ASTM-F2914:2012 Edition

$40.63

F2914-12 Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices

Published By	Publication Date	Number of Pages
ASTM	2012	7

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, ASTM

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Description

ASTM F2914-12

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

ASTM F2914

Scope

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.

Keywords

aging; establishment; shelf life; shelf-life; stability

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F2914-12

PDF Catalog

PDF Pages	PDF Title
1	Scope Terminology Significance and Use Procedure
2	FIG. 1
3	TABLE 1
4	Shelf-life Establishment Report TABLE 2
5	TABLE 3
6	Keywords TABLE 4 TABLE 5

Additional information

Standard Title	F2914-12 Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
Published Code	ASTM
Publication Date	2012
Pages Count	7
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics