SIST EN 62083:2010

SLOVENSKI STANDARD
01-februar-2010
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SIST EN 62083:2002
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Medical electrical equipment - Requirements for the safety of radiotherapy treatment
planning systems (IEC 62083:2009)
Medizinische elektrische Geräte - Festlegungen für die Sicherheit von
Bestrahlungsplanungssystemen (IEC 62083:2009)
Appareils électromédicaux - Règles particulières de sécurité pour les systèmes de
planification de traitement en radiothérapie (CEI 62083:2009)
Ta slovenski standard je istoveten z: EN 62083:2009
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 62083
NORME EUROPÉENNE
December 2009
EUROPÄISCHE NORM
ICS 11.040.60 Supersedes EN 62083:2001

English version
Medical electrical equipment -
Requirements for the safety of radiotherapy treatment planning systems
(IEC 62083:2009)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Exigences de sécurité Festlegungen für die Sicherheit
pour les systèmes de planification von Bestrahlungsplanungssystemen
de traitement en radiothérapie (IEC 62083:2009)
(CEI 62083:2009)
This European Standard was approved by CENELEC on 2009-11-01. 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, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: Avenue Marnix 17, B - 1000 Brussels

© 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 62083:2009 E
Foreword
The text of document 62C/473/FDIS, future edition 2 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 2009-11-01.
This European Standard supersedes EN 62083:2001.
other standards referred to in this standard.
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) 2010-08-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2012-11-01
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive MDD (93/42/EEC). See Annex ZZ.
In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: in roman type;
– explanations, advice, general statements, exceptions and notes: in small roman type;
– test specifications: in italic type;
– TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN LISTED IN THE INDEX OF DEFINED TERMS AND
CLAUSE 3, OR IN OTHER STANDARDS: SMALL CAPITALS.
DEFINED IN
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 62083:2009 was approved by CENELEC as a European
Standard without any modification.
__________
- 3 - EN 62083:2009
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application 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  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year

IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic safety
and essential performance
1) 2)
IEC 60601-1-2 - Medical electrical equipment - EN 60601-1-2 2007
(mod) Part 1-2: General requirements for basic
safety and essential performance - Collateral
standard: Electromagnetic compatibility -
Requirements and tests
IEC 60601-2-1 2009 Medical electrical equipment - - -
Part 2-1: Particular requirements for the basic
safety and essential performance of electron
accelerators in the range 1 MeV to 50 MeV

IEC 60601-2-11 1997 Medical electrical equipment - EN 60601-2-11 1997
Part 2-11: Particular requirements for the
safety of gamma beam therapy equipment

IEC/TR 60788 2004 Medical electrical equipment - - -
Glossary of defined terms
1) 2)
IEC 60950-1 (mod) - Information technology equipment - Safety - EN 60950-1 2006
Part 1: General requirements + A11 2009

1) 2)
IEC 61000-4-1 - Electromagnetic compatibility (EMC) - EN 61000-4-1 2007
Part 4-1: Testing and measurement
techniques - Overview of IEC 61000-4 series

1) 2)
IEC 61000-4-2 - Electromagnetic compatibility (EMC) - EN 61000-4-2 2009
Part 4-2: Testing and measurement
techniques - Electrostatic discharge immunity
test
1) 2)
IEC 61000-4-3 - Electromagnetic compatibility (EMC) - EN 61000-4-3 2006
Part 4-3: Testing and measurement
techniques - Radiated, radio-frequency,
electromagnetic field immunity test

1) 2)
IEC 61000-4-4 - Electromagnetic compatibility (EMC) - EN 61000-4-4 2004
Part 4-4: Testing and measurement
techniques - Electrical fast transient/burst
immunity test
1) 2)
IEC 61217 - Radiotherapy equipment - Coordinates, EN 61217 1996
movements and scales
1) 2)
IEC 62304 - Medical device software - Software life-cycle EN 62304 2006
processes + corr. November 2008

1)
Undated reference.
2)
Valid edition at date of issue.

Publication Year Title EN/HD Year

IEC 62366 2007 Medical devices - Application of usability EN 62366 2008
engineering to medical devices

ICRU Report 42 1987 Use of Computers in External Beam - -
Radiotherapy Procedures with High Energy
Photons and Electrons
- 5 - EN 62083:2009
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
IEC 62083 ®
Edition 2.0 2009-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Requirements for the safety of radiotherapy
treatment planning systems
Appareils électromédicaux – Exigences de sécurité pour les systèmes de
planification de traitement en radiothérapie

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
U
CODE PRIX
ICS 11.040.60 ISBN 2-8318-1062-2
– 2 – 62083 © IEC:2009
CONTENTS
FOREWORD.4
INTRODUCTION.6
1 Scope.7
2 Normative references .7
3 Terms, definitions and abbreviations .8
3.1 Terms and definitions .8
3.2 Abbreviations .9
4 General .9
4.1 Development .9
4.2 Testing during installation.9
5 ACCOMPANYING DOCUMENTS.10
6 General requirements for operational safety .11
6.1 Distances and linear and angular dimensions .11
6.2 RADIATION quantities.11
6.3 Date and time format.11
6.4 Protection against unauthorized use.11
6.5 Data limits .12
6.6 Protection against unauthorized modification.12
6.7 Correctness of data transfer .13
6.8 Coordinate systems and scales .13
6.9 Saving and archiving data .13
7 RADIOTHERAPY TREATMENT EQUIPMENT MODELLING and BRACHYTHERAPY SOURCE
MODELLING .14
7.1 EQUIPMENT MODEL .14
7.2 BRACHYTHERAPY SOURCE MODEL .14
7.3 Dosimetric information.15
7.4 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL acceptance .15
7.5 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL deletion.16
8 ANATOMY MODELLING .16
8.1 Data acquisition .16
8.2 Coordinate systems and scales .16
8.3 Contouring of regions of interest .17
8.4 PATIENT ANATOMY MODEL acceptance .17
8.5 PATIENT ANATOMY MODEL deletion.18
9 TREATMENT PLANNING .18
9.1 General requirements.18
9.2 TREATMENT PLAN preparation .18
9.3 TREATMENT PLAN identification .18
9.4 TREATMENT PLAN deletion.19
9.5 Electronic signatures .19
10 ABSORBED DOSE distribution calculation .19
10.1 Algorithms used .19
10.2 Accuracy of algorithms .19
11 TREATMENT PLAN report .20
11.1 Incomplete TREATMENT PLAN report .20

62083 © IEC:2009 – 3 –
11.2 Information on the TREATMENT PLAN report .20
11.3 Transmitted TREATMENT PLAN information.21
12 General hardware diagnostics .21
13 Data and code .22
14 Human errors in software design .22
15 Change in software versions.22
16 USE ERRORS.23
Annex A (normative) Hardware safety.24
Annex B (informative) Imported and exported data.26
Bibliography.27
Index of defined terms .28

Table 1 – Clauses and subclauses in this standard that require the provision of
information in the ACCOMPANYING DOCUMENTS and the technical description .10
Table A.1 – Table indicating correlation .24

– 4 – 62083 © IEC:2009
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
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, nuclear medicine and radiation dosimetry, of IEC technical committee 62:
Electrical equipment in medical practice.
This second edition replaces the first edition of IEC 62083, published in 2000. This edition
constitutes a technical revision, which brings this standard in line with changes to the other
standards referred to in this standard.
The text of this standard is based on the following documents:
FDIS Report on voting
62C/473/FDIS 62C/479/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 2.

62083 © IEC:2009 – 5 –
In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: in roman type;
– explanations, advice, general statements, exceptions and notes: in small roman type;
– test specifications: in italic type;
– TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN LISTED IN THE INDEX OF DEFINED
TERMS AND DEFINED IN CLAUSE 3, OR IN OTHER STANDARDS: SMALL CAPITALS.
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.
– 6 – 62083 © IEC:2009
INTRODUCTION
A RADIOTHERAPY TREATMENT PLANNING SYSTEM (RTPS) is a device, usually a PROGRAMMABLE
ELECTRICAL MEDICAL 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, RESPONSIBLE
ORGANIZATION 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
OPERATOR to make informed choices during the TREATMENT PLANNING process.
Generally, an RTPS is not used in the presence of PATIENTS, so it 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.
• Relationship to other standards
The BASIC SAFETY of hardware, such as for protection against electric shock and fire, and for
assuring ELECTROMAGNETIC COMPATIBILITY requires that these subjects be addressed by the
MANUFACTURER 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.
A RTPS is principally a software application for medical purposes. IEC 62304 applies (see
Clause 14).
IEC 61217 gives guidance on the designation of ME 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.
IEC 62366 applies (see Clause 16).

62083 © IEC:2009 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY
TREATMENT PLANNING SYSTEMS
1 Scope
This International Standard applies to the design, manufacture and some installation aspects
of a radiotherapy treatment planning systems(RTPS)
– for use in RADIOTHERAPY TREATMENT PLANNING in human medical practice;
– that imports data either through input by the OPERATOR or directly from other devices;
– that outputs data either in printed form for review or directly 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.
2 Normative references
The following referenced documents are indispensable for the application 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 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
IEC 60601-2-1:2009, Medical electrical equipment – Part 2-1: Particular requirements for the
basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
IEC 60601-2-11:1997, Medical electrical equipment – Part 2: Particular requirements for the
safety of gamma beam therapy equipment
IEC/TR 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 60950-1, Information technology equipment – Safety – Part 1: General requirements
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

– 8 – 62083 © IEC:2009
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 4-4: Testing and measurement
techniques – Electrical fast transient/burst immunity test
IEC 61217, Radiotherapy equipment – Coordinates, movements and scales
IEC 62304, Medical device software – Software life cycle processes
IEC 62366:2007, Medical devices – Application of usability engineering to medical devices
ICRU Report 42:1987, Use of Computers in External Beam Radiotherapy Procedures with
High Energy Photons and Electrons
3 Terms, definitions and abbreviations
3.1 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
NOTE See the Index of defined terms for a full list of terms used in this standard and their source.
3.1.1
ANATOMY MODELLING
process of establishing the PATIENT ANATOMY MODEL
3.1.2
BRACHYTHERAPY SOURCE MODEL
all physical, geometric and RADIATION parameters required to plan a course of RADIOTHERAPY
for a particular BRACHYTHERAPY RADIOACTIVE SOURCE
3.1.3
EQUIPMENT MODEL
all physical, geometric and RADIATION parameters required to plan a course of RADIOTHERAPY
for particular ME EQUIPMENT
3.1.4
EQUIPMENT MODELLING
process of establishing the EQUIPMENT MODEL
3.1.5
PATIENT ANATOMY MODEL
all physical and anatomical parameters required to plan a course of RADIOTHERAPY for a
particular patient
3.1.6
RADIOTHERAPY TREATMENT PLANNING SYSTEM
RTPS
device, usually a PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM including its associated
peripherals, that is used to simulate the application of RADIATION to a patient for a proposed
RADIOTHERAPY TREATMENT
NOTE 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 ACCELERATORS, GAMMA BEAM THERAPY EQUIPMENT, or in BRACHYTHERAPY
from RADIOACTIVE SOURCES.
62083 © IEC:2009 – 9 –
3.1.7
SOURCE MODELLING
process of establishing the BRACHYTHERAPY SOURCE MODEL
3.1.8
TREATMENT PLAN
all patient and dosimetric information that is intended for use by appropriately qualified
persons for the purpose of prescribing or administering RADIOTHERAPY, including any
information to be transmitted to other equipment
NOTE A printed or plotted TREATMENT PLAN is referred to as a TREATMENT PLAN report.
3.1.9
TREATMENT PLANNING
process of establishing the TREATMENT PLAN
3.2 Abbreviations
Certain defined terms have been abbreviated in this document as follows:
Defined term Abbreviation
RADIOTHERAPY TREATMENT PLANNING SYSTEM RTPS
BEAM LIMITING DEVICE BLD
COMPUTED TOMOGRAPHY CT
Magnetic resonance imaging MRI
Central processing unit CPU
4 General
4.1 Development
Compliance with IEC 62304 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 of this standard. 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 statement of compliance to this standard shall be included in the technical
description.
Compliance is checked by inspection of the records of the MANUFACTURER.
4.2 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 10.2 and tests of geometric relationships. The tests shall
also demonstrate correct functioning of the RTPS hardware components and their ability to
achieve predetermined results when performing TREATMENT PLANNING functions.
Due to the complexity of TREATMENT PLANNING functions and the possible use of configurations
beyond those specified by the MANUFACTURERS, it is usually not possible for the
MANUFACTURER to demonstrate complete fitness for use of the RTPS at time of installation.
The technical description shall provide explicit warnings to the RESPONSIBLE ORGANIZATION to
add additional tests specific for the installation of the RTPS at the RESPONSIBLE ORGANIZATION.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.

– 10 – 62083 © IEC:2009
5 ACCOMPANYING DOCUMENTS
The ACCOMPANYING DOCUMENTS shall include a technical description and the INSTRUCTIONS FOR
USE, which 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 reference INSTRUCTIONS FOR USE Technical description
1 4.1
2 4.2
3 6.4 a)
4 6.4 c)
5 6.4 d)
6 6.5
7 6.7 a)
8 6.7 b)
9 6.8
10 7.1 g)
11 7.2 b)
12 7.3 b)
13 8.1 a)
14 8.2 a)
15 8.2 c)
16 8.3 c)
17 9.2 a)
18 9.5 a)
19 10.1 a)
20 10.1 b)
21 10.2 a)
22 10.2 c)
23 10.2 c)
24 10.2 d)
25 10.2 e)
26 12
27 13
28 14 b)
29 15 a)
30 15 b)
31 15 d)
32 16
33 A.1
34 A.3
35 A.3
36 Annex B
NOTE The check reference is given as an aid for checking the availability of compliance documentation.

62083 © IEC:2009 – 11 –
6 General requirements for operational safety
6.1 Distances and linear and angular dimensions
Distance measurements and linear dimensions shall be indicated in centimetres or in
millimetres but not both. Angular dimensions shall be indicated in degrees (°) All values of
distance measurements and linear and angular dimensions requested, displayed, or printed
shall include their units.
Compliance is checked by inspection of the DISPLAY and output information.
6.2 RADIATION quantities
All values of RADIATION quantities requested, displayed or printed shall include their units.
RADIATION quantities should conform to the SI convention.
Units of
Compliance is checked by inspection of the DISPLAY and output information.
6.3 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.
NOTE 1 Examples acceptable: "03 Apr 2005", "03/04/2005 (dd/mm/yyyy)".
NOTE 2 Examples not acceptable: "03/04/05", "03 Apr 05".
When the time is requested, displayed or printed, it shall be represented on a 24 h clock
basis, or the letters "a.m." and "p.m." shall be appropriately included. Measurements of time
shall include units (hours, minutes, seconds).
NOTE 3 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).
It shall be possible to enter, display and print time together with an indication of the time zone
and, where applicable, the use of daylight saving time. The OPERATOR should have the
possibility to select or de-select this option.
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.
6.4 Protection against unauthorized use
PASSWORD protection feature, or the use of a key, shall be provided by the
a) A
MANUFACTURER as a means for the RESPONSIBLE ORGANIZATION to ensure that only
authorized persons operate the TREATMENT PLANNING system. 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 RESPONSIBLE ORGANIZATION. 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 RESPONSIBLE ORGANIZATION can specify the levels of protection for
SPECIFIC OPERATORS.
– 12 – 62083 © IEC:2009
EXAMPLE 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.
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 RESPONSIBLE
ORGANIZATION);
– 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.
Compliance is checked by testing and by inspection of the ACCOMPANYING DOCUMENTS.
c) The MANUFACTURER may employ copy protection to prevent the creation of a useable
duplicate RTPS not intended by the MANUFACTURER to be used for TREATMENT PLANNING. If
copy protection is employed, it shall permit backup of data. The existence of copy
protection shall be stated in the INSTRUCTIONS FOR USE.
Compliance is checked by testing and by inspection of the ACCOMPANYING DOCUMENTS.
d) Protection against unauthorized changes to software or data (e.g., viruses) shall be
employed. The manufacturer shall state in the INSTRUCTIONS FOR USE the means of
protection employed.
Compliance is checked by testing and by inspection of the ACCOMPANYING DOCUMENTS.
6.5 Data limits
Data elements entered by the OPERATOR 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 unless the OPERATOR 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 OPERATOR shall be provided in the
INSTRUCTIONS FOR USE and/or shall be provided as part of the error messages displayed by the
RTP when these limits are exceeded.
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 10.2 b).
Compliance is checked by testing and by inspection of the output information and
ACCOMPANYING DOCUMENTS.
6.6 Protection against unauthorized modification
See clause 13.
62083 © IEC:2009 – 13 –
6.7 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.
EXAMPLE DICOM 3 or FTP, each of which includes error detection.
Compliance is checked by inspection of the communication protocol specifications, and by
ACCOMPANYING DOCUMENTS.
inspection of the
b) If data are transmitted for use by another device, other than closed communication with a
peripheral or a component of an integrated RTPS/delivery system that has been type
tested by the MANUFACTURER, 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.
6.8 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 ME 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 ME EQUIPMENT displayed according to
the customization for the particular ME EQUIPMENT performed during EQUIPMENT MODELLING.
In either case, the TREATMENT PLAN reports used for RADIOTHERAPY TREATMENT prescription
shall show the scales and coordinates of ME EQUIPMENT according to the customization for the
particular ME EQUIPMENT performed during EQUIPMENT MODELLING.
The method of display of scales shall be explained in the INSTRUCTIONS FOR USE.
Compliance is checked by testing and by inspection of the DISPLAY, output information and
ACCOMPANYING DOCUMENTS.
6.9 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.

– 14 – 62083 © IEC:2009
7 RADIOTHERAPY TREATMENT EQUIPMENT MODELLING and BRACHYTHERAPY SOURCE
MODELLING
7.1 EQUIPMENT MODEL
a) An EQUIPMENT MODEL shall contain all information required to identify the available
RADIATION QUALITY from the RADIOTHERAPY ME EQUIPMENT in the required detail to prevent
ambiguity. For each RADIATION QUALITY available, this shall include, but not be limited to
– RADIATION QUALITY;
– NOMINAL ENERGY;
– where applicable ABSORBED DOSE profiles and DEPTH DOSE distribution data measured
under, or validated for, conditions that permit modelling in human tissue.
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 ME EQUIPMENT for
which the direction of motion and reference position of motions of ME 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 shall clearly indicate the direction of view from which the OPERATOR is
observing the ME EQUIPMENT.
f) It shall be possible for the OPERATOR to select the convention established by IEC 61217.
g) The means by which ME EQUIPMENT data are input 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 any value without confirmation by
the OPERATOR.
NOTE Some TREATMENT PLANNING functions, such as virtual simulation, may require only a simple EQUIPMENT
MODEL because the ME EQUIPMENT 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 6.5 regarding data limits for parameters entered by the OPERATOR, and 6.8 regarding
coordinate systems and scales.
Compliance is checked by the tests of a), b), c), d), e), f) and h) and by inspection of the
ACCOMPANYING DOCUMENTS.
7.2 BRACHYTHERAPY SOURCE MODEL
a) A BRACHYTHERAPY SOURCE MODEL shall contain:
– parameters describing the ABSORBED DOSE profiles for a nominal source strength (e.g.,
a TG43 model) mea
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