ISO 10993-15 Biological Evaluation of Medical Devices - Identification and Quantification of Decomposition Products from Metals and Alloys

This standard specifies general requirements for the design of tests for the identification and quantification of degradation products from final metallic medical devices. Devices or related material samples are completed ready for clinical use. This standard applies only to degradation products produced by chemical modification of the final metallic device in an in vitro degradation test. Due to the nature of in vitro tests, test results are close to in vivo test results. Behavior of the implant or material. The described chemical methodologies are a means of producing degradation products for further evaluation.

This standard applies to both materials designed to degrade in the body and materials not intended to degrade.

This standard does not apply to the assessment of deterioration by purely mechanical processes; Methodologies for the production of such decomposition product are described in specific product standards where available.

Due to the wide variety of metallic materials used in medical devices, no specific analytical techniques have been described to measure degradation products. The identification of trace elements in a specific metal or alloy is not covered in this standard, and no specific requirements for acceptable levels of degradation products are given in this document.

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