ABSORBED DOSE D at that point, using the formula: H = Q × D.
[SOURCE: ICRP Publication 116:2010]
201.3.232
RADIATION HEAD
structure from which the RADIATION BEAM emerges
[SOURCE: IEC TR 60788:2004, rm-20-06]
201.3.233
RANGE MODULATION DEVICE
RMD
device used to modulate the penetration of a RADIATION BEAM into a PATIENT to tailor the DEPTH
DOSE distribution during the delivery of one PORTAL
Note 1 to entry: The device may consist of a propellor shaped material that spins in the beam, a filter containing a
repeating pattern of metallic ridges (e.g. ridge filter, mini-ridge filter, ripple filter), a cone or set of cones, or a set of
uniform thickness blocks programmable in a binary fashion. Sub-types include discrete and programmable.
Note 2 to entry: The corresponding note to entry in the French text indicates that the abbreviation "RMD" stands for
"RANGE MODULATION DEVICE" in English.
201.3.234
RANGE SHIFTER
range modifying device that has a constant thickness at all positions lateral to the central axis
of the beam
201.3.235
REDUNDANT DOSE MONITORING COMBINATION
utilization of two DOSE MONITORING SYSTEMS where both systems are arranged to TERMINATE
cause TERMINATION OF IRRADIATION according to the pre-selected number of DOSE MONITOR UNITS
201.3.236
SCANNING MODE
method of delivering a scanned RADIATION BEAM to generate a laterally broad field
Note 1 to entry: Types of SCANNING MODES include: none, UNIFORM SCANNING and MODULATED SCANNING.
201.3.237
SITE TEST
after installation, test of an individual device or ME EQUIPMENT to establish compliance with
SPECIFIED criteria
Note 1 to entry: It is understood that SITE TESTS shall be performed but may or may not be performed by the
MANUFACTURER, per the agreement between the MANUFACTURER and the end USER.
[SOURCE: IEC 60601-2-1:2009, 201.3.221, modified – The note to entry has been added
IEC 60601-2-1:2020, 201.3.253, modified – In Note 1 to entry, replacement of “responsible
organization” with “end user”.]
201.3.238
TABLE TOP
an exchangeable device attached to the patient positioner to which registration and
immobilization devices are attached and upon which the patient is placed.
201.3.239238
TECHNICAL DOCUMENTATION
documentation that enables the conformity of the product with the requirements of the
standard(s) to be assessed
Note 1 to entry: This may include schedule drawings when a certification body is involved.
Note 2 to entry: It covers the design, manufacture and operation of the product and may contain:
– a general description;
– design and manufacturing drawings and layouts of components, sub-assemblies, circuits, etc.;
– descriptions and explanations necessary for the understanding of drawings and layouts and the operation of the
product;
– a list of the standards referred to in the Ex certificate, applied in full or in part, and descriptions of the solutions
adopted to meet the requirements of the standards;
– results of design calculations made, examinations carried out, etc.;
– test reports
Note 3 to entry: The technical description includes information derived from the TECHNICAL DOCUMENTATION.
[SOURCE: ISO/IEC 80079-34:20112018, 3.1210, modified – A third note to entry has been
added Note 1 to entry to Note 3 to entry are removed.]
201.3.240239
TERMINATION OF IRRADIATION
TERMINATE IRRADIATION
stopping of/to stop IRRADIATION and movements, with no possibility of restarting without
returning to the PREPARATORY STATE
Note 1 to entry: Examples of events that may TERMINATE cause TERMINATION OF IRRADIATION and stop movements
include:
− when the pre-selected value of DOSE MONITOR UNITS is reached,
− when the pre-selected value is reached in the termination system independent of the DOSE MONITORING
SYSTEM,
− by a deliberate manual act,
− by the operation of an INTERLOCK, or
− in MODULATED SCANNING, when pre-programmed scanning pattern is completed.
[SOURCE: IEC 60601-2-11:2013, 201.3.225, modified – The wording of both the definition and
Note 1 to entry is slightly different.]
201.3.241240
TRANSMISSION DETECTOR
RADIATION DETECTOR through which the LIGHT ION BEAM passes
[SOURCE: IEC 60601-2-1:20092020, 201.3.226257, modified – The term "RADIATION BEAM" has
been replaced by "LIGHT ION BEAM".]
201.3.242241
TYPE TEST
test on a representative sample of the equipment with the objective of determining if the
equipment, as designed and manufactured, can meet the requirements of this document
[SOURCE: IEC 60601-1:2005, 3.135]
201.3.243242
UNIFORM SCANNING
SCANNING MODE wherein a RADIATION BEAM is scanned laterally in a pre-defined pattern to
produce a field large enough to treat the target such that the FLUX of the RADIATION BEAM is not
intentionally changed throughout the lateral scan so that the resultant dose distribution within
the field is uniform
Note 1 to entry: The scanning may be accomplished by changing the current in electromagnets through which the
RADIATION BEAM passes or the use of permanent magnets mechanically rotated or translated.
201.3.244243
USER
when used in an IEC standard on electromedical EQUIPMENT, organization or individual
responsible for the use and maintenance of the EQUIPMENT
[SOURCE: IEC TR 60788:2004, rm-85-01]
201.4 General requirements
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2011 and IEC 60601-1:2005/AMD2:2020,
Clause 4 of the general standard applies.
201.5 General requirements for testing of ME EQUIPMENT
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2011 and IEC 60601-1:2005/AMD2:2020,
Clause 5 of the general standard applies, except as follows:
201.5.1 TYPE TESTS
Replacement of the title:
201.5.1 TYPE TESTS and SITE TESTS
Additional subclause:
201.5.1.101 Test grades
Three grades of TYPE TEST and two grades of SITE TEST procedures are SPECIFIED in this
document. Their requirements are as follows:
– TYPE TEST grade A: An analysis of ME EQUIPMENT design, as related to the SPECIFIED
RADIATION safety provisions, which shall result in a statement included in the technical
description, regarding the working principles or constructional means by which the
requirement is fulfilled.
– TYPE TEST/SITE TEST grade B: Visual inspection or functional test or measurement of the ME
EQUIPMENT. The test shall be in accordance with the procedure SPECIFIED in this document
and shall be based on operating states, including fault condition states, which are
achievable only without interference with the circuitry or construction of the ME EQUIPMENT.
–
...

IEC 60601-2-64 ®
Edition 2.0 2025-12
NORME
INTERNATIONALE
Appareils électromédicaux -
Partie 2-64: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils électromédicaux par faisceau d'ions légers
ICS 11.040.60  ISBN 978-2-8327-0866-8

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SOMMAIRE
AVANT-PROPOS . 2
INTRODUCTION . 5
201.1 Domaine d'application, objet et normes connexes . 6
201.2 Références normatives . 8
201.3 Termes et définitions . 9
201.4 Exigences générales . 15
201.5 Exigences générales relatives aux essais des APPAREILS EM . 16
201.6 Classification des APPAREILS EM et des SYSTEMES EM . 17
201.7 Identification, marquage et documentation des APPAREILS EM . 18
201.8 Protection contre les DANGERS d'origine électrique provenant des
APPAREILS EM . 21
201.9 Protection contre les DANGERS MECANIQUES des APPAREILS EM et des
SYSTEMES EM . 21
201.10 Protection contre les DANGERS dus aux rayonnements involontaires ou

excessifs . 27
201.11 Protection contre les températures excessives et les autres DANGERS . 52
201.12 Précision des commandes, des instruments et protection contre les
caractéristiques de sortie présentant des risques . 52
201.13 SITUATIONS DANGEREUSES et conditions de défaut pour les APPAREILS EM . 52
201.14 SYSTEMES ELECTROMEDICAUX PROGRAMMABLES (SEMP) . 52
201.15 Construction de l'APPAREIL EM . 53
201.16 SYSTEMES EM . 53
201.17 PERTURBATIONS ELECTROMAGNETIQUES des APPAREILS EM et SYSTEMES EM . 55
201.101 DISPOSITIFS D'IMAGERIE ELECTRONIQUES (EID) . 56
201.102 Fonctionnement des parties d'APPAREILS EM depuis l'extérieur de l'installation . 56
206 Aptitude à l'utilisation . 57
Annexes . 60
Annexe B (informative) Ordre des essais . 60
Annexe I (informative) Aspects des SYSTEMES EM . 60
Bibliographie . 61
Index des termes définis utilisés dans le présent document . 62

Figure 201.101 – Mouvements du POSITIONNEUR DE PATIENT . 57
Figure 201.102 – Diagramme représentant un exemple de composants de TETE
RADIOGENE et de position potentielle du PATIENT pour les EXIGENCES CONCERNANT LES
RAYONNEMENTS NON PRIMAIRES . 58
Figure 201.103 – Diagramme représentant la distance le long du plan du PATIENT afin
de mesurer la DOSE ABSORBEE PAR RAYONNEMENTS NON PRIMAIRES . 59

Tableau 201.101 – Données exigées dans la description technique pour justifier la
conformité au 201.10 . 19

COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE
____________
Appareils électromédicaux -
Partie 2-64: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils électromédicaux
par faisceau d'ions légers
AVANT-PROPOS
1) La Commission Électrotechnique Internationale (IEC) est une organisation mondiale de normalisation composée
de l'ensemble des comités électrotechniques nationaux (Comités nationaux de l'IEC). L'IEC a pour objet de
favoriser la coopération internationale pour toutes les questions de normalisation dans les domaines de
l'électricité et de l'électronique. À cet effet, l'IEC – entre autres activités – publie des Normes internationales,
des Spécifications techniques, des Rapports techniques, des Spécifications accessibles au public (PAS) et des
Guides (ci-après dénommés "Publication(s) de l'IEC"). Leur élaboration est confiée à des comités d'études, aux
travaux desquels tout Comité national intéressé par le sujet traité peut participer. Les organisations
internationales, gouvernementales et non gouvernementales, en liaison avec l'IEC, participent également aux
travaux. L'IEC collabore étroitement avec l'Organisation Internationale de Normalisation (ISO), selon des
conditions fixées par accord entre les deux organisations.
2) Les décisions ou accords officiels de l'IEC concernant les questions techniques représentent, dans la mesure du
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sont représentés dans chaque comité d'études.
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indépendants.
6) Tous les utilisateurs doivent s'assurer qu'ils sont en possession de la dernière édition de cette publication.
7) Aucune responsabilité ne doit être imputée à l'IEC, à ses administrateurs, employés, auxiliaires ou mandataires,
y compris ses experts particuliers et les membres de ses comités d'études et des Comités nationaux de l'IEC,
pour tout préjudice causé en cas de dommages corporels et matériels, ou de tout autre dommage de quelque
nature que ce soit, directe ou indirecte, ou pour supporter les coûts (y compris les frais de justice) et les dépenses
découlant de la publication ou de l'utilisation de cette Publication de l'IEC ou de toute autre Publication de l'IEC,
ou au crédit qui lui est accordé.
8) L'attention est attirée sur les références normatives citées dans cette publication. L'utilisation de publications
référencées est obligatoire pour une application correcte de la présente publication.
9) L'IEC attire l'attention sur le fait que la mise en application du présent document peut entraîner l'utilisation d'un
ou de plusieurs brevets. L'IEC ne prend pas position quant à la preuve, à la validité et à l'applicabilité de tout
droit de brevet revendiqué à cet égard. À la date de publication du présent document, l'IEC n'avait pas reçu
notification qu'un ou plusieurs brevets pouvaient être nécessaires à sa mise en application. Toutefois, il y a lieu
d'avertir les responsables de la mise en application du présent document que des informations plus récentes
sont susceptibles de figurer dans la base de données de brevets, disponible à l'adresse https://patents.iec.ch.
L'IEC ne saurait être tenue pour responsable de ne pas avoir identifié de tels droits de brevets.
L'IEC 60601-2-64 a été établie par le sous-comité 62C: Appareils de radiothérapie, de
médecine nucléaire et de dosimétrie du rayonnement, du comité d'études 62 de l'IEC:
Équipement médical, logiciels et systèmes médicaux. Il s'agit d'une Norme internationale.
Cette deuxième édition annule et remplace la première édition parue en 2014. Cette édition
constitue une révision technique.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition
précédente:
a) harmonisation avec l'IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2011 et
l'IEC 60601-1:2005/AMD2:2020;
b) harmonisation avec l'IEC 62667:2017 pour les termes définis et les définitions;
c) révision de la section relative aux neutrons en dehors du champ d'irradiation.
Le texte de cette Norme internationale est issu des documents suivants:
Projet Rapport de vote
62C/954/FDIS 62C/964/RVD
Le rapport de vote indiqué dans le tableau ci-dessus donne toute information sur le vote ayant
abouti à son approbation.
La langue employée pour l'élaboration de cette Norme internationale est l'anglais.
Ce document a été rédigé selon les Directives ISO/IEC, Partie 2, il a été développé selon les
Directives ISO/IEC, Partie 1 et les Directives ISO/IEC, Supplément IEC, disponibles sous
www.iec.ch/members_experts/refdocs. Les principaux types de documents développés par
l'IEC sont décrits plus en détail sous www.iec.ch/publications.
Dans le présent document, les caractères d'imprimerie suivants sont utilisés:
– exigences et définitions: caractères romains;
– modalités d'essais: caractères italiques;
– indications de nature informative qui apparaissent hors des tableaux, comme les notes, les exemples et les
références: petits caractères. Le texte normatif à l'intérieur des tableaux est également en petits caractères;
– TERMES DEFINIS A L'ARTICLE 3 DE L'IEC 60601-1:2005, L'IEC 60601-1:2005/AMD1:2012 ET
L'IEC 60601-1:2005/AMD2:2020, DANS LA PRESENTE NORME PARTICULIERE OU COMME CELA EST
NOTE: PETITES MAJUSCULES.
Concernant la structure du présent document, le terme:
– "article" désigne l'une des dix-sept divisions numérotées dans la table des matières, avec
toutes ses subdivisions (par exemple, l'Article 7 inclut les paragraphes 7.1, 7.2, etc.);
– "paragraphe" désigne une subdivision numérotée d'un article (par exemple, 7.1, 7.2 et 7.2.1
sont tous des paragraphes qui appartiennent à l'Article 7).
Dans le présent document, les références à des articles sont précédées du mot "Article" suivi
du numéro de l'article concerné. Dans la présente norme particulière, les références aux
paragraphes utilisent uniquement le numéro du paragraphe concerné.
Dans le présent document, la conjonction "ou" a la valeur d'un "ou inclusif". Ainsi, un énoncé
est vrai si une combinaison des conditions, quelle qu'elle soit, est vraie.
Les formes verbales utilisées dans le présent document sont conformes à l'usage donné à
l'Article 7 des Directives ISO/IEC, Partie 2. Pour les besoins du présent document:
– le verbe "devoir" signifie que la conformité à une exigence ou à un essai est obligatoire pour
assurer la conformité au présent document;
– l'expression "il convient" signifie que la conformité à une exigence ou à un essai est
recommandée, mais n'est pas obligatoire pour assurer la conformité au présent document;
– "pouvoir" mis au présent de l'indicatif est utilisé pour décrire un moyen admissible pour
satisfaire à une exigence ou à un essai.
Une liste de toutes les parties de la série IEC 60601, publiées sous le titre général Appareils
électromédicaux, se trouve sur le site web de l'IEC.
Le comité a décidé que le contenu de ce document ne sera pas modifié avant la date de stabilité
indiquée sur le site web de l'IEC sous webstore.iec.ch dans les données relatives au document
recherché. À cette date, le document sera
– reconduit,
– supprimé, ou
– révisé.
INTRODUCTION
L'utilisation des APPAREILS ELECTROMEDICAUX PAR FAISCEAU D'IONS LEGERS à des fins de
RADIOTHERAPIE peut exposer les PATIENTS à un danger soit parce qu'une défaillance de
l'APPAREIL EM l'empêche de délivrer la dose exigée au PATIENT, soit parce que la conception de
l'APPAREIL EM n'est pas conforme aux normes de sécurité électrique et mécanique.
APPAREIL EM peut également présenter des dangers pour des personnes qui se trouvent à
L'
proximité, soit parce que l'APPAREIL EM lui-même n'est pas apte à contenir correctement le
RAYONNEMENT, soit parce que la conception de la SALLE DE TRAITEMENT n'est pas appropriée.
La présente norme particulière décrit les exigences que doivent respecter les FABRICANTS lors
de la conception et de la construction des APPAREILS EM PAR FAISCEAU D'IONS LEGERS destinés à
être utilisés en RADIOTHERAPIE; elle n'a pas pour objet de définir des exigences de performances
optimales. La présente norme a pour objet d'identifier les caractéristiques de conception
reconnues actuellement comme essentielles pour la sécurité de fonctionnement de tels
APPAREILS EM. Elle définit les limites de détérioration des performances des APPAREILS EM, qui
peuvent faire suite à une condition de défaut et qui impliquent le déclenchement d'un
VERROUILLAGE afin de neutraliser le fonctionnement continu de l'APPAREIL EM.
Le 201.10 donne les limites de tolérance au-dessus desquelles les VERROUILLAGES empêchent
'IRRADIATION, INTERROMPENT L'IRRADIATION ou provoquent la FIN DE L'IRRADIATION de manière à
L
assurer les PERFORMANCES ESSENTIELLES et ainsi éviter une situation dangereuse. Les ESSAIS
DE TYPE effectués par le FABRICANT ou les ESSAIS SUR LE SITE qui ne sont pas nécessairement
effectués par le FABRICANT sont SPECIFIES pour chacune des exigences. Il convient d'être
conscient du fait qu'avant installation, un FABRICANT peut délivrer un certificat de conformité
concernant seulement les ESSAIS DE TYPE. Il convient d'intégrer les résultats obtenus au cours
ESSAIS SUR LE SITE à la DOCUMENTATION D'ACCOMPAGNEMENT, sous forme d'un rapport des
des
ESSAIS SUR LE SITE, par les personnes qui effectuent les essais de l'APPAREIL EM lors de son
installation.
L'IEC 62667 est étroitement liée au présent document. Elle spécifie les méthodes d'essai et les
modèles de rapport applicables aux essais de performance des APPAREILS ELECTROMEDICAUX
par FAISCEAU D'IONS LEGERS à utiliser en RADIOTHERAPIE, afin de fournir des méthodes
correspondantes uniformes. L'Annexe A de l'IEC 62667:2017 fournit des modèles de
présentation des valeurs de performances, mesurées selon les méthodes SPECIFIEES.

201.1 Domaine d'application, objet et normes connexes
L'Article 1 de l'IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2012 et
l'IEC 60601-1:2005/AMD2:2020 s'applique, avec les exceptions suivantes:
201.1.1 Domaine d'application
Remplacement:
Le présent document s'applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des
APPAREILS ELECTROMEDICAUX PAR FAISCEAU D'IONS LEGERS, désignés ci-après par le terme
APPAREILS EM, utilisés pour le traitement des PATIENTS.
Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux
APPAREILS EM, ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce
paragraphe l'indiquent. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois
aux APPAREILS EM et aux SYSTEMES EM, selon le cas.
Le présent document, y compris les ESSAIS DE TYPE et les ESSAIS SUR LE SITE, s'applique
respectivement au FABRICANT et à certains aspects d'installation des APPAREILS
ELECTROMEDICAUX PAR FAISCEAU D'IONS LEGERS
– destinés à être utilisés à des fins de RADIOTHERAPIE dans la pratique médicale des patients,
y compris les appareils dont le choix et l'AFFICHAGE des paramètres de fonctionnement
peuvent être contrôlés automatiquement par des SOUS-SYSTEMES ELECTRONIQUES
PROGRAMMABLES (PESS),
– qui, en UTILISATION NORMALE, délivrent un FAISCEAU DE RAYONNEMENT d'IONS LEGERS dont
l'ENERGIE PAR NUCLEON se situe dans la plage 10 MeV/n à 500 MeV/n,
et
– destinés à être
• pour une UTILISATION NORMALE, manipulés, sous la responsabilité de PERSONNES
QUALIFIEES ou dûment autorisées par des OPERATEURS qui disposent des compétences
exigées pour une application médicale particulière, à des fins cliniques SPECIFIEES
particulières, entretenus conformément aux recommandations données dans les
INSTRUCTIONS D'UTILISATION,
• soumis à des contrôles périodiques de performance de l'assurance qualité et
d'étalonnage par une PERSONNE QUALIFIEE.
NOTE 1 Dans le présent document, toutes les références à l'installation se rapportent à l'installation dans les locaux
de l'ORGANISME RESPONSABLE.
NOTE 2 Dans le présent document, toutes les références à la DOSE ABSORBEE se rapportent à la DOSE
ABSORBEE dans l'eau.
NOTE 3 Les informations concernant le guidage par image radiologique figurent dans l'IEC 60601-2-68.
NOTE 4 L'IEC 61217 donne des recommandations concernant la désignation des mouvements des APPAREILS EM,
le marquage des échelles, leurs positions zéro et le sens de déplacement avec l'augmentation de la valeur (voir le
201.7.4.101).
201.1.2 Objet
Remplacement:
L'objet du présent document est d'établir des exigences particulières pour la SECURITE DE BASE
et les PERFORMANCES ESSENTIELLES des APPAREILS ELECTROMEDICAUX PAR FAISCEAU D'IONS
LEGERS dans la plage 10 MeV/n à 500 MeV/n et de SPECIFIER des essais destinés à vérifier la
conformité aux exigences.
NOTE L'adoption du présent document permet de s'assurer que l'APPAREIL EM:
− préserve la sécurité du PATIENT au cours des mouvements de l'APPAREIL EM et en cas de défaillance du
RESEAU D'ALIMENTATION;
− délivre le TYPE DE RAYONNEMENT, l'ENERGIE PAR NUCLEON, les types d'IONS LEGERS et la DOSE ABSORBEE
présélectionnés;
− délivre au PATIENT les FAISCEAUX D'IONS LEGERS présélectionnés, en utilisant des dispositifs de modification
du FAISCEAU D'IONS LEGERS, etc., sans occasionner de risque inutile au PATIENT, à l'OPERATEUR, à d'autres
personnes ou à l'environnement.
201.1.3 Normes collatérales
Addition:
La présente norme particulière fait référence aux normes collatérales applicables énumérées à
l'Article 2 des normes IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 et
IEC 60601-1:2005/AMD2:2020 et au 201.2 du présent document.
L'IEC 60601-1-6:2010, l'IEC 60601-1-6:2010/AMD1:2013 et l'IEC 60601-1-6:2010/AMD2:2020
ne s'appliquent, avec les modifications apportées par l'Article 206. L'IEC 60601-1-3,
l'IEC 60601-1-8, l'IEC 60601-1-9 [1] et l'IEC 60601-1-10 [2] ne s'appliquent pas. Toutes les
autres normes collatérales publiées dans la série IEC 60601-1 s'appliquent telles qu'elles sont
publiées.
NOTE Les normes collatérales publiées après la date de publication du présent document s'appliquent uniquement
lors de tout nouvel amendement du présent document.
201.1.4 Normes particulières
Remplacement:
Dans la série IEC 60601, des normes particulières peuvent modifier, remplacer ou supprimer
des exigences contenues dans l'IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2012 et
l'IEC 60601-1:2005/AMD2:2020 et dans les normes collatérales en fonction de l'APPAREIL EM à
l'étude. Elles peuvent également ajouter des exigences supplémentaires pour la SECURITE DE
BASE et les PERFORMANCES ESSENTIELLES.
Une exigence d'une norme particulière prévaut sur l'exigence correspondante de
l'IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2012 et l'IEC 60601-1:2005/AMD2:2020.
___________
Les chiffres entre crochets renvoient à la Bibliographie.
La numérotation des articles et des paragraphes du présent document correspond à celle de
l'IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2012 et l'IEC 60601-1:2005/AMD2:2020 avec le
préfixe "201" (par exemple, le 201.1 du présent document concerne le contenu de l'Article 1 de
l'IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2012 et l'IEC 60601-1:2005/AMD2:2020) ou à
celle de la norme collatérale applicable avec le préfixe "20x", où x représente le ou les derniers
chiffres du numéro de document de la norme collatérale (par exemple, le 202.4 concerne le
contenu de l'Article 4 de la norme collatérale IEC 60601-1-2, le 203.4 concerne le contenu de
l'Article 4 de la norme collatérale IEC 60601-1-3, etc.). Les modifications apportées au texte de
l'IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2012 et l'IEC 60601-1:2005/AMD2:2020 sont
précisées en utilisant les termes suivants:
"Remplacement" signifie que l'article ou le paragraphe de l'IEC 60601-1:2005,
l'IEC 60601-1:2005/AMD1:2012 et l'IEC 60601-1:2005/AMD2:2020 ou de la norme collatérale
applicable est remplacé complètement par le texte du présent document.
"Addition" signifie que le texte du présent document vient s'ajouter aux exigences de
l'IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2012 et l'IEC 60601-1:2005/AMD2:2020 ou de
la norme collatérale applicable.
"Amendement" signifie que l'article ou le paragraphe de l'IEC 60601-1:2005,
l'IEC 60601-1:2005/AMD1:2012 et l'IEC 60601-1:2005/AMD2:2020 ou de la norme collatérale
applicable est modifié comme cela est indiqué par le texte du présent document.
Les paragraphes, figures ou tableaux qui sont ajoutés à ceux de l'IEC 60601-1:2005,
l'IEC 60601-1:2005/AMD1:2012 et l'IEC 60601-1:2005/AMD2:2020 sont numérotés à partir de
201.101. Toutefois, en raison du fait que les définitions dans l'IEC 60601-1:2005,
l'IEC 60601-1:2005/AMD1:2012 et l'IEC 60601-1:2005/AMD2:2020 sont numérotées de 3.1 à
3.154, les définitions qui sont ajoutées dans le présent document sont numérotées à partir de
201.3.201. Les annexes complémentaires sont indiquées par AA, BB, etc., et les points
complémentaires par aa), bb), etc.
Les paragraphes, tableaux et figures qui sont ajoutés à une norme collatérale sont numérotés
à partir de 20x, où "x" est le chiffre de la norme collatérale, par exemple 202 pour
l'IEC 60601-1-2, 203 pour l'IEC 60601-1-3, etc.
Lorsque le présent document ne comprend pas d'article ou de paragraphe correspondant,
l'article ou le paragraphe de l'IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2012 et
l'IEC 60601-1:2005/AMD2:2020 ou de la norme collatérale applicable, bien qu'il puisse être
sans objet, s'applique sans modification; lorsqu'il est demandé qu'une partie quelconque de
l'IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2012 et l'IEC 60601-1:2005/AMD2:2020 ou de
la norme collatérale applicable, bien que potentiellement pertinente, ne s'applique pas, cela est
expressément mentionné dans le présent document.
201.2 Références normatives
NOTE Les références informatives sont énumérées dans la bibliographie.
L'Article 2 de l'IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2012 et
l'IEC 60601-1:2005/AMD2:2020 s'applique, avec les exceptions suivantes:
Addition:
IEC 60601-1:2005, Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité
de base et les performances essentielles
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC 60601-2-1:2020, Appareils électromédicaux - Partie 2-1: Exigences particulières pour la
sécurité de base et les performances essentielles des accélérateurs d'électrons dans la gamme
de 1 MeV à 50 MeV
IEC 60601-2-68:2014, Appareils électromédicaux - Partie 2-68: Exigences particulières pour la
sécurité de base et les performances essentielles des appareils de radiothérapie à
rayonnement X assistée par imagerie médicale, destinés à être utilisés avec les accélérateurs
d'électrons, les appareils de thérapie par faisceau d'ions légers et les appareils de thérapie par
faisceau de radionucléides
IEC TR 60788:2004, Medical electrical equipment - Glossary of defined terms (disponible en
anglais seulement)
IEC 61217:2011, Appareils utilisés en radiothérapie - Coordonnées, mouvements et échelles
CISPR 11, Appareils industriels, scientifiques et médicaux - Caractéristiques de perturbations
radioélectriques – Limites et méthodes de mesure
201.3 Termes et définitions
Pour les besoins du présent document, les termes et définitions de l'IEC 60601-1:2005,
l'IEC 60601-1:2005/AMD1:2012, l'IEC 60601-1:2005/AMD2:2020, l'IEC 60601-2-1:2020 et
l'IEC TR 60788:2004 s'appliquent, avec les exceptions suivantes:
NOTE Un index des termes définis est donné après la Bibliographie.
Termes et définitions supplémentaires:
201.3.201
CHARIOT D'APPLICATION
TETE RADIOGENE qui ne peut être retirée sans l'aide d'outils à laquelle
partie la plus distale de la
des APPLICATEURS DE FAISCEAU D'IONS LEGERS interchangeables sont fixés et qui peut s'étendre
en direction et se rétracter de l'ISOCENTRE ou DE L'ERP
Note 1 à l'article: En anglais, "applicator carriage" (CHARIOT D'APPLICATION) est parfois communément appelé
"snout".
201.3.202
APPAREIL DE CONTROLE DE LA REPARTITION DE LA FLUENCE DU FAISCEAU
système qui permet de contrôler directement ou indirectement la répartition de la FLUENCE du
faisceau afin de fournir des informations sur l'orientation ou le déplacement latéral du faisceau
Note 1 à l'article: Cet appareil de contrôle peut être utilisé comme substitut pour la distribution de la DOSE appliquée
au patient.
Note 2 à l'article: Les exemples d'APPAREILS DE CONTROLE DE LA REPARTITION DE LA FLUENCE DU FAISCEAU incluent
les chambres d'ionisation à feuille à quadrants, à anneau concentrique ou à bandes multiples, les plaques à
scintillateur et les sondes de champ à aimant de balayage.
201.3.203
APPAREIL DE CONTROLE DE FLUX DU FAISCEAU
système qui permet de contrôler le FLUX du faisceau
Note 1 à l'article: Cet appareil de contrôle peut être utilisé comme substitut pour la DISTRIBUTION DU DEBIT DE DOSE
appliquée au patient.
___________
Une nouvelle édition de l'IEC 60601-2-68 a été publiée en 2025.
201.3.204
DECLENCHEMENT DU FAISCEAU
tolérance ou neutralisation de l'IRRADIATION et des mouvements des appareils associés selon
l'état fourni par un SIGNAL DE DECLENCHEMENT DU FAISCEAU
201.3.205
SIGNAL DE DECLENCHEMENT DU FAISCEAU
signal généré à des fins de DECLENCHEMENT DU FAISCEAU
EXEMPLE Les exemples incluent les spiromètres respiratoires, les électrocardiogrammes, les détecteurs optiques,
etc.
201.3.206
MINUTERIE
dispositif qui mesure le temps pendant lequel l'IRRADIATION est effectuée et qui provoquer la FIN
DE L'IRRADIATION lorsqu'un temps prédéterminé est atteint
[SOURCE: IEC 60601-2-1:2020, 201.3.210]
201.3.207
UNITE DE SURVEILLANCE DE DOSE
paramètre, consigné par le SYSTEME DE SURVEILLANCE DE DOSE, à partir duquel, au moyen d'une
procédure d'étalonnage associée à des informations supplémentaires, la DOSE ABSORBEE
délivrée peut être calculée
201.3.208
DEBIT DE L'UNITE DE SURVEILLANCE DE DOSE
UNITE DE SURVEILLANCE DE DOSE par unité de temps
201.3.209
SYSTEME DE SURVEILLANCE DU DEBIT DE L'UNITE DE SURVEILLANCE DE DOSE
système de dispositifs qui mesurent et affichent une grandeur liée au rayonnement en relation
directe avec le DEBIT DE L'UNITE DE SURVEILLANCE DE DOSE
201.3.210
SYSTEME DE SURVEILLANCE DE DOSE
système de dispositifs qui mesurent et affichent une grandeur liée au rayonnement en relation
directe avec la DOSE ABSORBEE
201.3.211
ENERGIE PAR NUCLEON
énergie cinétique totale de l'ion divisée par le nombre de nucléons dans le noyau au point de
pénétration de l'ion dans la TETE RADIOGENE avant de transiter par des modificateurs de faisceau
201.3.212
POINT DE REFERENCE DES APPAREILS
ERP
point dans l'espace utilisé pour référencer les dimensions des appareils et effectuer les
mesurages de dosimétrie
Note 1 à l'article: Typiquement, le point de référence correspond à l'ISOCENTRE. Si l'appareil d'application du
faisceau n'est pas ISOCENTRIQUE, le centre des systèmes d'alignement du PATIENT peut alors être utilisé.
Note 2 à l'article: L'abréviation "ERP" est dérivée du terme anglais développé correspondant "EQUIPMENT REFERENCE
POINT".
201.3.213
FLUENCE
quotient de dN par dA, où dN est le nombre de particules incidentes sur une sphère de section
maximale dA, d'où
Φ = dN/dA
Note 1 à l'article: Définition tirée du rapport ICRU 85a:2011, 3.1.3.
201.3.214
FLUX
quotient de dN par dt, où dN est l'augmentation du nombre de particules dans l'intervalle de
temps dt, d'où
N = dN/dt
Note 1 à l'article: Définition tirée du rapport ICRU 85a:2011, 3.1.2.
201.3.215
CIRCUIT CABLE
condition d'un système selon laquelle les propriétés de ce dernier ne peuvent être modifiées
qu'en retirant ou en déplaçant physiquement des fils de câblage qui sont reliés physiquement
[SOURCE: IEC 60601-2-1:2020, 201.3.224]
201.3.216
INTERRUPTION DE L'IRRADIATION
arrêt de l'IRRADIATION et des mouvements, avec la possibilité de reprendre l'irradiation sans
resélectionner les conditions de fonctionnement
[SOURCE: IEC 60601-2-1:2020, 201.3.227]
201.3.217
DISPOSITIF DE DEPLACEMENT LATERAL
LSD
dispositif qui permet d'accroître les dimensions latérales (Xg, Yg) d'un FAISCEAU D'IONS LEGERS
de plus faible diamètre produit par un accélérateur
EXEMPLE Les exemples de dispositifs de déplacement incluent une mince feuille métallique qui permet la diffusion
des ions ou un aimant qui permet de défocaliser le faisceau ou de le balayer latéralement sur le VOLUME CIBLE prévu.
Note 1 à l'article: Xg et Yg sont définies dans l'IEC 61217:2011.
201.3.218
ION LEGER
variété d'ion dont le numéro atomique est inférieur ou égal à celui du néon (Z ≤ 10) et est
SPECIFIE par son nombre de protons, son nombre de nucléons et l'état d'ionisation
201.3.219
FAISCEAU D'IONS LEGERS
ensemble d'IONS LEGERS qui se déplacent dans la même direction générale
201.3.220
APPLICATEUR DE FAISCEAU D'IONS LEGERS
dispositif qui permet de maintenir un DISPOSITIF ou un ACCESSOIRE DE LIMITATION DU FAISCEAU à
proximité de la peau du PATIENT lors de l'application d'un FAISCEAU D'IONS LEGERS
Note 1 à l'article: Plusieurs APPLICATEURS DE FAISCEAU D'IONS LEGERS peuvent être disponibles pour réduire le poids
des OUVERTURES soulevées par l'OPERATEUR, pour réduire la distance peau-ouverture/ACCESSOIRE, et pour réduire
le rayonnement de fuite.
201.3.221
SYSTEME DE REPARTITION DU FAISCEAU D'IONS LEGERS
système de composants et système de commande utilisés pour acheminer le RAYONNEMENT
d'une SOURCE DE RAYONNEMENT vers plusieurs stations de TRAITEMENT, stations
d'expérimentation ou décharges de faisceau
EXEMPLE Les exemples de composants incluent les tuyaux et conduites à vide, les aimants et les bobines
d'orientation.
201.3.222
GAMME D'IONS LEGERS
profondeur d'un FANTOME le plus éloigné de sa surface à laquelle la DOSE ABSORBEE est une
valeur SPECIFIEE, donnée dans la DOCUMENTATION D'ACCOMPAGNEMENT, de la dose au taux de
modulation central nominal, ou de la dose maximale pour un faisceau non modulé par la
distance, mesuré sur l'AXE DU FAISCEAU DE RAYONNEMENT dans un CHAMP DE RAYONNEMENT
SPECIFIE et avec la surface du FANTOME située à une distance SPECIFIEE de l'ERP sans
DECALEURS ou ACCESSOIRES de distance installés dans la TETE RADIOGENE en aval de l'ENERGIE
PAR NUCLEON ou du système de surveillance de la distance
201.3.223
BALAYAGE MODULE
MODE DE BALAYAGE dans lequel un FAISCEAU d'IONS LEGERS de petit diamètre fait l'objet d'un
balayage sur une cible afin de créer un champ suffisamment grand pour couvrir la cible, de
sorte que la FLUENCE prévue fournie au PATIENT soit différente en des emplacements latéraux
différents
Note 1 à l'article: Différents diagrammes de balayage spatiotemporels peuvent être utilisés pour générer la
répartition de FLUENCE modulée.
201.3.224
RAYONNEMENT NON PRIMAIRE
RAYONNEMENT émis par les APPAREILS ELECTROMEDICAUX PAR FAISCEAU D'IONS LEGERS non
destiné à traiter le PATIENT
201.3.225
POSITIONNEUR DE PATIENT
ensemble d'appareils sur lequel le PATIENT est placé et positionné pour
l'APPAREIL EM DE RADIOTHERAPIE
[SOURCE: IEC 60601-2-1:2020, 201.3.235, modifié – "la RADIOTHERAPIE" a été remplacé par
"APPAREIL EM DE RADIOTHERAPIE".]
201.3.226
PARTIE SUPERIEURE DU POSITIONNEUR DE PATIENT
composant du POSITIONNEUR DE PATIENT auquel les dispositifs d'enregistrement et
d'immobilisation sont fixés et sur lequel est placé le PATIENT
Note 1 à l'article: LES PARTIES SUPERIEURES DES POSITIONNEURS DE PATIENT sont souvent échangeables afin de
maintenir les PATIENTS ou les appareils dans des positions d'orientations différentes, par exemple un panneau plat
ou un siège.
[SOURCE: IEC 60601-2-1:2020, 201.3.254, modifié – Le terme principal "plateau de table" a
été remplacé par "partie supérieure du positionneur de patient"; le début de la définition
"dispositif échangeable fixé à l'appareil de maintien" a été remplacé par "composant du
POSITIONNEUR DE PATIENT" et la Note 1 a été remplacée].
201.3.227
PORTAIL
ensemble d'un ou de plusieurs segments de TRAITEMENT préprogrammés, traités
automatiquement au moyen d'une installation du PATIENT unique
Note 1 à l'article: Les segments peuvent comprendre l'IRRADIATION, le déplacement des dispositifs ou la formation
d'images.
201.3.228
MOUVEMENT PREPROGRAMME
mouvements des éléments d'APPAREILS EM qui se produisent selon un programme préétabli
sans l'intervention de l'OPERATEUR au cours du traitement d'un PATIENT ou lors de la formation
d'images
201.3.229
COMBINAISON PRIMAIRE/SECONDAIRE DE SURVEILLANCE DE DOSE
utilisation de deux SYSTEMES DE SURVEILLANCE DE DOSE pour lesquels l'un constitue le SYSTEME
DE SURVEILLANCE DE DOSE PRIMAIRE et l'autre constitue le SYSTEME DE SURVEILLANCE DE DOSE
SECONDAIRE
201.3.230
PORTAIL A MODULATION PAR LA DISTANCE PROGRAMMABLE
PRMP
PORTAIL D'IONS LEGERS dans lequel un programme, avec ou sans DISPOSITIF DE MODULATION PAR
LA DISTANCE (RMD) permet d'adapter la distribution de la DOSE EN PROFONDEUR en faisant varier
les facteurs de pénétration et de pondération de plusieurs segments constitutifs
Note 1 à l'article: Habituellement, la distribution de la DOSE EN PROFONDEUR est adaptée pour obtenir une
distribution de la dose uniforme sur les profondeurs de résidence du VOLUME CIBLE.
201.3.231
FACTEUR DE QUALITE
Q
FACTEUR DE QUALITE en un point d'un tissu qui est donné par:
1 ∞
Q= Q(L) D dL
L
∫
L=0
D
où D est la DOSE ABSORBEE en ce point, D est la distribution de D en matière de transfert
L
linéique d'énergie illimitée L au point d'intérêt, et Q(L) est le FACTEUR DE QUALITE par rapport
à L
Note 1 à l'article: L'intégration doit porter sur la distribution D , en raison de l'ensemble des particules chargées, à
L
l'exclusion de leurs électrons secondaires.
Note 2 à l'article: Le FACTEUR DE QUALITE Q en un point du tissu relie l'EQUIVALENT DE DOSE H en ce point à la DOSE
ABSORBEE D en ce point, à l'aide de la formule: H = Q × D.
[SOURCE: ICRP Publication 116:2010]
201.3.232
TETE RADIOGENE
structure d'où émerge le FAISCEAU DE RAYONNEMENT
[SOURCE: IEC TR 60788:2004, rm-20-06]
201.3.233
DISPOSITIF DE MODULATION PAR LA DISTANCE
RMD
dispositif utilisé pour moduler la pénétration d'un FAISCEAU DE RAYONNEMENT dans le corps d'un
PATIENT afin d'adapter la distribution de la DOSE EN PROFONDEUR lors de la fourniture d'un
PORTAIL
Note 1 à l'article: Le dispositif peut consister en un matériau à profil hélicoïdal qui s'enroule dans le faisceau, un
filtre contenant un motif à répétition de nervures (par exemple, filtre nervuré, filtre nervuré miniature, filtre
d'ondulations), un cône ou ensemble de cônes, voire un ensemble de blocs à épaisseur uniforme à programmation
binaire. Les sous-types de blocs incluent les blocs discrets et programmables.
201.3.234
DECALEUR DE DISTANCE
dispositif de modification de la distance dont l'épaisseur est constante à toutes les positions
latérales par rapport à l'axe central du faisceau
201.3.235
COMBINAISON REDONDANTE DE SURVEILLANCE DE DOSE
utilisation de deux SYSTEMES DE SURVEILLANCE DE DOSE disposés de manière à provoquer la FIN
DE L'IRRADIATION selon le nombre présélectionné d'UNITES DE SURVEILLANCE DE DOSE
201.3.236
MODE DE BALAYAGE
FAISCEAU DE RAYONNEMENT balayé afin de produire un champ à
méthode d'application d'un
largeur latérale
Note 1 à l'article: Les types de MODES DE BALAYAGE incluent: aucun, un BALAYAGE UNIFORME et un BALAYAGE MODULE.
201.3.237
ESSAI SUR LE SITE
essai, après installation, d'un dispositif individuel ou d'un APPAREIL EM pour vérifier leur
conformité aux critères SPECIFIES
Note 1 à l'article: Il est admis que les ESSAIS SUR LE SITE doivent être effectués, mais qu'ils peuvent ne pas être
effectués par le FABRICANT, selon l'accord entre le FABRICANT et l'UTILISATEUR final.
[SOURCE: IEC 60601-2-1:2020, 201.3.253, modifié – Dans la Note 1 à l'article, "organisme
responsable" a été remplacé par "utilisateur final".]
201.3.238
DOCUMENTATION TECHNIQUE
documentation permettant d'évaluer la conformité du produit aux exigences de la ou des normes
[SOURCE: ISO/IEC 80079-34:2018, 3.10, modifié – Les Notes 1 à 3 à l'article ont été
supprimées.]
201.3.239
FIN DE L'IRRADIATION
arrêt de l'IRRADIATION et des mouvements, avec impossibilité de remettre en marche sans
retourner à l'ETAT PREPARATOIRE
Note 1 à l'article: Les événements qui peuvent provoquer la FIN DE L'IRRADIATION et arrêter les mouvements peuvent
être par exemple:
− lorsque la valeur présélectionnée des UNITES DE SURVEILLANCE DE DOSE est atteinte,
− lorsque la valeur présélectionnée est atteinte dans le système d'interruption, indépendamment du SYSTEME
DE SURVEILLANCE DE DOSE,
− par une action manuelle volontaire,
− par le fonctionnement d'un VERROUILLAGE, ou
− en BALAYAGE MODULE, lorsque le diagramme de balayage préprogrammé est achevé.
[SOURCE: IEC 60601-2-11:2013, 201.3.225, modifié – La formulation de la définition et de la
Note 1 à l'article est légèrement différente.]
201.3.240
DETECTEUR A TRANSMISSION
DETECTEUR DE RAYONNEMENT qui est traversé par le FAISCEAU D'IONS LEGERS
[SOURCE: IEC 60601-2-1:2020, 201.3.257, modifié – Le terme "FAISCEAU DE RAYONNEMENT" a
été remplacé par "FAISCEAU D'IONS LEGERS".]
201.3.241
ESSAI DE TYPE
essai sur un spécimen représentatif de l'appareil en vue de déterminer si celui-ci, tel qu'il est
conçu et construit, peut satisfaire aux exigences du présent document
[SOURCE: IEC 60601-1:2005, 3.135]
201.3.242
BALAYAGE UNIFORME
MODE DE BALAYAGE dans lequel un FAISCEAU DE RAYONNEMENT fait l'objet d'un balayage latéral
selon un diagramme prédéfini afin de produire un champ suffisamment grand pour traiter la
cible, de sorte que le FLUX du FAISCEAU DE RAYONNEMENT ne soit pas volontairement modifié
tout au long du balayage latéral, afin que la distribution de la dose résultante dans le champ
soit uniforme
Note 1 à l'article: Le balayage peut être effectué en modifiant le courant qui circule dans les électroaimants par
lesquels passe le FAISCEAU DE RAYONNEMENT, ou en utilisant des aimants permanents à rotation ou à translation
mécanique.
201.3.243
UTILISATEUR
dans le cadre d'une norme de l'IEC relative aux APPAREILS électromédicaux, organisme ou
personne responsable de l'utilisation et de l'entretien de l'APPAREIL
[SOURCE: IEC TR 60788:2004, rm-85-01]
201.4 Exigences générales
L'Article 4 de l'IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2011 et
l'IEC 60601-1:2005/AMD2:2020 s'applique.
201.5 Exigences générales relatives aux essais des APPAREILS EM
L'Article 5 de l'IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2011 et
l'IEC 60601-1:2005/AMD2:2020 s'applique, avec les exceptions suivantes:
201.5.1 ESSAIS DE TYPE
Remplacement du titre:
201.5.1 ESSAIS DE TYPE et ESSAI SUR LE SITE
Paragraphe supplémentaire:
201.5.1.101 Catégories d'essai
Trois catégories de méthodes d'ESSAI DE TYPE et deux catégories de méthodes d'ESSAIS SUR LE
SITE sont SPECI
...

IEC 60601-2-64 ®
Edition 2.0 2025-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment -
Part 2-64: Particular requirements for the basic safety and essential performance
of light ion beam medical electrical equipment

Appareils électromédicaux -
Partie 2-64: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils électromédicaux par faisceau d'ions légers
ICS 11.040.60  ISBN 978-2-8327-0866-8

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CONTENTS
FOREWORD . 2
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 . 15
201.5 General requirements for testing ME EQUIPMENT . 15
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 16
201.7 ME EQUIPMENT identification, marking and documents . 17
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 20
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 20
201.10 Protection against unwanted and excessive radiation HAZARDS . 25
201.11 Protection against excessive temperatures and other HAZARDS . 47
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 47
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 47
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 48
201.15 Construction of ME EQUIPMENT . 48
201.16 ME SYSTEMS . 48
201.17 ELECTROMAGNETIC DISTURBANCES of ME EQUIPMENT and ME SYSTEMS . 50
201.101 ELECTRONIC IMAGING DEVICES (EID) . 51
201.102 Operation of ME EQUIPMENT parts from outside the facility . 51
206 Usability . 51
Annexes . 55
Annex B (informative) Sequence of testing . 55
Annex I (informative) ME SYSTEMS aspects . 55
Bibliography . 56
Index of defined terms used in this document . 57

Figure 201.101 – PATIENT POSITIONER movements . 52
Figure 201.102 – Diagram illustrating example RADIATION HEAD components and
possible PATIENT position for NON-PRIMARY RADIATION REQUIREMENTS . 53
Figure 201.103 – Diagram illustrating distance along PATIENT plane to measure
NON-PRIMARY RADIATION ABSORBED DOSE . 54

Table 201.101 – Data required in the technical description to support Clause 201.10
compliance . 18

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
Medical electrical equipment -
Part 2-64: Particular requirements for the basic safety and essential
performance of light ion beam medical electrical equipment

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
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preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
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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
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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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6) All users should ensure that they have the latest edition of this publication.
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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) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s), which
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the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
IEC 60601-2-64 has been prepared by subcommittee 62C: Equipment for radiotherapy, nuclear
medicine and radiation dosimetry, of IEC technical committee 62: Medical equipment, software,
and systems. It is an International Standard.
This second edition cancels and replaces the first edition published in 2014. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) harmonization with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2011 and
IEC 60601-1:2005/AMD2:2020;
b) harmonization with IEC 62667:2017 for defined terms and definitions;
c) address revision to neutrons outside the field of irradiation.
The text of this International Standard is based on the following documents:
Draft Report on voting
62C/954/FDIS 62C/964/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
In this document, 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 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 AND
IEC 60601-1:2005/AMD2:2020, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
– "clause" means one of the 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 document are preceded by the term "Clause" followed by the
clause number. References to subclauses within this particular standard are by number only.
In this document, 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 document conform to usage described in Clause 7 of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance with
this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
– reconfirmed,
– withdrawn, or
– revised.
INTRODUCTION
The use of LIGHT ION BEAM ME EQUIPMENT for RADIOTHERAPY purposes can expose PATIENTS to
danger if the ME EQUIPMENT fails to deliver the required dose to the PATIENT, or if the ME
EQUIPMENT design does not satisfy standards of electrical and mechanical safety. The ME
EQUIPMENT can also cause danger to persons in the vicinity if the ME EQUIPMENT itself fails to
RADIATION adequately or if there are inadequacies in the design of the TREATMENT
contain the
ROOM.
This particular standard establishes requirements to be complied with by MANUFACTURERS in the
design and construction of LIGHT ION BEAM ME EQUIPMENT for use in RADIOTHERAPY; it does not
attempt to define their optimum performance requirements. Its purpose is to identify those
features of design that are regarded, at the present time, as essential for the safe operation of
ME EQUIPMENT; it places limits on the degradation of ME EQUIPMENT performance beyond
such
which it can be presumed that a fault condition exists and where an INTERLOCK then operates
to prevent continued operation of the ME EQUIPMENT.
Clause 201.10 contains limits beyond which INTERLOCKS prevent IRRADIATION, cause
INTERRUPTION OF IRRADIATION or cause TERMINATION OF IRRADIATION in order to insure that
ESSENTIAL PERFORMANCE is maintained and to avoid an unsafe condition. TYPE TESTS that are
MANUFACTURER, or SITE TESTS, which are not necessarily performed by the
performed by the
MANUFACTURER, are SPECIFIED for each requirement. It should be understood that, before
installation, a MANUFACTURER can provide a compliance certificate relating only to TYPE TESTS.
Data available from SITE TESTS should be incorporated in the ACCOMPANYING DOCUMENTATION, in
the form of a SITE TEST report, by those who test the ME EQUIPMENT at installation.
Closely related to this document is IEC 62667. It specifies test methods and reporting formats
LIGHT ION BEAM ME EQUIPMENT for use in RADIOTHERAPY, with the aim of
for performance tests of
providing uniform methods of doing so. Annex A of IEC 62667:2017 provides forms for
presenting performance values, measured per the methods SPECIFIED.

201.1 Scope, object and related standards
Clause 1 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.1.1 Scope
Replacement:
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LIGHT ION BEAM ME
EQUIPMENT, hereafter referred to as ME EQUIPMENT, used for treatment of PATIENTS.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME
SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case,
the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
This document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the
MANUFACTURER and SPECIFIED installation aspects of LIGHT ION BEAM ME EQUIPMENT
– intended for RADIOTHERAPY in human medical practice, including those in which the selection
and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE
ELECTRONIC SUBSYSTEMS (PESS),
– that, in NORMAL USE, deliver a RADIATION BEAM of LIGHT IONS having ENERGY PER NUCLEON in
the range 10 MeV/n to 500 MeV/n,
and
– intended to be
• for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED
PERSONS by OPERATORS having the required skills for a particular medical application, for
particular SPECIFIED clinical purposes maintained in accordance with the
recommendations given in the INSTRUCTIONS FOR USE,
• subject to regular quality assurance performance and calibration checks by a QUALIFIED
PERSON.
NOTE 1 In this document, all references to installation refer to installation in the RESPONSIBLE ORGANIZATION's
premises.
NOTE 2 In this document, all references to ABSORBED DOSE refer to ABSORBED DOSE in water.
NOTE 3 Information regarding x-ray image guidance can be found in IEC 60601-2-68.
NOTE 4 IEC 61217 gives guidance on the designation of ME EQUIPMENT movements, the marking of scales, their
zero positions and the direction of movement with increasing value (see 201.7.4.101).
201.1.2 Object
Replacement:
The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for LIGHT ION BEAM ME EQUIPMENT in the range 10 MeV/n to 500 MeV/n and to
SPECIFY tests to check compliance to those requirements.
NOTE The adoption of this document helps to ensure that the ME EQUIPMENT
− maintains PATIENT safety during ME EQUIPMENT movements and failure of the SUPPLY MAINS;
− delivers the pre-selected RADIATION TYPE, ENERGY PER NUCLEON, LIGHT ION species, and ABSORBED DOSE;
− delivers pre-selected LIGHT ION BEAMS to the PATIENT, by utilizing LIGHT ION BEAM modifying devices, etc.,
without causing unnecessary risk to the PATIENT, the OPERATOR, other persons or the environment.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 and Clause 201.2 of this document.
IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020
applies as modified in Clause 206. IEC 60601-1-3, IEC 60601-1-8, IEC 60601-1-9 [1] and
IEC 60601-1-10 [2] do not apply. All other published collateral standards in the IEC 60601-1
series apply as published.
NOTE Collateral standards published after the date of publication of this document will only apply subject to further
amendment to this document.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
The numbering of clauses and subclauses of this document corresponds to that of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 with the
prefix "201" (e.g. 201.1 in this document addresses the content of Clause 1 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020) 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 addresses the content of Clause 4 of the IEC 60601-1-2
collateral standard, 203.4 addresses the content of Clause 4 of the 60601-1-3 collateral
standard, etc.). The changes to the text of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012
and IEC 60601-1:2005/AMD2:2020 are specified by the use of the following words:
"Replacement" means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is replaced completely by the text in this document.
"Addition" means that the text of this document is additional to the requirements of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard.
"Amendment" means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is amended as indicated by the text of this document.
___________
Numbers in square brackets refer to the Bibliography.
Subclauses, figures or tables which are additional to those of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered starting from
201.101. However, due to the fact that definitions in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered 3.1 through
3.154, additional definitions in this document 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.
Where there is no corresponding clause or subclause in this document, the clause or subclause
of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard, although possibly not relevant, applies without modification;
where it is intended that any part of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 or applicable collateral standard, although possibly relevant, is
not to be applied, a statement to that effect is given in this document.
201.2 Normative references
NOTE Informative references are listed in the bibliography.
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 2 applies, except as follows:
Addition:
IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC 60601-2-1:2020, Medical electrical equipment - Part 2-1: Particular requirements for the
basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
IEC 60601-2-68:2014, Medical electrical equipment - Part 2-68: Particular requirements for the
basic safety and essential performance of x-ray-based image guided radiotherapy equipment
for use with electron accelerators, light ion beam therapy equipment and radionuclide beam
therapy equipment
IEC TR 60788:2004, Medical electrical equipment - Glossary of defined terms
IEC 61217:2011, Radiotherapy equipment - Coordinates, movements and scales
CISPR 11, Industrial, scientific and medical equipment - Radio-frequency disturbance
characteristics - Limits and methods of measurement
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, IEC 60601-2-1:2020, and
IEC TR 60788:2004 apply, except as follows:
NOTE An index of defined terms is given after the Bibliography.
___________
A newer edition of IEC 60601-2-68 was published in 2025.
Additional terms and definitions:
201.3.201
APPLICATOR CARRIAGE
most distal part of the RADIATION HEAD that cannot be removed without using tools to which
interchangeable LIGHT ION BEAM APPLICATORS are attached and which may extend toward and
retract away from the ISOCENTRE or ERP
Note 1 to entry: Colloquially the APPLICATOR CARRIAGE has sometimes been called a snout.
201.3.202
BEAM FLUENCE DISTRIBUTION MONITOR
system to monitor directly or indirectly the FLUENCE distribution of the beam to provide beam
steering or lateral spreading information
Note 1 to entry: This monitor may be used as a surrogate monitor for the DOSE distribution delivered to the patient.
Note 2 to entry: Examples of BEAM FLUENCE DISTRIBUTION MONITORS include quadrant foil ionization chambers,
concentric ring ionization chambers, multi-strip ionization chambers, scintillator plates, and scanning magnet field
probes.
201.3.203
BEAM FLUX MONITOR
system to monitor the FLUX of the beam
Note 1 to entry: This monitor may be used as a surrogate monitor for the ABSORBED DOSE RATE delivered to the
patient.
201.3.204
BEAM GATING
allowance or inhibition of IRRADIATION and related equipment movements according to the status
provided by a BEAM GATING SIGNAL
201.3.205
BEAM GATING SIGNAL
signal generated for the purpose of BEAM GATING
EXAMPLE Examples include a respiratory spirometer, electrocardiogram, optical sensor, etc.
201.3.206
CONTROLLING TIMER
device to measure the time during which IRRADIATION occurs and, if a predetermined time is
reached, to cause TERMINATION OF IRRADIATION
[SOURCE: IEC 60601-2-1:2020, 201.3.210]
201.3.207
DOSE MONITOR UNIT
parameter, reported by the DOSE MONITORING SYSTEM, from which, through a calibration
procedure and with additional information, the ABSORBED DOSE delivered can be calculated
201.3.208
DOSE MONITOR UNIT RATE
DOSE MONITOR UNIT per unit time
201.3.209
DOSE MONITOR UNIT RATE MONITORING SYSTEM
system of devices for the measurement and DISPLAY of a radiation quantity related to DOSE
MONITOR UNIT RATE
201.3.210
DOSE MONITORING SYSTEM
system of devices for the measurement and DISPLAY of a radiation quantity related to the
ABSORBED DOSE
201.3.211
ENERGY PER NUCLEON
total kinetic energy of the ion divided by the number of nucleons in the nucleus at the point
where the ion enters the RADIATION HEAD before passing through any beam modifiers
201.3.212
EQUIPMENT REFERENCE POINT
ERP
point in space used for referencing dimensions of equipment and performing dosimetry
measurements
Note 1 to entry: Typically, the reference point is coincident with the ISOCENTRE. If the beam delivery equipment is
not ISOCENTRIC, then the centre of the PATIENT alignment systems may be used.
Note 2 to entry: The corresponding note to entry in the French text indicates that the abbreviation "ERP" stands for
"EQUIPMENT REFERENCE POINT" in English.
201.3.213
FLUENCE
quotient of dN by dA, where dN is the number of particles incident on a sphere of cross-sectional
area dA, thus
Φ = dN/dA
Note 1 to entry: Definition from ICRU 85a:2011, 3.1.3.
201.3.214
FLUX
quotient of dN by dt, where dN is the increment of the particle number in the time interval dt,
thus
.
N = dN/dt
Note 1 to entry: Definition from ICRU 85a:2011, 3.1.2.
201.3.215
HARD-WIRED
condition of a system where its features of a system can be modified only by physically removing
and re-routing linked wires
[SOURCE: IEC 60601-2-1:2020, 201.3.224]
201.3.216
INTERRUPTION OF IRRADIATION
stopping of stop IRRADIATION and movements with the possibility of continuing without
reselecting operating conditions
[SOURCE: IEC 60601-2-1:2020, 201.3.227]
201.3.217
LATERAL SPREADING DEVICE
LSD
device used to increase the lateral (Xg, Yg) dimensions of a small diameter LIGHT ION BEAM
produced by an accelerator
EXAMPLE Examples of spreading devices include a thin metal foil for scattering the ions or a magnet to defocus
the beam or to scan the beam laterally across the intended TARGET VOLUME.
Note 1 to entry: Xg and Yg are defined in IEC 61217:2011.
201.3.218
LIGHT ION
species of ion with an atomic number less than or equal to that of neon (Z ≤ 10) and SPECIFIED
by its number of protons, number of nucleons and ionization state
201.3.219
LIGHT ION BEAM
collection of LIGHT IONS travelling in the same general direction
201.3.220
LIGHT ION BEAM APPLICATOR
device for holding a BEAM LIMITING DEVICE or ACCESSORY close to the PATIENT's skin during
delivery of LIGHT ION BEAM
Note 1 to entry: Several LIGHT ION BEAM APPLICATORS may be available to reduce the weight of APERTURES lifted by
the OPERATOR, decrease the distance from the skin to ACCESSORIES and reduce leakage radiation.
201.3.221
LIGHT ION BEAM DISTRIBUTION SYSTEM
system of components and a control system used to transport the RADIATION from a RADIATION
SOURCE to several TREATMENT stations, experimental stations or beam dumps
EXAMPLE Examples of components include vacuum pipes, magnets, and steering coils.
201.3.222
LIGHT ION RANGE
depth in a PHANTOM most distant from its surface at which the ABSORBED DOSE is a SPECIFIED
ACCOMPANYING DOCUMENTATION, of the dose at the nominal centre-of-
value, given in the
modulation depth or of the dose maximum for a non-range-modulated beam, which is measured
on the RADIATION BEAM AXIS in a SPECIFIED RADIATION FIELD and with the surface of the PHANTOM
at a SPECIFIED distance from the ERP without RANGE SHIFTERS or ACCESSORIES installed in the
RADIATION HEAD downstream of the ENERGY PER NUCLEON or range monitoring system
201.3.223
MODULATED SCANNING
SCANNING MODE wherein a small diameter LIGHT ION BEAM is scanned across a target to create
a field large enough to cover the target such that the intended FLUENCE delivered to the PATIENT
is different at different lateral locations
Note 1 to entry: Various spatial and temporal scanning patterns may be used to generate the modulated FLUENCE
distribution.
201.3.224
NON-PRIMARY RADIATION
RADIATION emitted from the LIGHT ION BEAM ME EQUIPMENT that is not intended to treat the PATIENT
201.3.225
PATIENT POSITIONER
assembly of equipment upon which the PATIENT is placed and positioned for
RADIOTHERAPY ME EQUIPMENT
[SOURCE: IEC 60601-2-1:2020, 201.3.235, modified – Addition of “ME EQUIPMENT”.]
201.3.226
PATIENT POSITIONER TOP
component of the PATIENT POSITIONER to which registration and immobilization devices are
attached and upon which PATIENT is placed
Note 1 to entry: PATIENT POSITIONER TOPS are often exchangeable to hold PATIENTS or equipment in different
orientations, for instance, a flat board or seat.
[SOURCE: IEC 60601-2-1:2020, 201.3.254, modified – Main term “table top” replaced with
“patient positioner top”; beginning of the definition “device attached to the table top support”
replaced with “component of the PATIENT POSITIONER”; Note 1 replaced.]
201.3.227
PORTAL
collection of one or more pre-programmed TREATMENT segments treated automatically with a
single PATIENT set-up
Note 1 to entry: Segments may consist of IRRADIATION, motion of devices, or imaging.
201.3.228
PRE-PROGRAMMED MOVEMENT
movement of ME EQUIPMENT parts that takes place according to a previously planned programme
without intervention by the OPERATOR during a PATIENT treatment or imaging
201.3.229
PRIMARY/SECONDARY DOSE MONITORING COMBINATION
utilization of two DOSE MONITORING SYSTEMS where one is arranged to be the PRIMARY DOSE
MONITORING SYSTEM and the other the SECONDARY DOSE MONITORING SYSTEM
201.3.230
PROGRAMMABLE RANGE MODULATED PORTAL
PRMP
LIGHT ION PORTAL in which a program is used, with or without a RANGE MODULATION DEVICE (RMD),
to tailor the DEPTH DOSE distribution by varying the penetration and weighting factors of several
component segments
Note 1 to entry: Typically the DEPTH DOSE distribution is tailored to give a uniform dose distribution over the depths
where the TARGET VOLUME resides.
201.3.231
QUALITY FACTOR
Q
QUALITY FACTOR at a point in tissue given by:
∞
Q= Q L D dL
( )
∫ L
L=0
D
where D is the ABSORBED DOSE at that point, D is the distribution of D in unrestricted linear
L
energy transfer L at the point of interest, and Q(L) is the QUALITY FACTOR as a function of L
Note 1 to entry: The integration is to be performed over D , due to all charged particles, excluding their secondary
L
electrons.
Note 2 to entry: The QUALITY FACTOR Q at a point in tissue relates the DOSE EQUIVALENT H at that point to the
ABSORBED DOSE D at that point, using the formula: H = Q × D.
[SOURCE: ICRP Publication 116:2010]
201.3.232
RADIATION HEAD
structure from which the RADIATION BEAM emerges
[SOURCE: IEC TR 60788:2004, rm-20-06]
201.3.233
RANGE MODULATION DEVICE
RMD
RADIATION BEAM into a PATIENT to tailor the DEPTH
device used to modulate the penetration of a
DOSE distribution during the delivery of one PORTAL
Note 1 to entry: The device may consist of a propellor shaped material that spins in the beam, a filter containing a
repeating pattern of ridges (e.g. ridge filter, mini-ridge filter, ripple filter), a cone or set of cones, or a set of uniform
thickness blocks programmable in a binary fashion. Sub-types include discrete and programmable.
201.3.234
RANGE SHIFTER
range modifying device that has a constant thickness at all positions lateral to the central axis
of the beam
201.3.235
REDUNDANT DOSE MONITORING COMBINATION
utilization of two DOSE MONITORING SYSTEMS where both systems are arranged to cause
TERMINATION OF IRRADIATION according to the pre-selected number of DOSE MONITOR UNITS
201.3.236
SCANNING MODE
method of delivering a scanned RADIATION BEAM to generate a laterally broad field
Note 1 to entry: Types of SCANNING MODES include: none, UNIFORM SCANNING and MODULATED SCANNING.
201.3.237
SITE TEST
after installation, test of an individual device or ME EQUIPMENT to establish compliance with
SPECIFIED criteria
Note 1 to entry: It is understood that SITE TESTS shall be performed but may or may not be performed by the
MANUFACTURER, per the agreement between the MANUFACTURER and the end USER.
[SOURCE: IEC 60601-2-1:2020, 201.3.253, modified – In Note 1 to entry, replacement of
“responsible organization” with “end user”.]
201.3.238
TECHNICAL DOCUMENTATION
documentation that enables the conformity of the product with the requirements of the
standard(s) to be assessed
[SOURCE: ISO/IEC 80079-34:2018, 3.10, modified – Note 1 to entry to Note 3 to entry are
removed.]
201.3.239
TERMINATION OF IRRADIATION
stopping of IRRADIATION and movements, with no possibility of restarting without returning to the
PREPARATORY STATE
Note 1 to entry: Examples of events that may cause TERMINATION OF IRRADIATION and stop movements include:
− when the pre-selected value of DOSE MONITOR UNITS is reached,
− when the pre-selected value is reached in the termination system independent of the DOSE MONITORING
SYSTEM,
− by a deliberate manual act,
− by the operation of an INTERLOCK, or
− in MODULATED SCANNING, when pre-programmed scanning pattern is completed.
[SOURCE: IEC 60601-2-11:2013, 201.3.225, modified – The wording of both the definition and
Note 1 to entry is slightly different.]
201.3.240
TRANSMISSION DETECTOR
RADIATION DETECTOR through which the LIGHT ION BEAM passes
[SOURCE: IEC 60601-2-1:2020, 201.3.257, modified – The term "RADIATION BEAM" has been
replaced by "LIGHT ION BEAM".]
201.3.241
TYPE TEST
test on a representative sample of the equipment with the objective of determining if the
equipment, as designed and manufactured, can meet the requirements of this document
[SOURCE: IEC 60601-1:2005, 3.135]
201.3.242
UNIFORM SCANNING
SCANNING MODE wherein a RADIATION BEAM is scanned laterally in a pre-defined pattern to
produce a field large enough to treat the target such that the FLUX of the RADIATION BEAM is not
intentionally changed throughout the lateral scan so that the resultant dose distribution within
the field is uniform
Note 1 to entry: The scanning may be accomplished by changing the current in electromagnets through which the
RADIATION BEAM passes or the use of permanent magnets mechanically rotated or translated.
201.3.243
USER
when used in an IEC standard on electromedical EQUIPMENT, organization or individual
responsible for the use and maintenance of the EQUIPMENT
[SOURCE: IEC TR 60788:2004, rm-85-01]
201.4 General requirements
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2011 and IEC 60601-1:2005/AMD2:2020,
Clause 4 applies.
201.5 General requirements for testing ME EQUIPMENT
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2011 and IEC 60601-1:2005/AMD2:2020,
Clause 5 applies, except as follows:
201.5.1 TYPE TESTS
Replacement of the title:
201.5.1 TYPE TESTS and SITE TESTS
Additional subclause:
201.5.1.101 Test grades
Three grades of TYPE TEST and two grades of SITE TEST procedures are SPECIFIED in this
document. Their requirements are as follows:
– TYPE TEST grade A: An analysis of ME EQUIPMENT design, which shall result in a statement
included in the technical description, regarding the working principles or constructional
means by which the requirement is fulfilled.
– TYPE TEST/SITE TEST grade B: Visual inspection or functional test or measurement of the ME
EQUIPMENT. The test shall be in accordance with the procedure SPECIFIED in this document
and shall be based on operating states, including fault condition states, which are
achievable only without interference with the circuitry or construction of the ME EQUIPMENT.
– TYPE TEST/SITE TEST grade C: Functional test or measurement of the ME EQUIPMENT. The test
shall be in accordance with the principle SPECIFIED in this document. The SITE TEST
procedure shall be included in the technical description. When the procedure involves
operating states that require interference with circuitry or the construction of the ME
EQUIPMENT, the test should be performed by, or under the direct supervision of, the
MANUFACTURER or his agent.
It is understood that SITE TESTS shall be performed but may or may not be performed by the
MANUFACTURER, per the agreement between the MANUFACTURER and end USER.
201.5.4 Other conditions
Replacement:
The MANUFACTURER shall state in the ACCOMPANYING DOCUMENTATION any additional
requirements for testing.
201.5.5 Supply voltages, type of current, nature of supply, frequency
Replacement of clause a):
a) Where test results are influenced by deviations of the characteristics of the SUPPLY MAINS
from their RATED values, the effect of such deviations is taken into account.
The values used during testing are according to 4.10.2 or according to that marked on the
LIGHT ION BEAM ME EQUIPMENT (see 7.2.6), whichever is least favorable, unless it can be
demonstrated by risk management that for PERMANENTLY INSTALLED ION BEAM ME EQUIPMENT
protective measure(s) are in place to avoid possible deviations of the characteristics of the
SUPPLY MAINS from their RATED values that could have an impact on BASIC SAFETY or
ESSENTIAL PERFORMANCE.
The conditions for testing shall be disclosed in the ACCOMPANYING DOCUMENTATION and the
analysis of the implemented protective measure(s) shall be included in the TECHNICAL
DOCUMENTATION.
NOTE Protective measures that avoid deviations of the characteristics of the SUPPLY MAINS include:
uninterruptible power systems, line monitoring devices, etc.
201.5.7 Humidity preconditioning treatment
Replacement of first paragraph:
Prior to the tests of 8.7.4 and 8.8.3, all LIGHT ION BEAM ME EQUIPMENT or its parts shall be
subjected to a humidity preconditioning treatment except for those that are to be used only in
controlled environments, as specified in the ACCOMPANYING DOCUMENTATION.
Addition:
LIGHT ION BEAM ME EQUIPMENT or its parts that are to be used only in controlled environments,
For
the ACCOMPANYING DOCUMENTATION shall specify the duration for which the room environmental
operating conditions shall be maintained prior to powering the system on.
Compliance is checked by inspection of the ACCOMPAN
...