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

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