KS P ISO 8835-3-2009 Inhalational anaesthesia systems-Part 3:Transfer and receiving systems of anaesthetic gas scavenging systemss《吸入麻醉装置 第3部分 麻醉气体清除装置 传送和接收装置》.pdf

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1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 8835 3 3: KS P ISO 8835 3:2009 2009 1 6 http:/www.kats.go.krKS P ISO 8835 3:2009 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) : :2003 12 30 :2009 1 6 2009-0003 : : ( 025097266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 8835 3:2009 i . iii iv 1 * .1

2、 2 1 3 .2 4 .3 4.1 .3 4.2 .4 4.3 4 5 * .4 5.1 .4 5.2 .5 6 * .5 7 * .5 7.1 .5 7.2 .6 8 * .6 8.1 .6 8.2 .6 8.3 .6 8.4 7 8.5 7 8.6 7 9 7 9.1 7 9.2 7 10 7 11 7 12 8 13 * .8 A( ) AGSS 9 A.1 .9 A.2 9 A.3 9 B( ) 11 B.1 .11 B.2 11 KS P ISO 8835 3:2009 ii C( ) 11 C.1 .11 C.2 11 D( ) 11 D.1 .11 D.2 .11 E( ) .

3、11 E.1 .11 E.2 11 E.3 .11 E.4 11 E.5 11 F( ) .11 G( ) 11 11 KS P ISO 8835 3:2009 iii . KS P ISO 8835 3: 2003 . . , , . , , . KS P ISO 8835 3:2009 iv 2007 2 ISO 8835 3, Inhalational anaesthesia systems Part 3: Transfer and receiving systems of anaesthetic gas scavenging systems . (*) F . KS P ISO 883

4、5 3:2009 3: Inhalational anaesthesia systems Part 3: Transfer and receiving systems of anaesthetic gas scavenging systemss 1 * ( AGSS) . , . . ISO 7396 2 AGSS( AGSS) ( ) KS C IEC 60601 2 13 DD 2 . . ( ) . KS C IEC 60601 1, KS C IEC 60601 2-13, KS P ISO 5356 1, 1: KS P ISO 5356 2, 2: KS P ISO 7396 2,

5、 2: KS P ISO 8835 2, 2: KS S ISO 7000, ISO 594 2, Conical fittings with a 6 %(Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings ISO 4135, Anaesthetic and respiratory equipment Vocabulary ISO 5359: 2000, Low-pressure hose assemblies for use with medical gases

6、 ISO 9170 1, Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuum ISO 9170 2, Terminal units for medical gas pipeline systems Part 2: Terminal units for anaesthetic KS P ISO 8835 3:2009 2 gas scavenging systems ISO 21647, Medical ele

7、ctrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors 3 ISO 4135 KS C IEC 60601 2-13 . 3.1 (anaesthetic gas scavenging system) AGSS / (3.3) , . , . . , AGSS , . 3.2 (active anaesthetic gas scavenging system) AGSS (active AGSS) (3.4) (3.1

8、) 3.3 (anaesthetic gas) / 3.4 (disposal system) / (3.3) (3.13) (3.14) AGSS(3.2) , . 3.5 (disposal hose) (3.13) AGSS 2 (3.3) (3.4) 3.6 (extract flow) AGSS(3.1) (3.16) (3.14) (3.4) 3.7 (high-flow transfer and receiving system) ISO 9170 2 1 L AGSS(3.1) KS P ISO 7396 2 KS P ISO 8835 3:2009 3 (3.4) (3.16

9、) (3.14) 3.8 (induced flow) (3.4) (3.13) (3.16) 3.9 (low-flow transfer and receiving system) ISO 9170 2 1 L AGSS(3.1) KS P ISO 7396 2 (3.4) (3.16) (3.14) 3.10 (maximum extract flow) (3.8) (3.4) 3.11 (minimum extract flow) (3.15) (3.4) 3.12 (non-operator-detachable connector) 3.13 (power device) AGSS

10、(3.2) (3.4) 3.14 (receiving system) (3.16) (3.4) AGSS(3.1) 3.15 (spillage) AGSS(3.1) / (3.3) 3.16 (transfer system) / (3.3) (3.14) AGSS(3.1) 3.17 (transfer tube) (3.14) (3.3) AGSS(3.1) 4 4.1 KS P ISO 8835 3:2009 4 AGSS . . 4.2 . . 4.3 , . , . 5 * 5.1 5.1.1 * AGSS 75 L/min , 350 Pa(3.5 cm H2O) . ( ).

11、 , . 5.1.2 * AGSS AGSS 50 mL/min . 5.1.3 * AGSS 50 Pa(0.5 cm H2O) . 5.1.4 20 cycles/min 1 L I: E 1: 1 , 100 mL/min . E 5.1.5 (100.5) L/min , 100 mL/min . KS P ISO 8835 3:2009 5 . . . . 5.2 5.2.1 AGSS 75 L/min , 2.0 kPa (20 cm H2O) . 5.2.2 AGSS AGSS 500 mL/min . 5.2.3 AGSS 50 Pa(0.5 cm H2O) . 6 * 6.1

12、 , . 6.2 30 mm KS P ISO 5356 1 . 6.3 AGSS . (ISO 9170 1 ISO 9170 2 ), (ISO 5359 ), (KS P ISO 8835 2 ) AGSS . 30 mm , KS P ISO 5356 1 KS P ISO 5356 2 . 6.4 , AGSS ISO 594 2 . 7 * 7.1 7.1.1 , KS P ISO 5356 1 30 mm . 7.1.2 . a) , KS P ISO 8835 3:2009 6 b) 5.2.1 . ( ) 7.1.3 6.1 6.3 . 7.2 7.2.1 , 6.1 6.2

13、 30 mm . 7.2.2 6.1 6.3 . 8 * 8.1 9.1 . 9.2 . . 8.2 8.2.1 , 6.2 30 mm . 8.2.2 6.3 . 8.3 . 1L 1H 1L 1H ISO 9170 2 . KS P ISO 8835 3:2009 7 1 (KS P ISO 7396 2 ISO 9170 2 ). 2 AGSS , , . 8.4 AGSS , . . 8.5 . , . 8.6 ISO 5359 5.1( ), 4.4.6( ), 5.7( ) , 8.2.1 . , KS P ISO 7396 2 , ISO 9170 2 2 . 9 9.1 25

14、L/min 2 kPa(20 cm H2O) , 50 L/min 1 kPa(10 cm H2O) . 9.2 50 L/min 2 kPa(20 cm H2O) , 80 L/min 1 kPa(10 cm H2O) . 10 , KS C IEC 60601 1 . 11 . a) , , b) , AGSS KS P ISO 8835 3:2009 8 c) , d) , e) , f) , g) , 12 , AGSS KS C IEC 60601 1 6. . . a) , . b) / c) , KS S ISO 7000 1641 ( ) d) . 75 L/min, 50 L

15、/min, 13 * AGSS , (magenta) . (Munsell Book of Color) 10 P hue/4/10 . KS P ISO 8835 3:2009 9 A ( ) AGSS A.1 A.1.1 5 % A.1.2 5 % A.2 A.2.1 AGSS A.1 A.2 . X X AGSS . A.2.2 A.1 A.2 , X X , . A.2.3 75 L/min . A.2.4 . . A.3 A.3.1 AGSS A.1 A.2 . X X AGSS . A.3.2 A.1 A.2 , X X . , A.3 . . A.3.3 75 L/min .

16、. KS P ISO 8835 3:2009 10 (key) 1 2 3 4 5 AGSS 6 a b X X AGSS ( ) A.1 AGSS KS P ISO 8835 3:2009 11 (key) 1 2 3 4 5 6 AGSS 7 a b X X AGSS ( ) A.2 AGSS KS P ISO 8835 3:2009 12 : mm (key) 1 2 (200 N) 3 4 5 A.3 AGSS KS P ISO 8835 3:2009 13 B ( ) B.1 B.1.1 50 Pa 5 Pa B.2 A.1 A.2 (B.1.1) . . . . KS P ISO

17、8835 3:2009 14 C ( ) C.1 C.1.1 10 mL/min C.2 C.2.1 C.1 , X X (C.1.1) AGSS . AGSS , 50 L/min 75 L/min . C.2.2 . (key) 1 2 3 AGSS 4 a X X AGSS C.1 KS P ISO 8835 3:2009 15 D ( ) D.1 D.1.1 D.1 . D.1.2 A.1 . D.2 D.2.1 D.1 . . D.2.2 25 L/min . D.2.3 . D.2.4 25 L/min . D.2.5 D.2.4 D.2.2 . 9.1 . D.2.6 . D.2.7 50 L/min D.2.2 D.2.5 . 9.1 . D.2.8 , 80 L/min D.2.1 D.2.5 9.2 . KS P ISO 8835 3:2009 16 (key) 1 / (7.2 ) 2 3 4 a X X AGSS D.1 KS P ISO 8835 3:2009 17 E ( ) E.1 AGSS (test enclosure, E.1 ) . , . , 10 % . E.2

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