ASTM F 2914 : 2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
Hardcopy , PDF
25-01-2024
English
15-01-2012
Important note : Users cannot be edited or removed once added to your Multi user PDF.CONTAINED IN VOL. 13.01, 2015 Describes the determination of appropriate device attributes for testing as part of a shelf-life study for endovascular devices.
| Committee |
F 04
|
| DocumentType |
Guide
|
| Pages |
6
|
| ProductNote |
THIS STANDARD ALSO REFERS TO:ASTM Guide F1980, TIR 17
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy |
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.
| ANSI/AAMI/ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
| ISO/TS 17137:2014 | Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants |
| PD ISO/TS 17137:2014 | Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants |
| AAMI ISO TIR 17137 : 2014 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOVASCULAR ABSORBABLE IMPLANTS |
| ASTM F 3036 : 2013 | Standard Guide for Testing Absorbable Stents |
| BS EN ISO 25539-1:2017 | Cardiovascular implants. Endovascular devices Endovascular prostheses |
| I.S. EN ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| DIN EN ISO 25539-1:2015-07 (Draft) | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| ASTM F 3172 : 2015 | Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices |
| DIN EN ISO 25539-1:2017-09 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
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