標準號：ISO 16428-2005
中文標準名稱：外科植入物.可植入物質和醫療器械的靜態和動態腐蝕試驗用試驗溶液和環境條件
英文標準名稱：Implants for surgery - Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
標準類型：C35
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C35
國際標準分類號：11.040.40
適用范圍：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.