DIN EN ISO 10993-15-2009 医疗设备的生物评估.第15部分:金属与合金降解产物的识别与定性(ISO 10993-15:2000,DIN EN ISO 10993-15:2009-

标准号：DIN EN ISO 10993-15-2009
中文标准名称：医疗设备的生物评估.第15部分:金属与合金降解产物的识别与定性(ISO 10993-15:2000,DIN EN ISO 10993-15:2009-10的英文版本)
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); English version of DIN EN ISO 10993-15:2009-10
标准类型：C30
发布日期：1999/12/31 12:00:00
实施日期：2009/10/1 12:00:00
中国标准分类号：C30
国际标准分类号：11.100.20
适用范围：This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying andquantifying degradation products from finished metallic medical devices or corresponding material samples finishedas 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 chemicalmethodologies 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.NOTE Mechanically induced degradation, such as wear, may be covered in the appropriate product specific standard.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 areidentified for quantifying the degradation products. The identification of trace elements (<10) contained in the specific metal or alloy is not addressed in this part of ISO 10993, nor are specific requirements for acceptable levels of degradation products provided in this part of ISO 10993.This part of ISO 10993 does not address the biological activity of the degradation products; see instead theapplicable clauses of ISO 10993-1 and ISO 10993-17.