ASTM F 3225 : 2017 : R2022
Current
The latest, up-to-date edition.
Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)
Hardcopy , PDF
English
09-09-2022
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
F 04
|
| DocumentType |
Guide
|
| Pages |
7
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Current
|
| Supersedes |
1.1This guide is intended as a resource for individuals and organizations involved in the development, production, delivery, and regulation of tissue engineered medical products (TEMPs) intended for use in the surgical repair, replacement, shunting, and/or bypass of blood vessels. This guide is intended for use related to the in vitro assessment of TEMP vascular grafts. In vitro cellular characterization and in vivo testing are not within scope for this standard guide.
1.2This 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.
1.3This 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.
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| ASTM F 2312 : 2011 : R2020 | Standard Terminology Relating to Tissue Engineered Medical Products |
| ASTM F 1635 : 2024 | Standard Test Method for <emph type="ital">in vitro</emph> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants |
| ASTM F 2382 : 2018 | Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) |
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