SIST EN IEC 62083:2026

SLOVENSKI STANDARD
01-april-2026
Nadomešča:
SIST EN 62083:2010
Programska oprema za medicinske aparate - Zahteve za varnost sistemov za
načrtovanje radioterapevtske obravnave (IEC 62083:2025)
Medical device software - Requirements for the safety of radiotherapy treatment planning
systems (IEC 62083:2025)
Medizinische elektrische Geräte - Festlegungen für die Sicherheit von
Bestrahlungsplanungssystemen (IEC 62083:2025)
Appareils électromédicaux - Exigences de sécurité pour les systèmes de planification de
traitement en radiothérapie (IEC 62083:2025)
Ta slovenski standard je istoveten z: EN IEC 62083:2026
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 62083

NORME EUROPÉENNE
EUROPÄISCHE NORM February 2026
ICS 11.040.60 Supersedes EN 62083:2009
English Version
Medical device software - Requirements for the safety of
radiotherapy treatment planning systems
(IEC 62083:2025)
Logiciels de dispositifs médicaux - Exigences de sécurité Medizinische elektrische Geräte - Festlegungen für die
pour les systèmes de planification de traitement en Sicherheit von Bestrahlungsplanungssystemen
radiothérapie (IEC 62083:2025)
(IEC 62083:2025)
This European Standard was approved by CENELEC on 2026-01-13. 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 62083:2026 E
European foreword
The text of document 62C/957/FDIS, future edition 3 of IEC 62083, 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 62083:2026.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2027-02-28
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2029-02-28
document have to be withdrawn
This document supersedes EN 62083:2009 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 has been prepared under a standardization request addressed to CENELEC by the
European Commission. The Standing Committee of the EFTA States subsequently approves these
requests for its Member States.
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 62083:2025 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 60601-1:2005 NOTE Approved as EN 60601-1:2006 (not modified) +A11:2011
IEC 61217:2011 NOTE Approved as EN 61217:2012 (not modified)
IEC 62304:2006 NOTE Approved as EN 62304:2006 (not modified)
IEC 62304:2006/A1:2015 NOTE Approved as EN 62304:2006/A1:2015 (not modified)
IEC 60601-2-8:2010 NOTE Approved as EN 60601-2-8:2015 (not modified)
IEC 60601-2-8:2010/A1:2015 NOTE Approved as EN 60601-2-8:2015/A1:2016 (not modified)
ISO 13485:2016 NOTE Approved as EN ISO 13485:2016 (not modified) +A11:2021
ISO 27789:2021 NOTE Approved as EN ISO 27789:2021 (not modified)
IEC 62366-1:2015/A1:2020 NOTE Approved as EN 62366-1:2015/A1:2020 (not modified)
IEC 60601-2-1:2020 NOTE Approved as EN IEC 60601-2-1:2021 (not modified)
IEC 60601-2-17:2013 NOTE Approved as EN 60601-2-17:2015 (not modified)
IEC 60601-2-68:2025 NOTE Approved as EN IEC 60601-2-68:2025 (not modified)
Approved as EN 60601-2-44:2009 (not modified)
IEC 60601-2-44:2009 NOTE
+A11:2011
IEC 62676-1-1:2013 NOTE Approved as EN 62676-1-1:2014 (not modified)
IEC 60601-2-64:2014 NOTE Approved as EN 60601-2-64:2015 (not modified)
ISO 13485 NOTE Approved as EN ISO 13485
ISO 14971:2019 NOTE Approved as EN ISO 14971:2019 (not modified) +A11:2021
IEC 61157:2007 NOTE Approved as EN 61157:2007 (not modified)
IEC 60601-2-11:2013 NOTE Approved as EN 60601-2-11:2015 (not modified)
IEC 60601-1-3:2008 NOTE Approved as EN 60601-1-3:2008 (not modified) +A11:2016
IEC 62304 NOTE Approved as EN 62304
IEC 81001-5-1:2021 NOTE Approved as EN IEC 81001-5-1:2022 (not modified)
IEC 62366-1:2015 NOTE Approved as EN 62366-1:2015 (not modified)
IEC 60601-2 (series) NOTE Approved as EN 60601-2-8:2015/A1 (series)
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.
Publication Year Title EN/HD Year
ISO 80000-1 2022 Quantities and units - Part 1: General EN ISO 80000-1 2022
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
- - + A1:2013/AC 2014
- - + A12 2014
+ A2 2020 + A2 2021
- - + AC 2022-12
- - + A13 2024
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 62083 ®
Edition 3.0 2025-12
INTERNATIONAL
STANDARD
Medical device software - Requirements for the safety of radiotherapy treatment
planning systems
ICS 11.040.60  ISBN 978-2-8327-0914-6

IEC 62083:2025-12(en)
IEC 62083:2025 © IEC 2025
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 8
4 General . 20
4.1 Quality, security, and risk management . 20
4.2 Test grades . 20
4.3 Compliance . 21
4.4 Testing the radiotherapy treatment planning system installation. 21
5 Accompanying documentation . 22
5.1 General . 22
5.2 Instructions for use . 23
6 General requirements for operational safety . 23
6.1 Distances and linear and angular dimensions . 23
6.2 Coordinate systems, movements, and scales (see Clause A.2) . 24
6.3 Radiation quantities . 25
6.4 Date and time format. 25
6.5 Security . 26
6.5.1 Protection against unauthorized use . 26
6.5.2 Data backup and recovery . 26
6.5.3 Protection against unauthorized activities . 27
6.5.4 Change in software versions . 27
6.5.5 Installation of radiotherapy treatment planning system . 28
6.6 Data limits . 28
6.7 Patient identification . 29
6.8 Interfaces . 29
6.8.1 Correctness of data transfer . 29
6.8.2 Data input to the radiotherapy treatment planning system . 30
6.8.3 Data output from the radiotherapy treatment planning system . 31
7 Approvals and modifications . 31
7.1 Approving an item . 31
7.2 Modifying an approved item . 31
7.3 Deletion of an approved item . 32
7.4 History of an approved item . 32
8 Algorithms . 32
8.1 Algorithms affecting clinical decisions . 32
8.2 Absorbed dose calculation . 33
8.2.1 Accuracy . 33
8.2.2 Absorbed dose calculation algorithm input data . 33
8.2.3 Patient specific beam modifying devices calculation . 34
8.2.4 Elapsed time calculations in brachytherapy. 35
8.2.5 Imaging dose calculation . 35
8.3 Radiobiological effect . 35
9 Modelling . 36
9.1 Equipment modelling . 36
IEC 62083:2025 © IEC 2025
9.1.1 General equipment modelling . 36
9.1.2 Equipment model approval . 37
9.1.3 Radiation modelling. 37
9.1.4 Preconfigured model . 39
9.1.5 External beam equipment . 40
9.1.6 Imaging equipment . 41
9.1.7 Immobilization and supporting devices modelling . 42
9.1.8 Patient specific beam modifying devices modelling . 42
9.2 Patient modelling . 42
9.2.1 General patient modelling . 42
9.2.2 Patient model identification . 43
9.2.3 Regions of interest . 43
9.2.4 Image registration . 43
9.2.5 Patient model approval . 43
9.3 Radiobiological effect modelling . 44
9.3.1 General radiobiological effect modelling . 44
9.3.2 Radiobiological effect model approval . 44
10 Radiation treatment prescription . 44
10.1 Display of radiation treatment prescription . 44
10.2 Change of radiation treatment prescription . 45
10.3 Radiation treatment prescription approval . 45
11 Treatment planning . 45
11.1 Display of radiation treatment prescription . 45
11.2 Treatment plan limits. 45
11.3 Patient orientation . 45
11.4 Summation of absorbed dose distributions . 46
11.5 Evaluation of absorbed dose distribution . 46
11.6 Treatment plan identification . 46
11.7 Treatment plan approval . 47
12 Quality assurance plan . 47
13 Treatment plan record . 47
13.1 Treatment plan record parameters . 47
13.2 Treatment plan record parameters for external beam equipment . 48
13.3 Treatment plan record parameters for brachytherapy . 49
14 Treatment plan report. 49
14.1 Treatment plan report information . 49
14.2 Treatment plan report for external beam equipment. 50
14.3 Treatment plan report for brachytherapy . 50
14.4 Treatment plan report for a treatment plan with unapproved models . 50
15 Treatment plan export . 50
15.1 Treatment plan export parameters . 50
15.2 Treatment plan export parameters for external beam equipment . 51
15.3 Treatment plan export parameters for brachytherapy . 51
16 Adaptive radiotherapy . 52
16.1 Treatment plans correlations . 52
16.2 Offline adaptive radiotherapy . 52
16.3 Online adaptive radiotherapy . 52
16.4 Real-time adaptive radiotherapy . 53
IEC 62083:2025 © IEC 2025
Annex A (informative) Particular guidance and rationale . 54
A.1 Imported and exported data . 54
A.2 Coordinate systems, movements, and scales . 54
Bibliography . 55

Figure 1 – Afterloading equipment geometry parameters . 39

Table 1 – Clauses and subclauses in this document that require the provision of
information in the accompanying documentation, instruction for use and the technical
description . 22

IEC 62083:2025 © IEC 2025
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
Medical device software - Requirements for the safety of radiotherapy
treatment planning systems
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 62083:2025 © IEC 2025
IEC 62083 has been prepared by IEC 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 third edition cancels and replaces the second edition published in 2009. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
– modification of the title from Medical electrical system - Requirements for the safety of
radiotherapy treatment planning systems, to Medical device software - Requirements for the
safety of radiotherapy treatment planning systems;
– adaptive radiotherapy is added in Clause 16;
– the title reflects different implementations of radiotherapy treatment planning systems.
The text of this document is based on the following documents:
FDIS Report on voting
62C/957/FDIS 62C/966/RVD
Full information on the voting for the approval of this standard 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.
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 62083:2025 © IEC 2025
INTRODUCTION
A radiotherapy treatment planning system is used to simulate the application of radiation to a
patient. An important function of radiotherapy treatment planning system is to provide estimates
of absorbed dose distributions in tissue using a particular algorithm or series of algorithms.
These estimations, referred in this document as absorbed dose distributions, are used by a
qualified person in planning a radiotherapy treatment course.
This document recognizes that modern radiotherapy treatment planning system use off-the-
shelf hardware with manufacturer written software and therefore concerns itself with the safety
of radiotherapy treatment planning software that is type tested against the hardware
configurations specified by the manufacturer. It is this combination of software and hardware
that is referred to as the radiotherapy treatment planning system in this document.
The output of a radiotherapy treatment planning system is used by appropriately qualified
persons for clinical decisions and for treatment delivery. Inaccuracies in the input data, the
limitations of the algorithms, errors in the treatment planning process, or improper use of output
data, can represent a safety hazard to patients should the resulting output data be used for
treatment purposes. This document defines requirements to be compliant with by manufacturers
in the design and development of a radiotherapy treatment planning system in order to provide
protection against the occurrence of such hazards. It establishes the minimum requirements for
the contents of the accompanying documentation that will permit the operator to make informed
choices during the treatment planning process.
Generally, a radiotherapy treatment planning system does not have direct interface to the
patients. Consequently, this document is written in an independent format rather than as a
particular standard to IEC 60601-1:2005.
This document introduces the concept of ensuring consistency of machine calibration (MU/Dose
conversion) between the radiotherapy treatment planning system and the delivery systems.
Where a medical electrical equipment has the capability, a check of the consistency of the
machine calibration can be performed prior to any treatment delivery to ensure a match between
the plan and medical electrical equipment settings for reference conditions.
IEC 61217:2011 defines coordinate systems and movements, the marking of scales, their zero
position, and the direction of movement with increasing value. While the provided coordinate
system and movements defined in IEC 61217:2011 is the preferred coordinate system, it was
deemed more of a safety risk to force this coordinate system for use with equipment that was
not IEC compliant. Hence the requirement that coordinates will be in the delivery machine’s
coordinate system.
IEC TR 63183:2019 provides guidelines on error and warning messages for software used in
radiotherapy.
This third edition of this document considers many aspects of technology used by healthcare
organizations. Clause 16 has been designed to facilitate current practice between radiotherapy
treatment medical electrical equipment, image guided radiotherapy medical electrical
equipment, radiotherapy treatment planning systems, and Radiotherapy Treatment
Management Systems. To pursue compatibility, the equipment standards for this equipment are
being developed in parallel as much as possible to facilitate workflow communication.
In the case of online adaptive radiotherapy and real-time adaptive radiotherapy, Clause 16
should be used in conjunction with other particular standards of the IEC 60601-2.
Type tests that are performed by the manufacturer, or site tests that are not necessarily
performed by the manufacturer, are specified for each requirement. It is understood that site
tests can be required from the manufacturer, per the agreement between the manufacturer and
the responsible organization.
IEC 62083:2025 © IEC 2025
Given that before installation a manufacturer cannot provide site test data, data collected during
site tests can be provided in a site test report with the accompanying documentation by those
who test the radiotherapy treatment planning system at installation.
Further reading:
IEC 62304:2006, Medical device software - Software life cycle processes [4]
IEC 62304:2006/AMD1:2015, Amendment 1 - Medical device software - Software life cycle
processes [5]
IEC 60601-2-8:2010, Medical electrical equipment – Part 2-8: Particular requirements for basic
safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV
to 1 MV [6]
IEC 60601-2-8:2010/AMD1:2015 [7]
ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory
purposes [8]
ISO 27789:2021, Health informatics - Audit trails for electronic health records [9]
ICRU Report 29:1978, Dose Specification for Reporting External Beam Therapy with Photons
and Electrons [10]
ICRU Report 42:1987, Use of Computers in External Beam Radiotherapy Procedures with High
Energy Photons and Electrons [11]
ICRU Report 50:1993, Prescribing, Recording and Reporting Photon Beam Therapy [12]
ICRU Report 62:1999, Prescribing, Recording and Reporting Photon Beam Therapy
(Supplement to ICRU Report 50) [13]
ICRU Report 71:2004, Prescribing, Recording and Reporting Electron Beam Therapy [14]
ICRU Report 78:2007, Prescribing, Recording and Reporting Proton-Beam Therapy [15]
ICRU Report 83:2010, Prescribing, Recording, and Reporting Photon-Beam Intensity -
Modulated Radiation Therapy (IMRT) [16]
ICRU Report 85:2013, Fundamental Quantities and Units for Ionizing Radiation [17]
ICRU Report 91:2014, Prescribing, Recording, and Reporting of Stereotactic Treatments with
Small Photon Beams [18]
ICRU Report 89:2016, Prescribing, Recording, and Reporting Brachytherapy for Cancer of the
Cervix [19]
ICRU Report 93:2016, Prescribing, Recording, and Reporting Light Ion Beam Therapy [20]
Dosimetry of interstitial brachytherapy sources: Recommendations of the AAPM Radiation
Therapy Committee Task Group No. 43Med. Phys., 1995, 22, p. 209-234 [21]
Technical Reports Series No. 430, Commissioning and Quality Assurance of Computerized
Planning Systems for Radiation Treatment of Cancer, International Atomic Energy Agency,
Vienna, 2004 [22]
IMRT Commissioning Tests Instructions for Planning, Measurement, and Analysis, AAPM Task
Group 119, Version 10/21/2009 [23]
IEC 62083:2025 © IEC 2025
1 Scope
This document, with the inclusion of type tests and site tests, applies to the design,
manufacture, installation, and maintenance of the radiotherapy treatment planning system.
This document applies to the communication of the radiotherapy treatment planning system
with other devices
– used in medical practice,
– that imports data either through input by the operator or from other devices,
– that outputs data to other devices, and
– that is intended to be
• for normal use, under the authority of appropriately qualified persons, by operators
having the required skills and training,
• used and maintained in accordance with the recommendations given in the instructions
for use, and
• used within the environmental conditions specified in the technical description.
This document applies to any software application that is used for the development, evaluation,
or approval of a treatment plan, whether stand-alone or part of another system.
NOTE Such software applications include prescribing systems, image registration, contouring systems, quality
assurance systems, plan analysis systems, or plan review systems.
2 Normative references
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.
ISO 80000-1:2022, Quantities and units - Part 1: General
IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012, Amendment 1 - Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
IEC 60601-1:2005/AMD2:2020, Amendment 2 - Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
IEC TR 60788:2004, Medical electrical equipment - Glossary of defined terms
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, IEC 60601-1:2005/AMD2:2020, IEC TR 60788:2004 and the
following apply.
ISO and IEC maintain terminology databases for use in standardization at the following
addresses:
– IEC Electropedia: available at https://www.electropedia.org/
– ISO Online browsing platform: available at https://www.iso.org/obp
IEC 62083:2025 © IEC 2025
3.1
absorbed dose
D
mean energy imparted by ionizing radiation to matter
Note 1 to entry: Absorbed dose is determined as the quotient of 𝑑𝑑𝜀𝜀 by dm, where 𝑑𝑑𝜀𝜀 is the mean energy imparted
by ionizing radiation to matter of mass dm:
𝑑𝑑𝜀𝜀
𝐷𝐷=
d𝑚𝑚
-1
The unit of absorbed dose is the joule per kilogram (J.kg ). The special name of the unit of absorbed dose is the
-2 -1.
gray (Gy). The earlier unit of absorbed dose was the rad, 1 rad being equal to 10 J.kg
[SOURCE: IEC TR 60788:2004, rm-13-08, modified - Second and third sentences converted to
a Note 1 to entry.]
3.2
absorbed dose rate
˙
𝐷𝐷
absorbed dose per unit time
Note 1 to entry: Absorbed dose rate is determined as the quotient of dD by dt, where dD is the increment of
absorbed dose in the time interval dt:
˙
𝑑𝑑𝐷𝐷
𝐷𝐷 =
𝑑𝑑𝑑𝑑
A unit of absorbed dose rate is any quotient of the gray or its multiples or submultiples by a suitable unit of time
-1 -1
(Gy⋅s , mGy⋅h , etc.)
[SOURCE: IEC TR 60788:2004, rm-13-09, modified - Second sentence converted as a Note 1
to entry.]
3.3
accessory
additional part for use with equipment in order to:
– achieve the intended use,
– adapt it to some special use,
– facilitate its use,
– enhance its performance, or
– enable its functions to be integrated with those of other equipment
[SOURCE: IEC 60601-1:2005, 3.3]
3.4
accompanying documentation
materials accompanying a medical device and containing information for the user or those
accountable for the installation, use, maintenance, decommissioning and disposal of the
medical device, particularly regarding safe use
Note 1 to entry: The accompanying documentation can consist of the instructions for use, technical description,
installation manual, quick reference guide, etc.
Note 2 to entry: Accompanying documentation is not necessarily a written or printed document but could involve
auditory, visual, or tactile materials and multiple media types.
Note 3 to entry: Medical devices that can be used safely without instructions for use are exempted from having
instructions for use by some authorities with jurisdiction.
[SOURCE: IEC 62366-1:2015/AMD1:2020, 3.2]
IEC 62083:2025 © IEC 2025
3.5
action level
threshold value beyond which action is taken
3.6
adaptive radiotherapy
radiotherapy that monitors patient anatomy or physiology and, based upon the monitored
information, allows changes to treatment parameters throughout the course of treatment
Note 1 to entry: Image guided radiotherapy (IGRT) is one form of adaptive radiotherapy.
[SOURCE: IEC 60601-2-1:2020, 201.3.201, modified - In Note 1 to entry, replacement of
"radiation therapy" with "radiotherapy".]
3.7
afterloading
automatically-controlled transfer of one or more sealed radioactive sources or X-ray sources
between a storage container or, in the case of X-ray sources, a reference position, and pre-
positioned source applicators for brachytherapy
[SOURCE: IEC 60601-2-17:2013, 201.3.201]
3.8
archive
removed data from its original storage location placed in a separate storage location from which
the data can be retrieved for subsequent use
3.9
brachytherapy
intracavitary, interstitial or superficial radiotherapy using one or more sealed radioactive
sources
[SOURCE: IEC TR 60788:2004, rm-42-52, modified - The original term "brachyradiotherapy"
was converted to "brachytherapy".]
3.10
brachytherapy source model
physical, geometric and radiation parameters required to plan a course of radiotherapy for a
particular brachytherapy radioactive source
3.11
commissioning
process of configuring and validating a radiotherapy
treatment planning system for clinical use by determining the operating characteristics and
limitations of the radiotherapy treatment planning system, collecting and installing facility
specific data, and, if necessary, instructing personnel
3.12
computed tomography
CT
reconstructive tomography in which recording and processing is effected by a computing system
[SOURCE: IEC TR 60788:2004, rm-41-20]

IEC 62083:2025 © IEC 2025
3.13
cone beam computed tomography
CBCT
computed tomography performed using a cone beam of X-radiation
[SOURCE: IEC 60601-2-68:2025, 201.3.203]
3.14
CT scanner
X-ray equipment intended to generate cross-sectional images of the body by computer
reconstruction of X-ray transmission data obtained at different angles, which may include signal
analysis and display equipment, patient support, support parts and accessories
[SOURCE: IEC 60601-2-44:2009, 201.3.201, modified - Notes removed.]
3.15
data backup
process of copying data to enable the recovery of the original recording in the event that the
original recording is lost or damaged
[SOURCE: IEC 62676-1-1:2013, 3.1.36]
3.16
display
visual presentation of information
[SOURCE: IEC TR 60788:2004, rm-84-01]
3.17
dose monitor unit
in a dose monitoring system, arbitrary unit in which a quantity is displayed and from which
absorbed dose can be calculated
[SOURCE: IEC TR 60788:2004, rm-13-26]
3.18
electron beam applicator
device that, on its own or in combination with an interchangeable aperture, is a beam limiting
device for electron radiation beams
[SOURCE: IEC 60601-2-1:2020, 201.3.213]
3.19
equipment model
representation of physical, geometric, and radiation parameters for any particular equipment
required to plan a course of radiotherapy
3.20
equipment reference point
EPR
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.
IEC 62083:2025 © IEC 2025
[SOURCE: IEC 60601-2-64:2014, 201.3.212]
3.21
export
electronic data transfer out of the system
3.22
external beam equipment
EBE
external radiation equipment utilizing electron accelerators, light ion beam medical electrical
equipment or radionuclide beam therapy equipment
[SOURCE: IEC 60601-2-68:2025, 201.3.208]
3.23
external monitoring device
device that can be connected to medical electrical equipment and monitors patient anatomy or
physiology
[SOURCE: IEC 60601-2-1:2020, 201.3.220]
3.24
gamma beam therapy equipment
radionuclide beam therapy equipment, in which the radionuclide is a gamma emitter
[SOURCE: IEC TR 60788:2004, rm-24-01, modified - The original term "radionuclide beam
therapy equipment" was replaced with "gamma beam therapy equipment".]
3.25
gantry
part of the medical electrical equipment supporting the radiation head
Note 1 to entry: The gantry is any mechanical device that supports the radiation head regardless of movement
limitations.
[SOURCE: IEC 60601-2-1:2020, 201.3.222]
3.26
hazard
potential source of harm
[SOURCE: IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020, 3.39]
3.27
image guided radiotherapy
IGRT
radiotherapy process by which the location of a radiotherapy beam relative to the intended
target volume within a patient’s anatomy is determined by imaging of the target volume and
surrounding anatomical structures at the time of treatment, so as to enable any necessary
positional corrections to the intended relative location of beam to target volume
Note 1 to entry: The time period of "at the time of treatment" is specified in the definitions of offline IGRT, online
IGRT and real-time IGRT.
[SOURCE: IEC 60601-2-68:2025, 201.3.211]
IEC 62083:2025 © IEC 2025
3.28
image registration
method for mapping or registering corresponding points from one image data set to another
Note 1 to entry: Image registration can be rigid or deformable.
[SOURCE: IEC 60601-2-68:2025, 201.3.214]
3.29
import
electronic data transfer into the system
3.30
instructions for use
those parts of accompanying documents giving the necessary information for safe and proper
use and operation of the equipment
[SOURCE: IEC TR 60788:2004, rm-82-02]
3.31
irradiation
exposing of a living being or matter to radiation
Note 1 to entry: In radiology, exposing of a living being or matter to ionizing radiation.
Note 2 to entry: Examples of ionizing radiation include: X-rays, gamma-rays, electrons, neutrons, and light ions.
[SOURCE: IEC TR 62926:2019, 3.7]
3.32
irradiation time
duration of an irradiation determined according to specific methods, usually the time a rate of
a radiation quantity exceeds a specified level
[SOURCE: IEC TR 60788:2004, rm-36-11]
3.33
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
[SOURCE: IEC 60601-2-64:2014, 201.3.218]
3.34
manufacturer
natural or legal person with responsibility for the design, manufacture, packaging, or labelling
of medical electrical equipment, assembling an medical electrical system, or adapting medical
electrical equipment or an medical electrical system, regardless of whether these operations
are performed by that person himself or on his behalf by another person(s)
Note 1 to entry: ISO 13485 defines "labelling" as "label, instructions for use, and any other information that is
rel
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