KS C IEC 60601-2-40-2008 Electromyographs and evoked response equipment《医用电气设备 第2-40部分 电子肌动描记器及诱发反应设备安全专用要求》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS C IEC 60601 2-40 KS C IEC 60601 2-40:2008 2008 11 28 http:/www.kats.go.krKS C IEC 60601 2-40:2008 : ( ) ( ) FITI ( ) : (http:/www.standard.go.kr) ： ： 1990 11 5 ： 2008 11 28 2008-0810 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS C IEC 60601 2-40:

2、2008 i (KS) (IS) 1998 1.0 IEC 60601 2-40, Medical electrical equipment Part 2-40, Particular requirements for the safety of electromyographs and evoked response equipment , . . , , . , , . KS C IEC 60601 2-40:2008 Electromyographs and evoked response equipment 1 KS C IEC 60601 1 . 1 KS C IEC 60601 1

3、 1. . 1.1 KS C IEC 60601 1 1.1 . 2.1.101 2.1.102 . , . 1.2 KS C IEC 60601 1 1.2 . 2.1.101 2.1.102 . 1.5 KS C IEC 60601 1 1.5 . IEC 60601 1-1 1 IEC 60601 1-2 (6.8.2 36. ). 2 KS C IEC 60601 1 2. . KS C IEC 60601 1 2. . 2.1.101 (electromyograph) KS C IEC 60601 2-40:2008 2 . 2.1.102 (evoked response equ

4、ipment) . , , , , . 2.1.103 (electrical stimulator) . 2.1.104 (pulse duration) 50 % . 2.1.105 (waveform) ( ) . 2.1.106 (auditory stimulator) ( ) . 2.1.107 (visual stimulator) . 2.1.108 (biopotential input part) . 5 KS C IEC 60601 1 5. . *5.2 KS C IEC 60601 1 5.2 . B *5.6 KS C IEC 60601 1 5.6 . KS C

5、IEC 60601 2-40:2008 3 6 , KS C IEC 60601 1 6. . 6.1 j) ： 7.1 aa) 5 . *p) KS C IEC 60601 1 6.1 . 1 000 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 . 51.102 6.8 6.8.2 KS C IEC 60601 1 6.8 . . *aa) , d.c. , , , / *bb) cc) d.c. *dd) ( ) ee) , ff) , . ( 1 m) . *gg) (6.8

6、.3 ) 1 10 mA r.m.s. 10 V r.m.s. 10 mJ KS C IEC 60601 2-40:2008 4 2 mA r.m.s./cm2 hh) KS C IEC 60601 1 KS C IEC 60601 1-1 *ii) 6.8.3 KS C IEC 60601 1 6.8 . aa) 6.8.2 aa) . . 7 KS C IEC 60601 1 7. . 7.1 KS C IEC 60601 1 7.1 . aa) (6.8.3 ) , . 2 KS C IEC 60601 1 2 . 3 KS C IEC 60601 1 3 . 14 KS C IEC 6

7、0601 1 14. . *14.6 B, BF, CF KS C IEC 60601 1 14.6 . , BF CF . 20 KS C IEC 60601 1 20. . 20.2 KS C IEC 60601 2-40:2008 5 KS C IEC 60601 1 20.2 . B b： , . . , . 4 KS C IEC 60601 1 4 . 5 , KS C IEC 60601 1 5 . 36 EMC KS C IEC 60601 1-2 . 36.20 36.201.1.7 ： 400 mm 1 000 mL , ( 101 ). 36.202 ： . 36.202.

8、1 36.202.6 / , , , 10 % . 36.202.2.1 . / , , . 36.202.1 KS C IEC 60601 1 36.202 . KS C IEC 60601 2-40:2008 6 , . . 36.202.2 *36.202.2.2 KS C IEC 60601 1 36.202 . d) ： d) 400 mm 1 000 mL , ( 101 ). 6 KS C IEC 60601 1 6 . 7 KS C IEC 60601 1 7 . 42 KS C IEC 60601 1 42. . KS C IEC 60601 1 7.1 aa) . *46

9、KS C IEC 60601 1 46. . , . , 5 , 5 . . 8 KS C IEC 60601 1 8 . 50 KS C IEC 60601 1 50. . KS C IEC 60601 2-40:2008 7 *50.1 KS C IEC 60601 1 50.1 . 1 mA 5 V . 2 % . . *50.2 KS C IEC 60601 1 50.2 . (6.8.2 ) , 10 % 30 % (6.8.3 ). . 51 KS C IEC 60601 1 51. . KS C IEC 60601 1 . *51.101 10 % , 10 % . . 51.1

10、02 1 000 10 mA r.m.s. 10 V r.m.s. 10 mJ , . . . *51.103 1 000 50 mJ . . KS C IEC 60601 2-40:2008 8 51.104 (LED) KS C IEC 60825 1 . *51.105 125 dB HTL . . 9 ； KS C IEC 60601 1 9 . 10 KS C IEC 60601 1 10 . 101 36.201.1.7 36.202.2.2(d) 1000 mLKS C IEC 60601 2-40:2008 9 L KS C IEC 60601 1 . ： KS C IEC 6

11、0601 1, KS C IEC 60601 1-1, 1-1： ： KS C IEC 60601 1-2, 1-2： ： KS C IEC 60825 1, 1： , IEC 60645 3： 1994, Audiometers Part 3： Auditory test signals of short duration for audiometric and neuro-otologial purposes KS C IEC 60601 2-40:2008 10 AA ( ) . . . 5.2 . 5.6 1 , . . 6.1 p) . 6.8.2 aa) d.c. . bb) .

12、dd) . gg) . ii) . 14.6 5.2 36.202.2.2 EMC , . . 36.202.2.1 , . 46 / . 50.1 . KS C IEC 60601 2-40:2008 11 . . 50.2 30 % . 51.101 KS C IEC 60601 1 51.101 . 51.102 . 51.103 , . 51.105 125 dB HTL IEC 60645 3 . KS C IEC 60601 2-40:2008 12 KS C IEC 60601 2-40:2008 . 1 “KS P 1209： 1990, ” , “IEC 60601 2-40

13、(Medical electrical equipment Part 2： Particular requirements for the safety of electromyographs and evoked response equipment)” . 2 a) . b) “KS P 1209： 1990” , KS . “KS P 1209： 1990” . 3 KS P 1209： 1990 , KS C IEC 60601 2-40: 2008 IEC 60601 2-40 . IEC 60601 2-40 . 4 “KS C IEC 60601 1： 2002, ” . KS

14、C IEC 60601 1 . KS C IEC 60601 1 101 , AA, BB , aa), bb) . “ ” KS C IEC 60601 1 . , KS C IEC 60601 1 . , KS C IEC 60601 1 . KS C IEC 60601 1 . (*) “ AA” . 135513 7017 (02)60094114 (02)600948878 http:/ KS C IEC 60601 2-40:2008 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Electromyographs and evoked response equipment ICS 11.040 Korean Agency for Technology and Standards http:/www.kats.go.kr