Standards BEHIND 
THE HEADLINES

We have arrived in the era of transplant technology—where 3D bioprinted artificial organs can make a life-changing difference. While patients who require organ transplants face a myriad of challenges including organ shortage, uncertain waiting periods, and transplant rejection, a new initiative from the Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), aims to improve patient outcomes through bioengineered solutions for life-threatening conditions.

The agency awarded grants to several research teams that will use “state-of-the-art bioprinting technology and a regenerative medicine approach” to 3D print personalized, on-demand human organs that don’t require immunosuppressive drugs.

ARPA-H reports that the goal is to use patient cells or a biobank to quickly produce immune- and blood type-matched replacement organs, such as kidneys, hearts, and livers. Ultimately, 3D-printed organs could revolutionize transplant procedures across healthcare systems.

“Developing universally matched organs has never been done before in the history of transplantation,” said Alicia Jackson, Ph.D., ARPA-H director. “Printing a precisely matched, functional human organ will fundamentally change what is possible in transplant medicine and will save countless lives. Through the PRINT program, ARPA-H will strengthen U.S. leadership at the frontiers of biotechnology and biomedical innovation.” 

Among the research award recipients, Carnegie Mellon University reveals that it will produce human-sized and functional bioprinted livers, initially for acute liver failure with the long-term goal to address all liver failure.

“The goal is to create a piece of liver tissue that you can use as an alternative to transplant, specifically for acute liver failure,” said Adam Feinberg, professor of biomedical engineering at Carnegie Mellon and principal investigator. “The liver we are creating would last for about two to four weeks. It would give patients time for their own liver to regenerate, and then, they would not need a liver transplant, freeing up those livers for other patients. The liver is just the first application, with the plan to expand to the heart, pancreas, and other organs. This innovation would fundamentally change healthcare as we know it, because most people suffer at some point from end-stage organ failure.”

Standards Support the Evolution of 3D Printing

3D printing—also known as additive manufacturing—has helped revolutionize a number of industries from manufacturing to automotive. The terms refer to the transformation of a digital CAD (Computer-Aided Design) file into a three-dimensional physical solid object or part. The process involves depositing materials, layer by layer, in precise geometric shapes using a printhead, nozzle, or other printing technology. As technology advances into biomedical applications, robust standards frameworks are essential to assure safety and interoperability.

Several core standards support the evolution of the 3D printing industry. They include:

• ISO/ASTM 52915:2020, Specification for additive manufacturing file format (AMF) Version 1.2, which provides the specification for the Additive Manufacturing File Format (AMF), an interchange format to address the current and future needs of additive manufacturing technology. The standard was developed by ISO Technical Committee (TC) 261, Additive manufacturing, in cooperation with ANSI member ASTM International’s committee ASTM F 42.91, Terminology. The ANSI-accredited U.S. Technical Advisory Group (TAG) for ISO/TC 261 is administered by ASTM International. 
• ASME Y14.2-2014 (R2020), Line Conventions and Lettering, establishes the line and lettering practices for use in the preparation of engineering drawings, including the recognition of the requirements for CAD and manual preparation for their reduction and reproduction. The standard was developed by ANSI member the American Society of Mechanical Engineers (ASME).
• ISO 17296-2, describes the process fundamentals of additive manufacturing. It also gives an overview of existing process categories, which are not and cannot be exhaustive due to the development of new technologies. This standard was also developed by ISO TC 261.

Additionally, ANSI supports additive manufacturing progress through the America Makes & ANSI Additive Manufacturing Standardization Collaborative (AMSC), a cross-sector coordinating body whose objective is to accelerate the development of industry-wide additive manufacturing standards and specifications consistent with stakeholder needs to facilitate the growth of the additive manufacturing industry. The AMSC does not develop standards or specifications; rather, it helps drive coordinated standards development activity.

Medical-Specific 3D Printing Standards

As 3D printing extends into organ bioprinting, medical-specific standards and guidance are also critical. Key standards include:

• ASTM F3659-24, Standard Guide for Bioinks Used in Bioprinting, a resource for bioprinting tissue-engineered medical products (TEMPs) with bioinks and biomaterial inks. While there are existing standards that cover biomaterials and scaffolds in a more general fashion (Guide F2150, Guide F2027, ISO 10993 series), this guide focuses specifically on extrusion bioprinting utilizing bioinks and biomaterial inks with inherent or inducible fluidic properties with or without encapsulated cells used to construct Tissue-Engineered Medical Products, or TEMPs. It was developed by ASTM International.
• ISO/IEC 3532-1:2023, Information technology - Medical image-based modelling for 3D printing - Part 1: General requirements,specifies the requirements for medical image-based modelling for 3D printing for medical applications. The document was prepared by the Joint Technical Committee of the International Organization for Standardization and the International Electrotechnical Commission, ISO/IEC JTC 1, Information technology. The U.S. plays a leading role in JTC 1, with ANSI serving as Secretariat.

Standards Support Opportunities in Medical Innovations

The aforementioned organizations and others will continue to play a pivotal role in establishing the frameworks to advance revolutionary technology from research breakthrough to widespread clinical reality.

Read more about the ARPA-H program and more about JTC 1’s 3D printing efforts in its recent newsletter.