FprEN IEC 62083:2025

SLOVENSKI STANDARD
oSIST prEN IEC 62083:2024
01-oktober-2024
Programska oprema za medicinske aparate - Zahteve za varnost sistemov za
načrtovanje radioterapevtske obravnave
Medical device software - Requirements for the safety of radiotherapy treatment planning
systems
Medizinische elektrische Geräte - Festlegungen für die Sicherheit von
Bestrahlungsplanungssystemen
Appareils électromédicaux - Exigences de sécurité pour les systèmes de planification de
traitement en radiothérapie
Ta slovenski standard je istoveten z: prEN IEC 62083:2024
ICS:
11.040.60 Terapevtska oprema Therapy equipment
oSIST prEN IEC 62083:2024 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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CONTENTS
FOREWORD . 4
INTRODUCTION. 6
1 Scope . 8
2 Normative references. 8
3 Terms and definitions . 9
3.1 Terms defined in this document. 10
3.2 Terms defined in other documents . 13
4 General. 20
4.1 Quality and security risk management . 20
4.2 Test grades. 21
4.3 Compliance . 21
4.4 Testing the radiotherapy treatment planning system (RTPS) installation. 21
5 Accompanying documentation . 22
5.1 General. 22
5.2 Instructions for use . 23
6 General requirements for operational safety. 24
6.1 Distances and linear and angular dimensions . 24
6.2 *Coordinate systems, movements, and scales . 24
6.3 Radiation quantities. 25
6.4 Date and time format. 26
6.5 Security . 26
6.5.1 Protection against unauthorized use. 26
6.5.2 Data backup and recovery . 27
6.5.3 Protection against unauthorized activities. 27
6.5.4 Change in software versions. 28
6.6 Data limits. 29
6.7 Patient identification . 29
6.8 Interfaces. 30
6.8.1 Correctness of data transfer. 30
6.8.2 Data input to the radiotherapy treatment planning system (RTPS). 31
6.8.3 Data output from the radiotherapy treatment planning system (RTPS) . 31
7 Approvals and modifications . 32
7.1 Approving an item . 32
7.2 Modifying an approved item . 32
7.3 Deletion of an approved item . 33
7.4 History of an approved item . 33

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8 Algorithms . 33
8.1 Algorithms affecting clinical decisions with unverifiable results . 33
8.2 Absorbed dose Calculation . 34
8.2.1 Accuracy. 34
8.2.2 absorbed dose calculation algorithm input data. 35
8.2.3 patientspecific beam modifying devices calculation. 36
8.2.4 Elapsed time calculations in brachytherapy . 36
8.2.5 Imaging dose calculation. 37
8.3 Radiobiological effect . 37
9 Modelling . 38
9.1 Equipment modelling. 38
9.1.1 General equipment modelling . 38
9.1.2 Equipment model approval. 38
9.1.3 Radiation modelling. 39
9.1.4 Preconfigured model . 42
9.1.5 external beam equipment (EBE) . 43
9.1.6 Imaging equipment modelling . 44
9.1.7 Immobilization and supporting devices modelling. 45
9.1.8 patient specific beam modifying devices modelling . 45
9.2 Patient modelling. 45
9.2.1 General patient modelling . 45
9.2.2 patient model identification. 46
9.2.3 Regions of interest . 46
9.2.4 image registration. 47
9.2.5 patient model approval. 47
9.3 Radiobiological effect modelling. 47
9.3.1 General radiobiological effect modelling . 47
9.3.2 Radiobiological effect model approval. 47
10 radiation treatment prescription. 48
10.1 Display of radiation treatment prescription. 48
10.2 Change of radiation treatment prescription . 48
10.3 radiation treatment prescription approval. 48
11 Treatment planning. 49
11.1 Display of radiation treatment prescription . 49
11.2 treatment plan limits . 49
11.3 Patient orientation. 49
11.4 Summation of absorbed dose distributions . 49
11.5 Evaluation of absorbed dose distribution. 50

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11.6 treatment plan identification. 50
11.7 treatment plan approval. 51
12 QA plan. 51
13 treatment plan record . 51
13.1 Common treatment planrecord parameters . 51
13.2 treatment plan record parameters for external beam equipment (EBE) . 53
13.3 Treatment plan record parameters for brachytherapy. 53
14 treatment plan report. 53
14.1 Common treatment plan report information . 54
14.2 treatment plan report for external beam equipment (EBE) . 54
14.3 treatment plan report for brachytherapy. 55
14.4 treatment plan report for a treatment plan with unapproved models. 55
15 treatment plan export . 55
15.1 Common treatment planexport parameters . 55
15.2 treatment planexport parameters for external beam equipment (EBE). 56
15.3 treatment plan export parameters for brachytherapy . 57
16 adaptive radiotherapy. 57
16.1 treatment plan correlations. 57
16.2 Offline adaptive radiotherapy . 57
16.3 Online adaptive radiotherapy . 58
16.4 Real-time adaptive radiotherapy . 59
Annex A (informative). 60
A.1 Imported and exported data. 60
A.2 6.2 Coordinate systems, movements, and scales . 60
Bibliography. 61
Figure 1 - afterloading equipment geometry parameters, only one channel is shown. 42
Table 1
- Clauses and subclauses in this standard that require the provision of information in the
accompanying documentation, instructions for use and the technical description
................................................................................................................................................. 23

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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 provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
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) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 62083 has been prepared by IEC subcommittee 62C: Equipment
for radiotherapy (3.2.52) , nuclear medicine and radiation (3.2.46) dosimetry, of IEC technical
committee 62: Medical equipment, software, and systems.
This third edition replaces the second edition of IEC 62083, published in 2009.
With this edition the title was changed from medical electrical system (mes) (3.2.32) -
requirements for the radiotherapy treatment planning system (RTPS) (3.1.14) to medical
device software (3.2.30) - requirements for the safety of radiotherapy treatment planning
system (RTPS) (3.1.14) .
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The edition of this standard considers many aspects of technology used by healthcare
organizations. Clause 16 has been designed to facilitate current practice between radiotherapy
(3.2.52) treatment (3.2.66) medical electrical equipment (MEE) (3.2.31) , image guided
radiotherapy (IGRT) (3.1.8) medical electrical equipment (MEE) (3.2.31) , radiotherapy
treatment planning system (RTPS) (3.1.14) , 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.
The text of this standard is based on the following documents:
FDIS Report on voting
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
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/standardsdev/publications .
The committee has decided that the contents of this publication will remain unchanged until the
maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in the
data related to the specific publication. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
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INTRODUCTION
A radiotherapy treatment planning system (RTPS) (3.1.14) is a device that is used to simulate
the application of radiation (3.2.46) to a patient (3.2.40) for a proposed radiotherapy (3.2.52)
treatment (3.2.66) . It usually, but not necessarily, provides estimates of absorbed dose (3.2.1)
distributions in human tissue using a particular algorithm or series of algorithms. These
estimations, referred to in this International Standard as absorbed dose (3.2.1) distributions,
are used by a qualified person (3.1.12) in planning a radiotherapy (3.2.52) treatment (3.2.66)
course.
The output of a radiotherapy treatment planning system (RTPS) (3.1.14) is used by
appropriately qualified person (3.1.12) for clinical decisions and for treatment (3.2.66) delivery.
Inaccuracies in the input data, the limitations of the algorithms, errors in the treatment (3.2.66)
planning process, or improper use of output data, can represent a safety hazard (3.2.19) to
patient (3.2.40) should the resulting output data be used for treatment (3.2.66) purposes. This
standard defines requirements to be complied with by manufacturer (3.2.28) in the design and
construction of an radiotherapy treatment planning system (RTPS) (3.1.14) in order to provide
protection against the occurrence of such hazard (3.2.19) . It establishes the minimum
requirements for the contents of the accompanying documentation (3.2.4) (3.2.4) that will
permit the operator (3.2.39) to make informed choices during the treatment (3.2.66) planning
process.
Generally, a radiotherapy treatment planning system (RTPS) (3.1.14) does not have direct
interface to the patient (3.2.40) . Consequently, this standard is written in an independent
format rather than as a particular standard to IEC 60601-1. For the purpose of this standard,
radiotherapy treatment planning system (RTPS) (3.1.14) is a software application for medical
purposes, therefore, IEC 62304 Medical device software - Software life cycle processes and
IEC 62366-1:2015/AMD1:2020 Application of usability (3.2.68) engineering to medical devices
apply.
This new edition of the radiotherapy treatment planning system (RTPS) (3.1.14) standard
introduces the concept of ensuring consistency of machine calibration (MU/Dose conversion)
between the radiotherapy treatment planning system (RTPS) (3.1.14) and the delivery
systems. Where an medical electrical equipment (MEE) (3.2.31) has the capability, a check of
the consistency of the machine calibration can be performed prior to any treatment (3.2.66)
delivery to ensure a match between the plan and medical electrical equipment (MEE) (3.2.31)
settings for reference conditions.
IEC 61217 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 is the preferred coordinate system, it was
deemed more of a safety risk (3.2.56) 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 (3.2.52) . Messages should be implemented according to the guidance of IEC/TR
63183.
In the case of online adaptive radiotherapy (3.1.10) and real-time adaptive radiotherapy
(3.2.53) , Clause 16 should be used in conjunction with other particular standards of the IEC
60601-2 series.
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type test (3.2.70) that are performed by the manufacturer (3.2.28) , or site test (3.2.58) , that
are not necessarily performed by the manufacturer (3.2.28) , are specified (3.2.61) for each
requirement. It is understood that site test (3.2.58) can be required from the manufacturer
(3.2.28) , per the agreement between the manufacturer (3.2.28) and responsible organization
(3.2.55) .
Given that before installation a manufacturer (3.2.28) cannot provide site test (3.2.58) data,
data collected during site tests should be provided in a site test (3.2.58) report with the
accompanying documentation (3.2.4) by those who test the radiotherapy treatment planning
system (RTPS) (3.1.14) at installation.

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MEDICAL DEVICE SOFTWARE - REQUIREMENTS FOR THE SAFETY OF
RADIOTHERAPY TREATMENT PLANNING SYSTEMS –
1 Scope
This International Standard, with the inclusion of type test (3.2.70) and site test (3.2.58) ,
applies to the design, manufacture, installation, and maintenance of the radiotherapy treatment
planning system (RTPS) (3.1.14) as well as communication of the radiotherapy treatment
planning system (RTPS) (3.1.14) with other devices
• used in medical practice;
• that imports data either through input by the operator (3.2.39) or from other devices;
• that outputs data to other devices; and
• that is intended to be
◦ for normal use (3.2.36) , under the authority of appropriately qualified person (3.1.12)
, by operator (3.2.39) having the required skills and training;
◦ used and maintained in accordance with the recommendations given in the
instructions for use (3.2.23) , and
◦ used within the environmental conditions specified (3.2.61) in the technical
description.
This standard applies to any software application that is used for the development, evaluation,
or approval of a treatment plan (3.1.18) , whether stand-alone or part of another system.
NOTE: Such software applications include prescribing systems, contouring systems, quality assurance (3.2.45)
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.
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 60601-2-1:2020, 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 60601-2-17:2013, Medical electrical equipment - Part 2: Particular requirements for the
basic safety and essential performance of automatically-controlled brachytherapy afterloading
equipment
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IEC 60601-2-44:2009, Medical electrical equipment - Part 2-44: Particular requirements for the
basic safety and essential performance of X-ray equipment for computed tomography
IEC 60601-2-44:2009/AMD1:2012,
IEC 60601-2-44:2009/AMD2:2016,
IEC 60601-2-68:2014, Medical electrical equipment - Part 2: 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 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
IEC 62366-1:2015/AMD1:2020, Amendment 1 - Medical devices - Part 1: Application of
usability engineering to medical devices
IEC 62676-1-1:2013, 3.1.36, Video surveillance systems for use in security applications - Part
1-1: System requirements - General
IEC TR 62926:2019, Medical electrical system - Guidelines for safe integration and operation
of adaptive external-beam radiotherapy systems for real-time adaptive radiotherapy
IEC TR 63183:2019, Guidance on error and warning messages for software used in
radiotherapy
ISO 80000-1:2022, Quantities and units - Part 1: General
EN 60601-2-17:2015, Medical electrical equipment - Part 2-17: Particular requirements for the
basic safety and essential performance of automatically-controlled brachytherapy afterloading
equipment
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005/
AMD1:2012/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

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3.1 Terms defined in this document
3.1.1
action level
threshold value beyond which action is taken
3.1.2
to archive
remove data from its original storage location and place it in a separate storage location from
which the data can be retrieved for subsequent use
3.1.3
brachytherapy source model
all physical, geometric and radiation (3.2.46) parameters required to plan a course of
radiotherapy (3.2.52) for a particular brachytherapy (3.2.7) radioactive source (3.2.50)
3.1.4
commissioning
process of preparing an radiotherapy treatment
planning system (RTPS) (3.1.14) for clinical use by determining the operating characteristics
and limitations of the radiotherapy treatment planning system (RTPS) (3.1.14), collecting and
installing facility specific (3.2.60) data, and, if necessary, instructing personnel
3.1.5
CT scanner
X-ray equipment intended to generate cross-sectional images of the body by computer
reconstruction of X-ray transmission (3.2.65) data obtained at different angles, which may
include signal analysis and display (3.2.11) equipment, patient (3.2.40) support, support parts
and accessories
[SOURCE: IEC 60601-2-44:2009+A1:2012+A2:2016, 201.3.201, modified - notes removed]
3.1.6
equipment model
representation of physical, geometric, and radiation (3.2.46) parameters for any particular
equipment required to plan a course of radiotherapy (3.2.52)
3.1.7
export
automated or semi-automated data transfer from one system to another
3.1.8
image guided radiotherapy (IGRT)
radiotherapy (3.2.52) process by which the location of a radiotherapy (3.2.52) beam relative to
the intended target volume (3.2.64) within a patient (3.2.40)’s anatomy is determined by
imaging of the target volume (3.2.64) and surrounding anatomical structures at the time of
treatment (3.2.66), so as to enable any necessary positional corrections to the intended
relative location of the beam to the target volume (3.2.64)
Note 1 to entry: The time period of "at the time of treatment (3.2.66)" is specified (3.2.61) in the
definitions of real-time IGRT (3.1.15), online IGRT (3.1.10) and offline IGRT (3.1.9).

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[SOURCE: IEC 60601-2-68:2014, 201.3.209 modified - Note 1 replaced.]
3.1.9
offline adaptive radiotherapy
process wherein the patient (3.2.40) setup or treatment plan (3.1.18) is adjusted for application
in subsequent treatment (3.2.66) delivery sessions
[SOURCE: IEC 60601-2-1:2020, 201.3.232]
3.1.10
online adaptive radiotherapy
process wherein the patient (3.2.40) setup or treatment plan (3.1.18) is adjusted immediately
prior to or during the therapeutic irradiation session requiring operator (3.2.39) initiated
adjustments
Note 1 to entry: the patient (3.2.40) stays on the patient positioner (3.2.41) and is immobile during and in-
between adaptive calculations and treatment (3.2.66).
[SOURCE: IEC 60601-2-1:2020, 201.3.233]
3.1.11
patient model
representation of physical, anatomical, or physiological parameters for a particular patient
(3.2.40) required to plan a course of radiotherapy (3.2.52)
3.1.12
qualified person
person recognised by a competent authority as having the requisite knowledge and training to
perform particular duties
[SOURCE: IEC 60601-2-1:2020, 201.3.237, modified - Word "specified" replaced by
"particular" in the definition.]
3.1.13
radiation treatment prescription
quantitative description of the clinical aims that guide treatment (3.2.66) planning
Note 1 to entry: For radiotherapy (3.2.52) treatment (3.2.66), this may include various levels of detail,
such as the treatment (3.2.66) site, delivery method, dose per fraction, number of fractions and total
dose.
3.1.14
radiotherapy treatment planning system (RTPS)
computer system, that is used to develop simulations and to determine, evaluate, and approve
optimal arrangements of the application of radiation (3.2.46) to a patient (3.2.40) for
radiotherapy (3.2.52) treatment (3.2.66)
Note 1 to entry: An radiotherapy treatment planning system (RTPS) (3.1.14) usually, but not necessarily,
provides estimations of absorbed dose (3.2.1) distributions in human tissue using a particular algorithm
or algorithms. These algorithms provide simulations of radiation (3.2.46) that typically emanates from, but

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not necessarily limited to, medical electron accelerators, light ion (3.2.26) beam medical equipment,
gamma beam therapy equipment (3.2.17), or brachytherapy (3.2.7) equipment.
Note 2 to entry: An radiotherapy treatment planning system (RTPS) (3.1.14) is any software application
that participates in the development, evaluation, or approval of a treatment plan (3.1.18), whether stand-
alone or part of another system.
Note 3 to entry: An radiotherapy treatment planning system (RTPS) may include software for interfacing
with peripherals. Examples of peripherals are digitizer, CT scanner (3.1.5), surface scanner, printer, film
scanner.
3.1.15
real-time adaptive radiotherapy
radiotherapy (3.2.52) that, throughout therapeutic irradiation (3.2.24), monitors patient (3.2.40)
anatomy or physiology and based upon that information, allows autonomous adjustments of
treatment (3.2.66) parameters throughout the therapeutic irradiation without operator (3.2.39)
intervention
[SOURCE: IEC 60601-2-1:2020, 201.3.243]
3.1.16
table top
device attached to the table top support (3.2.63) to which registration or immobilization devices
are attached and upon which the patient (3.2.40) is placed
Note 1 to entry: The table top (3.1.16) can be exchangeable.
[SOURCE: IEC 60601-2-64:2014, 201.3.238, modified - Words "an exchangeable device
attached to the patient positioner" have been replaced by "device attached to the table top
support", and note added.]
3.1.17
treatment parameter
data that describes one aspect of the irradiation (3.2.24) or setup of a patient (3.2.40) during
radiotherapy (3.2.52)
Note 1 to entry: Examples of a treatment parameter (3.1.17) include such values as radiation (3.2.46)
energy, source strength ,treatment (3.2.66) time, imaging and patient positioner (3.2.41) settings.
[SOURCE: IEC 60601-2-17:2013, 201.3.214, modified - Information in the note was removed
from the definition.]
3.1.18
treatment plan
all information that is intended for use by appropriately qualified persons (3.1.12) for the
purpose of prescribing or administering radiotherapy (3.2.52) treatment (3.2.66), including any
information to be transmitted to other equipment
Note 1 to entry: Typical other equipment include treatment (3.2.66) management systems and treatment
(3.2.66) delivery systems.
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3.2 Terms defined in other documents
3.2.1
absorbed dose
[SOURCE: IEC/TR 60788:2004, rm-13-08]
3.2.2
absorbed dose rate
[SOURCE: IEC/TR 60788:2004, rm-13-09]
3.2.3
accessory
[SOURCE: IEC 60601-1:2005+A1:2012+A2:2020, 3.3]
3.2.4
accompanying documentation
[SOURCE: IEC 62366-1:2015/AMD1:2020]
3.2.5
adaptive radiotherapy
[SOURCE: IEC 60601-2-1:2020, 201.3.201]
3.2.6
afterloading
[SOURCE: IEC 60601-2-17:2013, 201.3.201]
3.2.7
brachytherapy
[SOURCE: IEC/TR 60788:2004, rm-42-52]
3.2.8
computed tomography (CT)
[SOURCE: IEC/TR 60788:2004, rm-41-20]
3.2.9
cone beam computed tomography (CBCT)

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[SOURCE: IEC 60601-2-68:2014]
3.2.10
data backup
[SOURCE: IEC 62676-1-1:2013, 3.1.36]
3.2.11
display
[SOURCE: IEC/TR 60788:2004, rm-84-01]
3.2.12
dose monitor unit
[SOURCE: IEC/TR 60788:2004, rm-13-26]
3.2.13
electron beam applicator
[SOURCE: IEC 60601-2-1:2009, 201.3.213]
3.2.14
equipment reference point
[SOURCE: IEC 60601-2-64, 201.3.212]
3.2.15
external beam equipment (EBE)
[SOURCE: IEC 60601-2-68:2014, 201.3.207]
3.2.16
external monitoring device
[SOURCE: IEC 60601-2-1:2020, 201.3.220]
3.2.17
gamma beam therapy equipment
[SOURCE: IEC/TR 60788:2004, rm-24-01]
3.2.18
gantry
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[SOURCE: IEC 60601-2-1:2009, 201.3.222]
3.2.19
hazard
[SOURCE: IEC 60601-1:2005+A1:2012+A2:2020, 3.39]
3.2.20
image guided radiotherapy (IGRT)
[SOURCE: IEC 60601-2-68:2014, 201.3.209]
3.2.21
image registration
[SOURCE: IEC 60601-2-68, 201.3.211]
3.2.22
information technology equipment
[SOURCE: IEC 60601-1-2:2007, 3.16]
3.2.23
instructions for use
[SOURCE: IEC/TR 60788:2004, rm-82-02]
3.2.24
irradiation
[SOURCE: IEC TR 62926:2019]
3.2.25
irradiation time
[SOURCE: IEC/TR 60788:2004, rm-36-11]
3.2.26
light ion
[SOURCE: IEC 60601-2-64, 201.3.218]
3.2.27
light ion range
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[SOURCE: IEC 60601-2-64, 201.3.222]
3.2.28
manufacturer
[SOURCE: IEC 60601-1:2005+A1:2012+A2:2020, 3.55]
3.2.29
medical diagnostic ultrasonic equipment
[SOURCE: IEC 61157, 3.15]
3.2.30
medical device software
3.2.31
medical electrical equipment (MEE)
[SOURCE: IEC 60601-1:2005 + A1:2012 + A2:2020, 3.63]
3.2.32
medical electrical system (mes)
[SOURCE: IEC 60601-1:2005 + A1:2012 + A2:2020, 3.63]
3.2.33
medical electron accelerator
[SOURCE: IEC/TR 60788:2004, rm-23-01]
3.2.34
multileaf collimatormlc (MLC)
[SOURCE: IEC 60601-2-1:2020]
3.2.35
nominal energy
[SOURCE: IEC 60601-2-1:2009, 201.3.231]
3.2.36
normal use
[SOURCE: IEC 60601-1:2005+A1:2012+A2:2020, 3.71]

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3.2.37
offline adaptive radiotherapy
[SOURCE: IEC 60601-2-1:2020, 201.3.232]
3.2.38
online adaptive radiotherapy
[SOURCE: IEC 60601-2-1:2020, 201.3.233]
3.2.39
operator
[SOURCE: IEC 60601-1:2005+A1:2012+A2:2020, 3.73]
3.2.40
patient
[SOURCE: IEC 60601-1:2005+A1:2012+A2:2020, 3.76]
3.2.41
patient positioner
[SOURCE: IEC 60601-2-1, 201.3.235]
3.2.42
penumbra
[SOURCE: IEC/TR 60788:2004, rm-37-08]
3.2.43
programmable electrical medical system (PEMS)
[SOURCE: IEC 60601-1:2005+A1:2012+A2:2020, 3.90]
3.2.44
qualified person
[SOURCE: IEC 60601-2-1:2020, 201.3.239]
3.2.45
quality assurance
[SOURCE: IEC/TR 61258:2008, 2.5]

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3.2.46
radiation
[SOURCE: IEC/TR 60788:2004, rm-11-01]
3.2.47
radiation beam
[SOURCE: IEC/TR 60788:2004, rm-37-05]
3.2.48
radiation head
[SOURCE: IEC 60601-2-64, 201.3.232]
3.2.49
radiation source
[SOURCE: IEC/TR 60788:2004, rm-20-01]
3.2.50
radioactive source
[SOURCE: IEC/TR 60788:2004, rm-20-02]
3.2.51
radionuclide
[SOURCE: IEC/TR 60788:2004, rm-11-22]
3.2.52
radiotherapy
[SOURCE: IEC/TR 60788:2004, rm-40-05]
3.2.53
real-time adaptive radiotherapy
[SOURCE: IEC 60601-2-1:2020, 201.3.243]
3.2.54
record
[SOURCE: IEC 60601-1:2005+A1:2012+A2:2020, 3.98]

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3.2.55
responsible organization
[SOURCE: IEC 60601-1:2005+A1:2012+A2:2020, 3.101]
3.2.56
risk
[SOURCE: IEC 60601-1:2005+A1:2012+A2:2020, 3.102]
3.2.57
risk control
[SOURCE: IEC 60601-1:2005+A1:2012+A2:2020, 3.105]
3.2.58
site test
[SOURCE: IEC 60601-2-1:2020]
3.2.59
source strength
[SOURCE: EN 60601-2-17:2015]
3.2.60
specific
[SOURCE: IEC/TR 60788:2004, rm-74-01]
3.2.61
specified
[SOURCE: IEC/T 60788:2004, rm-74-02]
3.2.62
table top
[SOURCE: IEC 60601-2-1:2020, 201.3.254]
3.2.63
table top support
[SOURCE: IEC 60601-2-1:2020, 201.3.254]

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3.2.64
target volume
[SOURCE: IEC/TR 60788:2004, rm-37-20]
3.2.65
transmission
[SOURCE: IEC/TR 60788:2004, rm-12-10]
3.2.66
treatment
[SOURCE: IEC 60601-2-11:1997, 2.118]
3.2.67
treatment parameter
[SOURCE: IEC 60601-2-17:2013, 201.3.214]
3.2.68
usability
[SOURCE: IEC 60601-1:2005+A1:2012+A2:2020, 3.136]
3.2.69
wedge filter
[SOURCE: IEC/TR 60788:2004, rm-35-10]
3.2.70
type test
[SOURCE: IEC 60601-1:2005 + A1:2012 + A2:2020, 3.63]
4 General
4.1 Quality and security risk (3.2.56) management
The manufacturer (3.2.28) shall establish processes for performing security activities in the
product life cycle and managing risk (3.2.56) associated with security based on an established
and documented quality management system and risk (3.2.56) management system.
NOTE: The quality management system can be implemented according to ISO 13485. The software life cycle process
can be implemented according to the specifications of IEC 62304 and with emphasis on cybersecurity by
implementation of IEC 81001-5-1.

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4.2 Test grades
Three grades of type test (3.2.70) and three of site test (3.2.58) procedures are specified
(3.2.61) . Their requirements are as follows:
• type test (3.2.70) /site test (3.2.58) grade A: An analysis of radiotherapy treatment
planning system (RTPS) (3.1.14) design, as related to the specified (3.2.61) safety
provisions, that shall result in a statement included in the technical description, regarding
the working principles by which the requirement is fulfilled.
• type test (3.2.70) /site test (3.2.58) grade B: Visual inspection or functional test or
measurement of the radiotherapy treatment planning system (RTPS) (3.1.14) . The test
shall be in accordance with the procedure specified (3.2.61) in this document and shall be
based on operating states, including fault condition states, that are achievable only
without modifying the radiotherapy treatment planning system (RTPS) (3.1.14) .
• type test (3.2.70) /site test (3.2.58) grade C: Functional test or measurement of the
radiotherapy treatment planning system (RTPS) (3.1.14) . The test shall be in accordance
with the principle specified (3.2.61) in this document and shall be achievable only by
bypassing safety features or editing data. The site test (3.2.58) procedure shall be
included in the technical description. When the procedure involves operating states that
require bypassing safety features or editing data, the test should be performed by, or
under the direct supervision of, the manufacturer (3.2.28) or his agent.
4.3 Compliance
Demonstration of compliance with the requirements of this standard shall be by explicit
reference to each requirement of this standard.
A statement of compliance to this standard shall be included in the technical description.
Compliance is checked as follows:
type test (3.2.70) grade A - Statement regarding protocols and expected results, providing
details for exact reproducibility.
type test (3.2.70) grade A - Statement regarding compliance to this standard
4.4 Testing the radiotherapy treatment planning system (RTPS) (3.1.14) installation
The risk (3.2.56) analysis of the manufacturer (3.2.28) shall include assessments of the
dependencies of the radiotherapy treatment plan
...