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——植入材料和医疗设备静态和动态腐蚀试验的试验溶液和环境条件
发布日期:
2005-04-12
ISO 16428:2005规定了用于植入、外科植入和医疗设备的金属材料试验的标准环境条件。所述测试条件以一种简单的方式模拟生理条件,控制测试溶液、温度、气体气氛以及样品大小和溶液体积的比例。
必要时,可将这些环境试验条件与各种静态或动态试验结合使用,以考虑生理环境的影响。典型应用包括腐蚀疲劳试验和选定的微动磨损试验,以及一般电化学试验。
ISO 16428:2005未考虑典型的关节模拟试验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,如用于磨损研究的解决方案,不在ISO 16428的范围内:
2005.
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.