KS P ISO 5367-2009 Breathing tubes intended for use with anaesthetic apparatus and ventilators《麻醉仪器和通风机用呼吸管》.pdf

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1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 5367 KS P ISO 5367:2009 2009 12 25 http:/www.kats.go.krKS P ISO 5367:2009 : ( ) ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2004 12 18 ：2009 12 25 2009-0868 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 5367:2009 .1 1 1 2 1 3 .1 4

2、3 4.1 .3 4.2 .3 4.3 .3 4.4 .3 4.5 .4 4.6 .4 4.7 .5 4.8 .5 4.9 5 5 5 6 5 6.1 5 6.2 6 7 6 7.1 .6 7.2 .6 7.3 6 7.4 .7 8 7 A( ) .8 B( ) 10 C( ) .11 D( ) 12 E( ) 13 F( ) .14 G( ) .15 16 i KS P ISO 5367:2009 Breathing tubes intended for use with anaesthetic apparatus and ventilators 2000 4 ISO 5367, Breat

3、hing tubes intended for use with anaesthetic apparatus and ventilators . 1 , , , , . Y . ( ) (tapered) . . 2 . . ( ) . KS C IEC 60601 1, KS P ISO 53561, 1： KS P ISO 10993 1, 1： ISO 468, Surface roughnessParameters, their values and general rules for specifying requirements ISO 11607, Packaging for t

4、erminally sterilized medical devices EN 556： 1994, Sterilization of medical devices Requirements for medical devices to be labelled “STERILE” 3 . KS P ISO 5367:2009 3.1 APL (APL valve, adjustable pressure limiting valve) pop off (pop off valve) ISO 4135 3.2 (breathing tube) ISO 4135 3.3 (adaptor) ,

5、KS P ISO 5356 1 3.4 (assembled end) 3.5 (plain end) KS P ISO 5356 1 (male) 3.6 (patient end) Y 3.7 (machine end) , 3.8 (anti-static) 3.9 (compliance) ISO 4135 3.10 (patient connection port) , , ISO 4135 2 KS P ISO 5367:2009 3.11 3 (3 way breathing system connector) Y (Y piece) , ISO 4135 3.12 3 (swi

6、vel 3 way breathing connector) Y (swivel Y piece) 3 ISO 4135 3.13 (rated flow) 4.5.1 4.5.2 4 4.1 8.2 . 4.2 KS P ISO 10993 1 . G . 4.3 , KS P ISO 5356 1 22 mm 15 mm . 1 . 2 22 mm . 3 G . 4.4 4.4.1 . . 4.4.2 Y Y . 4.4.3 10 % . 3 KS P ISO 5367:2009 4.5 4.5.1 . 4.5.2 ( Y ) A 7.2 d 7.3 d , 0.2 kPa . 4.5.

7、3 A 7.2 e 7.3 e , m 0.1 kPa . 4.6 4.6.1 4.6.1.1 4.6.1.2 1 a 22 mm 21 mm , 15 mm 14 mm . 4.6.1.2 KS P ISO 5356 1 22 mm 1 b 26.5 mm . 4.6.1.3 B , 40 N . a) b) 1 4.6.2 KS P ISO 5356 1 22 mm 15 mm . 4.6.3 C , 45 N . , Y . 4 KS P ISO 5367:2009 4.6.4 Y Y , Y (male) 22 mm (female) 15 mm , KS P ISO 5356 1 1

8、5 mm (female) . 4.7 4.7.1 D , m 10 mL/min . . 4.7.2 D , 25 mL/min . 4.7.3 D , Y 50 mL/min . 4.7.4 , Y a) D 50 mL/min , b) D 7.2 f) 7.3 f) . 4.7.5 4.7.4 b) 150 mL/min . 4.7.6 4.7.4 b) 10 % . 4.8 E , 150 % . 4.9 6 kPa F m 10 mL/kPa . 5 5.1 7.2 c) KS C IEC 60601 1 39.3 b) . 5.2 5.1 . 6 6.1 5 KS P ISO 5

9、367:2009 “STERILE” EN 556 ： 1994 4.1 . 6.2 6.2.1 “STERILE” . 6.2.2 ISO 11607 . 6.2.3 . 7 7.1 EN 1041 . 7.2 7.3 KS S ISO 7000 EN 980 . 7.2 . a) b) c) “ANTISTATIC” . d) , 7.4 . 30 L/min 0.2 kPa e) , m 7.4 , . 30 L/min 0.1 kPa/m f) 4.7.4 b) , (mL/min) . 7.3 7.2 . . a) “STERILE” b) “single use” c) 4.4 d

10、) , 7.2 . 6 KS P ISO 5367:2009 30 L/min 0.2 kPa e) , 7.4 , . 30 L/min 0.1 kPa/m f) 4.7.4 b) , (mL/min) . 7.4 10 L/min 0.5 L/min . 10 L/min 30 L/min 1 L/min . 30 L/min 5 L/min . 8 8.1 , . 8.2 1 , , . 7 KS P ISO 5367:2009 A () A.1 . A.2 1 m . A.3 A.3.1 2.5 % A.3.2 0.01 kPa A.3.3 A.1 5 L . . A.3.2 . ,

11、. A.4 A.4.1 . A.4.2 1 m (23 2) 1 , . A.4.3 A.1 ( A.3.3) . , 30 ( A.3.1). ( A.3.2) ( p1) . A.4.4 ( A.3.3) . Y , . . A.4.5 , 30 . (A.3.2) ( p2) . A.4.6 p2p1 , kPa , . A.4.7 Y , A.4.4A.4.6 . 2 8 KS P ISO 5367:2009 . A.5 , kPa (p2p1) . , kPa (p2p1) . 1 2 3 4 , 5 6 7 A.1 9 KS P ISO 5367:2009 B () B.1 . B

12、.2 . B.3 B.3.1 150 mm (50 5) mm/min , 40 N B.3.2 2 N B.3.3 KS P ISO 5356 1 22 mm ISO 468 0.8 m (roughness number N6) A 22 mm 15 mm B.4 B.4.1 (42 3) 80 % 1 . B.4.2 ( B.3.3) . . . B.4.3 (50 5) mm/min 150 mm ( B.3.1) 40 N . 10 KS P ISO 5367:2009 C () C.1 . C.2 . C.3 C.3.1 150 mm 1 45 N C.3.2 2 N C.3.3

13、(50 5) mm/min , 45 N C.4 C.4.1 (423) 1 80 % . C.4.2 (C.3.1) . C.4.3 (50 5) mm/min 150 mm (C.3.3) 45 N . 11 KS P ISO 5367:2009 D () D.1 . . . . . D.2 . D.3 D.3.1 (60.3) kPa D.3.2 (232) D.3.3 4.7 5 % D.3.4 B.3.3 D.4 D.4.1 . D.4.2 , 1 m . D.4.3 (23 2) 1 , . D.4.4 , B.4.2 . D.4.5 Y , B.4.2 , 2 APL . D.4

14、.6 (60.3) kPa ( D.3.1) . ( D.3.3) . D.5 D.5.1 . D.5.2 , . 12 KS P ISO 5367:2009 E () E.1 A . . . E.2 . E.3 E.3.1 2.5 cm E.3.2 (E.3.1) E.3.3 A.3 , E.3.4 (423) E.4 E.4.1 . E.4.2 1 (42 3) . E.4.3 (E.3.3) . E.4.4 (42 3) ( E.3.4) . 30 (p1). E.4.5 ( E.3.1) , ( E.3.2). E.4.6 . 5 ( p2). E.5 p1 p2 . 13 KS P ISO 5367:2009 F () F.1 D , . F.2 . F.3 F.3.1 (60.3) kPa F.3.2 A.3.2 F.3.3 ( , ) F.4 F.4.1 D . 1 mL/min . F.4.2 . F.4.3 1 (42 3) . F.4.4 Y . F.4.5 , . Y , . F.4.6 (F.3.2) . F.4.7 (60.3) kPa . F.5 1 . 14 KS P ISO 5367:2009 G () G.1 ( , ). . (遊離) . , . G.2 1 , , . . G.3