NF EN ISO 10993-15, S99-501-15 (05/2023)

This document specifies general requirements for the design of assays for the identification and quantification of degradation products from final metallic medical devices or samples of the corresponding materials ready for clinical use. This document only applies to degradation products created by chemical modification of the final metal device and by means of an in vitro degradation test. Due to the nature of in vitro testing, the test results approximate the in vivo behavior of the implant or material. Due to the accelerated nature of these tests, the chemical methodology described is a means of generating degradation products for subsequent analyses. This document applies to materials designed to degrade in the body, as well as materials that are not designed to degrade. This document is not applicable to the assessment of degradation that occurs solely as a result of mechanical processes; the methodologies for generating this type of degradation product are described, where applicable, in the standards for the products considered. NOTE Purely mechanical degradation mainly results in material in the form of particles. Although outside the scope of this document, such degradation products may cause a biological response and may undergo biological evaluation such as that described in other parts of ISO 10993. Due Due to the wide variety of metallic materials used in the manufacture of medical devices, this part of ISO 10993 does not specify any specific analytical techniques for the quantification of degradation products. This document does not address the identification of trace elements (< 10-6 w/w) contained in the metal or alloy analyzed. It does not provide any specific requirements for permissible levels of degradation products. This document does not cover the biological activity of degradation products (for this, see the corresponding clauses of ISO 10993-1 and ISO 10993-17).
(Automatic translation from French)