Regenerative Medicine Standards in Development Updates: ASTM

Technical Program Manager Kelly Sauerwein recently attended the ASTM Committee F04 on Medical and Surgical Materials and Devices meeting in Denver, where she discussed the status of SCB-coordinated projects and gathered valuable community input and updates on regenerative medicine standards. Below are highlights from the meeting.

SCB-Coordinated ASTM Standard Projects

  • Sampling Methods of Tissue Engineered Medical Products (TEMPs) for Sterility Assurance in TEMPs (SCB-coordinated project): Recommended to become a new work item (WK). The project is expected to be submitted for approval as a WK by the end of summer 2019.

  • ASTM WK65476: New Guide for Characterizing Fiber-Based Constructs for Tissue Engineered Medical Products (SCB-coordinated project): Discussed at the meeting and will be revised and submitted for ballot in September.

  • ASTM WK65680: New Test Methods for Printability of Bioinks and Biomaterial Inks (SCB-coordinated project): A draft was presented at the meeting and is currently being revised. It is expected to be submitted for ballot soon.

Additional In-Development ASTM Standards

  • ASTM WK55364: Practice for Quantifying Cell Proliferation in 3D-Scaffolds by a Non-Destructive Method: This standard is currently in ballot at the subcommittee level until August 8.

  • ASTM WK57514: Guide for Evaluating Extracellular Matrix Decellularization: This standard is currently in ballot concurrently at the committee and subcommittee levels until August 12.

  • ASTM F2900-2011: Guide for Characterization of Hydrogels used in Regenerative Medicine: This standard is due for revision/renewal and must be balloted to F04 committee by November 1 and approved by December 31 or it will be withdrawn. A technical contact and expert input are still needed. Please contact SCB to get involved in this project.

Get Involved

SDO committees play a key role in standards development and are made up of volunteers from industry, government, and academia. Learn more about how ASTM develops standards and how you can get involved.

Calling All SDOs: Contact SCB if you have any updates on regenerative medicine standards you would like us to share with the regenerative medicine community.