DANSK DSF/FPREN ISO 10993-15 PDF

This document provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from final metallic medical devices or corresponding material samples finished as ready for clinical use. This document is applicable only to those degradation products generated by chemical alteration of the final 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 document considers both materials designed to degrade in the body as well as materials that are not intended to degrade. This document is not applicable to degradation products induced by applied mechanical stress. Mechanically induced degradation, such as wear, can 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 are identified for quantifying the degradation products. The identification of trace elements (< 10 –6 w/w) 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 document does not address the biological activity of the degradation products; see instead the applicable clauses of ISO 10993-1 and ISO 10993-17.