KS C IEC 61674-2007 Medical electrical equipment－Dosimeters with ionization chambers and or semi-conductor detectors as used in X-ray diagnostic imaging《医用电气设备 用于X射线诊断成像中带电离室和 或半导体.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS C IEC 61674 X KS C IEC 61674： 2007(2012 ) 2007 11 29 http:/www.kats.go.krKS C IEC 61674： 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 61674： 2007 (2012 ) X

2、 Medical electrical equipment Dosimeters with ionization chambers and/or semi-conductor detectors as used in X-ray diagnostic imaging 1997 1 IEC 61674, Medical electrical equipment Dosimeters with ionization chambers and/or semi-conductor detectors as used in X-ray diagnostic imaging 2002 6 IEC 6167

3、4 1 , . 1 1.1 150 kV X (MAMMOGRAPHY), (RADIOSCOPY) (CT) (RADIOGRAPHY) (AIR KERMA LENGTH) (AIR KERMA RATE) (AIR KERMA) , 3.1 , (DOSIMETERS) . X . 1.2 . a) (DOSIMETERS) . b) . . . , KS C IEC 61010 1 . 2 KS C IEC 61674： 2007 2 . . ( ) . KS A 4920： IEC/TR 60788： 2004, Medical electrical equipment Glossa

4、ry of defined terms KS C IEC 61000 4 1： (EMC) 4： 1： KS C IEC 61000 4 IEC 61000 4 1 ： 2006, Electromagnetic compatibility(EMC) Part 4 1 ： Testing and measurement techniques Overview of IEC 61000 4 series KS C IEC 61000 4 2： (EMC) 4： 2： IEC 61000 4 2 ： 1995, Electromagnetic compatibility(EMC) Part 4 2

5、 ： Testing and measurement techniques Electrostatic discharge immunity test KS C IEC 61000 4 3： (EMC) 4： 3： IEC 61000 4 3 ： 1995, Electromagnetic compatibility(EMC) Part 4 3 ： Testing and measurement techniques Radiated, radio-frequency, electromagnetic field immunity test KS C IEC 61000 4 4： (EMC)

6、4： 4： IEC 61000 4 4 ： 1995, Electromagnetic compatibility(EMC) Part 4 4 ： Testing and measurement techniques Electrical fast transient/burst immunity test KS C IEC 61000 4 5： (EMC) 4： 5： IEC 61000 4 5 ： 2001, Electromagnetic compatibility(EMC) Part 4 5 ： Testing and measurement techniques Surge immu

7、nity test KS C IEC 61000 4 6： (EMC) 4： 6： EMC IEC 61000 4 6 ： 2001, Electromagnetic compatibility(EMC) Part 4 6 ： Testing and measurement techniques Immunity to conducted disturbances induced by radio-frequency fields KS C IEC 61000 4 11： (EMC) 4 11： , IEC 61000 4 11 ： 1994, Electromagnetic compatib

8、ility(EMC) Part 4 11 ： Testing and measurement techniques Voltage dips, short interruptions and voltage variation immunity tests KS C IEC 61267： X IEC 61267： 1994, Medical diagnostic X-ray equipment Radiation conditions for use in the determination of characteristics IEC 60417： 1973, Graphical symbo

9、ls for use on equipment Index, survey and compilation of the single sheets IEC 61187： 1993, Electrical and electronic measuring equipment Documentation 3 “shall” . “may” . . KS C IEC 61674： 2007 3 KS A 4920： IEC/TR 60788： 2004, Medical electrical equipment Glossary of defined terms ISO Guide 99： 199

10、3, International vocabulary of basic and general terms in metrology(VIM) . , . . B . . 3.1 ( ) (DIAGNOSTIC) DOSIMETER X (AIR KERMA), (AIR KERMA LENGTH) (AIR KERMA RATE) (IONIZATION CHAMBERS) (SEMI-CONDUCTOR DETECTORS) . (DIAGNOSTIC DOSIMETER) . (DETECTOR ASSEMBLIES) (MEASURING ASSEMBLY) ( ) (STABILI

11、TY CHECK DEVICES) 3.1.1 (DETECTOR ASSEMBLY) (RADIATION DETECTOR) (MEASURING ASSEMBLY) . 1 . ( )(stem or body) ( ). 3.1.1.1 (RADIATION DETECTOR) , (element). . a) (IONIZATION CHAMBER) , (CHAMBER) (IONIZATION RADIATION) . (CHAMBER) . . b) (VENTED CHAMBER) . . . c) (SEMI-CONDUCTOR DETECTOR) 1) 2) KS C

12、IEC 61674： 2007 4 1) (shorted junction) 2) 3.1.2 (MEASURING ASSEMBLY) (AIR KERMA), (AIR KERMA LENGTH) (AIR KERMA RATE) 3.1.3 (STABILITY CHECK DEVICE) / (STABILITY CHECK DEVICE) (radiation source) . 3.1.4 CT (CT DOSIMETER) X (IONIZATION CHAMBER) / CT . (DETECTOR ASSEMBLIES) (MEASURING ASSEMBLY) 3.1.5

13、 CT (CT DETECTOR) CT 3.2 (INDICATED VALUE) 3.3 (TRUE VALUE) 3.4 (CONVENTIONAL TRUE VALUE) (TRUE VALUE) , (CONVENTIONAL TRUE VALUE) (STANDARD) . 3.4.1 (STANDARD) KS C IEC 61674： 2007 5 ( ) . 3.5 (MEASURED VALUE) (CORRECTION FACTORS) (CALIBRATION FACTOR) 3.5.1 (ERROR OF MEASUREMENT) 3.5.2 (OVERALL UNC

14、ERTAINTY) , (4.5 ). 3.5.3 (EXPANDED UNCERTAINTY) . 3.6 (CORRECTION FACTOR) . 3.7 (INFLUENCE QUANTITY) ( , , ). 3.8 (INSTRUMENT PARAMETER) . 3.9 (REFERENCE VALUE) (INFLUENCE QUANTITY) (INSTRUMENT PARAMETER) , ( ) ( ) 3.9.1 (REFERENCE CONDITIONS) 3.10 (STANDARD TEST VALUES) , , , . KS C IEC 61674： 200

15、7 6 3.10.1 (STANDARD TEST CONDITIONS) 3.11 (INTRINSIC ERROR) (CONVENTIONAL TRUE VALUE) ( , ) 3.11.1 (RELATIVE INTRINSIC ERROR) (INTRINSIC ERROR) 3.12 (PERFORMANCE CHARACTERISTIC) (RESPOND), (LEAKAGE CURRENT) 3.12.1 (RESPONSE) 3.12.2 (RESOLUTION OF THE DISPLAY) . . . 3.12.3 (EQUILIBRATION TIME) (INFL

16、UENCE QUANTITY) 3.12.4 (RESPONSE TIME) 3.12.5 (STABILIZATION TIME) (DOSIMETER) (IONIZATION CHAMBER) 3.12.6 (LEAKAGE CURRENT) . KS C IEC 61674： 2007 7 3.13 (VARIATION) , ( ) ( ) (STANDARD TEST VALUES) , y/y 3.14 (LIMITS OF VARIATION) , y . L % , y/y , L % L % . 3.15 (of INDICATED VALUES) (EFFECTIVE R

17、ANGE) , ( ) ( ) . , . 1 . 2 CT . , 1 Gy m 2 Gy m 3.16 (of USE) (RATED RANGE) . 3.16.1 (MINIMUM RATED RANGE) 3.17 (of RADIATION DETECTOR) (REFERENCE POINT) (CONVENTIONAL TRUE VALUE) 3.18 (MEDICAL ELECTRICAL) (EQUIPMENT) (SUPPLY MAINS) (KS P IEC 606011： 2007, 2.2.15). 3.18.1 (SUPPLY MAINS) KS C IEC 61

18、674： 2007 8 (KS P IEC 60601 1： 2007, 2.12.10). 3.18.2 (PATIENT) ( )(KS P IEC 60601 1： 2007, 2.12.4) 3.18.3 (ACCESSIBLE METAL PART) (TOOL) (METAL PART)(KS P IEC 60601 1： 2007, 2.1.2) 3.18.4 (TOOL) (fasteners) (KS P IEC 60601 1： 2007, 2.12.12) 3.19 (UNATTENUATED BEAM) X 3.19.1 (UNATTENUATED BEAM QUALI

19、TY) , X 3.20 (ATTENUATED BEAM) X 3.20.1 (ATTENUATED BEAM QUALITY) X 3.21 (RATED LENGTH) CT 3.21.1 (EFFECTIVE LENGTH) 50 % CT 3.22 (AIR KERMA) (letter symbol K) ICRU 33 C.6 K dEtr dm . dEtr dm . Gy (1 Gy 1 J kg 1). 3.22.1 AIR KERMA RATE (letter symbol K&) ICRU 33 C.7 dt dK dt . dK dtKS C IEC 61674： 2

20、007 9 . Gy/s 1 (Gy/min, Gy/h). 3.22.2 (AIR KERMA LENGTH) (letter symbol K l) CT X , . Gy m (mGy m). 3.23 X (X-RAY) (TUBE VOLTAGE) X , (electron emitter), (anode) 3.24 (COFFICIENT OF VARIATION) 3.25 (ACCOMPANYING DOCUMENTS) , , (accessory) , , (KS A 4920, rm 82 01) 3.25.1 (INSTRUCTIONS FOR USE) (KS A

21、 4920, rm 8202) 3.25.2 (USER) IEC , (KS A 4920, rm 85 01). 3.26 (OPERATOR) (KS A 4920, rm 85 02) 3.27 (MANUFACTURER) “ ” KS A 4920 rm 85 03 . 4 (General requirements) 4.1 (performance requirements) 5. 6. . 4.4 5. 6. . 4.2 (REFERENCE VALUES and STANDARD TEST VALUES) KS C IEC 61674： 2007 10 1 . 4.3 (g

22、eneral test conditions) 4.3.1 (STANDARD TEST CONDITIONS) 1 . a) (INFLUENCE QUANTITY) b) , . 4.3.2 (statistical fluctuations) (low AIR KERMA) (AIR KERMA RATES) . . 2 (confidence level) 95 % . n ( ) (COEFFICIENT OF VARIATION), v . 4.3.3 (STABILIZATION TIME) , . , . 4.3.4 (adjustments during test) . , . , 0 (LEAKAGE CURRENT) . 4.3.5 (batteries) . 4.4 (constructional requirements as related to performance) 4.4.1 (components) , . KS C IEC 61674： 2007 11