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Work Item

ASTM WK92613

Revision of F2027-16 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products

Rationale

The standard has been reviewed and revised for reapproval. Changes are shown in redlines below. Subcommittee F04.42 discussed the necessity of maintaining this standard based on the general nature and an increasing number of more targeted and detailed options. We decided to pursue reapproval because some members noted that the standard is still helpful to some users, especially as not all raw or starting materials are yet covered by other standards. Edits have been included for: 1) Updating, adding, or correcting referenced document information, 2) Changing most occurrences of “shall” and “requirement” to “should” and “attribute”, and other edits, to match the purpose of the guide in providing recommendations, and 3) Clarifying the use of the guide for materials from natural sources.

Details

Developed by Subcommittee: F04.42

Committee: F04

Staff Manager: Kate Chalfin

Work Item Status

Date Initiated: 10-24-2024

Technical Contact: Nikhil Gheewala

Item: 009

Ballot: F04 (24-07)

Status: Ballot Item Approved

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