Standard Guide for Identification of Shelf-Life Test Attributes for Endovascular Devices

Standard Guide for Identification of Shelf-Life Test Attributes for Endovascular Devices

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1.   Scope

This guide addresses the determination of appropriate device attributes for testing as part of a shelf-life study for endovascular devices. Combination and biodegradable devices (for example, drug devices, biologic devices, or drug biologics) may require additional considerations, depending on their nature.