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IEC/TR 62926 Ed. 1.0 en:2019 Medical electrical system - Guidelines for safe integration and operation of adaptive external-beam radiotherapy systems for real-time adaptive radiotherapy, 2019
- CONTENTS
- FOREWORD
- INTRODUCTION
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General safety guidelines for an AEBRS for intra-fractionally moving rigid target volumes [Go to Page]
- 4.1 Target volumes addressed in this document
- 4.2 Relationship between system configuration of an AEBRS, existing standards, and this document [Go to Page]
- 4.2.1 General
- 4.2.2 Representative configurations of AEBRSs, their relationships to existing standards, and this document
- 4.2.3 Representative AEBRS reference models
- 4.3 Risk management of an AEBRS [Go to Page]
- 4.3.1 General
- 4.3.2 Risk analysis of an AEBRS
- 4.3.4 Risk control
- 4.3.5 Evaluation of overall residual risk acceptability
- 4.3.6 Risk management report
- 4.3.7 Examples of risk management of an AEBRS
- 5 Guidance for design elements that should be considered for safe integration of an AEBRS for intra-fractionally moving target volumes [Go to Page]
- 5.1 General
- 5.2 Specific guidelines for an AEBRS [Go to Page]
- 5.2.1 Configuration of the AEBRS
- 5.2.2 Interlocks
- 5.2.3 Coordinate system
- 5.2.4 Communication between pieces of equipment
- 5.2.5 Interactions between mde, mcf and ebe
- 5.2.6 Status check of each piece of equipment
- 5.2.7 Failure state judgement
- 5.2.9 Typical verification items of the AEBRS
- 5.2.10 Validation of AEBRS
- 5.3 Specific guidelines for the motion coordination function [Go to Page]
- 5.3.1 PREDICTION MODEL
- 5.3.2 Gating and tracking
- Annex A (informative)A minimum set of hazards to consider for adaptive treatment functions [Go to Page]
- A.1 Overview
- A.2 Reference design for adaptive treatment functionality
- A.3 Overview of hazardous situations
- Annex B (informative)An example of risk analysis for an AEBRS with gating function using x-ray fluoroscope as an mde [Go to Page]
- B.1 Configuration of the example AEBRS
- B.2 Process overview
- B.3 Hazardous situations and risk fishbone diagram
- B.4 Failure Mode and Effect Analysis (FMEA)
- B.5 RISK ANALYSIS
- Annex C (informative)An example of risk analysis for an AEBRS with tracking function using two different mdes [Go to Page]
- C.1 Configuration of the example AEBRS
- C.2 Failure Mode and Effect Analysis (FMEA)
- Annex D (informative)Dynamic phantom for validation tests [Go to Page]
- D.1 Necessity of a dynamic phantom
- D.2 Guidelines for a simple dynamic phantom
- D.3 Example of dosimetric validation test using the dynamic phantom
- Bibliography
- Index of defined terms
- Figures [Go to Page]
- Figure 1 – Concept of AEBRS with information flow
- Figure 2 – Example of system configuration
- Figure 3 – AEBRS incorporating an mde addressed by particular standards
- Figure 4 – AEBRS incorporating an mde not addressed by a particular standard
- Figure 5 – AEBRS incorporating an mde with an interface to an mcf
- Figure 6 – AEBRS incorporating an mcf with an interface to an ebe
- Figure 7 – AEBRS with a gating interface between an mcf and an ebe
- Figure 8 – Functions and information flow of an AEBRS
- Figure 9 – Beam gating system for intra-fractionally moving rigid target volumes
- Figure 10 – Beam tracking system for intra-fractionally moving rigid target volumes
- Figure A.1 – Functional decomposition of adaptive treatment control for gating and tracking functionality in the AEBRS
- Figure B.1 – Risk fishbone diagram for an AEBRS
- Figure B.2 – Tables for risk analysis
- Figure D.1 – Sketch of a simple dynamic phantom
- Tables [Go to Page]
- 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
- 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, and medical electron accelerator as ebe [Go to Page]
