ASTM F2914-12(2024)

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

standard by ASTM International , 01/15/2024

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Full Description

1.1 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.

1.2 This guide does not directly provide any test methods for conducting shelf-life testing.

1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Product Details

Published:: 01/15/2024
Number of Pages:: 6
File Size:: 1 file , 410 KB
Note:: This product is unavailable in Russia, Ukraine, Belarus