標準號：BS EN ISO 10993-15-2009
中文標準名稱：醫療器械的生物評定.第15部分:金屬與合金降解產物的識別與量化(ISO 10993-15-2000)
英文標準名稱：Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
標準類型：C37
發布日期：2009/7/31 12:00:00
實施日期：2009/7/31 12:00:00
中國標準分類號：C37
國際標準分類號：11.100.20
引用標準：ISO 3585;ISO 3696;ISO 8044;ISO 10993-1;ISO 10993-9;ISO 10993-12;ISO 10993-13;ISO 10993-14;ISO 10993-16
適用范圍：This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding material samples finished as ready for clinical use. It is applicable only to those degradation products generated by chemical alteration of the finished metallic device in an in vitro accelerated degradation test. Because of the accelerated nature of these tests, the test results may not reflect the implant or material behavior in the body. The described chemical methodologies are a means to generate degradation products for further assessments.This part of ISO 10993 is not applicable to degradation products induced by applied mechanical stress.Where product-group standards provide applicable product-specific methodologies for the identification and quantification of degradation products, those standards should be considered.Because of the wide range of metallic materials used in medical devices, no specific analytical techniques are identified for quantifying the degradation products. The identification of trace elements (<10