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IEC TR 62926
Edition 1.0 2019-05
TECHNICAL
REPORT
colour
inside
Medical electrical system –
Guidelines for safe integration and operation of adaptive external-beam
radiotherapy systems for real-time adaptive radiotherapy
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IEC TR 62926
Edition 1.0 2019-05
TECHNICAL
REPORT
colour
inside
Medical electrical system –
Guidelines for safe integration and operation of adaptive external-beam
radiotherapy systems for real-time adaptive radiotherapy
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.50 ISBN 978-2-8322-6911-4
– 2 – IEC TR 62926:2019 © IEC 2019
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 9
2 Normative references . 9
3 Terms and definitions . 9
4 General safety guidelines for an AEBRS for intra-fractionally moving rigid TARGET
VOLUMEs . 12
4.1 TARGET VOLUMEs addressed in this document . 12
4.2 Relationship between system configuration of an AEBRS, existing standards,
and this document. 13
4.2.1 General . 13
4.2.2 Representative configurations of AEBRSs, their relationships to existing
standards, and this document . 13
4.2.3 Representative AEBRS reference models . 16
4.3 RISK MANAGEMENT of an AEBRS . 17
4.3.1 General . 17
4.3.2 RISK ANALYSIS of an AEBRS . 18
4.3.3 RISK EVALUATION . 18
4.3.4 RISK control . 18
4.3.5 Evaluation of overall RESIDUAL RISK acceptability . 18
4.3.6 RISK MANAGEMENT report . 19
4.3.7 Examples of RISK MANAGEMENT of an AEBRS . 19
5 Guidance for design elements that should be considered for safe integration of an
AEBRS for intra-fractionally moving TARGET VOLUMEs . 19
5.1 General . 19
5.2 Specific guidelines for an AEBRS . 20
5.2.1 Configuration of the AEBRS . 20
5.2.2 INTERLOCKs . 20
5.2.3 Coordinate system . 21
5.2.4 Communication between pieces of equipment. 21
5.2.5 Interactions between MDE, MCF and EBE . 22
5.2.6 Status check of each piece of equipment . 23
5.2.7 Failure state judgement . 23
5.2.8 LATENCY related to an AEBRS. 23
5.2.9 Typical verification items of the AEBRS . 25
5.2.10 Validation of AEBRS . 25
5.3 Specific guidelines for the MOTION COORDINATION FUNCTION . 25
5.3.1 PREDICTION MODEL. 25
5.3.2 Gating and tracking . 25
Annex A (informative) A minimum set of HAZARDs to consider for adaptive TREATMENT
functions . 27
A.1 Overview. 27
A.2 Reference design for adaptive TREATMENT functionality . 27
A.3 Overview of HAZARDOUS SITUATIONS . 28
Annex B (informative) An example of RISK ANALYSIS for an AEBRS with gating function
using X-RAY FLUOROSCOPE as an MDE . 32
B.1 Configuration of the example AEBRS . 32
B.2 PROCESS overview . 32
B.3 HAZARDOUS SITUATIONS and RISK fishbone diagram . 33
B.4 Failure Mode and Effect Analysis (FMEA) . 33
B.5 RISK ANALYSIS. 37
Annex C (informative) An example of RISK ANALYSIS for an AEBRS with tracking
using two different MDEs . 38
function
C.1 Configuration of the example AEBRS . 38
C.2 Failure Mode and Effect Analysis (FMEA) . 38
Annex D (informative) Dynamic phantom for validation tests . 42
D.1 Necessity of a dynamic phantom . 42
D.2 Guidelines for a simple dynamic phantom . 42
D.3 Example of dosimetric validation test using the dynamic phantom . 42
Bibliography . 44
Index of defined terms . 46
Figure 1 – Concept of AEBRS with information flow . 7
Figure 2 – Example of system configuration . 7
Figure 3 – AEBRS incorporating an MDE addressed by particular standards . 14
Figure 4 – AEBRS incorporating an MDE not addressed by a particular standard . 14
Figure 5 – AEBRS incorporating an MDE with an interface to an MCF . 14
Figure 6 – AEBRS incorporating an MCF with an interface to an EBE . 14
Figure 7 – AEBRS with a gating interface between an MCF and an EBE . 15
Figure 8 – Functions and information flow of an AEBRS . 15
Figure 9 – BEAM GATING system for intra-fractionally moving rigid TARGET VOLUMEs . 16
Figure 10 – Beam tracking system for intra-fractionally moving rigid TARGET VOLUMEs . 17
Figure A.1 – Functional decomposition of adaptive TREATMENT control for gating and
tracking functionality in the AEBRS . 28
Figure B.1 – Risk fishbone diagram for an AEBRS . 33
Figure B.2 – Tables for RISK ANALYSIS . 37
Figure D.1 – Sketch of a simple dynamic phantom . 43
Table B.1 – Failure Mode and Effect Analysis (FMEA) for an AEBRS using fluoroscope
as a MDE, gating function as an MCF, and proton beam therapy machine as an EBE . 34
Table C.1 – Failure Mode and Effect Analysis (FMEA) for an AEBRS with tracking
function as an MCF, and Infrared (IR) camera as MDE 1, x-ray fluoroscope as MDE 2,
MEDICAL ELECTRON ACCELERATOR as EBE . 39
and
– 4 – IEC TR 62926:2019 © IEC 2019
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL SYSTEM –
GUIDELINES FOR SAFE INTEGRATION AND OPERATION OF ADAPTIVE
EXTERNAL-BEAM RADIOTHERAPY SYSTEMS FOR REAL-TIME ADAPTIVE
RADIOTHERAPY
FOREWORD
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