GOST ISO 10555-5-2012 Sterile single-use intravascular catheters Part 5 Over-needle peripheral catheters《一次使用血管内的灭菌导管 第5部分 弯针外周导管》.pdf

《GOST ISO 10555-5-2012 Sterile single-use intravascular catheters Part 5 Over-needle peripheral catheters《一次使用血管内的灭菌导管 第5部分 弯针外周导管》.pdf》由会员分享，可在线阅读，更多相关《GOST ISO 10555-5-2012 Sterile single-use intravascular catheters Part 5 Over-needle peripheral catheters《一次使用血管内的灭菌导管 第5部分 弯针外周导管》.pdf（19页珍藏版）》请在麦多课文档分享上搜索。

1、 , () INTERSTATE COUNCIL FOR STANDARTIZATION, METROLOGY AND CERTIFICATION (ISC) 5 (ISO 10555-5:1996, IDT) 2013 ISO 10555-5 2012 ISO 10555-52012 II , 1.092 . 1.22009 . , . , , , 1 - () 2 () 3 , ( 41-2012 24 2012 .) : ( 3166) 004-97 ( 3166) 004-97 AZ AM BY KZ KG MD - RU TJ UZ UA 4 19 2012 . 1917- ISO

2、10555-52012 1 2015 . ISO 10555-52012 III5 ISO 10555-5:1996 Sterile, single-use intravascular catheters Part 5: Over-needle peripheral catheters ( . 5. ). (IDT). 10555-599. . 6 ( ) , . C, 2013 , ISO 10555-52012 V ISO 10555-599 . 5. , 84 . : - 1 ; - 2 ; - 3 ; - 4 ; - 5 . ISO 10555-52012 1 5 Sterile, s

3、ingle-use intravascular catheters. Part 5. Over-needle peripheral catheters 2015-01-01 1 ( ) , . , , ISO 11070 1, , ISO 14972 2. . 2 : ISO 10555-1:1995 Sterile, single-use intravascular catheters Part 1: General requirements ( . 1. ) ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syring

4、es, needles and certain other medical equipment Part 1: General requirements ( 6 % () , . 1. ) ISO 10555-52012 2 ISO 9626:1991 Stainless steel needle tubing for the manufacture of medical devices ( ) 3 , ISO 10555-1, : 3.1 : , ( ) ( ) . 3.2 : , , ( 1). 3.3 : , . 3.4 : , , . l1 ; 1 ; 2 ; 3 ; 4 ; 5 ;

5、6 ; 7 1 , , , ISO 10555-52012 3 , . . . 3.5 : , , , . 3.6 : , ( 1). 3.7 : . 4 4.1 , , ISO 10555-1. 4.2 . . . . 4.3 , . 4.4 4.4.1 1, . ISO 10555-52012 4 1 1), 2)3)0,6 0,5500,649 26 0,7 0,6500,749 24 0,8; 0,9 0,7500,949 - 22 1,0; 1,1 0,9501,149 20 1,2; 1,3 1,1501,349 - 18 1,4; 1,5 1,3501,549 17 1,6; 1

6、,7; 1,8 1,5501,849 16 1,9; 2,0; 2,1; 2,2 1,8502,249 14 2,3; 2,4; 2,5 2,2502,549 13 2,6; 2,7; 2,8 2,5502,849 - 12 3,3; 3,4 3,2503,549 - 10 1) . . 2) . 3) . 4.4.2 . , 1 ( 1). 4.4.3 4.4.3.1 , , . , ISO 9626. , , . 4.4.3.2 2,5 , , . ISO 10555-52012 5 , . . 4.4.3.3 ( ) . , 6 %- , ISO 594-1. 4.4.3.4 . 4.4

7、.4 . 15 . 4.4.5 80 % 125 % , 1,0 90 % 115 % , , 1,0 . 4.5 , , , ISO 10555-1, : ) ; ) ; ) , . , , . ISO 10555-52012 6 () .1 , , . .2 .2.1 20 1 %. .3 .3.1 (22 2) 40 % 60 % 2 . .3.2 100 /: 10 0,6 ; 20 0,6 . .3.3 . .4 : ) ; ) ; ) (, 10 20 ); ) , . ISO 10555-52012 7 () .1 , . .2 . 1 ; 2 ; 3 ; 4 ; 5 ; 6 6 %- ; 7 - ; 8 / .1 .3 .3.1 , 6 %- ISO 594-1, (525 25) /, , (1000 5) . .1. .3.2 , , 1 %. .3.3 . .4 .4.1 , (22 2) . 6 %- . ISO 10555-52012 8 .4.2 . ( 30 ) , , 1000 /3. .4.3 .4.1, .4.2 . .5 . . .6 : ) ; ) . ISO 10555-52012 9 () .1. .1 ,