Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000, IDT)
This Malaysian Standard 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 Malaysian Standard 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 deg
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29/05/2019
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NSC 18 - Medical Devices and Facilities for Healthcare
