IEC TR 62926-2019 pdf free.Medical electrical system – Guidelines for safe integration and operation of adaptive external-beam radiotherapy systems for real-time adaptive radiotherapy.
1.This document 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 itaddresses 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”ishereafter used to refer to an AEBRS.
This document specifies the safety guidelines for a MANUFACTURER or RESPONSIBLEORGANiZATION who integrates the AEBRS for intra-fractionally moving rigid TARGET VOLUMEs. Ifa RESPONSIBLE ORGANIZATION integrates an AEBRS, then it takes the role of MANUFACTURERand will be referred to as a MANUFACTURER throughout this document.
This document includes reference models of the AEBRS for intra-fractionally moving rigidTARGET 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 todeformations of the TARGET VOLUME are out of the scope of this document. The scope islimited to rigid TARGET VOLUMEs exhibiting intra-fractional movements,both translational androtational. While technical HAZARDs are discussed in this document, the RESPONSIBLEORGANIZATION is reminded that clinical judgement is always employed when determiningclinical usability and reviewing TREATMENT PARAMETER changes.
This document does not specifically address HAZARD mitigations for each of the HAZARDSmentioned in the document; however, some mitigations are given as examples in Clauses 4and 5. All guidelines in this document are intended to be implemented in accordance with thegeneral standard lEC 60601-1:2005 and lEC 60601-1:2005/AMD1:2012,with special attentionto 4.2 of lEC 60601-1:2005 and lEC 60601-1:2005/AMD1:2012.
2.Normative references
The following documents are referred to in the text in such a way that some or all of theircontent constitutes requirements of this document. For dated references,only the editioncited applies. For undated references, the latest edition of the referenced document (includingany amendments) applies.
IEC 60601-1:2005,Medical electrical equipment — Part 1: General requirements for basic safety and essential performance IEC60601-1:2005/AMD1:2012
ISO 14971:2007,Medical devices – Application of risk management to medical devices
3.Terms and definitions
For the purposes of this document, the following terms and definitions apply.IEC TR 62926 pdf download.