1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS C IEC 60601 2 11 KS C IEC 60601 2 11: 2007(2012 ) 2007 11 29 http:/www.kats.go.krKS C IEC 60601 2 11: 2007 : ( ) ( ) ( ) : (http:/www.standard.go.kr) : :2002 10 8 :2007 11 29 :2012 12 20 : 2012-0725 : ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS C I
2、EC 60601 2 11: 2007 (2012 ) Gamma beam therapy equipment 1997 2 IEC 60601 2 11, Medical electrical equipment Part 2 :Particular requirements for the safety of gamma beam therapy equipment 2004 Amendment 1 . 1 KS P IEC 60601 1 1. . 1 KS P IEC 60601 1 1. . 1.1 KS P IEC 60601 1 1.1 . aa) (PES) . bb) 5
3、cm . . . . cc) . dd) . ee) . 1.2 KS P IEC 60601 1 1.2 . aa) , . KS C IEC 60601 2 11: 2007 2 bb) . . 1.3 KS P IEC 60601 1( ) . KS P IEC 60601 1 “ ” “ ” . KS P IEC 60601 1 2 KS P IEC 60601 1 3. . 2.101 (beam off) 2.102 (beam on) 2.103 (controlling timer) 2.104 (field size) 2.105 (gantry) 2.106 (geomet
4、rical field size) . . . 2.107 interruption(of irradiation)/to interrupt(irradiation) . , 2.108 (normal treatment distance) 2.109 KS C IEC 60601 2 11: 2007 3 1 /2 primary/secondary(timer) combination 1 2 2 2.110 1 (primary timer) 2.111 (programmable electronic system, PES) , , . , (actuator) 1 (CPU)
5、. 2.112 (qualified person) 2.113 ( ) redundant (timer) combination 2 2 2.114 (relative surface dose) 0.5 mm . 2.115 2 (secondary timer) 1 2.116 (site test) 2.117 termination (of irradiation)/to terminate (irradiation) . , . , 2.118 (treatment) 2.119 KS C IEC 60601 2 11: 2007 4 (treatment field) 2.12
6、0 (type test) 2.121 (zero applicator) 2.122 (Helmet) MSSR 3 (MIBLS) 2.123 (Repositioning) MIBLS 2.124 (Repositioning point) MIBLS 2.125 (Repositioning time) 2.126 (Stereotaxis) 3 2.127 (Transition time) MIBLS 2.128 (Transition radiation) 4 KS P IEC 60601 1 5. . 4.1 KS P IEC 60601 1 5.1 . aa) 3 . KS
7、C IEC 60601 2 11: 2007 5 A: : : B: , . , . C: . . . . . . 4.6 KS P IEC 60601 1 5.4 . aa) . A B C 1 1 . . , . . a) b) c) , d) e) , . 4.8 KS P IEC 60601 1 5.6 . aa) 4.10 . 4.10 KS C IEC 60601 2 11: 2007 6 KS P IEC 60601 1 5.7 . aa) . . 5 KS P IEC 60601 1 6. . 5.1 1 . 5.2 B . , MSSR B BF . 5.3 (IPX0) .
8、 5.4 ( ) . 5.5 AP APG . 5.6 . 6 , KS P IEC 60601 1 7. . 6.1 KS P IEC 60601 1 7.2 . z) / aa) . 6.2 KS P IEC 60601 1 7.3 . aa) KS P IEC 60601 1 D.1 14 “ , .” . 6.3 KS P IEC 60601 1 7.4 . KS C IEC 60601 2 11: 2007 7 aa) 1) . 2) KS C IEC 61217 ( , ) . 3) . 4) . 6.7 KS P IEC 60601 1 7.8 . a) aa) . ON 2 (
9、LEDs) . LEDs . . MSSR , . MSSR , KS C IEC 61217 . MSSR . 6.8 6.8.1 KS C IEC 60601 1 7.9 . 6.8.2 KS P IEC 60601 1 7.9.2 . a) aa) . 1) 2) 3) 4) 5) (29.1.1.3 ) 6) KS C IEC 60601 2 11: 2007 8 (29.1.3.3 ) 7) 1 . (29.1.3.3 ) 8) 2 (29.1.3.5 ) 9) 29.2 . 10) (field) 29.3 MSSR . 11) 29.3.2 12) (29.4.4.1 ) 13)
10、 14) (wipe tests) (29.4.4.5 ) 15) 29.4.5 bb) , . cc) , . , 100 W , . , 6.8.3 KS P IEC 60601 1 7.9.2.5 . a) aa) . 1) 2) . . 3) 1 m 4) 5) 6) 7) , 8) MSSR KS C IEC 60601 2 11: 2007 9 9) MSSR 10) MSSR 0.5, 1.0, 1.5, 2.0 m ( 105 ) 2 10 . 10.1 . aa) bb) . 10.2 . 3 KS P IEC 60601 1 8. . 16 KS P IEC 60601 1
11、 8. . KS P IEC 60601 1 8. . 18 , KS P IEC 60601 1 8.6 . b) , . . B : . 19 KS P IEC 60601 1 8.7 . KS C IEC 60601 2 11: 2007 10 19.1 a) b) 19.3 . B : . a) b) 19.2 19.3 . B : . 19.3 10 mA 0.5 mA 19.4 KS P IEC 60601 1 8.7.4 . 20 KS P IEC 60601 1 8.8.3 . . . 4 KS P IEC 60601 1 9. . 21 KS P IEC 60601 1 9.
12、1 . . . KS C IEC 60601 2 11: 2007 11 22 . a) . 2 . . MSSR , 2 . , B : MSSR . b) . . c) 2 , 10 mm . B : . . 2 , 10 mm . d) 1 1 . 7 . 1 , 1 0.5 . 2 . 12 13(6.3 aa ) 10 mm/s . 50 mm/s . 10 mm . (6.3 9, 10 11) 50 mm/s . 50 mm/s . , 10 mm . e) . B : . 5 . . f) MSSR . KS C IEC 60601 2 11: 2007 12 g) MSSR . B : . 27 . , 2 , 10 mm . C : . . 28 KS P IEC 60601 1 9.8.3 . ( ) . A : . B : . . 5 , KS P IEC 60601 1 10. . 29 X KS P IEC 60601 1 10.1 . 29 . , , , , , KS C IEC 60601 2 11: 2007 13 . 29. . 1.1 , 1.2 , 4.1 aa), 4.6 aa), 6.3
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