GOST ISO 8537-2011 Sterile single-use syringes with or without needle for insulin Technical requirements and test methods《带或不带针头的一次性无菌胰岛素注射器 技术要求和试验方法》.pdf

1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) (ISO 8537:2007, IDT) 2013 ISO 85372011 ISO 8537 2011 II , 1.092 . 1.22009 . , . , , , 1 - () 2 () 3 , ( 40-2011 29 2011 .) : ( 3166) 00497 ( 3166) 00497 BY KZ KG RU 4 13 2011 . 1360- ISO 85372011 1 2013 . 5 ISO 8537:2007

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3、011 1 Sterile single-use syringes, with or without needle, for insulin. Technical requirements and test methods 2013-01-01 1 , . 40 / (INSULIN U-40) 100 / (INSULIN U-100). . 2 : ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1

4、: General requirements ( 6 % () , . 1. ) ISO 8537 2011 2 ISO 7864:1993 Sterile hypodermic needles for single use ( ) ISO 9626:1991 Stainless steel needle tubing for the manufacture of medical devices ( ) 3 ( 1): 3.1 (graduated capacity): (20 3) C (27 3) C, , . 3.2 (needle cap): , ( ) . 3.3 (needle s

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6、7 2011 55 , , . 6 6.1 pH , A, pH- . 6.2 , A, 5 / , , , , . 0,1 /. 7 , , , . 8 , 1. ISO 8537 2011 6 1 , , , , , , 0,3 41 0,5 1 0,5 43 1 1,0 57 1 U-100 1,0 57 2 0,5 43 0,5 0,5 43 1 1,0 50 1 2,0 60 1 U-40 2,0 60 2 1 % + 2 % 5 % , , . , , , 1. 9 9.1 . (). , 1. (. 3.1). ISO 8537 2011 7 0,2 0,4 . , . . 0,5 . . . 9.2 5 0,3 0,5 10 1,0 2,0 . 3 . , , , , . , , . ISO 8537 2011 8 10 10.1 , 10 % - 5 . 10.2 , , 10 . . , , , . 11 -