ASTM F 2914 : 2012 : R2018

Name: ASTM F 2914 : 2012 : R2018
Brand: ASTM
Price: 62.61 GBP

Superseded

View Superseded by

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

Available format(s)

Hardcopy , PDF

Superseded date

25-01-2024

Language(s)

English

Published date

20-11-2018

Publisher

American Society for Testing and Materials

This guide addresses the determination of appropriate device attributes for testing as part of a shelf-life study for endovascular devices.

1.1This 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.

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

1.3This 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.

1.4This 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.

Committee	F 04
DocumentType	Guide
Pages	6
PublisherName	American Society for Testing and Materials
Status	Superseded
SupersededBy	ASTM F 2914 : 2012 : R2024
Supersedes	ASTM F 2914 : 2012

ASTM F 3172 : 2015	Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices
ASTM F 3036 : 2013	Standard Guide for Testing Absorbable Stents
ASTM F 3172 : 2015 : R2021	Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices
ASTM F 3036 : 2021	Standard Guide for Testing Absorbable Stents
ASTM F 3089 : 2023	Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions