WK84054 - New Guide for Heart Valve TEMPs

Work Item

ASTM WK84054

New Guide for Heart Valve TEMPs

1. Scope

This 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 and/or replacement of heart valves. This guide is intended for use related to the in vitro assessment of TEMP heart valves.

Keywords

heart valves; heart valve substitutes; tissue engineered medical products; TEMPS

Rationale

There is currently no standard guide to assist heart valve TEMP manufacturers with in vitro assessment.

Details

Developed by Subcommittee: F04.44

Committee: F04

Staff Manager: Kate Chalfin

Work Item Status

Date Initiated: 11-02-2022

Technical Contact: Chrysanthi Williams

Item: 024

Ballot: F04 (23-05)

Status: Will Reballot Item

Item: 010

Ballot: F04 (24-03)

Status: Negative Votes Need Resolution