BS ISO 16428-2005
外科植入物.可植入物质和医疗装置的静态和动态腐蚀试验用试验溶液和环境条件

Implants for surgery - Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices


 

 

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标准号
BS ISO 16428-2005
发布日期
2005年06月10日
实施日期
2005年06月10日
废止日期
中国标准分类号
C35
国际标准分类号
11.040.40
发布单位
GB-BSI
被代替标准
03/305239 DC-2003
适用范围
This International Standard specifies standard environmental conditions for the testing of metallic materials intended for implantation, surgical implants, and medical devices. The test conditions described simulate physiological conditions in a simplified manner controlling the test solution, the temperature, the gaseous atmosphere and the proportions of sample size and volume of solution. These environmental testing conditions can be employed where necessary in combination with various static or dynamic tests where the effect of the physiological environment is to be considered. Typical applications are corrosion fatigue tests and selected fretting and wear tests, as well as general electrochemical tests. Typical articulating joint simulator tests and aspects particular to the dental field are not considered by this International Standard. Solutions that attempt to replicate the tribological properties of body fluids, such as those used in wear studies, are outside the scope of this International Standard.




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