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 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.
IEC 60601-2-64:2025 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.

Appareils électromédicaux - Partie 2-64: Exigences particulières pour la sécurité de base et les performances essentielles des appareils électromédicaux par faisceau d'ions légers

L'IEC 60601-2-64:2025 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.
L'IEC 60601-2-64:2025 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.

General Information

• Status: Published
• Publication Date: 04-Dec-2025
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: SC 62C - Equipment for radiotherapy, nuclear medicine and radiation dosimetry
• Drafting Committee: WG 1 - TC 62/SC 62C/WG 1
• Current Stage: PPUB - Publication issued
• Start Date: 05-Dec-2025
• Completion Date: 05-Dec-2025

Relations

• Revises: IEC 60601-2-64:2014 - Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
• Effective Date: 05-Sep-2023

Overview

IEC 60601-2-64:2025 - "Medical electrical equipment - Part 2-64" - defines the basic safety and essential performance requirements for light ion beam medical electrical equipment used in human radiotherapy. This second edition (2025) replaces the 2014 edition and is a technical revision harmonized with recent updates to the IEC 60601‑1 series and IEC 62667. The standard applies to ME equipment and ME systems that, in normal use, deliver light-ion radiation beams with energy per nucleon from 10 MeV/n to 500 MeV/n, and it covers both manufacturer (type tests) and installation (site tests) responsibilities.

Key topics and technical requirements

• Scope and applicability
  • Covers devices intended for clinical radiotherapy operated by licensed or qualified personnel and maintained by qualified persons.
• Safety and essential performance
  • Requirements derived from IEC 60601‑1 general clauses, adapted for light ion beam hazards and system complexities.
• Type tests and site tests
  • Distinguishes tests performed by manufacturers (type tests) and those required at installation (site tests) with associated documentation and reporting.
• Programmable Electronic Subsystems (PESS)
  • Addresses automated control and display of operating parameters, including requirements for PESS used in clinical control and safety functions.
• Radiation protection and interlocks
  • Specifies limits and protective measures for unwanted or excessive radiation; Clause 201.10 defines conditions where interlocks must interrupt or terminate irradiation to preserve essential performance.
• Neutron considerations
  • Includes revised guidance on neutrons outside the treatment field (technical change from the previous edition).
• Labeling, documentation and usability
  • Identification, markings, movement designations (per IEC 61217 guidance), and instructions for use to support safe operation and clinical workflows.
• Quality assurance
  • Equipment is required to be subject to regular QA performance and calibration checks by qualified personnel.

Practical applications - who uses this standard

• Medical device manufacturers - to design, test, and certify light ion beam therapy systems for compliance.
• Clinical engineers and medical physicists - for commissioning, site testing, QA, and calibration protocols.
• Hospital procurement and radiation safety officers - to evaluate equipment safety and installation requirements.
• Regulators and notified bodies - for conformity assessment and approval of radiotherapy ME equipment.
• System integrators and installers - to perform and document required site tests and safety interlocks.

Related standards

• IEC 60601‑1:2005 and amendments (general requirements for basic safety and essential performance)
• IEC 62667:2017 (terminology and test/reporting formats for light ion beam equipment)
• IEC 61217 (guidance on equipment movements and marking)
• IEC 60601‑2‑68 (x‑ray image guidance - under development)

This standard is essential reading for stakeholders responsible for the safe design, installation, operation and regulatory compliance of light ion beam radiotherapy systems.

Standards Content (Sample)

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
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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)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
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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.
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.
–
...