PD IEC TR 62926:2019 - Medical electrical system. Guidelines for safe integration and operation of adaptive external-beam radiotherapy systems for real-time adaptive radiotherapy

PD IEC TR 62926:2019

Medical electrical system. Guidelines for safe integration and operation of adaptive external-beam radiotherapy systems for real-time adaptive radiotherapy

Status : Current   Published : June 2019

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PDF

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HARDCOPY



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.




Standard NumberPD IEC TR 62926:2019
TitleMedical electrical system. Guidelines for safe integration and operation of adaptive external-beam radiotherapy systems for real-time adaptive radiotherapy
StatusCurrent
Publication Date07 June 2019
Normative References(Required to achieve compliance to this standard)IEC 60601-1:2005, ISO 14971:2007, IEC 60601-1:2005/AMD1:2012
Informative References(Provided for Information)IEC 62304, ASTM F-2761:2013, IEC 60601-2-1, NEMA RT 1-2014:2014, ISO 13485, ISO TS 10974, IEC 60601-1, IEC 60601-1-8, IEC 60601-1-2, IEC 61217, IEC 60601-2-17:2013, IEC 60601-2-33:2010, IEC 62083:2009, IEC 60601-2-68:2014, IEC 60601-2-64:2014, IEC 62570:2014, ISO/TR 24971:2013, IEC 60601-2-5:2009, IEC TR 60788:2004, IEC 60601-2-44:2009, IEC 60747-14-4:2011
International RelationshipsIEC TR 62926:2019
DescriptorsVolume, Safety, Radiotherapy, Beams, Medical electrical equipment
ICS11.040.50
CommitteeCH/62/3
ISBN978 0 580 95475 7
PublisherBSI
FormatA4
DeliveryYes
Pages50
File Size2.166 MB
Price£240.00


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