oSIST prEN IEC 62083:2024

Medical device software - Requirements for the safety of radiotherapy treatment planning systems

2019-05-29 IP: Link to legislation (MDD) removed following CLC/TC 62 decision 02/2019 decision (May 2019 plenary)

Medizinische elektrische Geräte - Festlegungen für die Sicherheit von Bestrahlungsplanungssystemen

Appareils électromédicaux - Exigences de sécurité pour les systèmes de planification de traitement en radiothérapie

Programska oprema za medicinske aparate - Zahteve za varnost sistemov za načrtovanje radioterapevtske obravnave

General Information

• Status: Not Published
• Public Enquiry End Date: 31-Oct-2024
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 04-Sep-2024
• Due Date: 22-Jan-2025
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: prEN IEC 62083:2024 - Medical device software - Requirements for the safety of radiotherapy treatment planning systems

Relations

• Revises: SIST EN 62083:2010 - Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems (IEC 62083:2009)
• Effective Date: 26-Jan-2023
• Revises: SIST EN 62083:2010 - Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems (IEC 62083:2009)
• Effective Date: 05-Feb-2019

Standards Content (Sample)

SLOVENSKI STANDARD
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
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
S
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