IEC TR 62926:2019
(Main)Medical electrical system - Guidelines for safe integration and operation of adaptive external-beam radiotherapy systems for real-time adaptive radiotherapy
Medical electrical system - Guidelines for safe integration and operation of adaptive external-beam radiotherapy systems for real-time adaptive radiotherapy
IEC TR 62926:2019 provides guidelines for safe integration and operation of an adaptive external-beam RADIOTHERAPY system (AEBRS) for intra-fractionally moving rigid TARGET VOLUMEs, where required equipment can be sourced from one or several MANUFACTURERs. In particular it addresses guidelines to help ensure safe integration and operation for the PATIENT, OPERATOR, other persons and sensitive devices in the vicinity. In this document, the word “system” is hereafter used to refer to an AEBRS.
This document specifies the safety guidelines for a MANUFACTURER or RESPONSIBLE ORGANIZATION who integrates the AEBRS for intra-fractionally moving rigid TARGET VOLUMEs. If a RESPONSIBLE ORGANIZATION integrates an AEBRS, then it takes the role of MANUFACTURER and will be referred to as a MANUFACTURER throughout this document.
This document includes reference models of the AEBRS for intra-fractionally moving rigid TARGET VOLUMEs and HAZARDs which, at a minimum, are considered during the RISK ANALYSIS.
Although TARGET VOLUMES and OARs can deform during motion, adaptations in response to deformations of the TARGET VOLUME are out of the scope of this document. The scope is limited to rigid TARGET VOLUMEs exhibiting intra-fractional movements, both translational and rotational. While technical HAZARDs are discussed in this document, the RESPONSIBLE ORGANIZATION is reminded that clinical judgement is always employed when determining clinical usability and reviewing TREATMENT PARAMETER changes.
This document does not specifically address HAZARD mitigations for each of the HAZARDs mentioned in the document; however, some mitigations are given as examples in Clauses 4 and 5. All guidelines in this document are intended to be implemented in accordance with the general standard IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, with special attention to 4.2 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.
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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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