SCB Launches Two New Bioprinting Standards Efforts

In January, we wrote about SCB’s work helping to coordinate the drafting of an ASTM standard for New Test Methods for Printability of Bioinks and Biomaterial Inks. Bioprinting presents a great opportunity to speed testing timelines for new therapies and help treat various health conditions through 3D printing of synthetic human tissues.

In addition to this ASTM standard, SCB recognized other standards needs in the area, specifically for bioprinter hardware and software and data governance. After working closely with the American Society of Mechanical Engineers (ASME) and the Institute of Electrical and Electronics Engineers (IEEE) to explore the potential for additional standards related to bioprinting, we have launched new standards projects in these two areas.

Bioprinter Software and Data Governance

Data governance and software standards help to improve the safety and quality of the printed medical product by providing a standard way to maintain a manufacturing chain of custody. SCB is working with IEEE and ARMI|BioFabUSA to coordinate the development of a standard for bioprinter software and data governance. A project working group has been established to assess feasibility, which includes identifying potential barriers to standard development related to technical knowledge, expert availability, and implementation feasibility, as well as several other factors. The working group will begin to develop a standard scope and outline, once it has fully considered all these factors and determined that the standard effort has sufficient resources and community interest to move forward.

Bioprinting Equipment

Another challenge in the bioprinting space is ensuring consistency and accuracy in the printed product. To address this challenge, SCB is working with ASME and ARMI|BioFabUSA to develop guidelines for the calibration, compatibility, and interoperability of bioprinter hardware and related components. SCB has organized a working group to draft the standard, and the project has advanced to ASME for development.

Get Involved

SCB is looking for additional experts to help advance these bioprinting standards efforts. Contact us if you would like to join one of these working groups or provide expert input into any of the draft standards.