Alcance
This document specifies general requirements for the design of tests for identifying and quantifyingdegradation products from final metallic medical devices or corresponding material samples finishedas ready for clinical use.This document is applicable only to those degradation products generated by chemical alteration of thefinal metallic device in an in vitro degradation test. Because of the nature of in vitro tests, the test resultsapproximate the in vivo behaviour of the implant or material. The described chemical methodologiesare 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 thatare not intended to degrade.This document is not applicable to evaluation of degradation which occurs by purely mechanicalprocesses; methodologies for the production of this type of degradation product are described inspecific product standards, where available.NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from thescope of this document, such degradation products can evoke a biological response and can undergo biologicalevaluation as described in other parts of ISO 10993.Because of the wide range of metallic materials used in medical devices, no specific analyticaltechniques 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 specificrequirements for acceptable levels of degradation products provided in this document.This document excludes the biological activity of the degradation products. (See instead the applicableclauses of ISO 10993-1 and ISO 10993-17).