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.
General Information
Standards Content (Sample)
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
IEC TR 62926:2019-05(en)
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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
Warning! Make sure that you obtained this publication from an authorized distributor.
® Registered trademark of the International Electrotechnical Commission
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– 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 .
...
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