1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 5366 1 1： KS P ISO 5366 1:2009 2009 12 21 http:/www.kats.go.krKS P ISO 5366 1:2009 : ( ) ( ) () () ( ) : (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 1:2009 i . ii 1
2、 1 2 1 3 .1 4 4 5 5 6 .6 7 .7 8 8 A( ) .10 A.1 .10 A.2 .10 A.3 .10 A.4 .11 B( ) 12 B.1 .12 B.2 .12 B.3 .12 B.4 .12 C( ) .13 C.1 .13 C.2 .13 14 KS P ISO 5366 1:2009 ii 2000 4 ISO 5366 1, Anaesthetic and respiratory equipmentTracheostomy tubes Part 1： Tubes and connectors for use in adults , . . . , ,
3、 . 6.5 mm , 2.0 mm 6.0 mm KS P ISO 5366 3 . . , . , . . . . . . 15 mm . KS P 1305(ISO 7228) 15 mm . , . 1) . ( 6.5 mm ) 15 mm . 1) ISO/TR 11991 KS P ISO 5366 1:2009 1： Anaesthetic and respiratory equipment Tracheostomy tubes Part 1： Tubes and connectors for use in adults 1 / 6.5 mm . . 2 . . ( ) . K
4、S P ISO 5356 1, 1： KS P ISO 10993 1, 1： KS P ISO 11607 1, 1： , KS P ISO 11607 2, 2： , ISO 594 1, Conical fittings with a 6 %(Luer) taper for syringes, needles and certain other medical equipment Part 1： General requirements ISO 4135, Anaesthetic and respiratory equipment Vocabulary ISO 5361, Anaesth
5、etic and respiratory equipment Tracheal tubes and connectors EN 556： 1994, Sterilization of medical devices Requirements for medical devices to be labelled “STERILE” 3 . 3.1 (tracheostomy tube) 1 a) b) . KS P ISO 5366 1:2009 2 3.2 (machine end) 3.3 (machine end) 3.4 (patient end) 3.5 (nominal length
6、) 2 . 3.6 (outer tube) 3.7 (inner tube) 3.8 (cuff) 3.9 (inflating tube) KS P ISO 5366 1:2009 3 a) 1 b) 2 1 7 2 8 3 ( ) 9 4 10 5 , 11 6 KS P ISO 5356 1 15 mm 12 ( ) 1 KS P ISO 5366 1:2009 4 1 2 3 . 2 3.10 (Pilot ballon) 3.11 (neck plate, shield) 3.12 (introducer, obturator) 3.13 ( ) (bevel) 3.14 (ang
7、le of bevel) 4 4.1 4.1.1 ( ) (mm) , 6.5.1 1 . 4.1.2 (mm) 1 . KS P ISO 5366 1:2009 5 1 ： mm 6.5 6.50.2 7.0 7.00.2 7.5 7.50.2 8.0 8.00.2 8.5 8.50.2 9.0 9.00.2 9.5 9.50.2 10.0 10.00.2 10.5 10.50.2 11.0 11.00.2 4.2 4.2.1 a c (OD) , (mm) ( 2 ). . 4.2.2 a 0.2 mm . 4.2.3 c 0.5 mm . 4.3 4.3.1 ( 2, a b c) ,
8、(mm) . 4.3.2 2 mm . 4.3.3 A, B, C (mm) ( 2 ). A / B 0 0 . 4.3.4 (mm) . 4.4 () ( 2 ). 5 KS P ISO 10993 1 . KS P ISO 5366 1:2009 6 C 6 6.1 6.1.1 KS P ISO 5356 1 15 mm . A . 6.1.2 . 6.1.3 . 6.1.4 A . 6.2 6.2.1 . 6.2.2 . 6.2.3 . 6.2.4 A . 6.3 6.3.1 1.0 mm . 6.3.2 6.1 ( ) . 6.4 6.4.1 . 6.4.2 ISO 5361 . 6
9、.4.3 B 15 % . 6.5 KS P ISO 5366 1:2009 7 6.5.1 2.5 mm . ( ) 10 % . . 6.5.2 6.5.2.1 / . . 6.5.2.2 . 6.5.3 ( 1 ) . ISO 594 1 6 % (male luer) . 1 a) l1 40 mm . , ( ) 6 % 1 b) l2 10 mm . 6.6 () 50 ( 1 ). 6.7 , . . 7 7.1 “ ”(“STERILE”) EN 556： 1994 4.1 . 7.2 KS P ISO 5366 1:2009 8 7.2.1 . a) b) . 7.3 “ ”
10、(“STERILE”) . KS P ISO 11607 . , . 8 8.1 EN 1041 . 8.2 8.2.1 / . a) 4.1 (mm) b) 4.2.1 (mm) c) / ( ) (mm) . 8.2.2 B (mm) . 8.3 ( ) 8.3.1 8.3.2 8.3.3 EN 980 . 8.3.2 ( ) . a) b) 4.1 c) (mm) (4.2) d) (mm) (4.3.1). . e) 2 a. 2 b f) 4.4 g) / / KS P ISO 5366 1:2009 9 h) i) j) “ ”(“STERILE”) “ ”(“NON STERIL
11、E”) k) “ ”(“SINGLE USE”) l) B (mm) . m) . . 8.3.3 . . a) b) ( ) ( ) c) d) / / e) f) g) “ ”(“STERILE”) “ ”(“NON STERILE”) h) “ ”(“SINGLE USE”) . KS P ISO 5366 1:2009 10 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
12、 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 1:2009 11 b) (505) N (505) mm min 1 A.4 . KS P ISO 5366 1:2009 12 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
13、 1:2009 13 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 . . . (： , ) . KS P ISO 5366 1:2009 14 1 KS P ISO 5366 3, 3： 2 ISO/TR 11991, Guidance on airway management during laser surgery of upper airway 3 EN 980, Graphical symbols fo
14、r use in the labelling of medical devices 4 EN 1041, Terminology, symbols and information provided with medical devices Information supplied by the manufacturer with medical devices 1： 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 1:2009KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Anaesthetic and respiratory equipment Tracheostomy tubes Part 1： Tubes and connectors for use in adults ICS 11.040.10
