KS P ISO 10651-4-2008 Lung ventilators－Part 4：Particular requirements for operator-powered resuscitators《医用肺通气机 第4部分 操作员控制的呼吸器的特殊要求》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 10651 4 4： KS P ISO 10651 4:2008 2008 11 7 http:/www.kats.go.krKS P ISO 10651 4:2008 : ( ) ( ) ( ) ( ) : (http:/www.standard.go.kr) ： ： 2003 12 30 ： 2008 11 7 2008-0746 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 10651 4:2008 i ii .

2、1 1 1 2 1 3 .2 4 3 5 .4 6 .5 7 6 8 7 9 7 10 8 A( ) 9 B( ) .18 21 KS P ISO 10651 4:2008 ii . KS P ISO 10651 4： 2003 . . , , . , , . KS P ISO 10651 4:2008 4： Lung ventilators Part 4： Particular requirements for operator-powered resuscitators 2002 1 ISO 10651 4, Lung ventilators Part 4： Particular requ

3、irements for operator-powered resuscitators , . 1 , . . . B . R) . 2 . . ( ) . EN 148 1, Respiratory protective devices Threads for facepieces Part 1： Standard thread connection EN 556, Sterilization of medical devices Requirements for terminally-sterilized medical devices to be labelled “STERILE” E

4、N 737 1, Medical gas pipeline systems Part 1： Terminal units for compressed medical gases and vacuum EN 868 1, Packaging materials and systems for medical devices which are to be sterilized Part 1：General requirements and test methods EN 1041, Information supplied by the manufacturer with medical de

5、vices EN 1281 1, Anaesthetic and respiratory equipment Conical connectors Part 1： Cones and sockets prEN 13544 2, Respiratory therapy equipment Part 2： Specifications for tubing and connectors EN ISO 4135, Anaesthesiology Vocabulary(ISO 4135： 1995) KS P ISO 10651 4:2008 2 3 EN ISO 4135 . EN ISO 4135

6、 . EN ISO 4135 . 3.1 (reverse leakage) 3.2 (bag inlet valve) , 3.3 (bag refill valve) , 3.4 (compressible unit) 3.5 (delivered oxygen concentration) 3.6 (delivered volume) Vdel (mL) 3.7 (forward leakage) 3.8 (minute volume) V 3.9 (operator-powered resuscitator) “ ” . KS P ISO 10651 4:2008 3 3.10 (pa

7、tient connection port) 3.11 (patient connection port connector) 3.12 (patient valve) 3.13 (pressure limiting system) 3.14 (死腔 ) (resuscitator deadspace) VD,app 3.15 (tidal volume) V T (mL) 3.16 (ventilatory cycle) 4 4.1 EN 1281 1 15 mm 22 mm . 4.2 R) , . a) EN 1281 1 30 mm b) EN 1281 1 EN 737 1 . 4.

8、3 , EN 1281 1 22 mm 15 mm . 4.4 R) KS P ISO 10651 4:2008 4 , 32 mm . A.1 , . 4.5 EN 1281 1 . . 4.6 , EN 148 1 . 4.7 , prEN 13544 2 . ( ) . 5 5.1 , . 5.2 R) . 10.2 d) . 5.3 R) A.4.3 , 6.2, 6.4, 6.7.1 6.7.2 . . . 5.4 5.4.1 R) A.4.4 6.2, 6.4 6.7.1 . 5.5 R) KS P ISO 10651 4:2008 5 A.4.5 6.2, 6.4, 6.7.1

9、6.7.2 . 5.6 R) . 5.7 . 6 6.1 R) (6.7.1 ) A.4.6 15 L/min 35 % , 85 %( ) . 2 L/min, 4 L/min, 6 L/min, 8 L/min . 85 % . 6.2 R) ( ) A.4.7 0.5 kPa(5 cmH2O) 10.2 c) 8) . 6.3 R) A.4.8 , 0.5 kPa(5 cmH2O) 10.2 c) 8) . 6.4 R) A.4.9 , , 30 L/min 0.6 kPa(6 cmH2O) . 6.5 R) , . 6.6 R) A.4.10 , 5 mL 10 % (6.7.1 ).

10、 . KS P ISO 10651 4:2008 6 6.7 R) 6.7.1 R) (Vdel) 1 , , I： E A.4.11 , 1 . 6.7.2 R) 6.7.2.1 10 kg , A.4.12 4.5 kPa(45 cmH2O) . 3 kPa(30 cmH2O) . . 6.7.2.2 10 kg , 10.2(c)(9) . 6 kPa(60 cmH2O) . , ON OFF , . . 1 B akg L/kPa kPa/(L/s) ： 20 % f / 10 % VdelmL B 5 5 40 0.01 0.1 0.2 0.2 40 2 2 2 1： 1 1： 2

11、1： 2 1： 2 60 25 20 20 20 150 15Ba600 aB (kg) 7 7.1 40 60 4095 % ( ) 6.6( ) 6. . 7.2 R) A.4.13 , 1595 % 6. . 18 50 , (9.2 10. ) KS P ISO 10651 4:2008 7 8 8.1 “ ” EN 556： 1994 A1： 1998 4.1 . 8.2 EN 868 1 . . 9 9.1 , , EN 1041 . 9. EN 980 . 9.2 18 50 7.2 , . “ . . ” 1 . 1 10 50 9.3 , . 50 10 KS P ISO 1

12、0651 4:2008 8 10 10.1 . . 10.2 EN 1041 , . a) b) c) , 1) 2) 3) 4) ( , ) 5) 6) 7) , 8) , 9) , 0.2 kPa(2 cmH2O) . 10) 11) , 12) 13) , d) ( ) ( ) , . e) , f) g) h) i) . , . , . j) k) KS P ISO 10651 4:2008 9 A ( ) A.1 , 2025 , 45 75 % . A.2 A.2.1 A.1A.5 . . A.2.2 ( A.4 A.5 ) ( A.1 A.2 ). A.2.3 A.2.4 , A

13、.2.5 A.2.6 ( A.3 ) A.2.7 200 mL . A.2.8 A.2.9 A.2.10 ( 401) (701) 7 1595 % A.3 A.3.1 , . KS P ISO 10651 4:2008 10 A.3.2 , (NTPD) 20 , 1 atm1), 0 % . A.4 A.4.1 32 mm ( A.1) , . A.4.2 . A.4.3 A.4.3.1 A.4.3.2 (373) 175 mL . 10 kg 30 / 12 / . (A.2.2) . 30 . . . A.4.4 . 1 m . , . 6 . A.4.5 1 m (A.2.9) .

14、10 20 / . (A.2.2). 1) 1 atm 101 325 Pa 760 mmHgKS P ISO 10651 4:2008 11 A.4.6 C 20 R 20 (A.2.2) ( A.1 A.2 ). (A.2.8) . 12 / 600 mL . 15 L/min . . A.2 . A.4.7 10 kg , 5 L/min . . , 50 L/min . . A.4.8 10 kg , 5 L/min . . , 50 L/min . . A.4.9 C 20 R 20 (A.2.2) ( A.1 A.2 ). 12/ 600 mL . 30 L/min . 0.6 k

15、Pa(6 cmH2O) . A.4.10 A.4.10.1 100 % “bag-in-bottle” . . A.4.10.2 (A.2.6, A.3 ). (A.2.8). . . . . 100 % . 1 kPa(10 cmH2O) . 22 mm/15 mm 22 mm ( A.3 ). KS P ISO 10651 4:2008 12 100 % . 10 mm . . A.3 . . 100 % 5 L/min . , FbO2, . 1 kPa(10 cmH2O) . . . A.4.10.3 (A.4.10.2 ). A.4.10.4 . T2bOsystemD,7921VFV = VD,system ： FbO2 ： ( ) VD,system 20 mL . . systemD,T2bOD,app7921VVFV = A.4.11 A.1 A.2 (A.2.2, A.4 A.5 ) . (A.2.4). A.2 . . ( .) Vdel VT . A.4.12 10 kg , 15 L/min .