EN 62083:2001

SLOVENSKI SIST EN 62083:2002
prva izdaja
STANDARD
junij 2002
Medical electrical equipment - Requirements for the safety of radiotheraphy
treatment planning systems (IEC 62083:2000)
ICS 11.040.60 Referenčna številka
©  Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno

EUROPEAN STANDARD EN 62083
NORME EUROPÉENNE
EUROPÄISCHE NORM February 2001
ICS 11.040.60
English version
Medical electrical equipment
Requirements for the safety of radiotherapy treatment planning systems
(IEC 62083:2000)
Appareils électromédicaux Medizinische elektrische Geräte
Règles particulières de sécurité Festlegungen für die Sicherheit von
pour les systèmes de planification de Bestrahlungsplanungssystemen
traitement en radiothérapie (IEC 62083:2000)
(CEI 62083:2000)
This European Standard was approved by CENELEC on 2000-12-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic,
Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway,
Portugal, Spain, Sweden, Switzerland and United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels
© 2001 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 62083:2001 E
Foreword
The text of document 62C/280/FDIS, future edition 1 of IEC 62083, prepared by SC 62C, Equipment
for radiotherapy, nuclear medicine and radiation dosimetry, of IEC TC 62, Electrical equipment in
medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC
as EN 62083 on 2000-12-01
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2001-09-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2003-12-01
NOTE In this standard, the following print types are used:
- requirement: in roman type;
- test specifications: in italic type;
- notes: in smaller roman type.
Annexes designated "normative" are part of the body of the standard.
Annexes designated "informative" are given for information only.
In this standard, annexes A, C and ZA are normative and annex B is informative.
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 62083:2000 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
IEC 60601-2-1 NOTE: Harmonized as en 60601-2-1:1998 (not modified).
__________
- 3 - EN 62083:2001
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
Publication Year Title EN/HD Year
1) 2)
IEC 60601-1 Medical electrical equipment EN 60601-1 1990
Part 1: General requirements for safety
1) 2)
IEC 60601-1-2 Medical electrical equipment EN 60601-1-2 1993
2)
Part 1: General requirements for safety -- + corr. December 1997
2. Collateral standard: Electromagnetic
compatibility - Requirements and tests
1) 2)
IEC 60601-1-4 Medical electrical equipment EN 60601-1-4 1996
Part 1-4: General requirements for safety
-- Collateral standard: Programmable
electrical medical systems
1) 2)
IEC 60788 Medical radiology - Terminology HD 501 S1 1988
1) 2)
IEC 60950 (mod) Safety of information technology EN 60950 2000
equipment
1) 2)
IEC 61000-4-1 Electromagnetic compatibility (EMC) EN 61000-4-1 2000
Part 4-1: Testing and measurement
techniques - Overview of IEC 61000-4
series
1) 2)
IEC 61000-4-2 Part 4-2: Testing and measurement EN 61000-4-2 1995
techniques - Electrostatic discharge
immunity test
1) 2)
IEC 61000-4-3 Part 4-3: Testing and measurement
EN 61000-4-3 1996
(mod) techniques - Radiated, radio-frequency,
electromagnetic field immunity test
1) 2)
IEC 61000-4-4 Part 4-4: Testing and measurement EN 61000-4-4 1995
techniques - Electrical fast transient/burst
immunity test
1)
undated reference.
2)
valid edition at date of issue.

Publication Year Title EN/HD Year
1) 2)
IEC 61217 Radiotherapy equipment - Coordinates, EN 61217 1996
movements and scales
ICRU rapport 42 1987 Use of Computers in External Beam --
Radiotherapy Procedures with high
Energy Photons and Electrons
NORME CEI
INTERNATIONALE IEC
INTERNATIONAL
Première édition
STANDARD
First edition
2000-11
Appareils électromédicaux –
Règles particulières de sécurité
pour les systèmes de planification
de traitement en radiothérapie
Medical electrical equipment –
Requirements for the safety of
radiotherapy treatment planning systems
 IEC 2000 Droits de reproduction réservés  Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in
utilisée sous quelque forme que ce soit et par aucun procédé, any form or by any means, electronic or mechanical,
électronique ou mécanique, y compris la photocopie et les including photocopying and microfilm, without permission in
microfilms, sans l'accord écrit de l'éditeur. writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: +41 22 919 0300 e-mail: inmail@iec.ch IEC web site http://www.iec.ch
CODE PRIX
Commission Electrotechnique Internationale
U
PRICE CODE
International Electrotechnical Commission
Pour prix, voir catalogue en vigueur
For price, see current catalogue

62083 © IEC:2000 – 3 –
CONTENTS
Page
FOREWORD . 7
INTRODUCTION . 11
Clause
1 Scope and object . 13
2 Normative references . 13
3 Relationship to other standards . 15
3.1 Hardware SAFETY standards . 15
3.2 Software SAFETY standards . 15
3.3 IEC 61217 Radiotherapy equipment – Coordinates, movements and scales . 15
4 Terminology and definitions. 15
5 General requirements for tests . 17
5.1 Testing during development . 17
5.2 Testing during installation. 17
6ACCOMPANYING DOCUMENTS. 19
7 General requirements for operational safety . 21
7.1 Distances and linear dimensions . 21
7.2 RADIATION quantities . 21
7.3 Date and time format. 21
7.4 Protection against unauthorized use . 21
7.5 Data limits. 23
7.6 Protection against unauthorized modification . 25
7.7 Correctness of data transfer. 25
7.8 Coordinate systems and scales . 25
7.9 Saving and archiving data . 25
8 RADIOTHERAPY TREATMENT EQUIPMENT and BRACHYTHERAPY SOURCE MODELLING. 27
8.1 General. 27
8.2 Dosimetric information . 29
8.3 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL acceptance. 29
8.4 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL deletion . 31
9ANATOMY MODELLING . 31
9.1 Data acquisition . 31
9.2 Coordinate systems and scales . 31
9.3 Contouring of regions of interest. 33
9.4 PATIENT ANATOMY MODEL acceptance . 33
9.5 PATIENT ANATOMY MODEL deletion. 35
10 TREATMENT PLANNING. 35
10.1 General requirements. 35
REATMENT PLAN
10.2 T preparation . 35
10.3 TREATMENT PLAN identification . 37
10.4 TREATMENT PLAN deletion. 37
10.5 Electronic signatures. 37

62083 © IEC:2000 – 5 –
Clause Page
11 ABSORBED DOSE distribution calculation. 37
11.1 Algorithms used . 37
11.2 Accuracy of algorithms . 39
12 TREATMENT PLAN report. 41
12.1 Incomplete TREATMENT PLAN report . 41
12.2 Information on the TREATMENT PLAN report . 41
12.3 Transmitted TREATMENT PLAN information. 43
13 General hardware diagnostics . 43
14 Arithmetic processor . 43
15 Data and code. 43
16 Human errors in software design . 45
17 Change in software versions. 45
18 Human errors in use. 47
Annex A (normative) Hardware safety . 49
A.1 General requirements. 49
A.2 Completeness of hardware SAFETY . 51
A.3 Completeness of ACCOMPANYING DOCUMENTS . 51
Annex B (informative) Imported and exported data. 53
Annex C (normative) Terminology – Index of defined terms. 55
Bibliography . 59
Table 1 – Clauses and subclauses in this standard that require the provision of information
in the ACCOMPANYING DOCUMENTS and the technical description . 19
Table A.1 – Table indicating correlation . 49

62083 © IEC:2000 – 7 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
MEDICAL ELECTRICAL EQUIPMENT –
Requirements for the safety of
radiotherapy treatment planning systems
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the 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, the IEC publishes International Standards. 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. The 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 the 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 National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 62083 has been prepared by subcommittee 62C: Equipment for
radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62:
Electrical equipment in medical practice.
The text of this standard is based on the following documents:
FDIS Report on voting
62C/280/FDIS 62C/288/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.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 3.
Annexes A and C form an integral part of this standard.
Annex B is for information only.

62083 © IEC:2000 – 9 –
In this standard, the following print types are used:
– Requirements, compliance with which can be tested, and definitions: in roman type.
– Notes, explanations, advice, general statements, and exceptions: in small roman type.
– Test specifications: in italic type.
– TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN LISTED IN ANNEX C AND DEFINED IN
CLAUSE 4, OR IN IEC 60601-1 AND ITS COLLATERAL STANDARDS, OR IN IEC 60788: SMALL
CAPITALS.
Certain defined terms have been abbreviated, namely:
Defined term Abbreviation
RADIOTHERAPY TREATMENT PLANNING SYSTEM RTPS
BEAM LIMITING DEVICE BLD
COMPUTED TOMOGRAPHY CT
MAGNETIC RESONANCE IMAGING MRI
CENTRAL PROCESSING UNIT CPU
The committee has decided that the contents of this publication will remain unchanged
until 2005. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
62083 © IEC:2000 – 11 –
INTRODUCTION
A RADIOTHERAPY TREATMENT PLANNING SYSTEM (RTPS) is a device, usually a PROGRAMMABLE
ELECTRONIC SYSTEM, that is used to simulate the application of RADIATION to a PATIENT for a
proposed RADIOTHERAPY treatment. It usually, but not necessarily, provides estimates of
ABSORBED DOSE distribution in human tissue using a particular algorithm or algorithms. These
estimations, referred to in this International Standard as ABSORBED DOSE distributions, are used
by a QUALIFIED PERSON in planning a course of RADIOTHERAPY.
The output of an RTPS is used by appropriately QUALIFIED PERSONS as important information in
RADIOTHERAPY TREATMENT PLANNING. Inaccuracies in the input data, the limitations of the
algorithms, errors in the TREATMENT PLANNING process, or improper use of output data, may
represent a SAFETY HAZARD to PATIENTS should the resulting data be used for treatment
purposes. This standard defines requirements to be complied with by MANUFACTURERS in the
design and construction of an RTPS in order to provide protection against the occurrence of
such HAZARDS.
Specific types of input data and calculation algorithms are not addressed in this standard.
These are dependent on many factors, such as available technology, USER preference, and the
type of treatment being planned. However, this standard establishes the SAFETY requirements
that are common to algorithms. It also establishes the minimum requirements for the contents
of the ACCOMPANYING DOCUMENTS that will permit the USER to make informed choices during the
TREATMENT PLANNING process.
NOTE As it is not used in the presence of PATIENTS, an RTPS is not MEDICAL ELECTRICAL EQUIPMENT as defined
by IEC 60601-1. Consequently, this standard is written in an independent format rather than as a particular
standard to IEC 60601-1. Clause 3 contains related information.

62083 © IEC:2000 – 13 –
MEDICAL ELECTRICAL EQUIPMENT –
Requirements for the safety of
radiotherapy treatment planning systems
1 Scope and object
This International Standard applies to the design, manufacture and some installation aspects of
an RTPS
– for use in RADIOTHERAPY TREATMENT PLANNING in human medical practice;
– that imports data either through input by the OPERATOR or direct from other devices;
– that outputs data either in printed form for review or direct to other devices;
– and which is intended to be
• for NORMAL USE, under the authority of appropriately licensed or QUALIFIED PERSONS, by
OPERATORS having the required skills and training;
• maintained in accordance with the recommendations given in the INSTRUCTIONS FOR
USE, and
• used within the environmental and electrical supply conditions SPECIFIED in the technical
description.
An RTPS developed by a USER for its own use exclusively is not within the scope of this
standard, but it is highly recommended that the principles of this standard be applied in its
creation and use. If such an RTPS is provided to another USER in which the developers do not
directly control its use, and is represented as being suitable for use, then the developers
MANUFACTURER
assume the role of , and this standard applies.
An RTPS is principally a software application, and the object of this standard is to establish
the requirements for features, associated documentation, and testing of the software.
Requirements for SAFETY of hardware are not included in this standard, as they vary with the
nature of the hardware. See 3.1 and annex A for hardware requirements.
2 Normative references
The following normative documents contain provisions which, through reference in this text,
constitute provisions of this International Standard. For dated references, subsequent
amendments to, or revisions of, any of these publications do not apply. However, parties to
agreements based on this International Standard are encouraged to investigate the possibility
of applying the most recent editions of the normative documents indicated below. For undated
references, the latest edition of the normative document referred to applies. Members of IEC
and ISO maintain registers of currently valid International Standards.
IEC 60601-1, Medical electrical equipment – Part 1: General requirements for safety
IEC 60601-1-2, Medical electrical equipment – Part 1: General requirements for safety – 2.
Collateral Standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-1-4, Medical electrical equipment – Part 1: General requirements for safety – 4.
Collateral Standard: Programmable electrical medical systems

62083 © IEC:2000 – 15 –
IEC 60788, Medical radiology – Terminology
IEC 60950, Safety of information technology equipment
IEC 61000-4-1, Electromagnetic compatibility (EMC) – Part 4-1: Testing and measurement
techniques – Overview of IEC 61000-4 series
IEC 61000-4-2, Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement
techniques – Electrostatic discharge immunity test
IEC 61000-4-3, Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurement
techniques – Radiated, radio-frequency, electromagnetic field immunity test
IEC 61000-4-4, Electromagnetic compatibility (EMC) – Part 4: Testing and measurement
techniques – Section 4: Electrical fast transient/burst immunity test. Basic EMC Publication
IEC 61217, Radiotherapy equipment – Coordinates, movements and scales
ICRU report 42:1987: Use of Computers in External Beam Radiotherapy Procedures with high
Energy Photons and Electrons
3 Relationship to other standards
3.1 Hardware SAFETY standards
Requirements for the SAFETY of hardware, such as for protection against electric shock and
fire, and to assure for ELECTROMAGNETIC COMPATIBILITY, are not included in this standard.
SAFETY requires that these subjects be addressed by the MANUFACTURER separately through
compliance with an appropriate standard, depending upon the nature and environment of the
hardware used for the RTPS. See annex A for hardware SAFETY standards.
3.2 Software SAFETY standards
An RTPS is principally a software application for a medical purpose.
IEC Collateral Standard 60601-1-4 applies (see clause 16).
3.3 IEC 61217 Radiotherapy equipment – Coordinates, movements and scales
IEC 61217 gives guidance on the designation of EQUIPMENT movements, the marking of scales,
their zero position and the direction of movement with increasing value. The means of applying
IEC 61217 are specified in appropriate clauses and subclauses of this standard.
4 Terminology and definitions
For the purpose of this International Standard, the following terms and definitions apply, in
addition to the index of defined terms listed in annex C.
4.1
EQUIPMENT MODEL/EQUIPMENT MODELLING
all physical, geometric and RADIATION parameters required to plan a course of RADIOTHERAPY
for particular EQUIPMENT. The process of establishing the EQUIPMENT MODEL is referred to as
"EQUIPMENT MODELLING"
62083 © IEC:2000 – 17 –
4.2
BRACHYTHERAPY SOURCE MODEL/BRACHYTHERAPY SOURCE MODELLING
all physical, geometric and RADIATION parameters required to plan a course of RADIOTHERAPY
for a particular BRACHYTHERAPY RADIOACTIVE SOURCE. The process of establishing the
BRACHYTHERAPY SOURCE MODEL is referred to as "BRACHYTHERAPY SOURCE MODELLING"
4.3
PATIENT ANATOMY MODEL/ANATOMY MODELLING
all physical and anatomical parameters required to plan a course of RADIOTHERAPY for a
particular PATIENT. The process of establishing the PATIENT ANATOMY MODEL is referred to as
"ANATOMY MODELLING"
4.4
TREATMENT PLAN/TREATMENT PLANNING
PATIENT QUALIFIED
all and dosimetric information that is intended for use by appropriately
PERSONs for the purpose of prescribing or administering RADIOTHERAPY treatment. A TREATMENT
PLAN includes information transmitted to other EQUIPMENT for which the use of the information
for prescribing or administering IRRADIATION is indirect. A printed or plotted TREATMENT PLAN is
referred to as a TREATMENT PLAN report
4.5
RADIOTHERAPY TREATMENT PLANNING SYSTEM (RTPS)
a device, usually a PROGRAMMABLE ELECTRONIC SYSTEM including its associated peripherals,
that is used to simulate the application of RADIATION to a PATIENT for a proposed RADIOTHERAPY
treatment. It usually, but not necessarily, provides estimations of ABSORBED DOSE distribution in
human tissue using a particular algorithm or algorithms. These algorithms provide simulations
of RADIATION that is typically from, but not necessarily limited to, MEDICAL ELECTRON ACCELE-
RATORS, GAMMA BEAM THERAPY EQUIPMENT, or RADIOACTIVE SOURCES when BRACHYTHERAPY is
planned.
5 General requirements for tests
5.1 Testing during development
Compliance with IEC 60601-1-4 requires identification of HAZARDS, assessment of their RISKS,
and appropriate verification and validation of RISK controls. Demonstration of compliance with
the requirements of this standard shall be included as part of the above processes, with explicit
reference to each requirement. Compliance data shall be retained by the MANUFACTURER as a
permanent record. Each test shall include a protocol containing all the necessary input data,
sufficient detail to provide for exact reproducibility, and the expected result. A summary
description of the tests performed to demonstrate compliance to each clause and subclause of
this standard shall be included in the technical description.
5.2 Testing during installation
The MANUFACTURER shall provide an installation test document as part of the technical
description that includes, as a minimum, performance of the ABSORBED DOSE distribution
calculation algorithm tests given in 11.2. The tests shall also demonstrate correct functioning of
the RTPS hardware components and their ability to achieve predetermined results when
performing TREATMENT PLANNING functions.
TREATMENT PLANNING MANUFACTURER
NOTE Due to the complexity of functions, it is usually not possible for the to
demonstrate complete fitness for use of the RTPS at time of installation. Operational problems detected after
installation will normally be addressed subject to the conditions of the contract (see also item b) of clause 16).

62083 © IEC:2000 – 19 –
6 ACCOMPANYING DOCUMENTS
The technical description and the INSTRUCTIONS FOR USE shall contain the information as
required by this standard (see table 1 for references).
Table 1 – Clauses and subclauses in this standard that require
the provision of information in the ACCOMPANYING
DOCUMENTS and the technical description
Check INSTRUCTIONS Technical
reference FOR USE description
15.1
25.2
3 7.4 a)
4 7.4 b)
57.5
6 7.7 a)
7 7.7 b)
87.8
9 8.1 g)
10 8.2 b)
11 9.1 a)
12 9.2 a)
13 9.2 c)
14 9.3 c)
15 10.2 a)
16 10.5 a)
17 11.1 a)
18 11.1 b)
19 11.2 a)
20 11.2 c)
21 11.2 c)
22 11.2 d)
23 11.2 e)
24 13
25 15
26 16 b)
27 17 a)
28 17 b)
29 17 d)
30 18
31 A.1
32 A.3
33 A.3
34 Annex B
NOTE The check reference is given as an aid for checking the
availability of compliance documentation.

62083 © IEC:2000 – 21 –
7 General requirements for operational safety
7.1 Distances and linear dimensions
Distance measurements and linear dimensions shall be indicated in centimetres or in
millimetres but not both. All values of linear measurements requested, DISPLAYED, or printed
shall include their units.
Compliance is checked by inspection of the DISPLAY and output information.
7.2 RADIATION quantities
All values of RADIATION quantities requested, DISPLAYED or printed shall include their units.
Units of RADIATION quantities should conform to the SI convention.
Compliance is checked by inspection of the DISPLAY and output information.
7.3 Date and time format
When the date is DISPLAYED or printed, correct interpretation shall not depend upon the
OPERATOR's interpretation of format, and a DISPLAY of the year shall be in four digits.
Examples acceptable: "03 Apr 2005", "03/04/2005 (dd/mm/yyyy) ".
Examples not acceptable: "03/04/05", "03 Apr 05".
When the time is requested, DISPLAYED or printed, it shall be represented on a 24-hour clock
basis, or the letters "a.m." and "p.m." shall be appropriately included. Measurements of time
shall include units (hours, minutes, seconds).
NOTE By convention, noon is 12:00 p.m. and midnight is 12:00 a.m.
When time is entered, DISPLAYED or printed, each denomination of time shall be labelled. To
prevent confusion with numbers, single-letter abbreviations of time denomination shall not be
used (for example h, m, s). Acceptable examples: 2,05 min; 1 hour 33 minutes; 1:43:15 (hr:
min: sec).
Time-sensitive functions shall be performed correctly at transitions such as year boundaries,
leap years, year 2000, etc.
Compliance is checked by testing and by inspection of the DISPLAY and output information.
7.4 Protection against unauthorized use
a) A PASSWORD protection feature, or the use of a key, shall be provided by the MANUFACTURER
as a means for the USER to ensure that only authorized persons perform TREATMENT
PLANNING. A means to control PASSWORD access or key access shall be provided to ensure
that these may be controlled by an individual designated by the USER. The technical
description shall describe how protection is implemented and how access is controlled.
Protection against unauthorized use shall provide for selective access for different
functions so that the USER can specify the levels of protection for specific OPERATORS.
Examples: Not all OPERATORS qualified for TREATMENT PLANNING are likely to be qualified for BRACHYTHERAPY SOURCE
MODELLING and EQUIPMENT MODELLING; also, viewing TREATMENT PLANS, or printing out TREATMENT PLANS, may be
permitted with fewer restrictions than for TREATMENT PLANNING.

62083 © IEC:2000 – 23 –
Compliance is checked by testing and by inspection of the ACCOMPANYING DOCUMENTS.
b) Where network connection is permitted by the design, the following requirements apply:
– access to the RTPS shall be provided only to authorized EQUIPMENT or individuals who
are authorized (for example, by a PASSWORD under the control of the USER);
– access to EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL, and PATIENT ANATOMY
MODEL data, or to TREATMENT PLANS (with or without ABSORBED DOSE distribution
calculation) through the network shall be restricted so as to prevent unauthorized
access;
– protection against computer viruses shall be employed which alerts the OPERATOR when
a virus is detected. The MANUFACTURER shall state in the INSTRUCTIONS FOR USE the
means of virus protection employed, and that any other means shall be approved by
the MANUFACTURER prior to use.
Compliance is checked by testing and by inspection of the ACCOMPANYING DOCUMENTS.
c) To protect against improper use, software copy protection shall be employed. The copy
protection employed shall permit backup of data, and may also permit backup of programs.
However, it shall prevent the creation of a useable duplicate RTPS not intended by the
MANUFACTURER to be used for TREATMENT PLANNING. The protection procedure to be
followed against duplication shall be stated in the INSTRUCTIONS FOR USE.
Compliance is checked by testing and by inspection of the ACCOMPANYING DOCUMENTS.
7.5 Data limits
Data elements entered by the USER or acquired from a device or network shall be compared
against pre-established limits. Operation shall be prevented if the data are outside these limits
OPERATOR
unless the overrides a cautionary message at the time the data are found to be
outside the limits.
Limits for those data elements that are entered by the USER shall be provided in the
INSTRUCTIONS FOR USE.
Other consistency checks on data should also be performed as appropriate to the expected
nature of the data.
For TREATMENT PLANNING performed when the OPERATOR has overridden data limits, TREATMENT
PLAN reports shall include the message "CAUTION: SOME DATA ELEMENTS USED WERE
OUTSIDE NORMAL RANGE" or a similar statement.
NOTE The requirements in this subclause do not ensure that input data are correct or used appropriately by the
OPERATOR. The limits define the maximum ranges of input data elements. Defining these ranges permits safe use of
the system with input data, which the MANUFACTURER could not anticipate, and provides the MANUFACTURER with the
means to test algorithms for correct behaviour at established boundaries. See also 11.2 b).
Compliance is checked by testing and by inspection of the output information and
ACCOMPANYING DOCUMENTS
.
62083 © IEC:2000 – 25 –
7.6 Protection against unauthorized modification
See clause 15.
7.7 Correctness of data transfer
a) Data transferred to or from other devices shall use a communication protocol that verifies
error-free data transmission. The MANUFACTURER shall specify these protocols in the
technical description.
Examples: DICOM 3 or FTP, each of which includes error detection.
Compliance is checked by inspection of the communication protocol specifications, and by
inspection of the ACCOMPANYING DOCUMENTS.
b) If data are transmitted for use by another device, other than closed communication with a
peripheral, then
– the format of the output data shall be included in the technical description, including (but
not limited to) identification of all data elements, data types, and data limits;
– the data output shall include the name of the OPERATOR, the date on which the data was
written, and any relevant identifiers for the PATIENT, EQUIPMENT MODEL, BRACHYTHERAPY
SOURCE MODEL, PATIENT ANATOMY MODEL and TREATMENT PLAN.
NOTE See annex B concerning correctness of transferred data.
Compliance is checked by testing and by inspection of the output information and
ACCOMPANYING DOCUMENTS
.
7.8 Coordinate systems and scales
It shall be possible for the OPERATOR to perform all TREATMENT PLANNING functions with the
scales and coordinates of RADIOTHERAPY treatment EQUIPMENT displayed according to the
IEC 61217 convention. It should also be possible for the OPERATOR to perform all TREATMENT
PLANNING functions with the scales and coordinates of EQUIPMENT DISPLAYED according to the
customization for the particular EQUIPMENT performed during EQUIPMENT MODELLING.
In either case, the TREATMENT PLAN reports used for RADIOTHERAPY treatment prescription shall
show the scales and coordinates of EQUIPMENT according to the customization for the particular
EQUIPMENT performed during EQUIPMENT MODELLING.
The method of DISPLAY of scales shall be explained in the INSTRUCTIONS FOR USE.
DISPLAY
Compliance is checked by testing and by inspection of the , output information and
ACCOMPANYING DOCUMENTS.
7.9 Saving and archiving data
Means shall be provided such that an EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL,
TREATMENT PLAN, and other data critical to proper operation can be saved while work is in
progress so that it can be retrieved in the case of a system malfunction.
Means shall be provided for archiving data onto a separate medium from the primary storage,
such that it can be retrieved in the case of a failure of the data storage device or complete
RTPS.
Compliance is checked by testing.

62083 © IEC:2000 – 27 –
8 RADIOTHERAPY TREATMENT EQUIPMENT and BRACHYTHERAPY SOURCE MODELLING
8.1 General
a) An EQUIPMENT MODEL or BRACHYTHERAPY SOURCE MODEL shall contain all information
required to identify the available RADIATION QUALITY from the RADIOTHERAPY EQUIPMENT or
BRACHYTHERAPY RADIOACTIVE SOURCE in the required detail to prevent ambiguity. For each
RADIATION QUALITY available, this shall include, but not be limited to
• RADIATION QUALITY;
• NOMINAL ENERGY;
• ABSORBED DOSE profiles and DEPTH DOSE distribution data measured under, or validated
for, conditions that permit modelling in human tissue;
• physical characteristics of the BRACHYTHERAPY RADIOACTIVE SOURCE, and
• calibration factors and RADIOACTIVE HALF LIFE of the RADIONUCLIDES.
b) An EQUIPMENT MODEL shall include the available ranges of the BLD, GANTRY motion, and all
other motions and geometric factors that are pertinent to the TREATMENT PLANNING process.
c) An EQUIPMENT MODEL shall include all pertinent data for RADIATION BEAM modifying devices
that are to be useable during the TREATMENT PLANNING process, such as WEDGE FILTERS,
ELECTRON BEAM APPLICATORS, and multi-element BLD. The data shall be in the form of exact
values or bounded ranges (for example, for allowed RADIATION FIELD size). All such values
shall be DISPLAYED for the OPERATOR to review during the EQUIPMENT MODELLING process.
d) When appropriate, an EQUIPMENT MODEL shall specify all available locations, relative to the
RADIATION SOURCE, of blocking trays, compensators, or other customizable RADIATION BEAM
modifying devices.
e) Where the EQUIPMENT MODELLING process is not confined to particular EQUIPMENT for which
the direction of motion and reference position of motions of EQUIPMENT parts are known,
then the EQUIPMENT MODELLING process shall permit these parameters to be customizable
for each EQUIPMENT modelled. While the parameters are being customized, the DISPLAY
OPERATOR
shall clearly indicate the direction of view from which the is observing the
EQUIPMENT.
f) It shall be possible for the OPERATOR to select the convention established by IEC 61217.
g) The means by which EQUIPMENT and BRACHYTHERAPY SOURCE MODELLING data are entered
into the RTPS, and the complete data set required, shall be described in the INSTRUCTIONS
FOR USE.
The MANUFACTURER shall state in the INSTRUCTIONS FOR USE the minimum data required for
the RTPS to perform to the SPECIFIED accuracy, and shall also include any pertinent
instructions or precautions concerning the quality of the data to be entered.
h) Data to be entered by the OPERATOR shall not default to values approximating a clinically
useable BRACHYTHERAPY SOURCE MODEL or EQUIPMENT MODEL.
NOTE Some TREATMENT PLANNING functions, such as virtual simulation, may require only a simple BRACHYTHERAPY
SOURCE MODEL EQUIPMENT MODEL RADIOACTIVE SOURCE EQUIPMENT
or because the or is generic. In this case, most or
all of the requirements of this subclause may be addressed by the MANUFACTURER as being not applicable.
However, many other subclauses may nonetheless be applicable, such as 7.5 regarding data limits for parameters
entered by the OPERATOR, and 7.8 regarding coordinate systems and scales.

62083 © IEC:2000 – 29 –
Compliance is checked by the tests of a), b), c), d), e), f) and h) and by inspection of the
ACCOMPANYING DOCUMENTS g).
8.2 Dosimetric information
a) Where an EQUIPMENT MODEL or a BRACHYTHERAPY SOURCE MODEL is based on dosimetric
data entered by the OPERATOR during the modelling process, the dimensions of the volume
to which the dosimetric data apply (modelled dosimetric volume) shall be DISPLAYED during
the modelling process.
ABSORBED DOSE RATE
b) The outside the modelled dosimetric volume shall either be set to
zero or extrapolated. Extrapolated data shall be non-negative and shall
• be set to a specific constant relative ABSORBED DOSE RATE; or
• be determined by a specified mathematical formula dependent on a SPECIFIED distance
parameter.
The OPERATOR shall be informed through a message, or other means, of the method used
to estimate the ABSORBED DOSE outside the modelled volume during EQUIPMENT MODELLING
or TREATMENT PLANNING. The method used to estimate the ABSORBED DOSE outside the
modelled volume shall be explained in the technical description.
c) Where TRANSMISSION RATIOS or other parameters for RADIATION BEAM modifying devices that
are required for ABSORBED DOSE distribution calculation are to be entered, these values
DISPLAYED
shall be along with the physical parameters for the beam modifiers for the
OPERATOR to review during the EQUIPMENT MODELLING process.
Compliance is checked by the tests of a), b) and c) and by inspection of the ACCOMPANYING
DOCUMENTS b).
8.3 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL acceptance
a) It shall be possible to save an EQUIPMENT MODEL as "complete" after creation or modification
only when the OPERATOR has acknowledged
• that the data and parameters in the model have been reviewed and are correct, and
• that dosimetric data has been confirmed through alternative calculations, comparison to
published data, independent review, or other appropriate means.
NOTE See 10.1 regarding use of an incomplete model for TREATMENT PLANNING purposes.
b) Means shall be provided so that the OPERATOR may review all pertinent data prior to saving
the EQUIPMENT MODEL or BRACHYTHERAPY SOURCE MODEL as "complete". Graphical
representation of the data should be provided where applicable.
c) When the EQUIPMENT MODEL or BRACHYTHERAPY SOURCE MODEL is accepted and saved, it
shall be saved
• along with the date of acceptance;
• along with the OPERATOR'S identification, and
• under a separate name from other saved models, unless the OPERATOR overrides a
cautionary message.
Compliance is checked by the tests of a), b) and c).

62083 © IEC:2000 – 31 –
8.4 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL deletion
It shall not be possible to delete an EQUIPMENT MODEL or BRACHYTHERAPY SOURCE MODEL unless
the OPERATOR has received and overridden a cautionary message advising that the model
should be archived prior to being deleted.
Compliance is checked by testing.
9 ANATOMY MODELLING
9.1 Data acquisition
a) The means by which ANATOMY MODELLING data are entered into the RTPS shall be described
in the INSTRUCTIONS FOR USE.
b) When image data ar
...