Bioprinters

Background
Bioprinting, a method that uses 3D printing techniques to synthesize living tissues utilizing bioink products, could rapidly accelerate the timeline for testing new pharmaceuticals by allowing new products to be tested on synthetic human tissues rather than on animal subjects. This would allow greater accuracy of test results and a faster speed to market. Bioprinting is used to develop manufactured 3D living tissue, bone, blood vessels and potentially whole organs for use in medical procedures, training, and testing. With many different manufacturers and academic researchers developing bioink products, there is a lack of standardization for bioink printers such as nozzle temperature, printing time, dispensing pressure, printing speed, and nozzle diameter; all of which directly influence the precision and accuracy of bioink deposition. Standards in this area will allow product developers to more easily reproduce test results and control product quality.

ASME is collaborating, under the guidance of the Standards Coordinating Body (SCB), with ASTM and IEEE, who are developing complementary but distinct Standards.

Current status
ASME established the Bioprinters Standards Committee in 2021 with the following Charter:
Develop, review and maintain guidelines and standards for bioprinters hardware requirements. 
The initial work is concentrated on providing guidelines for extrusion bioprinting calibration of devices, operations, compatibility, and interoperability of these components to best print ex vivo “outside an organism” tissue results. 
To that effect, the committee is currently working on a BP-1 Extrusion Bioprinters Hardware Draft with the following scope:
 
This document Standard provides the requirements for extrusion bioprinting calibration of devices, operations, compatibility, and interoperability of these components to best print ex vivo tissue results. This Standard focuses on the equipment that can be adapted for use in a particular environment. 
This Standard is intended for bioprinter users including, but not limited to bioprinter manufacturers, tissue- engineered medical products (TEMPS) regulators and product developers, and bioink developers. 
 
Meetings and Events
The Bioprinters Standards Committee - Meets periodically via teleconference about every 1-2 months. For more specific meeting information, please refer to the committee page

Staff Contact
If you’re interested in learning more or participating in these activities, please contact Fred Constantino.

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