1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 7396 1 1： KS P ISO 7396 1:2008 2008 12 30 http:/www.kats.go.krKS P ISO 7396 1:2008 : ( ) ( ) () () ( ) : (http:/www.standard.go.kr) ： ： 2008 12 30 2008-1004 ： ： ( 025097266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 7396 1:2008 i . iii .1 1 1 2 2 3
2、 .2 4 .7 4.1 (*) .7 4.2 (*) 8 4.3 .8 4.4 9 5 .10 5.1 10 5.2 10 5.3 .12 5.4 .13 5.5 .13 5.6 .17 5.7 .17 5.8 .18 5.9 19 5.10 .19 6 19 6.1 .19 6.2 19 6.3 .20 6.4 .21 6.5 21 6.6 (*) 22 7 22 7.1 22 7.2 22 7.3 .23 7.4 2 .24 8 .24 8.1 .24 8.2 .25 KS P ISO 7396 1:2008 ii 8.3 .25 9 , , , 26 10 26 10.1 .26 10
3、.2 27 11 .27 11.1 27 11.2 28 11.3 28 11.4 29 12 , 29 12.1 29 12.2 .30 12.3 30 12.4 , .30 12.5 31 12.6 , 31 12.7 36 13 36 13.1 36 13.2 36 13.3 .37 13.4 “ ” 37 13.5 .38 A( ) .39 B( ) , 57 C( ) 58 D( ) .70 E( ) 100 F( ) 102 G( ) 111 H( ) .128 130 KS P ISO 7396 1:2008 iii . KS P ISO 7396： 2003 . . , , .
4、 , , . KS P ISO 7396 1, 1： KS P ISO 7396 2, 2： KS P ISO 7396 1:2008 1： Medical gas pipeline systems Part 1： Pipeline systems for compressed medical gases and vacuum 2007 2 ISO 7396 1, Medical gas pipeline systems Part 1： Pipeline systems for compressed medical gases and vacuum . (*) H . 1 , , , , ,
5、, . , , , (non-interchangeability) . . a) / ( 1 ) b) (*) c) . KS P ISO 7396 1:2008 2 1 / . 2 (*)EN 14931( 23) (hyperbaric chamber) , . 2 . . ( ) . KS B ISO 8573 1, KS C IEC 60601 1-8, 1-8： ： , KS I ISO 3746, ISO 5359, Low-pressure hose assemblies for use with medical gases ISO 9170 1, Terminal units
6、 for medical gas pipeline systems Part 1： Terminal units for use with compressed medical gases and vacuum ISO 10083, Oxygen concentrator supply systems for use with medical gas pipeline systems ISO 10524 2, Pressure regulators for use with medical gases Part 2： Manifold and line pressure regulators
7、ISO 11197, Medical supply units ISO 14971, Medical devices Application of risk management to medical devices ISO 15001： 2003, Anaesthetic and respiratory equipment Compatibility with oxygen ISO 21969, High-pressure flexible connections for use with medical gas systems EN 286 1, Simple unfired pressu
8、re vessels designed to contain air or nitrogen Part 1： Pressure vessels for general purposes EN 1041, Information supplied by the manufacturer with medical devices EN 13348, Copper and copper alloys Seamless, round copper tubes for medical gases or vacuum 3 . 3.1 (air compressor system) 3.2 (air for
9、 driving surgical tools) , . , , , KS P ISO 7396 1:2008 3 700 800 . 3.3 (branch) 3.4 (commissioning) 3.5 (control equipment) , , , , (non-return) ( .) . 3.6 (cryogenic liquid system) 150 3.7 (cylinder bundle) 3.8 (diversity factor) (maximum proportion) 3.9 2 (double-stage pipeline distribution syste
10、m) , 3.10 (emergency clinical alarm) 3.11 (emergency inlet point) 3.12 (emergency operating alarm) 3.13 (emergency supply) KS P ISO 7396 1:2008 4 3.14 (gas-specific) 3.15 (gas-specific connector) (quick connector), , (diameter-indexed safety system： DISS) . 3.16 (high-dependency patient) , 3.17 (inf
11、ormation signal) 3.18 (line pressure regulator) 3.19 (low-pressure hose assembly) , 1 400 kPa 3.20 (main line) 3.21 (maintenance supply assembly) 3.22 (maintenance supply) 3.23 (manifold) 3.24 (manifold pressure regulator) KS P ISO 7396 1:2008 5 3.25 (manufacturer) , , , 3 . 3.26 (maximum distributi
12、on pressure) 0 , 3.27 (medical air) , , . 1 . 2 (European Phamacopoeia 2005) “ ” . 3 (European Phamacopoeia 2005) “ ” . 3.28 (medical gas) , , 3.29 (medical pipeline system) , , 3.30 (minimum distribution pressure) 3.31 (nominal distribution pressure) 3.32 (nominal supply system pressure) 3.33 (non-
13、cryogenic liquid system) 50 3.34 (non-return valve) KS P ISO 7396 1:2008 6 3.35 (operating alarm) 3.36 (oxygen concentrator) 3.37 (oxygen-enriched air) 3.38 (pipeline distribution system) . 3.39 (pressure regulator) 3.40 (pressure-relief valve) (excess pressure) 3.41 1 (primary source of supply) 3.4
14、2 (proportioning unit) 3.43 (reserve source of supply) 1 2 3.44 (riser) , . 3.45 2 (secondary source of supply) 1 3.46 (shut-off valve) KS P ISO 7396 1:2008 7 3.47 (silencing) (audio pause) . 3.48 (single fault condition) 3.49 1 (single-stage pipeline distribution system) 3.50 (source of supply) 3.5
15、1 (supply pressure regulator) . , . 3.52 (supply system) . 3.53 (system design flow) 3.54 (terminal unit) ( ) 3.55 (vacuum system) (negative pressure) 4 4.1 (*) , , , , , ISO 14971 “ ” . 1 (fault) . / KS P ISO 7396 1:2008 8 , (unacceptable risk) . , . 2 ( , / , , , , , ) F . 4.2 (*) , ( ). 1 . . 2 (
16、： ) . 4.3 4.3.1 (*) . . 4.3.2 (*) . . . 1 ISO 15001 . 2 . 3 . , . . . 4.3.3 ( ) . ISO 15001 D.7 . KS P ISO 7396 1:2008 9 “ ” . ISO 15001 E . . 4.3.4 (*) , 1.5 5 . . . 4.3.5 (*) . ISO 10524 2 . . . 4.3.6 (*) (flexible connector) , . 108 mm EN 13348 . 108 mm EN 13348 . . . 1 . 2 108 mm EN 13348 . 3 .
17、4.3.7 (4.3.8 ), . 4.3.8 (*) , ISO 15001 . ISO 15001 . 4.3.9 ： (NMR), (magnetic resonance imaging) . 4.4 KS P ISO 7396 1:2008 10 4.4.1 / , . 1 , 16, 24, 25, 26, 30 . . 2 24 30 . 4.4.2 . . a) . . b) . c) 7.2 . . 5 5.1 5.1.1 , 3 . a) b) c) d) e) f) g) (ISO 10083 ) 5.1.2 2 . 5.1.3 3 . 5.1.4 A( A.1 A.27) . 5.2 5.2.1 KS P ISO 7396 1:2008 11 .
