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Standard Guide for Identification of Shelf-Life Test Attributes for Endovascular Devices
ASTM F2914-12
Organization:
ASTM - ASTM International
Year: 2024
Abstract: 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.
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Standard Guide for Identification of Shelf-Life Test Attributes for Endovascular Devices
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| contributor author | ASTM - ASTM International | |
| date accessioned | 2024-12-17T23:29:29Z | |
| date available | 2024-12-17T23:29:29Z | |
| date copyright | 2024 | |
| date issued | 2024 | |
| identifier other | F2914-12r24.pdf | |
| identifier uri | http://yse.yabesh.ir/std;jsery=auth/handle/yse/337909 | |
| description abstract | 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. | |
| language | English | |
| title | Standard Guide for Identification of Shelf-Life Test Attributes for Endovascular Devices | en |
| title | ASTM F2914-12 | num |
| type | standard | |
| page | 6 | |
| status | Active | |
| tree | ASTM - ASTM International:;2024 | |
| contenttype | fulltext | |
| 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, 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. | |
| identifier DOI | 10.1520/F2914-12R24 |