GOST R ISO 16428-2014 Implants for surgery Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices《外科植入物 可植入.pdf

1、 164282014 ISO 16428:2005 Implants for surgery Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices (IDT) 164282014 II 1 ( ) , 4 2 453 3 12 2014 . 2070- 4 16428:2005 . (ISO 16428:2005 Implants for surgery Test solutions and e

2、nvironmental conditions for static and dynamic corrosion tests on implantable materials and medical devices) , A. 5 1.02012 ( 8). ( 1 ) , . () . , (gost.ru) , 2015 , 164282014 III , . . , , . (NaCl). , , . , (Cl), . , NaCl . 164282014 1 Implants for surgery Test solutions and environmental condition

3、s for static and dynamic corrosion tests on implantable materials and medical devices 20160101 1 , . , , . , . -, . , , . , ( ) , , , . 2 : 3696 . (ISO 3696, Water for analytical laboratory use Specification and test methods) 3 . 3.1 (corrosion fatigue testing): , . - / . 3.2 (environmental testing

4、conditions): (), , , , , . 3.3 (isotonic sodium chloride solution): ( NaCl 0,9%), , ( ). - . 164282014 2 3.4 (Ringers solution): , , ( ) - . A. 3.5 (static and dynamic test): . - . 4 4.1 , , . 3 . . Cl, , , , , . 4.2 4.2.1 , . 4.2.2 (), , , , , . . - . , , / . 4.2.3 , . , , -, . , , , . (, ), , () (

5、5.1), ( 5) , . 4.2.4 . , . 5 5.1 0,9% 9 NaCl . 3696. 1000 ( . 3). 164282014 3 , NaCl, , . NaCl, - . . , , , ; .1. .2 , , . , , , X2 ASTM F 2129:20038. 5.2 (37 1)C . 5.3 . . (CO2) . . (, ) , , . , , , , , , . / , , . 5.4 , : a) - ; b) - . , . . . 5.5 10 /2 1. 5.6 , , . , , . , , . 5.7 . . . 164282014 4 , . , , , . , , . 6 , (.2), , , . . , , ( . .2).