KS P ISO 5358-2010 Anaesthetic machines for use with humans《人用麻醉机》.pdf

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1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 5358 KS P ISO 5358:2010 2010 12 30 http:/www.kats.go.krKS P ISO 5358:2010 : ( ) ( ) () () ( ) : () ( ) () () () ( ) () : (http:/www.standard.go.kr) ： ：2010 12 30 2010-0689 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 5358:2010 i ii .

2、1 1 1 2 1 3 .1 4 2 5 (Medical gas cylinder connections) 3 6 (Pipeline inlet connections) .4 7 (Pressure gauges, and pressure and contents indicators) .4 8 (Pressure regulators).5 9 (Machine gas piping)6 10 (Flow control system) .6 11 (Flowmeters).7 12 (Gas mixers) 8 13 (Vaporizers) 9 14 (Common gas

3、outlet) 10 15 (Gas power outlet) 11 16 (Oxygen flush) .11 17 (Oxygen supply failure) 11 18 .12 19 .12 A( ) .14 B( ) .15 B.1 .15 B.2 .15 C( ) .17 C.1 .17 C.2 .17 D( ) 19 D.1 .19 D.2 .19 D.3 ( ).19 20 KS P ISO 5358:2010 ii . . , , . , , . KS P ISO 5358:2010 Anaesthetic machines for use with humans 199

4、2 2 ISO 5358, Anaesthetic machines for use with humans . 1 . . . a) b) (breathing system) c) 2 . . ( ) . KS B ISO 32： 2005, KS B ISO 407： 2003, KS C IEC 60601 1-1, 1-1： ： KS I ISO 3744： 2002, KS P ISO 5356 1, 1： KS P ISO 5356 2, 2： KS P ISO 7396 1, 1： KS P ISO 7396 2, 2： ISO 4135, Anaesthesiology Vo

5、cabulary ISO 5359, Low-pressure flexible connecting assemblies(hose assemblies) for use with medical gas systems ISO 7767, Oxygen analyzers for monitoring patient breathing mixtures Safety requirements 3 KS P ISO 5358:2010 2 ISO 4135 . 3.1 (anaesthetic machines) 3.2 (gas mixer) , 3.3 (machine gas pi

6、ping) , . , , . 3.4 (common gas outlet) 3.5 (flow control system) 3.6 (flowmeter) 3.7 (pressure regulator) / ( ) , 3.8 (anaesthetic vaporizer) 3.9 (vaporizer chamber) 4 4.1 . . . KS P ISO 5358:2010 3 4.2 KS C IEC 60601 1-1 . a) 22. b) 23. , c) 24. d) 25. e) 28. (suspended masses) 4.3 , 215 1 . , , .

7、 , , , . 4.4 . 4.5 , (13.2.11 ) KS B ISO 32 . 4.6 . 5 (Medical gas cylinder connections) 5.1 . (reserve oxygen supply) . 5.2 100 m . 5.3 KS B ISO 407 , . KS B ISO 407 . 5.4 2 , 15 MPa 20 101.3 kPa 100 mL/min . a) b) c) 5.5 . KS P ISO 5358:2010 4 6 (Pipeline inlet connections) 6.1 , KS P ISO 7396 . I

8、SO 5359 ( 1 ) . 6.2 , 20 , 101.3 kPa 50 mL/min . 6.3 ( ) . 7 (Pressure gauges, and pressure and contents indicators) 7.1 . 7.1.1 . 20 3 33 % . 7.1.2 1 . 1 . 7.1.3 . (6.2 ). 33 % . 7.1.4 kPa100 (4.3 ). . 7.1.5 4 % . 7.1.6 , . . (restrictor) . KS P ISO 5358:2010 5 1 7.2 7.2.1 10 . 6 9 , 180 300 . 7.2.

9、2 . . . 7.2.3 50 mm , 38 mm . . 8 (Pressure regulators) 8.1 . 1 2 . , . 8.2 2 L/min 10 5 10 2 L/min1 L/min 2 . 8.3 2 . (pressure regulating system) , 50 % 3 . KS P ISO 5358:2010 6 9 (Machine gas piping) 9.1 2 . 9.2 , (flow control system) 20 , 101.3 kPa 25 mL/min . 9.3 20 , 101.3 kPa 3 kPa 50 mL/min

10、 . ： a) b) c) 9.4 , , . 9.5 . 10 (Flow control system) 10.1 . . . 10.2 , 10 % 30 mL/min 10 . 10.3 , . 10.4 , , 90 % 180 . 10.5 5 mL/min . 1 , 25 %(V/V) . 2 . KS P ISO 5358:2010 7 10.6 . 10.7 . 10.8 . 10.9 2 . . . . 1 mm . 10.10 10 N2 N 25 % 10 % 10 mL/min . 2 11 (Flowmeters) 11.1 . . KS P ISO 5358:2

11、010 8 (10.1 10.1 ). 11.2 20 101.3 kPa . . 1 L/min , 0 . 1 L/min . . , . . 45 . , (float) . . 11.3 , 10 % 300 mL/min 20 101.3 kPa 100 % 10 % . 11.4 . 11.5 . 11.6 (4.3 ). 11.7 . 12 (Gas mixers) 12.1 12.2 12.6 , / 25 %(V/V) . 12.2 (% V/V) . 12.3 , 11.3 . 10.2 . , . KS P ISO 5358:2010 9 19. h) . 12.4 5

12、%(V/V) . 12.5 . 12.6 A , 5 mL/min . 13 (Vaporizers) 13.1 13.1.1 / (16. ) . 13.1.2 KS P ISO 5356 1 23 mm . . . 13.1.3 . 13.2 13.2.1 . 20 3 , 101.3 kPa %(V/V) . 13.2.2 15 mL/min . 13.2.3 . . . 13.2.4 , . 13.2.5 . 13.2.6 / . “ ” “ ” ( “ ” ) . 13.2.7 B 19. m) 4) . KS P ISO 5358:2010 10 a) 0.1 %(V/V) . 1

13、) “ ” 2) “ ” 3) “ ” “ ” b) “ ” “ ” , 20 % 5 % . 13.2.8 C 19. m) 4) , 30 %/ 20 % 7.5 %/ 5 % . 13.2.9 D “ ” , 20 L/min . 13.2.10 “ ” . 13.2.11 . 1 . 1 a a 595a BS 5252 (Pantone)SS 01 91 00SS 01 91 03 (Munsell) DIN 6164 11105 22510 14187 15102 13655 04 E 5606 E 5514 E 5320 E 5610 E 5324 E 53200 144 334 294 115 252/2531374/R 0958 Y56R2356 B92G4052 R92B1070 Y