KS P ISO 7396-2-2008 Medical gas pipeline systems－Part 2：Anaesthetic gas scavenging disposal systems《医用气体管道系统 第2部分 麻醉用气体净化处理系统》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 7396 2 2： KS P ISO 7396 2:2008 2008 12 30 http:/www.kats.go.krKS P ISO 7396 2:2008 : ( ) ( ) () () ( ) : (http:/www.standard.go.kr) ： ： 2008 12 30 2008-1004 ： ： ( 025097266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 7396 2:2008 i . iii .1 1 1 2 1 3

2、.2 4 .6 4.1 .6 4.2 6 4.3 .6 4.4 7 5 8 6 .9 7 , 9 8 10 8.1 .10 8.2 10 8.3 .12 9 13 10 13 10.1 .13 10.2 .13 10.3 13 11 .13 12 , 15 12.1 15 12.2 15 12.3 , 15 12.4 12.3 , 16 12.5 .17 12.6 .17 13 .17 KS P ISO 7396 2:2008 ii 13.1 17 13.2 17 13.3 .18 13.4 18 13.5 .18 A( ) , 19 B( ) 20 C( ) AGS .23 D( ) 35

3、E( ) .42 43 KS P ISO 7396 2:2008 iii . KS P ISO 7396： 2003 . . , , . , , . KS P ISO 7396 1, 1： KS P ISO 7396 2, 2： KS P ISO 7396 2:2008 2： Medical gas pipeline systems Part 2： Anaesthetic gas scavenging disposal systems 2007 2 ISO 7396 2, Medical gas pipeline systems Part 2： Anaesthetic gas scavengi

4、ng disposal systems , . (*) E . 1 , , , , , . (power device), , , (anaesthetic gas scavenging： AGS) . . ISO 9170 2 AGSS KS P ISO 88353 AGSS . . AGSS AGSS 2 . . ( ) . KS P ISO 7396 1： 2008, 1： KS P ISO 7396 2:2008 2 KS P ISO 8835 3, 3： ISO 5359, Low-pressure hose assemblies for use with medical gases

5、 ISO 9170 2, Terminal units for medical gas pipeline systems Part 2： Terminal units for anaesthetic gas scavenging systems ISO 14971, Medical devices Application of risk management to medical devices ISO 15001, Anaesthetic and respiratory equipment Compatibility with oxygen EN 1041, Information supp

6、lied by the manufacturer with medical devices EN 13348, Copper and copper alloys Seamless, round copper tubes for medical gases or vacuum 3 . 3.1 AGSS (AGSS socket) , . 3.2 AGSS (AGSS terminal unit) AGSS (inlet) . 3.3 AGSS (AGSS terminal unit base block) AGSS . 3.4 1 AGSS (AGSS type 1 terminal unit)

7、 , . 1 3.5 1H AGSS (AGSS type 1H terminal units) 1 (high-flow) . 3.6 1L AGSS (AGSS type 1L terminal units) 1 (low-flow) . 3.7 2 AGSS (AGSS type 2 terminal unit) , . 1 3.8 AGSS (AGSS type-specific) AGSS . KS P ISO 7396 2:2008 3 3.9 ASGG (AGSS type-specific connection point) AGSS AGSS . 3.10 (air comp

8、ressor system) AGSS / / 3.11 (anaesthetic gas scavenging system) AGSS / AGSS 3 . , . 3 . , AGSS 1 (： ) . 3.12 (commissioning) 3.13 (disposal hose) / 2 AGSS AGSS 3.14 (disposal system) / . 3.15 (diversity factor) (maximum proportion) 3.16 (high-flow disposal system) KS P ISO 8835 3 3.17 (high-flow tr

9、ansfer and receiving system) ISO 9170 2 1H AGSS , KS P ISO 8835 3 KS P ISO 7396 2:2008 4 3.18 (low-flow disposal system) KS P ISO 8835 3 3.19 (low-flow transfer and receiving system) ISO 9170 2 1H AGSS , KS P ISO 8835 3 3.20 (manufacturer) , , , 3 . 3.21 (maximum operating pressure) 1 , 2 . 3.22 (ma

10、ximum test pressure) 3.23 (non-return valve) 3.24 (power device) AGS 3.25 (probe) 3.26 (quick connector) , 3.27 (receiving hose) / AGSS 3.28 (receiving system) AGSS KS P ISO 7396 2:2008 5 3.29 (shut-off valve) 1 11 / 12 2 13 (pendant) 3 / 14 4 / 15 5 16 6 17 7 18 8 19 ( ) 9 20 (30 mm) 10 21 1 / 22 2

11、 / 1 1 / , 2 / . 2 . . 1 AGSS KS P ISO 7396 2:2008 6 3.30 (single fault condition) . 3.31 (system design flow) 3.32 (transfer system) / 3.33 (transfer tube) / AGSS 4 4.1 AGS , , , , , ISO 14971 , . 1 . / . , 2 . . 2 ( , / , ) D . 4.2 AGS (： ) , . 1 . . 2 (： European Economic Area： EEA) . 4.3 KS P IS

12、O 7396 2:2008 7 4.3.1 . 1 . . 2 (： European Economic Area： EEA) . 4.3.2 EN 13348 . . 1 (： European Economic Area： EEA) . 2 4.3.2 KS P ISO 7396 1 . 4.3.3 ISO 14971 . AGS . 4.3.4 ISO 15001 . . ( ： ： European Economic Area： EEA) . 4.3.5 , . . ( ： ： European Economic Area： EEA) . 4.3.6 , . 4.4 AGS . . K

13、S P ISO 7396 2:2008 8 , AGS 2 2 , (dedicated) . AGS , . . 5 5.1 AGS . 5.2 . a) KS P ISO 7396 1 1 1 AGSS , 1 8.1.1 8.1.2 2(a) . b) KS P ISO 7396 1 2 AGSS 8.1.3 2(b) . 1 AGS . c) 2 , 2 . 3 , A . , . (*) KS P ISO 7396 1 AGSS . 5.3 1 8.1.1 8.1.2 , 2(c) . / . 5.4 . . ( ： ： European Economic Area： EEA) .

14、5.5 , . 5.6 KS P ISO 7396 1 , , , ISO 14971 . KS P ISO 7396 2:2008 9 a) b) c) 1 2 , , 3 4 1 5 2 6 7 8 9 2 6 AGS . 7 , 7.1 . ISO 5359 . 7.2 , , ISO 5359 . KS P ISO 7396 2:2008 10 , (hinge-arm boom), . 8 8.1 8.1.1 1L AGS 1L ( 1 ) , 50 L/min 1 kPa 50 L/min , 25 L/min 2 kPa 25 L/min (KS P ISO 8835 2, 10

15、.1 ). 8.1.2 1H AGS 1H ( 1 ) , 80 L/min 1 kPa 80 L/min , 50 L/min 2 kPa 50 L/min (KS P ISO 8835 2, 10.2 ). 8.1.3 2 AGS 2 AGSS 50 L/min 7.5 kPa . 8.2 8.2.1 8.2.1.1 . . a) b) 1 , . 8.2.1.2 . 8.2.1.3 . . 8.2.2 1L 8.2.2.1 KS P ISO 8835 3 , 1L 50 L/min 1 kPa( 1/50) 25 L/min 2 kPa( 2/25) . KS P ISO 7396 2:

16、2008 11 3 . 1 1 2 3 4 ( ) 3 1 AGS 8.2.2.2 8.2.2.2.1 AGS . 8.2.2.2.2 50 L/min 1 kPa( 1/50) 1L 1L . . 8.2.2.2.3 25 L/min 2 kPa( 2/50) 1L 1L . . 8.2.2.2.4 50 L/min 1 kPa( 1/50) 1L AGS 1L . 25 L/min 2 kPa( 2/25) 1L . . 8.2.2.2.5 8.2.2.2.2, 8.2.2.2.3 8.2.2.2.4 . C.7.1 ( C ) . 8.2.3 1H KS P ISO 7396 2:200

17、8 12 8.2.3.1 KS P ISO 8835 3 , 1L 50 L/min 1 kPa( 1/80) 50 L/min 2 kPa( 2/50) . 3 . 8.2.3.2 8.2.3.2.1 AGS . 8.2.3.2.2 80 L/min 1 kPa( 1/80) 1H 1H . . 8.2.3.2.3 50 L/min 2 kPa( 2/50) 1H 1H . . 8.2.3.2.4 80 L/min 1 kPa( 1/80) 1H AGS 1H . 50 L/min 2 kPa( 2/50) 1H . . 8.2.3.2.5 8.2.3.2.2, 8.2.3.2.3 8.2.3.2.4 . C.7.2 ( C ) . 8.2.4 2