Logo

ASTM F2914-12(2024)

Current Reaffirmation

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

$69.00

$69.00

$124.20


Sub Total (1 Item(s))

$ 0.00

Estimated Shipping

$ 0.00

Total (Pre-Tax)

$ 0.00


...

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.


3.1 The purpose of this guide is to provide a procedure for determining the appropriate attributes to evaluate in a shelf-life study for an endovascular device.

SDO ASTM: ASTM International
Document Number F2914
Publication Date Jan. 15, 2024
Language en - English
Page Count 6
Revision Level 12(2024)
Supercedes
Committee F04.30
Publish Date Document Id Type View
Jan. 15, 2012 F2914-12 Revision
Jan. 15, 2024 F2914-12R24 Reaffirmation
Nov. 1, 2018 F2914-12R18 Reaffirmation