KS P ISO 8835-2-2009 Inhalational anaesthesia systems－Part 2：Anaesthetic breathing systems for adults《吸入麻醉装置 第2部分 成人用麻醉剂周期吸入装置》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 8835 2 2： KS P ISO 8835 2:2009 2009 1 6 http:/www.kats.go.krKS P ISO 8835 2:2009 : ( ) ( ) () ( ) : (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 2:2009 i . iii iv 1 * .1

2、 2 1 3 .2 4 3 4.1 .3 4.2 .3 4.3 .3 4.4 .4 5 4 5.1 4 5.2 Y .4 5.3 4 5.4 .4 5.5 * .4 5.6 .5 5.7 .5 5.8 * 5 5.9 5 6 / .5 7 .5 7.1 * .5 7.2 * / .6 8 .6 8.1 .6 8.2 / .6 8.3 6 8.4 .6 9 6 9.1 .6 9.2 .7 9.3 / .7 9.4 .7 10 .8 10.1 .8 10.2 .8 11 * (3.3 ).8 KS P ISO 8835 2:2009 ii 11.1 8 11.2 .8 11.3 .8 11.4 8

3、 12 8 12.1 8 12.2 8 13 8 13.1 8 13.2 8 13.3 8 A( ) 8 A.1 .8 A.2 .8 A.3 / .8 A.4 8 A.5 8 A.6 .8 A.7 8 B( ) .8 B.1 .8 C( ) .8 D( ) 8 8 KS P ISO 8835 2:2009 iii . KS P ISO 8835 2： 2003 . . , , . , , . KS P ISO 8835 2:2009 iv 2007 3 ISO 8835 2, Inhalational anaesthesia systems Part 2 ：Anaesthetic breath

4、ing systems . (*) B . KS P ISO 8835 2:2009 2： Inhalational anaesthesia systems Part 2： Anaesthetic breathing systems for adults 1 * . , , , , (AGSS) . CO2 . , , CO2 . KS C IEC 60601 2-13 DD / . 2 . . ( ) . KS C IEC 60601 1, KS C IEC 60601 1-2, 1 2： ： KS C IEC 60601 2-13, KS M ISO 2878, KS P ISO 5356

5、 1, 1： KS P ISO 5356 2, 2： KS P ISO 5362, KS P ISO 5367, 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 KS P ISO 8835 2:2009 2 3 ISO 4135 KS C

6、 IEC 60601 2-13 . 3.1 (anaesthetic breathing system) ABS (3.6), (3.9) (3.5) (3.4) 3.2 (circle absorber assembly) CO2 , , 2 , (3.6), / (3.3) 3.3 (circle breathing system) , (circle) (3.1) 3.4 (exhaust port) / (AGSS) 3.5 (exhaust valve) / AGSS (APL) . 3.6 (fresh gas inlet) (3.1) 3.7 (interchangeable c

7、omponent) 3.8 (non-rebreathing exhaust valve) 3 (3.5), , (3.9) (3.4) . (3.1) . 3.9 (patient connection port) (3.1) , KS P ISO 8835 2:2009 3 . 3.10 Y (Y piece) (3.9) 2 3 4 4.1 . , . 4.2 . 1 . 2 IEC 60601 1-6 . . 4.3 4.3.1 * , KS C IEC 60601 1 KS C IEC 60601 1-2 . RF . (EMC) 4.3.2 D . 12.1 h) KS P ISO

8、 8835 2:2009 4 4.4 , KS P ISO 8835 . KS P ISO 8835 . 5 5.1 15 mm 22 mm . KS P ISO 5356 1 . . 5.2 Y Y KS P ISO 5356 1 22 mm KS P ISO 5367 . 5.3 . a) KS P ISO 5356 1 30 mm b) KS P ISO 5356 1 KS P ISO 5367 c) AGSS 12.1 c) 5.4 KS P ISO 5356 1 22 mm . 5.1 . 5.3 . 5.5 * . KS P ISO 5367 KS P ISO 5362 . 20

9、. 12.1 d) KS P ISO 8835 2:2009 5 5.6 KS P ISO 5356 1 KS P ISO 5356 2 22 mm . , KS P ISO 5356 1 KS P ISO 5367 . 12.1 e) 5.7 KS P ISO 5356 1 KS P ISO 5356 2 15 mm 22 mm . , KS P ISO 5356 1 22 mm . 5.8 * , KS P ISO 5356 1 KS P ISO 5356 2 22 mm 15 mm . 50 . 5.9 , , KS P ISO 5356 1 KS P ISO 5356 2 , . 1

10、( KS P ISO 8185) ( ) . 2 12.1 g) 6 / ( ) , . 12.1 i) 7 7.1 * 3.0 kPa(30 cm H2O) 150 mL/min(15.2 kPaL/min) . KS P ISO 8835 2:2009 6 1 150 mL/min . 2 A 7.2 * / 10 L/min , 60 L/min 0.6 kPa(6 cm H2O) . / 60 L/min 13.2 b) . A 8 8.1 . (design) . 8.2 / , 30 L/min 13.3.2 b) . 8.3 , 13.3.2 c) . 8.4 , 3 kPa(3

11、0 cmH2O) . 9 9.1 , . , KS P ISO 5356 1 KS P ISO 5356 2 . 12.1 i) KS P ISO 8835 2:2009 7 . . 9.2 9.2.1 , . 7.3.1 7.4 . 9.2.2 , 12.1 j) . “off” . 9.2.3 “on” “off” . “on” “off” 7.1 7.2 / . 9.2.4 , “on” “off” 7.1 7.2 / . 9.2.5 “off” , . 9.3 / , , 7. / . A 9.4 9.4.1 , . 9.4.2 / , 60 L/min / 13.3.4 a) . 2

12、0 mL/min 0.12 kPa(1.2 cm H2O) . A KS P ISO 8835 2:2009 8 9.4.3 * 0.5 kPa(5.0 cmH2O) 60 mL/min . 1 0.05 kPa(0.5 cmH2O) . . 5 kPa(50 cmH2O) 0.5 kPa(5.0 cm H2O) 60 mL/min . 2 A 10 10.1 10.1.1 . 10.1.2 kPa . ( cmH2O) . 1 kPa( 10 cm H2O) 6 kPa( 60 cm H2O) . ( 4 % 4 %) . 10.1.3 . 10.2 12.5 kPa(125 cmH2O)

13、. KS P ISO 5362 . 11 * (3.3 ) . 11.1 Y . 11.2 . KS P ISO 8835 2:2009 9 11.3 . CO2 . 11.4 Y . 12 12.1 . a) / / b) c) 5.3 “EXHAUST” / “AGS” d) 5.5 “BAG” / e) 5.6 “VENTILATOR” f) . g) 5.9 “GAS SAMPLE RETURN” h) “ANTISTATIC” “CONDUCTIVE” . i) “BAG” “VENTILATOR” / . j) “on” “off” “on” “off” “absorber” .

14、k) “FOR SINGLE USE” (“ ” ) KS S ISO 7000 No.1051 l) . KS P ISO 8835 2:2009 10 a) “ on” b) “ off” 1 12.2 . a) / / b) c) d) “FOR SINGLE USE” (“ ” ) KS S ISO 7000 No.1051 e) “STERILE” f) “ANTISTATIC” “CONDUCTIVE” 13 13.1 . a) b) c) , , d) e) f) g) h) i) j) k) 13.2 a) b) / KS P ISO 8835 2:2009 11 A c) 3 kPa(30 cmH2O) d) CO2 3 kPa(30 cmH2O) e) ISO 8835 1 , , f) 10 L/min / 13.3 13.3.1 a) b) 3 kPa(30 cmH2O) 150 mL/min 13.3.2 a) b) . , (ATPD) 30 L/min . c) 13.3.2 b) . d) e)