KS P ISO 5364-2009 Anaesthetic and respiratory equipment－Oropharyngeal airways《麻醉和呼吸设备 口咽部导气管》.pdf

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1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 5364 KS P ISO 5364:2009 2009 12 25 http:/www.kats.go.krKS P ISO 5364:2009 : ( ) ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2004 11 2 ：2009 12 25 2009-0868 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 5364:2009 .1 1 1 2 1 3 .1 4 2

2、 4.1 2 4.2 .3 5 3 6 3 7 .3 7.1 .3 7.2 (Patency of lumen) 3 8 4 9 .4 10 4 10.1 4 10.2 (symbol) .4 10.3 4 10.4 4 10.5 .5 11 5 A( ) .6 A.1 .6 A.2 .6 A.3 .6 A.4 6 B( ) 8 B.1 .8 B.2 .8 B.3 .8 B.4 .8 C( ) .10 11 i KS P ISO 5364:2009 Anaesthetic and respiratory equipmentOropharyngeal airways 2008 4 ISO 536

3、4, Anaesthetic and respiratory equipment Oropharyngeal airways . 1 / / . , . . . , . 2 . . ( ) . KS P ISO 10993 1, 1 ： KS P ISO 11607 1, 1：, KS S ISO 7000, EN 5561 ： 2001, Sterilization of medical devices Requirements for medical devices to be designated “STERILE” Part 1：Requirements for terminally

4、sterilized medical devices EN 980, Graphical symbols for use in the labelling of medical devices EN 1041, Information supplied by the manufacturer with medical devices 3 . KS P ISO 5364:2009 3.1 ISO 4135 3.2 (pharyngeal end) ISO 4135 3.3 (flanged end) ISO 4135 4 4.1 1 ( 1 l) . . 1 3 ( 1 ) 2 ( ) 4 a4

5、.1 4.2.1 1 2 KS P ISO 5364:2009 1 ()cm mm mm 3 3.5 4 4.5 5 5.5 6 6.5 7 8 9 10 11 12 302.5 352.5 402.5 452.5 502.5 552.5 602.5 652.5 70 0.55.2+805.0 905.0 1005.0 1105.0 1205.0 2.5 3.0 3.0 3.0 3.5 3.5 4.0 4.0 4.0 4.5 4.5 5.0 5.5 5.5 4.2 4.2.1 ( 1 l ) 1 . 4.2.2 1 . ( ) . 5 KS P ISO 10993 1 . 6 0.5 mm .

6、 7 7.1 A , 1 75 % . 7.2 (Patency of lumen) B , . 3 KS P ISO 5364:2009 8 “STERILE” EN 556 1： 2001 4.1 . 9 9.1 “STERILE” . 9.2 KS P ISO 11607 1 . 9.3 , . 9.4 . 9.5 . 10 10.1 EN 1041 . 10.2 ( symbol) 10.4 10.5 KS S ISO 7000 EN 980 . 10.3 10.3.1 . a) 4.1 (/cm)( 2 ) b) ( 2 ) 10.3.2 a) b) . 10.4 . a) , “S

7、TERILE” ( .) b) “1 (single use)” c) ( ) “ ()” 4 KS P ISO 5364:2009 1 2 1 2 . 2 10.5 . a) b) 4.1 c) / / d) e) , “STERILE” ( .) f) “1 (single use)” ( .) 11 11.1 1 , . 11.2 , ( ) ( ) . 5 KS P ISO 5364:2009 A () A.1 . A.2 A.2.1 (342) (conditioning) , A.2.2 (10010) N (200 20) N A.2.3 (compression) 0.10 m

8、m A.3 A.3.1 1 (34 2) . A.3.2 A.1 ( 1 ) . (60 2) (1.0 0.5) mm , ( A.1 ). A.3.3 5.5 (100 10) N 3 . A.3.4 6.0 (200 20) N 3 . A.4 1 . 6 KS P ISO 5364:2009 ：mm 1 A.3.3 A.3.4 X ： . R (10.5) mm A.1 7 KS P ISO 5364:2009 B () B.1 , (steel ball) . B.2 B.2.1 (342) (conditioning) , B.2.2 (clamp) B.2.3 (5.00.5)

9、N B.2.4 ( 1 ) 75 % B.3 B.3.1 1 (34 2) . B.3.2 , (5.0 0.5) N 1 ( B.1 ). B.3.3 ( B.2.4) . B.4 . 8 KS P ISO 5364:2009 1 ( ) 2 (clamp) 3 B.3.2 B.1 9 KS P ISO 5364:2009 C () C.1 (design) . C.2 1 , , . , ( 5. ). C.3 , . C.4 . C.5 . 10 KS P ISO 5364:2009 1 ISO 4135, Anaesthetic and respiratory equipmentVoc

10、abulary 2 ISO/TR 11991, Guidance on airway management during laser surgery of upper airway 11 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 5364:2009 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Anaes tic and respiratory theequipmentOropharyngeal airways ICS 11.040.10 Korean Agency for Technology and Standards http:/www.kats.go.kr