KS P ISO 8836-2009 Suction catheters for use in the respiratory tract《用于呼吸道的吸气引液导管》.pdf

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1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 8836 KS P ISO 8836:2009 2009 12 25 http:/www.kats.go.krKS P ISO 8836:2009 : ( ) ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2004 8 30 ：2009 12 25 2009-0866 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 8836:2009 .1 1 1 2 1 3 .1 4 2

2、 4.1 2 4.2 .3 5 4 6 4 6.1 .4 6.2 4 6.3 4 7 6 7.1 6 7.2 .6 7.3 .6 8 6 8.1 6 8.2 .6 9 6 9.1 .6 9.2 7 9.3 .7 9.4 .7 A( ) 8 B( ) .9 11 i KS P ISO 8836:2009 Suction catheters for use in the respiratory tract 2007 3 ISO 8836, Suction catheters for use in the respiratory tract . 1 . (lumen) . (angled-tip)

3、(Coud) , . 2 . . ( ) . KS P ISO 10993 1, 1 ： ISO 11607： 2003, Packaging for terminally sterilized medical devices EN 5561 ： 2001, Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 1：Requirements for terminally sterilized medical devices EN 1041, Informat

4、ion supplied by the manufacturer with medical devices 3 . 3.1 (adaptor) ISO 4135 4.2.3.1 3.2 (connector) ISO 4135 4.2.2.1 KS P ISO 8836:2009 3.3 (eye) ISO 4135 8.3.6 3.4 (machine end) (source) ISO 4135 8.3.2 3.5 (patient end) ISO 4135 8.3.3 3.6 (residual vacuum) (relief) , (negative pressure) 3.7 (s

5、haft) 3.8 ( 3.4) ( 3.5) ( 3.7) 3.9 (terminal orifice) ISO 4135 8.3.5 3.10 (tip) ISO 4135 8.3.4 3.11 ISO 4135 8.3.9 4 4.1 4.1.1 . 2 KS P ISO 8836:2009 a) (mm) . French(Charriere) gauge size( 1 ) . b) (mm) . 4.1.2 . , 1 . . 4.1.3 1 . 1 F Ch mm mm mm 4 1.33 0.10 0.55 4.5 1.5 0.10 0.70 5 1.67 0.10 0.80

6、6 2.0 0.10 1.0 6.5 2.1 0.10 1.1 7 2.33 0.10 1.25 7.5 2.5 0.10 1.45 8 2.67 0.10 1.50 9 3.0 0.15 1.75 10 3.33 0.15 2.00 12 4.0 0.15 2.45 14 4.67 0.20 2.95 15 5.0 0.20 3.20 16 5.33 0.20 3.40 18 6.0 0.20 3.90 20 6.67 0.20 4.30 4.2 4.2.1 , 1 . 1 , (F) 3 (1 mm 3F ). 2 . (tracheal) (tracheostomy) . 4.2.2 1

7、 90 % . 4.2.3 5 % . 3 KS P ISO 8836:2009 5 5.1 KS P ISO 10993 1 . 5.2 . . 5.3 , , , , . . 5.4 . 5.5 . 5.6 . 6 6.1 (eye) . 6.2 6.2.1 40 cm H2O(3.92 kPa) 2 cm . 6.2.2 0 cm H2O 40 cm H2O(3.92 kPa) . 6.2.3 90 % . 6.2.4 . . 6.2.5 . 6.2.6 ( 1 ). 6.3 6.3.1 7.1 . 6.3.2 . 4 KS P ISO 8836:2009 6.3.3 . 6.3.4 .

8、 6.3.5 6 mm . 6.3.6 (rigid) (semi-rigid) , 6 mm ( 1 ). 6.3.7 . 1 (female) 2 3 4 (male) 5 6 (eye) (tip) 7 1 5 KS P ISO 8836:2009 7 7.1 A , 2 . 2 () mm N 1.332.67 5 34.67 15 5 20 7.2 (232) 15 40 kPa(408 cm H2O) . 7.3 B 0.33 kPa(3.4 cm H2O) . 8 8.1 “ ” EN 556 1 ：2001 4.1 . 8.2 8.2.1 “ ” . 8.2.2 ISO 116

9、07 . 8.2.3 . 8.2.4 . 9 9.1 9.1.1 EN 1041 . 9.1.2 4.1 . F(Ch) 6 KS P ISO 8836:2009 4.1.1 a . 9.1.3 (cm) . 9.1.4 . 9.2 KS S ISO 7000 9.3 9.4 . 9.3 9.3.1 EN 1041 . 9.3.2 . a) b) 4.1.1 . 1) 6 mm500 mm 2) 6 mm(18 F)500 mm c) / / d) (batch) e) , “ ” . f) , “ ” “ ” . g) “ ” . 9.4 9.4.1 EN 1041 . 9.4.2 . a)

10、 b) 4.1.1 . 1) 6 mm500 mm 2) 6 mm(18 F)500 mm c) / / d) (batch) e) , “ ” . f) g) , “ ” “ ” . h) . i) “1 ” . 7 KS P ISO 8836:2009 A () A.1 . A.2 A.2.1 (232) (50 20) % , A.2.2 , (20020) mm/min , A.3 ( ) A.3.1 (232) (50 20) % 1 , . A.3.2 (20020) mm/min , 2 . A.4 2 . 8 KS P ISO 8836:2009 B () B.1 . B.2

11、B.2.1 , 5 % 30 L/min , 30 L/min 0.1 kPa B.2.2 B.2.3 , 0.01 kPa(0.1 cm H2O) B.3 B.3.1 B.1 . , . B.3.2 . B.3.3 30 L/min . B.4 , (kPa) . 9 KS P ISO 8836:2009 1 2 3 4 B.1 10 KS P ISO 8836:2009 1 ISO 4135, Anaesthetic and respiratory equipmentVocabulary 2 KS P ISO 53614, Tracheal tubes Part 4 ： Cole type

12、 3 KS P ISO 53661, 1： 4 KS P ISO 53663, 3： 5 KS S ISO 7000, 6 ISO/TR 11991, Guidance on airway management during laser surgery of upper airway 7 KS P ISO 15223, , 8 EN 556 2, Sterilization of medical devices Requirements for medical devices to be designated “STERILE” Part 2 : Requirements for aseptically processed medical devices 11 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 8836:2009 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Suction catheters for use in the respiratory tract ICS 11.040.10； 11.040.25 Korean Agency for Technology and Standards http:/www.kats.go.kr