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

Standard [CURRENT]

ASTM F 2914:2012

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

Publication date
2012 reapproved: 2024
Original language
English
Pages
6

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Publication date
2012 reapproved: 2024
Original language
English
Pages
6
DOI
https://dx.doi.org/10.1520/F2914-12R24

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Short 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 and health practices and determine the applicability of regulatory limitations prior to use.

ICS

11.040.40

DOI

https://dx.doi.org/10.1520/F2914-12R24
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