标准摘要
[中文适用范围]： 本国际标准规定了用于植入、外科植入物和医疗器械的金属材料测试的标准环境条件。 所描述的测试条件以简化的方式模拟生理条件，控制测试溶液、温度、气氛以及样品大小和溶液体积的比例。 这些环境测试条件可以在必要时与考虑生理环境影响的各种静态或动态测试结合使用。 典型应用是腐蚀疲劳测试和选定的微动和磨损测试，以及一般电化学测试。 本国际标准不考虑典型的关节模拟器测试和牙科领域特有的方面。 试图复制体液摩擦学特性的解决方案（例如磨损研究中使用的解决方案）不属于本国际标准的范围。 [外文原描述]： ISO 16428:2005 specifies standard environmental conditions for the testing of metallic materials intended for implantation, surgical implants, and medical devices. The testing 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 ISO 16428:2005. Solutions that attempt to replicate the tribological properties of body fluids, such as those used in wear studies, are outside the scope of ISO 16428:2005.
英文名称Implants for surgery — Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices