GOST ISO 10555-2-2011 Sterile single-use intravascular catheters Part 2 Angiographic cetheters《一次使用的血管内的灭菌导管 第2部分 血管造影术》.pdf

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1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) 2 (ISO 10555-2:1996, IDT) 2013 ISO 10555-2 2011 ISO 10555-22011 II , 1.092 . 1.22009 . , . , , , 1 - () 2 () 3 , ( 48 22 2011 .) : ( 3166) 00497 ( 3166) 00497 BY KZ KG RU TJ UZ 4 13 2011 . 1298- ISO 10555-22011 1 2013 .

2、5 ISO 10555-2:1996 Sterile, single-use intravascular catheters Part 2: Angiographic catheters ( . 2. ). (IDT). . 10555-299 6 ( ) . , . C, 2013 , ISO 10555-22011 IV ISO 10555-2:1996 , , . 2. , / 84 . : - 1 ; - 2 ; - 3 ; - 4 ; - 5 . ISO 10555-22011 1 2 Sterile, single-use intravascular catheters. Part

3、 2. Angiographic cetheters 2013 - 01 - 01 1 ( ), . , , ISO 11070 1. . 2 : ISO 10555-1 Sterile, single-use intravascular catheters Part 1: General requirements ( . 1. ) 3 , ISO 10555-1, : 3.1 : , / , . ISO 10555-22011 2 3.2 : , - , . 4 4.1 , ISO 10555-1. 4.2 . . . . 4.3 ISO 10555-1 , . , 0,1 . 4.4 4.

4、4.1 , , , . 4.4.2 . , . 4.4.3 ISO 10555-22011 3, , . 4.5 , , , ISO 10555-1, : ) 4.3; b) , ; c) , . 1 , . 2 , , . ISO 10555-22011 4 () .1 , . , . .2 .2.1 , , , , (37 2) . .2.2 . .2.3 . .2.4 , . .2.5 10 % . , .1. , , . ISO 10555-22011 51 ; 2 ; 3 ; 4 ; 5 ; 6 ; 7 (); 8 , ; 9 () .1 .3 , . .3.1 , . .3.2 ,

5、 , (37 2) . .3.3 , . .3.4 , , , . .3.5 . ISO 10555-22011 6 .3.6 , , , , 2 , . .3.7 , .3.6. .3.8 , ( ). , , , . .4 : ) ; b) ; c) ; d) ; e) . ISO 10555-22011 7 () .1 - ISO 10555-1 . 1. IDT ISO 10555-12011 . 1. : - IDT . ISO 10555-22011 8 1 ISO 1107098 , , ISO 10555-22011 9 615.472.5:006.354 11.040.20 22 IDT : , , ,

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