KS P ISO 5362-2012 Anaesthetic reservoir bags《麻醉剂储存袋》.pdf

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1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 5362 KS P ISO 5362:2012 2012 12 27 http:/www.kats.go.krKS P ISO 5362:2012 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2002 12 17 ：2012 12 27 2012-0767 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 5362:2012 i ii . iii 1 1 2 1 3 .

2、1 4 .2 4.1 .2 4.2 2 4.3 .2 4.4 .2 4.5 .2 4.6 ( / ) .3 4.7 .3 5 4 6 .4 6.1 4 6.2 4 7 4 7.1 4 7.2 4 7.3 .4 8 5 A( ) .6 B( ) .7 C( ) 22 mm .8 D( ) 9 E( ) ( / ).10 F( ) ( / ) 12 G( ) 13 14 KS P ISO 5362:2012 ii . KS P ISO 5362:2007 . . , , . , , . KS P ISO 5362:2012 iii 2006 4 ISO 5362, Anaesthetic rese

3、rvoir bags . KS P ISO 5362:2012 Anaesthetic reservoir bags 1 - (lung-ventilator breathing system) . , , . , (bellows) . , . 2 . . ( ) . KS B ISO 4287, (GPS) ： , KS P ISO 5356 1, 1： KS S ISO 7000, ISO 11607 1, Packaging for terminally sterilized medical devices Part 1： Requirements for materials, ste

4、rile barrier systems and packaging systems IEC 60601 1： 1988, Medical electrical equipment Part 1： General requirements for safety EN 556： 1994, Sterilization of medical devices Requirements for medical devices to be labelled “sterile” EN 980, Graphical symbol for use in the labelling of medical dev

5、ices 3 . 3.1 (anaesthetic reservoir bag) (ISO 4135) 3.2 (assembled neck) KS P ISO 5362:2012 2 3.3 (adaptor) . KS P ISO 5356 1 . 3.4 (plain neck) KS P ISO 5356 1 (male) . 3.5 (tail) 4 4.1 8. . 4.2 . 4.3 1 L (30.3) kPa 10 mL/min . 1 L (30.3) kPa 25 mL/min . 1 , . 2 A . . 4.4 B , 15 % . 4.5 4.5.1 4.5.1

6、.1 , . 4.5.1.2 22 mm KS P ISO 5356 1 , KS P ISO 5356 1 15 mm 22 mm . KS P ISO 5362:2012 3 , . 4.5.1.3 22 mm , 26 mm . C , 22 mm . 22 mm . 4.5.1.4 KS P ISO 5356 1 , (female) ( 1 ) . D , . 1 2 , , , . 1 4.5.2 20 mm . . 4.6 ( / ) 4.6.1 E (E.3.6 ), 3.0 kPa , 6.0 kPa . 4.6.2 E 30 ( V1, E.3.2 ) 10 % . , F

7、 . 4.7 G . 21KS P ISO 5362:2012 4 5 5.1 IEC 60601 1:1988, 39.3 b) . 5.2 , 5.1 . 6 6.1 “ ” EN 556:1994, 4.1 . 6.2 “ ” . , ISO 11607 . , . . 7 7.1 KS S ISO 7000 EN 980 7.2 7.3 . 7.2 . a) b) (4.2 ) c) “ (ANTISTATIC)” , “ ” . . . 7.3 “ ” 7.2 . ( ) . / . KS P ISO 5362:2012 5 8 , , , . ( ) . , EN 1041 . K

8、S P ISO 5362:2012 6 A ( ) A.1 , , . . , . . A.2 A.2.1 KS P ISO 5356 1 . A.2.2 (30.3) kPa . A.2.3 . A.2.4 , 4.3 5 % . A.3 A.3.1 (232) . A.3.2 . A.3.3 (30.3) kPa . . A.4 ( ) . KS P ISO 5362:2012 7 B ( ) B.1 , . B.2 B.2.1 B.2.2 , (232) B.3 B.3.1 . 25 mm . B.3.2 (232) . . B.4 , . KS P ISO 5362:2012 8 C

9、( ) 22 mm C.1 . C.2 C.2.1 22 mm KS P ISO 5356 1 . KS B ISO 4287 (Ra) 0.8 m . C.2.2 (404) N (505) mm/min (404) N 1 . C.3 C.3.1 (232) C.3.2 . C.3.3 100 mm (404) N (505) mm/min (404) N 1 . 22 mm . KS P ISO 5362:2012 9 D ( ) D.1 , . D.2 D.2.1 (404) N D.2.2 (404) N (505) mm/min (404) N 1 . D.3 D.3.1 (232

10、) . D.3.2 . D.3.3 100 mm (404) N (505) mm/min (404) N 1 . . KS P ISO 5362:2012 10 E ( ) ( / ) E.1 . , . E.2 E.2.1 B . E.2.2 , 10 mm . 6.0 kPa , . , (tap) T . E.2.3 3.0 kPa 6.0 kPa , (column) . E.3 E.3.1 (232) . E.3.2 B , V1 . E.3.3 . 25 mm . E.3.4 E.3.2 . E.3.5 . E.3.6 5 , E.3.2 4 . 3.0 kPa , 6.0 kP

11、a . E.3.7 . KS P ISO 5362:2012 11 E.3.8 30 , B , V2 . E.4 E.4.1 E.3.6 , , 3.0 kPa , 6.0 kPa . E.4.2 E.3.8 (V2) , (V1, E.3.2 ) . KS P ISO 5362:2012 12 F ( ) ( / ) F.1 . ( E , 4.6.2 ). B . F.2 F.2.1 ( ) 2 , 2 5 % . F.2.2 , 3.0 kPa , 6.0 kPa 10 % . F.2.3 KS P ISO 5356 1 . F.3 F.3.1 (232) . F.3.2 (F.2.1

12、) (F.2.3) . F.3.3 ( , 4.2 ) 2 , 2 . F.3.4 (F.2.2) . F.4 F.3.4 0.1 kPa . KS P ISO 5362:2012 13 G ( ) G.1 . , . G.2 , , . . G.3 , . KS P ISO 5362:2012 14 1 ISO 4135： 2001, Anaesthetic and respiratory equipment Vocabulary 2 EN 1041, Terminology, symbols and information provided with medical devices Information supplied by the manufacturer of medical devices 153787 1 92 3(16) (02)26240114 (02)262401489 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 5362:2012 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Anaesthetic reservoir bags ICS 11.040.10