標準號：BS EN 60976-2007
中文標準名稱：醫療電氣設備.醫療電子加速器.功能的特性特征
英文標準名稱：Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
標準類型：C43
發布日期：2008/4/30 12:00:00
實施日期：2004/3/30 12:00:00
中國標準分類號：C43
國際標準分類號：11.040.50; 13.280
引用標準：IEC 60580-2000;IEC 60601-1-2005;IEC 60601-2-1-1998;IEC 60788-2004;IEC 60977;IEC 61217;IEC 61223-1-1993
適用范圍：This International Standard applies to medical ELECTRON ACCELERATORS when used, fortherapy purposes, in human medical practice.This standard applies to medical ELECTRON ACCELERATORS which deliver a RADIATION BEAM ofeither X-RADIATION or ELECTRON RADIATION with NOMINAL ENERGIES in the range 1 MeV to 50 MeVat maximum ABSORBED DOSE RATES between 0,001 Gy s–1 and 1 Gy s–1 at 1 m from theRADIATION SOURCE and at NORMAL TREATMENT DISTANCES between 50 cm and 200 cm from theRADIATION SOURCE.The present standard describes measurements and test procedures to be performed by theMANUFACTURER at the design and construction stage of a medical ELECTRON ACCELERATOR butdoes not specify ACCEPTANCE TESTS to be performed after installation at the purchaser's site.The accompanying report, IEC 60977, however, does suggest that many of the testprocedures are appropriate for ACCEPTANCE TESTS.The measurement conditions described in the present standard differ from those previously inuse. This applies particularly to the PHANTOM position for measurements and themeasurement of distances from the ISOCENTRE. These new conditions should be substitutedfor and not be added to previous methods.This standard specifies test procedures for the determination and disclosure of functionalperformance characteristics, knowledge of which is deemed necessary for proper applicationand use of a medical ELECTRON ACCELERATOR and which are to be declared in theACCOMPANYING DOCUMENTS together with the greatest deviation or variation to be expectedunder specific conditions in NORMAL USE. A format for presentation of functional performancevalues is given in Annex A.It is recognized that inaccuracies in the test methods must be allowed for when assessingperformance. However, it was not felt to be advisable to combine the errors into an overallperformance tolerance but to keep them separate in the expectation that more accurate testmethods will be evolved.It is not intended that this standard should in any way inhibit the future development of newdesigns of equipment which may have operating modes and parameters different from thosedescribed herein, provided that such equipment achieves equivalent levels of performance forthe TREATMENT of PATIENTS.Except where otherwise stated this standard assumes that the medical ELECTRONACCELERATORS have an ISOCENTRIC GANTRY. Where the equipment is non-isocentric, thedescription of performance and test methods may need to be suitably adapted.