SIST EN IEC 60601-2-64:2026

SLOVENSKI STANDARD
01-marec-2026
Nadomešča:
SIST EN 60601-2-64:2015
Medicinska električna oprema - 2-64. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti medicinske opreme za lahkoionsko terapijo (IEC 60601-2-
64:2025)
Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and
essential performance of light ion beam medical electrical equipment (IEC 60601-2-
64:2025)
Medizinische elektrische Geräte - Teil 2-64: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Leichtionen-
Bestrahlungseinrichtungen (IEC 60601-2-64:2025)
Appareils électromédicaux - Partie 2-64: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils électromédicaux par faisceau d'ions
légers (IEC 60601-2-64:2025)
Ta slovenski standard je istoveten z: EN IEC 60601-2-64:2026
ICS:
11.040.60 Terapevtska oprema Therapy equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 60601-2-64

NORME EUROPÉENNE
EUROPÄISCHE NORM January 2026
ICS 11.040.60 Supersedes EN 60601-2-64:2015
English Version
Medical electrical equipment - Part 2-64: Particular requirements
for the basic safety and essential performance of light ion beam
medical electrical equipment
(IEC 60601-2-64:2025)
Appareils électromédicaux - Partie 2-64: Exigences Medizinische elektrische Geräte - Teil 2-64: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils électromédicaux par faisceau wesentlichen Leistungsmerkmale von Leichtionen-
d'ions légers Bestrahlungseinrichtungen
(IEC 60601-2-64:2025) (IEC 60601-2-64:2025)
This European Standard was approved by CENELEC on 2026-01-09. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-64:2026 E

European foreword
The text of document 62C/954/FDIS, future edition 2 of IEC 60601-2-64, prepared by SC 62C
"Equipment for radiotherapy, nuclear medicine and radiation dosimetry" of IEC/TC 62 "Medical
equipment, software, and systems" was submitted to the IEC-CENELEC parallel vote and approved
by CENELEC as EN IEC 60601-2-64:2026.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2027-01-31
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2029-01-31
document have to be withdrawn
This document supersedes EN 60601-2-64:2015 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
This document is read in conjunction with EN 60601-1:2006 and all of its amendments and corrigenda.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-2-64:2025 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standard indicated:
IEC 60601-1-9 NOTE Approved as EN 60601-1-9
IEC 60601-1-10 NOTE Approved as EN 60601-1-10
IEC 62667:2017 NOTE Approved as EN IEC 62667:2018 (not modified)
IEC 60601-2-11:2013 NOTE Approved as EN 60601-2-11:2015 (not modified)
ISO/IEC 80079-34:2018 NOTE Approved as EN ISO/IEC 80079-34:2020 (not modified)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1  Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cencenelec.eu.
Annex ZA of EN 60601-1:2006 and all of its amendments and corrigenda applies, except as follows:
Addition:
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + corrigendum Mar. 2010
+ A1 2012 + A1 2013
- - + A12 2014
+ A2 2020 + A2 2021
- - + A13 2024
IEC 60601-2-1 2020 Medical electrical equipment - Part 2-1: EN IEC 60601-2-1 2021
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 Electrical medical equipment - Part 2-68: EN 60601-2-68 2015
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, EN 61217 2012
movements and scales
CISPR 11 - Industrial, scientific and medical equipment EN IEC 55011 -
- Radio-frequency disturbance
characteristics - Limits and methods of
measurement
IEC 60601-2-64 ®
Edition 2.0 2025-12
INTERNATIONAL
STANDARD
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 978-2-8327-0866-8

IEC 60601-2-64:2025-12(en)
IEC 60601-2-64:2025 © IEC 2025
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

IEC 60601-2-64:2025 © IEC 2025
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,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) 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
may be required to implement this document. However, implementers are cautioned that this may not represent
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.
IEC 60601-2-64:2025 © IEC 2025
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.
IEC 60601-2-64:2025 © IEC 2025
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.
IEC 60601-2-64:2025 © IEC 2025
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.

IEC 60601-2-64:2025 © IEC 2025
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.
IEC 60601-2-64:2025 © IEC 2025
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.
IEC 60601-2-64:2025 © IEC 2025
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.
IEC 60601-2-64:2025 © IEC 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
IEC 60601-2-64:2025 © IEC 2025
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]
IEC 60601-2-64:2025 © IEC 2025
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
IEC 60601-2-64:2025 © IEC 2025
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.
IEC 60601-2-64:2025 © IEC 2025
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”.]
IEC 60601-2-64:2025 © IEC 2025
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]
IEC 60601-2-64:2025 © IEC 2025
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
...