KS C IEC 61303-2007 Medical electrical equipment－Radionuclide calibrators－Particular methods for describing performance《医用电气设备 放射性核素准直器 描述性能的特殊方法》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS C IEC 61303 KS C IEC 61303： 2007(2012 ) 2007 11 29 http:/www.kats.go.krKS C IEC 61303： 2007 : ( ) ( ) ( ) : (http:/www.standard.go.kr) ： ：2007 11 29 ：2012 12 20 2012-0725 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS C IEC 61303： 2007 (2012 ) Med

2、ical electrical equipment Radionuclide calibrators Particular methods for describing performance 1994 1 IEC 61303, Medical electrical equipment Radionuclide calibrators Particular methods for describing performance , . 1 1.1 . , . 1.2 . . ( ) . KS A 4920： 2001, IEC/TR 60788, Medical electircal equip

3、ment Glossary of defined terms IEC 61145： 1992, Calibration and usage of ionization chamber systems for assay of radionuclides 2 IEC/TR 60788 . 2.1 (radioactive standard source) . 2.1.1 KS C IEC 61303： 2007 2 (certified radioactive standard source) . 2.1.2 (traceable radioactive standard source) . 2

4、.2 (radionuclide factor) . 2.3 (overall uncertainty) 68 % . 2.4 (system linearity) (activity) . 2.5 - (air-density characteristic) 2 . 2.6 (sample volume characteristic) 2.7 (ionization chamber test source) . 5 . 5 0.5 % . 2.8 (ionizing radiation shield) . 2.9 (radioactive impurity) . 2.10 (referenc

5、e volume) . KS C IEC 61303： 2007 3 2.11 (radionuclide calibrator) 2.12 (instrument accuracy) 2.13 (random uncertainty) . 3 (Measurement of instrument accuracy) . . a) . . . b) a) . . , . 3.1 3.1.1 (test procedure) . ( ) ( , , ) . . . . , , . Sm So 2/10 . 3.1.2 ： (evaluation of instrument accuracy： p

6、rimary) (activity) Am . (activity) Ao . Al Al Am/Ao100 % . Am/Ao, Sm/Am, So/Ao . Al So/Ao Sm/Am . KS C IEC 61303： 2007 4 2mm2oo2l+=ASASA 3.2 (secondary test method) 3.2.1 (test procedure) 3.1 . . . (So： 3.1.1 3.1.2 ) 2/10 . , . . 241Am, 57Co, 137Cs, 60Co, 125I . 3.2.2 ： (evaluation of instrument acc

7、uracy： secondary) Ay . Az . Ay Sy . Az Sz . . Am/Ao, Sm/Sm, So/Ao(3.1.2 ), Az/Ay, Sz/Az, Sy/Ay . oylmZAAAAA = . 2yy2zz2mmoo2l2+=ASASASASA 4 (Measurement of system linearity) 4.1.1 4.1.2 . 4.2.1 4.2.2 KS C IEC 61303： 2007 5 . . , . . , . 4.1 (primary test methods) 4.1.1 (decaying source method) 4.1.1

8、.1 (test procedure) . . 2 , 10 . . . 4.1.1.2 (evaluation) . 1/40 ( ) . y ( ) x ( ) , . 0.74 MBq 37 MBq (0.02 mCi 1 mCi) , . y y (ER) . ER y , . 1 % 5 % . 4.1.2 (graduated sources method) 4.1.2.1 (test procedure) (series) . . . 10 . 10 10： 5： 2： 1 . , , . . 4.1.2.2 (evaluation) . . KS C IEC 61303： 20

9、07 6 , ER . ER . , 4.1.1.2 . 4.2 (secondary text methods) 4.2.1 (abbreviated decaying source method) 4.2.1.1 (test procedure) 4.1.1.1 10 . 4.2.1.2 4.1.1.2 . 10 100 . 3 . , ER 10 . 4.2.2 (abbreviated graduated sources method) 4.2.2.1 (test procedure) 10 4.1.2.1 . 4.1.2.1 . 4.2.2.2 4.1.2.2 . , ER 4.1.

10、2.2 . 5 (Measurement of system reproducibility) 5.1 . 5.2 . 5.1 (series) . 5 . 20 % . 10 . . 10 . 5.2 KS C IEC 61303： 2007 7 . 5 . 1 GBq 100 . . 10 . 5.3 (evaluation) A , CVA . )1(11ii1i2i=nnAAnACVnnA Ai ： i n ： A ： . 6 (Measurement of air-density characteristic) . . . . , . 6.1 (test method) 10 40

11、106 kPa 94 kPa . 10 106 kPa . . , . . kPa 10 15 20 25 30 35 40 106 104 102 100 98 96 94 KS C IEC 61303： 2007 8 . . 241Am, 57Co, 137Cs, 60Co, 125I . 6.2 (evaluation) . 20 To 100 kPa Po . . YT,P T P PPTTEooPT,273273+= , y YT,P x ET,P YT,P, ET,P . YTo,Po . YTo,Po YT,P . . 7 (Measurement of sample volum

12、e characteristic) 7.1 . . , , . . 7.1 (test method) . 1/10 . . , . . . 1/10 . . . . 7.2 (evaluation) Yv ( V ) y Yv , x V V . Yvo , Vo(3.1 ) . Yvo Yv . 8 (Measurement of background response) KS C IEC 61303： 2007 9 . . . 8.1 (inherent background response test method) 0.2 Sv/h . 137Cs . . . . . 8.2 (ba

13、ckground response to known radiation field test method) 137Cs 2 MBq 1 m . . 137Cs , . 10 , . , MBq ( )(ACTIVITY) . 9 (Measurement of long-term) 9.1 . . . 9.1 (method for measurement of long-term reproducibility) , . 10 . . . (5.3 ). 10 (Measurement of shielding performance) , . a) (3. ) b) (8. ) c)

14、(9. ) 137Cs . . 11 (Accompanying documents and declaration of perfor-mance) KS C IEC 61303： 2007 10 . 11.1 (nature and pressure of gas filling of ionization chamber) 11.2 (dimensions of ionization chamber well) 11.3 (dimensions of source holders) 11.4 (nature and thickness shielding) 11.5 (the maxim

15、um deviation for each parameter tested between a reference and an individual device shall be determined and stated). 11.6 (3.1 3.2 ) , , ( ) radionuclide factors and instrument accuracies for each radionuclide and for each sample container for the reference volume (with and without shielding, if opt

16、ional) as obtained by the relevant test method(3.1 or 3.2) 11.7 99mTc (maximum activity for which the instrument is calibrated and the corresponding activity of 99mTc at the reference volume) 11.8 (system reproducibility over the full range of activity values available from the ionization chamber) 11.9 (system linearity reported in activity units) 11.10 ( ) air-density characteristic(for unsealed chambers only) 11.11 (sample volume characteristics for each sample container type and for each radionuclide) 11.12 ( ) inherent background response (with and