1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 5366 3 3： KS P ISO 5366 3:2009 2009 12 21 http:/www.kats.go.krKS P ISO 5366 3:2009 : ( ) ( ) () () ( ) : (http:/www.standard.go.kr) ： ：1999 11 12 ：2009 12 21 2009-0834 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 5366 3:2009 i . ii 1
2、 1 2 1 3 .1 4 .2 4.1 .2 4.2 .2 4.3 .2 4.4 .3 5 3 6 .4 6.1 4 6.2 .4 6.3 4 6.4 5 6.5 .5 6.6 5 6.7 6 6.8 .6 7 .6 7.1 6 7.2 .6 8 7 8.1 .7 8.2 7 8.3 7 A( ) .9 A.1 .9 A.2 .9 A.3 .9 A.4 .10 B( ) .11 B.1 .11 B.2 .11 B.3 .11 B.4 .11 C( ) .12 C.1 .12 C.2 .12 13 KS P ISO 5366 3:2009 ii 2001 2 ISO 5366 3, Anaes
3、thetic and respiratory equipmentTracheostomy tubes Part 3： Paediatric tracheostomy tubes , . KS P ISO 5366 . KS P ISO 5366 1 . , , . . . . . . , . . , . KS P ISO 5366 3:2009 3： Anaesthetic and respiratory equipment Tracheostomy tubes Part 3： Paediatric tracheostomy tubes 1 2 mm 6 mm . 2 . . ( ) . KS
4、 P ISO 5356 1, 1： KS P ISO 5366 1, 1： KS P ISO 10993 1, 1： KS P ISO 11607( ), 1 , 2 ISO 594 1, Conical fittings with a 6 %(Luer) taper for syringes, needles and certain other medical equipment Part 1： General requirements ISO 5361, Anaesthetic and respiratory equipment Tracheal tubes and connectors
5、EN 556： 1994, Sterilization of medical devices Requirements for medical devices to be labelled “STERILE” 3 KS P ISO 5366 1 . 3.1 (paediatric tracheostomy tube) 3.2 (paediatric tracheostomy tube connector) KS P ISO 5366 3:2009 2 3.3 (machine end) 3.4 (patient end) 4 4.1 4.1.1 ( ) (mm) , 6.6.1 1 . 4.1
6、.2 15 mm (mm) 1 . 1 ： mm 2.0 2.02.00+2.5 2.52.00+3.0 3.02.00+3.5 3.52.00+4.0 4.02.00+4.5 4.53.00+5.0 5.03.00+5.5 5.53.00+6.0 6.03.00+4.2 4.2.1 A C (OD) (mm) ( 1 ). . 4.2.2 A 0.2 mm . 4.2.3 C 0.5 mm . 4.3 4.3.1 ( 1 A B C) , (mm) ( 1 ). KS P ISO 5366 3:2009 3 4.3.2 4.5 mm 1.5 mm , 4.5 mm 2 mm . 4.3.3
7、A, B C mm . A / B 0 0 . 4.3.4 (mm) . 4.4 () ( 1 ). a) b) a . 1 5 KS P ISO 10993 1 , ( ) aKS P ISO 5366 3:2009 4 . C 6 6.1 . a) KS P ISO 5356 1 15 mm . A . b) 6.2 . 6.2 6.2.1 2 . . 6.2.2 8.1(a) . 6.2.3 KS P ISO 5356 1 15 mm , 2 . 6.2.4 . 6.3 6.3.1 1.0 mm , 1.0 mm . 6.3.2 6.1 ( ) . KS P ISO 5366 3:200
8、9 5 2 ： mm 0.15 2.0 2.0 2.5 2.5 3.0 3.0 3.5 3.5 4.0 4.0 4.5 4.5 5.0 5.0 5.5 5.5 6.0 6.0 6.4 6.4.1 . 6.4.2 . 6.4.3 . 6.4.4 A . 6.5 6.5.1 . 6.5.2 ISO 5361 . 6.5.3 B 15 % . 6.6 6.6.1 2.5 mm . 10 % . . 6.6.2 6.6.2.1 / . KS P ISO 5366 3:2009 6 . 6.6.3 . ISO 594 1 6 % (Luer) . KS P ISO 5366 1 1 a) l1 40 m
9、m ( ). ( ) 6 % (Luer) KS P ISO 5366 1 1 b) l2 10 mm . . 6.7 () 50 1(b) . 6.8 , . . 7 7.1 “ ”(“STERILE”) EN 556： 1994 4.1 . 7.2 7.2.1 . a) b) c) . 7.2.2 “ ”(“STERILE”) . KS P ISO 11607 . KS P ISO 5366 3:2009 7 , . 8 8.1 / . a) 4.1 (mm) b) 4.2 (mm) c) / 8.2 . 8.3 8.3.1 EN 1041 . 8.3.2 8.3.3 EN 980 . 8
10、.3.2 . a) b) 4.1 c) (mm) (4.2) d) (mm) (4.3.1). . e) , f) 1 A. 1 B g) 4.4 h) / / i) j) k) “ ”(“STERILE”) “ ”(“NON STERILE”) l) “ ”(“SINGLE USE”) m) B (mm) . n) . o) , ( ) . KS P ISO 5366 3:2009 8 8.3.3 . . a) b) ( ) ( ) c) d) / / e) f) g) “ ”(“STERILE”) “ ”(“NON STERILE”) h) “ ”(“SINGLE USE”) i) , (
11、 ) . KS P ISO 5366 3:2009 9 A ( ) A.1 (axial separation force) . A.2 A.2.1 24 (372) 80 % A.2.2 (505) N (505) mm min 1 A.2.3 (151.5) N (505) N (505) mm min 1 A.3 A.3.1 24 (372) 80 % . A.3.2 . ( ) . A.3.3 10 (505) N (505) mm min 1 . A.3.4 . A.3.5 10 . a) (151.5) N (505) mmmin 1 KS P ISO 5366 3:2009 10
12、 b) (505) N (505) mm min 1 A.4 . KS P ISO 5366 3:2009 11 B ( ) B.1 . B.2 (20.1) kPa . B.3 B.3.1 (20.1) kPa , (232) 5 . B.3.2 45 . B.4 B.3.2 (mm) . KS P ISO 5366 3:2009 12 C ( ) C.1 C.1.1 . . C.1.2 “ ” , , . . (5. ). C.1.3 . C.1.4 X . C.1.5 , . C.2 C.2.1 . C.2.2 . C.2.3 . C.2.4 . C.2.5 . . . (： , ) .
13、 KS P ISO 5366 3:2009 13 1 ISO 4135, Anaesthetic and respiratory equipment Vocabulary 2 ISO/TR 11991, Guidance on airway management during laser surgery of upper airway 3 EN 980, Terminology, symbols and information provided with medical devices Graphical symbols for use in the labelling of medical
14、devices 4 EN 1041, Terminology, symbols and information provided with medical devices Information supplied by the manufacturer with medical devices 3： 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 5366 3:2009KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Anaesthetic and respiratory equipment Tracheostomy tubes Part 3： Paediatric tracheostomy tubes ICS 11.040.10
