ISO 10993-13 Biological Evaluation of Medical Devices - Identification and Quantification of Degradation Products from Polymeric Medical Devices

ISO 10993‑13 provides general requirements for test design in a simulated environment for the identification and quantification of degradation products from clinical ready-to-use polymeric medical devices.

ISO 10993‑13 describes two test methods for generating degradation products, accelerated degradation testing as a screening method and real-time degradation testing in a simulated environment. For materials intended to polymerize in situ, a set or cured polymer is used for testing. The data produced is used in the biological evaluation of the polymer. ISO 10993‑13 only considers non-absorbable polymers. Similar, but suitably modified procedures can be applied for absorbable polymers.

ISO 10993‑13 considers only degradation products produced by chemical modification of the finished polymeric device. It does not apply to degradation of the device induced during its intended use by mechanical stress, abrasion, or electromagnetic radiation, or by biological factors such as enzymes, other proteins, and cellular activity.

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