Work Item
ASTM WK83841
Revision of F1635-16 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
Rationale
This standard is being revised to add information and discussion on the following topics, as agreed to by members of Task Group F04.15.07 on absorbable polymer test methods. Add discussion regarding in vitro to in vivo correlation of degradation rate. Add language that clarifies how to deal with absorbable polymer degradation that is not primarily through hydrolysis. Add language that underscores the need to adjust degradation retrieval/evaluation points to specific systems rate of degradation (i.e. guide for degradation as opposed to a test with rigid evaluation points) Add language that hydrolytic characterization of the polymer does not reflect the degradation characteristics of the as-fabricated and sterilized finished device. NOTE: Technical changes need to be undertaken in both ASTM F1635 and ISO 13781 documents to assure harmonization (it was previously determined that both need to exist, since both are used extensively).
Work Item Status
Date Initiated: 10-20-2022
Technical Contact: Jon Moseley