Project: Specifications for Bioinks and Bioprinters
Type: Standards Advancement Project
Partners: ASTM International, the American Society of Mechanical Engineers (ASME), the Institute of Electrical and Electronics Engineers (IEEE), ARMI | BioFabUSA, and The SCB Tissue Engineering Sector Working Group
Get Involved:Accepting new working group members
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Description:
Bioprinting—a method that uses 3D printing techniques to synthesize living tissues—is a rapidly expanding field within regenerative medicine with the potential to accelerate the testing timeline for new biopharmaceuticals that can treat a variety of conditions. Bioinks are used in bioprinting to mimic the extracellular matrix that supports cells in three dimensions. As an emerging field with many different manufacturers and academic researchers independently developing products, bioprinting lacks standards for bioink properties such as viscosity and concentration and for bioprinter equipment and component specifications such as movement control, extruders, and printer housing. Standards in these areas will allow product developers to more easily reproduce test results and control product quality.
SCB is coordinating the development of three bioprinting standards, including an ASTM documentary standard that will evaluate and compare printability of bioinks and two complementary standards for bioprinting software change control and bioprinting hardware.
Anticipated Availability: 2022-2024
Progress:
(learn more about the standards advancement process)
Note: Projected start dates are estimates only. Development of a standard depends on SDO timelines, which can vary.
Bioink Printability Test Method: SCB assembled a team of experts to revise an initial draft of this standard. The draft was presented at the May 2019 ASTM International Committee F04 meeting (ASTM WK72274: New Test Method for Printability of Bioinks and Extrusion-Based Bioprinting). It is currently undergoing finalization.
Software Change Control for Bioprinting: SCB is also working with the IEEE to coordinate the development of a standard for software change control. The project was accepted as an official work item in IEEE in December 2019 (IEEE SA P2864: Guide for a Software Change Control System for Three-Dimensional (3D) Bioprinting of Tissue-Engineered Medical Products [TEMPs]) and is currently undergoing review and comment.
Bioprinter Hardware: SCB has organized a working group to draft a standard on bioprinting equipment and component specifications. The standard concept was accepted by ASME in August 2019 and began drafting in April 2020. It is undergoing finalization.
Get Engaged:
To join the working group or learn more about this initiative, please contact SCB.