Developing Additive Manufacturing Standards For a Rapidly Expanding Industry


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To provide clarity in the ever-evolving world of additive manufacturing, UL has developed downloadable guidelines like this one for medical equipment.

New uses and applications for additive manufacturing are unfurling exponentially, but not all 3D-printed objects are created equal.

Standards for 3D-printed products—as well as for the many steps between ideation and product completion—are all evolving as the uses for additive manufacturing (AM) multiply. However, it's not always evident to which standards manufacturers should comply to.

Generally speaking, official standards in the realm of AM are needed to ensure 3D-printed products are safe, uniform, reliable, and of a high quality.

"3D printing is a revolutionary way to design and produce a part," says Zhou, who is also an America Makes board member.

Because the emphasis for product standards is on the finished products parts themselves, she says, the manufacturing processes are secondary. In short, it doesn't matter how you get there, as long as you arrive at the final destination.

"Anything that's 3D-printed has to meet the same standards," Zhou says.

Standards vs. compliance

Simin Zhou

UL is known worldwide for its independent laboratory safety testing and certification program—which provides independent verification of compliance to standards—as well as its legacy safety standards in the field of electrical fire. For the last year and a half, the company has turned its safety science expertise toward 3D printing and additive manufacturing.

Though UL is in "the compliance business with extensive research in safety and quality science," Zhou says the company contributes to a number of standards-setting bodies, including the ASTM Committee F42 on AM technologies.

Zhou says UL and other groups—like the International Electrotechnical Commission, the International Organization for Standardization, and ASME, for example—are all on the lookout to see where additional 3D-printing standards may be necessary.

Medical device compliance

When it comes to medical applications of 3D printing, a manufacturer must comply with federal guidelines for medical devices—specifically Title 21 of the U.S. Code of Federal Regulations 820—in order to gain the approval required to develop commercial products.

Under these guidelines, a manufacturer must answer a litany of questions about a device's use, safety, and effectiveness, as well as provide data on its bio-compatibility, physicochemical characteristics, microbiological activity, sterilization, shelf life, and packaging.

To help bring some clarity, UL recently issued a downloadable guideline for compliance for medical equipment (see Library section) made with 3D printing. The document is aimed at helping manufacturers choose the right standards and develop a comprehensive test plan in order to meet the requirements to bring a product to market.

A lot of times, Zhou says, standards are client-specific. Larger companies, such as retailers, often have their own set of internal standards that a product must meet before shipment.

Zhou says that's where UL comes in.

“We will validate, test, inspect whatever necessary to see if something meets the requirements," she says.

More training required

Though 3D-printing designers don't need to meet complicated product standards and guidelines, they do need to worry about the safety of equipment and the materials being used, as well as the processing mechanisms, Zhou says.

"For a lot of the laser-sintering powder-based machines, the risk isn't even in the machines themselves, but in the material handling, pre- and post-processing," Zhou says.

To help people understand the right way of thinking about standards and certification, UL is developing a 3D-printing training curriculum that will cover safety and quality, along with the latest in technical design and the business case for AM.

“We really want to move this industry forward, help it mature, and help companies make 3D printing part of their design and manufacturing process," Zhou says.

The new frontier of additive manufacturing can be intimidating to navigate; fortunately, there‚Äôs the ASME AM3D conference to help guide you as you integrate AM into your business. Learn more about the ASME Additive Manufacturing and 3D Printing Conference and Expo here.

Holly B. Martin is an independent writer.

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June 2015

by Holly B. Martin