KS C IEC 60601-2-10-2008 Low frequency therapy equipment《低频治疗仪》.pdf

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1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS C IEC 60601 2-10 KS C IEC 60601 2-10:2008 2008 11 28 http:/www.kats.go.krKS C IEC 60601 2-10:2008 : ( ) ( ) FITI ( ) : (http:/www.standard.go.kr) ： ： 1979 12 24 ： 2008 11 28 2008-0810 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS C IEC 60601 2-10

2、:2008 i (KS) (IS) 1987 1.0 IEC 60601 2-10, Medical electrical equipment Part 2： Particular requirements for the safety of nerve and muscle stimulators , . . , , . , , . KS C IEC 60601 2-10:2008 Low frequency therapy equipment 1 1 KS C IEC 60601 1 . 1.1* KS C IEC 60601 1 1.1 . 2.1.101 . . . (： ) 2 .

3、2.1.5 (applied part) KS C IEC 60601 1 2.1.5 . KS C IEC 60601 2-10:2008 2 2.1.101 (stimulator) 2.1.102 (pulse duration) 50 % 2.1.103 (waveform) ( ) 3 KS C IEC 60601 1 . 4 KS C IEC 60601 1 . 4.1 b) KS C IEC 60601 1 4.1 b) . ： B 5* KS C IEC 60601 1 . 5.1* KS C IEC 60601 1 5.1 . 3 5.2* KS C IEC 60601 1

4、5.2 . B 5.6* KS C IEC 60601 1 5.6 . 6* , KS C IEC 60601 1 . 6.1* j) KS C IEC 60601 2-10:2008 3 7.3 aa) 5 . p) KS C IEC 60601 1 6.1 p) . 5 10 mA r.m.s. 10 V r.m.s. 14 (KS C IEC 60601 1 D ) . 6.7 KS C IEC 60601 1 6.7 . 51.103 6.8 6.8.2* KS C IEC 60601 1 6.8.2 . aa) . a) d.c. , , , / , b) c) d.c. d) (

5、) e) ： . ( 1 m ) . f) 10 mA r.m.s. 10 V r.m.s. ： 2 mA r.m.s./cm2 6.8.3 KS C IEC 60601 1 6.8.3 . aa) 6.8.2 aa) a) . . 7 KS C IEC 60601 1 . 7.3 KS C IEC 60601 1 7.3 . KS C IEC 60601 2-10:2008 4 aa) (6.8.3 ) . 2 8. 12. KS C IEC 60601 1 . 3 13 KS C IEC 60601 1 . KS C IEC 60601 1 13. . ( ) , . 14 KS C IE

6、C 60601 1 . 14.3* 3 . 14.4 a) KS C IEC 60601 1 14.4 a) . 3 14.6* KS C IEC 60601 1 14.6 . BF CF . 15. 18. KS C IEC 60601 1 . 19* KS C IEC 60601 1 . KS C IEC 60601 1 19. . KS C IEC 60601 1 ( 13. ) . 20* KS C IEC 60601 2-10:2008 5 KS C IEC 60601 1 . 20.2* KS C IEC 60601 1 20.2 . B b： . B f： KS C IEC 60

7、601 1 20.2 . B f , . 20.3 KS C IEC 60601 1 20.3 . B d： U 250 V (1 , 2 ) 1 500 V . 4 21. 28. KS C IEC 60601 1 . 5 29. 35. KS C IEC 60601 1 . 36* KS C IEC 60601 1 . KS C IEC 60601 1 36. . . , 10 % . . 1 3 . 101, 102, 103 . ISM ( 27.12 MHz) (R.F.： Radio Frequency) 2.5 W R.F. R.F. 800 R.F. d.c. a.c. 10

8、MHz . KS C IEC 60601 2-10:2008 6 , , . 1 101 . 2 , . . VSWR 1.3 ( 2 % ) R1 2.5 W10 % R.F. . AA( 101) . AA( 101) (2 ) . 2 102 . 2 , . . 400 mm 400 mm . VSWR 1.3 ( 2 % ) 1 W10 % R.F. . (L1, L2, C1, C2) BB R.F. . BB R.F. . 3( ) 103 . 2 , . . 400 mm 400 mm . VSWR 1.3 ( 2 % ) ( 103) 2.5 W10 % R.F. . CC (

9、 103) R.F. . R.F. . 6 37. 41. KS C IEC 60601 1 . KS C IEC 60601 2-10:2008 7 7 42 KS C IEC 60601 1 . KS C IEC 60601 1 42. . 7.3 aa) . 43. 45. KS C IEC 60601 1 . 46* KS C IEC 60601 1 . KS C IEC 60601 1 46. . 46.101* . . 10 5 . . 47. 49. KS C IEC 60601 1 . 8 50* KS C IEC 60601 1 . 50.1* KS C IEC 60601

10、1 50.1 . 1 mA 1 V . 2 % . . 50.2* KS C IEC 60601 1 50.2 . (6.8.2 ) , d.c. , (6.8.3 ) 10 % KS C IEC 60601 2-10:2008 8 30 % . . 51 KS C IEC 60601 1 . KS C IEC 60601 1 51. . 51.101* 10 % , 10 % . . 51.102* 10 mA r.m.s. 10 V r.m.s. . . . 51.103* 1 000 10 mA r.m.s. 10 V r.m.s. 10 mJ . . . 51.104* a) 500

11、. () d.c. 80 mA 400 Hz 50 mA 1 500 Hz 80 mA 1 500 Hz 100 mA a.c. d.c. . 0.1 500 300 mJ . d.c. KS C IEC 60601 2-10:2008 9 . 500 V . ( ) . b) 2 000 d.c. 10 mA . . . 9 ； 52. 53. KS C IEC 60601 1 . 10 54. 56. KS C IEC 60601 1 . 57* , KS C IEC 60601 1 . 57.3* c) KS C IEC 60601 1 57.3 c) . 3 A 2 0.5 mm2 .

12、 . 58. 59. KS C IEC 60601 1 . KS C IEC 60601 2-10:2008 10 101 (36.1 ) 100 mm d.c.a.c10 MHz KS C IEC 60601 2-10:2008 11 d.c.a.c10 MHz 400 mm() 50 102 (36.2 ) KS C IEC 60601 2-10:2008 12 103 (36.3 ) d.c.a.c10 MHz 400 mm() 50 KS C IEC 60601 2-10:2008 13 B ( ) / KS C IEC 60601 1 6.8.2 . (6.8.2 ) KS C IE

13、C 60601 1 20. . KS C IEC 60601 1 1 . C J KS C IEC 60601 1 . KS C IEC 60601 1 K . KS C IEC 60601 2-10:2008 14 AA ( ) . . . 1.1 . 5. 5.1 KS C IEC 60601 1 3 3 . 3 . 5.2 . 5.6 15 , . . 6. , 6.1 p) . 6.8.2 aa) a) d.c. d.c. . b) . d) . e) . . 36. 1 m . f) . 14.3 5.1 14.6 5.2 KS C IEC 60601 2-10:2008 15 19

14、. KS C IEC 60601 1 . 20. 20.2 B f： . 36. . . . . . 27 MHz ISM . . ( ) . . . 46. 46.101 . 50. 50.1 . . . 50.2 30 % . . 51.101 KS C IEC 60601 2-10:2008 16 . 51.102 . 51.103 . 51.104 / . 57. , 57.3 2 . KS C IEC 60601 2-10:2008 17 KS C IEC 60601 2-10:2008 . 1 “KS P 6310： 1990, ” , “IEC 60601 2-10 (Medical electrical equipment Part 2： Particular requirements for the safety of nerve and muscle stimulators)” . 2 a) . b) “KS P 6310： 1990” , KS . “KS P 6310： 1990” . 3 “KS C IEC 606011： 2002, ” . KS C IEC 606011 . KS C IEC 606011 101 , AA, BB , aa), bb) . “ ”