GOST R ISO 9626-2013 Stainless steel needle tubing for manufacture of medical devices《医疗器械制造用不锈钢针管》.pdf

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1、 9626 2013 ISO 9626:1991/ Amd.1.2001 Stainless steel needle tubing for manufacture of medical devices (IDT) 2014 96262013 II 1 , 4 2 436 3 7 2013 . 78- 4 9626:1991 (ISO 9626:1991 Stainless steel needle tubing for manufacture of medical devices), ISO 9626:1991 /Amd.1.2001. , A 5 1.02012 ( 8). ( 1 ) ,

2、 . () . , (gost.ru) , 2014 , 96262013 III ISO 9626:1991 /Amd.1.2001. : ) 0,20, 0,23 0,25 , , ; b) 0,30 0,36 , ; c) 0,6 ; d) , , ; ) , , 683-13. , 2, 3 4 ISO 9626:1991 /Amd.1.2001 . 9626 2013 1 Stainless steel needle tubing for manufacture of medical devices 2015 01 01 1 0,2 3,4 0,6 2,1 . , 0,8; 0,9;

3、 1,2; 1,4; 1,8 2,l . , , . , . , . , . 2 . . ( ). 3696:1987 . (ISO 3696:1987, Water for analytical laboratory use Specification and test methods) / 15510:1997 . (ISO/TR 15510:1997, Stainless steels Chemical composition) 10088-1:1995 . 1. (EN 10088-1:1995, Stainless steels Part 1: List of stainless s

4、teels) 3 , 1, , 2 / 15510. 1 / 15510 10088-1 1 2 / 15510 9626 683-13 ( ) X2CrNi 18-9 1 10 X5CrNi 18-9 6 11 X6CrNiNb 18-10 17 16 X5CrNiMo 17-12-2 26 20 X6CrNiMoTi 17-12-2 28 21 X6CrNiMoNb 17-12-2 29 23 4 . 96262013 2 5 . 6 A B, , , , 0,04 0,12 , . 7 , ( ), , -, -, . 8 2. 2 - 1) min max min - min - mi

5、n 0,20 33 0,203 0,216 0,089 0,105 0,23 32 0,229 0,241 0,089 0,105 0,25 31 0,254 0,267 0,114 0,125 0,30 30 0,298 0,320 0,133 0,165 0,33 29 0,324 0,351 0,133 0,190 0,36 28 0,349 0,370 0,133 0,190 0,40 27 0,400 0,420 0,184 0,241 0,45 26 0,440 0,470 0,232 0,292 0,50 25 0,500 0,530 0,232 0,292 0,55 24 0,

6、550 0,580 0,280 0,343 0,60 23 0,600 0,673 0,317 0,370 0,460 0,70 22 0,698 0,730 0,390 0,440 0,522 0,80 21 0,800 0,830 0,490 0,547 0,610 0,90 20 0,860 0,920 0,560 0,635 0,687 1,10 19 1,030 1,100 0,648 0,750 0,850 1,20 18 1,200 1,300 0,790 0,910 1,041 1,40 17 1,400 1,510 0,950 1,156 1,244 1,60 16 1,60

7、0 1,690 1,100 1,283 1,390 1,80 15 1,750 1,900 1,300 1,460 1,560 2,10 14 1,950 2,150 1,500 1,600 1,727 2,40 13 2,300 2,500 1,700 1,956 2,70 12 2,650 2,850 1.950 2,235 3,00 11 2,950 3,150 2,200 2,464 3,40 10 3,300 3,500 2,500 2,819 1) . 96262013 3 9 C , 3. 3 - - , , 0,1 , , 0,1 - -, , , 0,1 , 0,1 - -,

8、 , , 0,1 , 0,1 - -, 0,20 5,0 1,2 0,35 5,0 1,2 0,40 0,23 5,0 2,0 0,35 5,0 2,0 0,40 0,25 5,0 2,8 0,35 5,0 2,8 0,40 0,30 5,0 5,5 0,40 5,0 5,5 0,45 0,33 5,0 5,5 0,32 5,0 5,5 0,37 0,36 5,0 5,5 0,25 5,0 5,5 0,30 0,40 9,5 5,5 0,60 7,5 5,5 0,65 0,45 10,0 6,0 0,56 10,0 5,5 0,61 0,50 10,0 7,0 0,33 10,0 7,0 0,

9、43 0,55 10,0 10,0 0,50 10,0 10,0 0,55 0,60 12,5 10,0 0,40 12,5 10,0 0,45 12,5 10 0,50 0,70 15,0 10,0 0,45 15,0 10,0 0,50 15,0 10 0,55 0,30 15,0 15,0 0,41 15,0 15,0 0,50 1) 1) 1) 0,90 17,5 15,0 0,43 17,5 15,0 0,65 1) 1) 1) 1,10 25,0 10,0 0,45 25,0 10,0 0,55 25,0 10 0,65 1,20 25,0 20,0 0,45 25,0 20,0

10、0,55 1) 1) 1) 1,40 25,0 22,0 0,45 25,0 22,0 0,55 1) 1) 1) 1,60 25,0 22,0 0,25 25,0 22,0 0,30 25,0 22 0,34 1,30 25,0 25,0 0,35 25,0 25,0 0,45 1) 1) 1) 2,10 30,0 40,0 0,40 30,0 40,0 0,50 1) 1) 1) 2,40 40,0 40,0 0,33 40,0 40,0 0,65 2,70 40,0 50,0 0,31 40,0 50,0 0,45 3,00 50,0 50,0 0,41 50,0 50,0 0,55 3

11、40 50,0 60,0 0,32 50,0 60,0 0,46 1) . 96262013 4 10 D 4 . 4 , , 0,1 0,20 6,0 0,23 6,0 0,25 8,0 0,30 3,0 0,33 3,0 0,36 3,0 0,40 3,0 0,45 10,0 0,50 10,0 0,55 12,5 0,60 15,0 0,70 17,5 0,30 20,0 0,90 25,0 1,10 27,5 1,20 30,0 1,40 31,5 1,60 31,5 1,30 31,5 2,10 31,5 2,40 31,5 2,70 31,5 3,00 31,5 3,40 31,

12、5 11 E . 96262013 5 A () .1 . .2 .2.1 ( ) 0,2 0, l 95 %- (V/V) 100 . .2.2 , (NaOH) = 5 / ( ), 3 3696. .2.3 , (HCl) = 5 / ( ), 3 3696. .3 () B . .4 A.4.1 0,l (. .2.1) 20 ( B) . .4.2 (. .4.1) , (. .2.2) . .4.3 (. .4.1) , (. .2.3) . .4.4 , . .4.5 A.4.1 .4.4, 20 (. B.3.2) . .4.6 .4.4 .4.5 , , , . .5 , ,

13、 : a) ; b) : , ; c) , , , .4.6, , ; d) . 96262013 6 B () B.1 . .2 B.2.1 3 3696. B.2.2 . B.3 B.3.1 3 , , , , 250 (. .2.1), (. .2.2). (37 3) 1 . . B.3.2 , B.3.1, . 96262013 7 C () C.1 , , . C.2 C.2.1 , 60 0,1 , , , 60 , 1 5 . C.1. C.2.2 , 0,01 . C.3 C.3.1 , (. C.2.1) , : a) 3, b) (. .2.1), c) . C.3.2 1 / (. 3). C.3.3 (. C.2.2) 0,01 . C.1 C.4 , , : a) ; b) : , ; c) , , 0,01 ; d) . 96262013 8 D ()

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