1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 8835 5 5: KS P ISO 8835 5:2010 2010 12 30 http:/www.kats.go.krKS P ISO 8835 5:2010 : ( ) ( ) () ( ) : () ( ) () () () ( ) () : (http:/www.standard.go.kr) : :2010 12 30 2010-0689 : : ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 8835 5:201
2、0 i . iii .1 1 1 2 1 3 .2 4 .3 5 3 6 , .3 6.1 .3 6.3 4 7 .5 8 5 9 .5 10 .5 11 .5 12 .5 13 6 14 .6 15 / .6 16 6 17 6 18 , 6 19 .6 20 .6 21 .6 22 (moving parts)6 23 , 6 24 6 25 .7 26 .7 27 .7 28 (suspended mass) .7 29 X- .7 30 , , , .7 31 .7 KS P ISO 8835 5:2010 ii 32 ( ) 7 33 .7 34 .7 35 ( ).7 36 .7
3、37 .8 38 8 39 AP APG 8 40 AP (part and components) 8 41 APG (part and components) .8 42 8 43 .8 44 , , , , , , , 8 45 9 46 .9 47 .9 48 .9 49 .9 50 .10 51 .10 52 .10 53 .11 54 11 55 .11 56 .11 57 (mains parts), 11 58 11 59 .11 101 .11 101.1 11 101.2 .11 101.3 11 101.4 12 101.5 / .12 101.6 12 102 KS C
4、 IEC 60601 1: 2002 .12 AA( ) 13 BB( ) 14 15 KS P ISO 8835 5:2010 iii . . , , . , , . KS P ISO 8835 5:2010 5: Inhalational anaesthesia systems Part 5: Anaesthetic ventilators 2004 1 ISO 8835 5, Inhalational anaesthesia systems Part 5 :Anaesthetic ventilators . 1 KS C IEC 60601 1: 2002, 1. . (3.1 ) .
5、. BB . KS C IEC 60601 1: 2002 1(1991) 2(1995) . 2 . . ( ) . KS B ISO 407, KS B ISO 5145, KS C IEC 60079 4, 4: KS C IEC 60079 11, 11: “I” KS C IEC 60601 1: 2002, KS C IEC 60601 1-2, 1-2: KS C IEC 60601 2-12, 2-12: KS C IEC 60601 2-13: 2004, 2-13: KS P ISO 5356 1, 1: KS P ISO 5356 2, 2: KS P ISO 7396
6、1, 1: KS P ISO 8835 2, 2: KS P ISO 8835 5:2010 2 KS P ISO 8835 3, 3: ISO 4135: 2001, Anaesthetic and respiratory equipment Vocabulary ISO 5359: 2008, Low-pressure hose assemblies for use with medical gases ISO 10524: 1995, Pressure regulators and pressure regulators with flow-metering devices for me
7、dical gas systems 3 KS C IEC 60601 1, ISO 4135 KS C IEC 60601 2-13 . 3.1 (anaesthetic ventilator) 3.2 (breathing system connection port) 3.3 (legible) , , 6.101 3.4 (driving gas) 3.5 (driving gas inlet port) 3.6 (inflating gas) . 3.7 (inflating gas inlet port) 3.8 (maximum limited pressure) pLIM max
8、 KS C IEC 60601 2-12 KS P ISO 8835 5:2010 3 3.9 (minimum limited pressure) pLIM min 1 KS C IEC 60601 2-12 2 . 3.10 (maximum working pressure) pW max ISO 4135 3.11 (minimum working pressure) pW min ( ) ISO 4135 3.12 (oxygen-rich environment) 275 hPa 4 KS C IEC 60601 1: 2002 3. 4. . : 4.101 , . 5 KS C
9、 IEC 60601 1: 2002 5. . 6 , KS C IEC 60601 2-13: 2004 7. . 6.1 : KS P ISO 8835 5:2010 4 aa) : 6.3 : aa) , / . 6.8.2 : aa) . 1) KS P ISO 8835 2 2) KS P ISO 8835 3 / . bb) / : 1) 2) 3) , 4) 5) cc) . BB . dd) . 6.8.3 : KS P ISO 8835 5:2010 5 aa) , . ( ) I: E ( , ) (PEEP) (Triggering) / ( , ) 6.101 , 15
10、 , , , 215 lux65 lux 1 m10 % (log MAR scale) 0 6-6(20/20) ( ) . 7 KS C IEC 60601 1: 2002 7. . 8 KS C IEC 60601 1: 2002 8. . 9 KS C IEC 60601 1: 2002 9. . 10 KS C IEC 60601 1: 2002 10. . 11 KS C IEC 60601 1: 2002 11. . 12 KS C IEC 60601 1: 2002 12. . KS P ISO 8835 5:2010 6 13 KS C IEC 60601 1: 2002 1
11、3. . 14 KS C IEC 60601 1: 2002 14. . 15 / KS C IEC 60601 1: 2002 15. . 16 KS C IEC 60601 1: 2002 16. . 17 KS C IEC 60601 1: 2002 17. . 18 , KS C IEC 60601 1: 2002 18. . 19 KS C IEC 60601 1: 2002 19. . 20 KS C IEC 60601 1: 2002 20. . 21 KS C IEC 60601 1: 2002 21. . 22 (moving parts) KS C IEC 60601 1:
12、 2002 22. . 23 , KS C IEC 60601 1: 2002 23. . 24 KS C IEC 60601 1: 2002 24. . KS P ISO 8835 5:2010 7 25 KS C IEC 60601 1: 2002 25. . 26 KS C IEC 60601 1: 2002 26. . 27 KS C IEC 60601 1: 2002 27. . 28 (suspended mass) KS C IEC 60601 1: 2002 28. . 29 X- KS C IEC 60601 1: 2002 29. . 30 , , , KS C IEC 6
13、0601 1: 2002 30. . 31 KS C IEC 60601 1: 2002 31. . 32 ( ) KS C IEC 60601 1: 2002 32. . 33 KS C IEC 60601 1: 2002 33. . 34 KS C IEC 60601 1: 2002 34. . 35 ( ) KS C IEC 60601 1: 2002 35. . 36 KS C IEC 60601 1: 2002 36. . KS P ISO 8835 5:2010 8 37 KS C IEC 60601 1: 2002 37. . 38 KS C IEC 60601 1: 2002
14、38. . 39 AP APG KS C IEC 60601 1: 2002 39. . AP , APG 40 AP (part and components) KS C IEC 60601 1: 2002 40. . 41 APG (part and components) KS C IEC 60601 1: 2002 41. . 42 KS C IEC 60601 1: 2002 42. . 43 KS C IEC 60601 1: 2002 43. . 44 , , , , , , , KS C IEC 60601 1: 2002 44. . 44.3 : . KS C IEC 606
15、01 1: 2002 44.3 . 44.7 , . KS P ISO 8835 5:2010 9 / . . 44.8 : . . . 45 KS C IEC 60601 1: 2002 45. . 46 KS C IEC 60601 1: 2002 46. . : IEC 60601 1-6 . 47 KS C IEC 60601 1: 2002 47. . 48 KS C IEC 60601 1: 2002 48. . 49 KS C IEC 60601 1: 2002 49. . KS C IEC 60601 2-13 49.101.2 . 49.101.2 . . ( , ) . 6
16、.8.2 dd) . KS P ISO 8835 5:2010 10 : 49.102.2 , ( , ) . 49.101.3 , . 50 KS C IEC 60601 1: 2002 50. . 51 KS C IEC 60601 1: 2002 51. . : 51.101 . , 1 kPA(10 cm H2O) 15 % . * . 51.102 (failure-to-cycle alarm) “ ” . 51.103 51.103.1 . . 51.103.2 . . 52 KS C IEC 60601 1: 2002 52. . KS P ISO 8835 5:2010 11
17、 53 KS C IEC 60601 1: 2002 53. . 54 KS C IEC 60601 1: 2002 54. . 55 KS C IEC 60601 1: 2002 55. . 56 KS C IEC 60601 1: 2002 56. . 57 (mains parts), KS C IEC 60601 1: 2002 57. . 58 KS C IEC 60601 1: 2002 58. . 59 KS C IEC 60601 1: 2002 59. . 101 101.1 101.1.1 , KS B ISO 407 ISO 4135 . 101.1.2 100 m .
18、101.2 101.2.1 ISO 5359 (fittings) . 101.2.2 100 mL/min (0.281 Pa L/s) (reverse flowrate) . . 101.3 KS P ISO 8835 5:2010 12 101.3.1 , KS P ISO 5356 1 KS P ISO 5356 2 . 101.3.2 KS P ISO 7396 1 ISO 10524 , ISO 5359 . 101.4 . 101.5 / / . 101.6 KS P ISO 5356 1 KS P ISO 5356 2 22 mm . 102 KS C IEC 60601 1
19、: 2002 KS C IEC 60601 1: 2002 . : . KS P ISO 8835 5:2010 13 AA ( ) AA.51.101 . ( ) . , . KS P ISO 8835 5:2010 14 BB ( ) BB.1 . . , , , . BB.2 KS C IEC 60601 1: 2002 F KS C IEC 60079 3 , ( / ) . 10 3 . a) 1.0 A, d.c 20 V 0.15 A, d.c 100 V b) 10 mH, d.c 200 mA 1 000 mH, d.c 60 mA c) 1 F, d.c 100 V 20 F, d.c 20 V KS C IEC 60601 1