1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS C IEC 60601 2-38 KS C IEC 60601 2-38:2008 2008 11 28 http:/www.kats.go.krKS C IEC 60601 2-38:2008 : ( ) ( ) FITI ( ) : (http:/www.standard.go.kr) ： ： 1976 9 21 ： 2008 11 28 2008-0810 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS C IEC 60601 2-38:
2、2008 i . , , . , , . KS C IEC 60601 2 38:2008 Hospital beds 1996 1 , 1999 1 KS C IEC 60601 2-38, Medical electrical equipment Part 2： Particular requirements for the safety of electrically operated hospital beds , . 1 KS C IEC 60601 1 . 1 1.1 KS C IEC 60601 1 1.1 . 2.2.101 ( .) . , . 1.2 KS C IEC 60
3、601 1 1.2 . , , . 2 . KS C IEC 60601 1 3. . 2.1.5 (applied part) KS C IEC 60601 1 3.8 . KS C IEC 60601 2-38:2008 2 ( 111 ). 2.1.101 (pendant control) . 2.1.102 (side rail) “ (up)” . 2.1.103 (control side rail) . 2.1.104 / (integrated patient monitoring/communications systems control side rail) 2.1.1
4、03 . / , / , , . 2.1.105 / (head/foot panel assembly) . 2.1.106 (momentary contact switch) ( ) . ( ) . “ ” . 2.1.107 (mattress support platform) ( ) . , ( 101 112 ). *2.1.108 (trendelenburg) , 12 . 2.1.109 (壓潰點 ) (剪斷點 )( ) (squeezing and shearing points)(for fingers) 8 mm 25 mm . KS C IEC 60601 2-38
5、:2008 3 *2.1.110 (patient entrapment) / , . *2.2.101 electrically operated hospital bed(hereinafter referred to as BED) , , . “ ” AA *2.2.102 (lifting pole) . 3 KS C IEC 60601 1 4. . *3.101 , ( ) . , / / / 5.3, 54.101 . . , (ISO 14791 1 ) . 5 KS C IEC 60601 1 6. . *5.2 KS C IEC 60601 1 6.2 . B BF .
6、*5.3 KS C IEC 60601 1 6.3 . KS C IEC 60529 IPX4 . 6 , KS C IEC 60601 1 7. . KS C IEC 60601 2-38:2008 4 6.1 l) KS C IEC 60601 1 7.2 . “ ” , . *u) KS C IEC 60601 1 7.2 . ( / ) ( 108 ). w) KS C IEC 60601 1 7.2 . . 6.4 KS C IEC 60601 1 7.6 . aa) / . 107 108 . . 6.8.2 a) KS C IEC 60601 1 7.9.2 . . . . 1
7、. / , . “ ” , , . . . . ( , ) . , . 114 D / E , ( ) , ( KS C IEC 60601 2-38:2008 5 .) . ( ). b) KS C IEC 60601 1 7.9.2 . , , / . *aa) ( ) , . 2 KS C IEC 60601 1 . 3 KS C IEC 60601 1 8. . 17 KS C IEC 60601 1 . *c) KS C IEC 60601 1 8. . BF . 18 , KS C IEC 60601 1 8.6 . *e) KS C IEC 60601 1 8.6 . . 4 K
8、S C IEC 60601 1 9. . 21 KS C IEC 60601 1 9. . *21.3 / . . KS C IEC 60601 2-38:2008 6 21.3.101 , 1 700 N . 1 700 N . 1 350 N( ) 250 N( ) 150 N( ) ( 102 .) *21.3.102 750 N . 21.4 KS C IEC 60601 1 9. . / . / . 21.6 KS C IEC 60601 1 9. . . / , (0.40.1) m/s ( ) 3 . *21.6.101 / , / , / 450 N . 625 mm2 . 3
9、0 10 . *21.6.102 . . / / , , 10 . 20 mm, 80 mm , / (0.40.1) m/s . 22 KS C IEC 60601 1 9.2 . 22.2.101 KS C IEC 60601 2-38:2008 7 ( ) 200 mm , ( 109 110 ). , ( ) 120 mm 120 mm . 22.2.102 ( ) . . 22.4.101 . 23 , KS C IEC 60601 1 9.3 . *23.101 , 114 . . 28.4.103 , 114 A F 115 114 50 N . / , . (ISO 14971
10、 1 ). . 24 KS C IEC 60601 1 . 24.3 KS C IEC 60601 1 . *aa) ( ) ( 102 ) , . 2 250 N , 125 mm ( 103/105 ). 1 500 N , 125 mm ( 104/106 ). KS C IEC 60601 2-38:2008 8 *bb) . . . . 24.4 ( ) ( ) . . 10 ( ) ( ) . . 10 mm ( ) . 25 KS C IEC 60601 1 . 26.101 ( 102 ) 1 m 65 dB(A) . , . ISO 2204 . 28 KS C IEC 60
11、601 1 9.8 . 28.4 2) KS C IEC 60601 1 9.8.3 . 2 4 000 N . . 1 . ( 102 ). 3) KS C IEC 60601 1 9.8.3 . , , 4 . 9.8.3 28.4 2) . *28.4.101 , , . 2 . KS C IEC 60601 2-38:2008 9 , 2 1 . . . 28.4.102 / . . / / ( 113 ) / . 28.4.103 . . 10 , 30 , 113 / . 23.101 , . 5 , KS C IEC 60601 1 10. . 36 KS C IEC 60601
12、 1 2 . KS C IEC 60601 1 2, 1 2： ： 36.202 . 6 KS C IEC 60601 1 11. . 7 KS C IEC 60601 1 11. . 44 , , , , , , 44.6 KS C IEC 60601 1 11. . KS C IEC 60601 2-38:2008 10 44.6.101 IP KS C IEC 60529 . 44.6.102 IP KS C IEC 60529 (KS C IEC 60601 1 8.7) . 44.6.103 ( / ) . . (652) 10 . 16 . KS C IEC 60529 IPX6
13、. (KS C IEC 60529) 200 mm 200 mm 20 . 10 . KS C IEC 60601 1 8.8.3, 8.7 . , 57.10 . 8 KS C IEC 60601 1 . 9 ： 52 KS C IEC 60601 1 . *52.4.101 . 52.5 KS C IEC 60601 1 . . *52.5.9 KS C IEC 60601 1 . *52.5.101 *52.5.102 , (TRENDELENBUG) . *52.5.103 , KS C IEC 60601 2-38:2008 11 . KS C IEC 60601 1 4 ( ) . KS C IEC 60601 1 4, 1 4： ： 10 KS C IEC 60601 1D 15. . 54 KS C IEC 60601 1 15.1 . *54.101 . 56 KS C IEC 60601 1 15. . 56.1 KS C IEC 60601 1 15.4 . aa) . 56.1.101 . 56.8 KS C IEC 60601 1 15.4.4 . . *56.10 c) KS C IEC 60601 1 15.4.6 . aa) ( 112 “C”) 90 .
