BS EN ISO 10993-15:2023

Biological evaluation of medical devices. Identification and quantification of degradation products from metals and alloys | Status: Current

1 Scope This document specifies 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 degradation test. Because of the nature of in vitro tests, the test results approximate the in vivo behaviour of the implant or material. The described chemical methodologies are a means to generate degradation products for further assessments. This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade. This document is not applicable to evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available.

NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this document, such degradation products can evoke a biological response and can undergo biological evaluation as described in other parts of ISO 10993.

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 document, nor are specific requirements for acceptable levels of degradation products provided in this document. This document excludes the biological activity of the degradation products. (See instead the applicable clauses of ISO 10993‑1 and ISO 10993‑17).