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

New Guide for Heart Valve TEMPs

1. Scope

Keywords

Rationale

Details

Work Item Status

Related

New Guide for Heart Valve TEMPs

1. Scope

Keywords

Rationale

Details

Work Item Status

Related