Work Item
ASTM WK81186
New Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Tendon and Ligament Repair and Replacement
1. Scope
The guide will be intended as a general resource for individuals and organization involved in the production, delivery, and regulation of tissue engineered medical products (TEMPs) and other materials intended for repair or replacement of tendons and ligaments.
Keywords
Tendon; Ligament; Mechanics; Animal Models; Biochemical Composition
Rationale
There are currently no standards for engineered materials used to repair tendons and ligaments, thus there is a need for guidelines that address the basic needs in an engineered material in order to better assess clinical outcomes. This ASTM guide will provide basic background on differences in tendons and ligaments throughout the body and address appropriate biological, mechanical, and morphological assessment, appropriate repair techniques and animal models, and appropriate outcome measures.
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 03-08-2022
Technical Contact: Jennifer Puetzer
Item: 000
Ballot:
Status: