DANSK DSF/IEC TR 62926 ED1 PDF

This Technical Report 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 Technical Report, the word “system” is hereafter used to refer to an AEBRS. IEC 60601-1 Edition 3.1 sub-clause 4.2.3.2 HAZARDs not identified in the IEC 60601 series states as follows; “For HAZARDs or HAZARDOUS SITUATIONs that are identified for the particular ME EQUIPMENT or ME SYSTEM but are not specifically addressed in this standard or its collateral or particular standards, the MANUFACTURER shall address those HAZARDs in the RISK MANAGEMENT PROCESS as specified in 4.2.2.”