Work Item
ASTM WK88519

Revision of F2212-20 Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)

Rationale

Standard Guide F2212 was revised in 2020 and approved while maintaining the scope of the previous revision. During revision of Guide F3089, subcommittee members noted that both standards contain a large amount content related to viruses and Transmissible Spongiform Encephalopathyies (TSEs) agents, disproportionate compared to other topics and redundant with the authoritative documents on the topic. There is a risk that this document will not be updated when those authoritative documents are updated and causes users to follow outdated approaches. The goal of this draft is to reduce the content related to viruses and TSE agents, with the preference that users refer to the authoritative documents. Minor editorial changes may be also be included. 

Details

Developed by Subcommittee: F04.42

Committee: F04

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 11-10-2023

Technical Contact: Nikhil Gheewala