BS EN ISO 10993-15-2009 医疗器械的生物评定.第15部分:金属与合金降解产物的识别与量化(ISO 10993-15-2000)

标准号：BS EN ISO 10993-15-2009
中文标准名称：医疗器械的生物评定.第15部分:金属与合金降解产物的识别与量化(ISO 10993-15-2000)
英文标准名称：Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
标准类型：C37
发布日期：2009/7/31 12:00:00
实施日期：2009/7/31 12:00:00
中国标准分类号：C37
国际标准分类号：11.100.20
引用标准：ISO 3585;ISO 3696;ISO 8044;ISO 10993-1;ISO 10993-9;ISO 10993-12;ISO 10993-13;ISO 10993-14;ISO 10993-16
适用范围：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