1 Scope
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.
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 are identified for quantifying the degradation products. The identification of trace elements (< 10 –6) 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 the applicable clauses of ISO 10993-1 and ISO 10993-17.