Global standards developer ASTM International has introduced a new standard to provide guidance to medical device manufacturers on powder reuse within powder bed fusion (PBF) processes.
Now available as F3456, the standard was developed by ASTM’s additive manufacturing technologies committee.
“Additive manufacturers of medical devices and regulatory bodies will find this new guide to be useful,” said Matthew Di Prima, ASTM International member.
“This guide may also be useful to AM manufacturers to generally describe their reuse process to customers without having to give away specific manufacturing process information.”
Certification in AM
Standardizing the processes behind additive manufacturing is a key factor in driving the technology’s wider adoption. To this end, the likes of ASTM are continuing to work with manufacturing partners to develop new standards to improve the quality of 3D printed parts.
The organization contributes to the development of additive manufacturing standards via its F42 additive manufacturing technologies committee, and its Additive Manufacturing Center of Excellence (AM CoE). For instance, the AM CoE has previously signed a cooperative agreement with NASA to identify potential 3D printing projects to execute, and launched a new round of funding to support research projects that encourage standardization within the additive manufacturing field.
ASTM has also worked to develop additive manufacturing facility safety standards, published a special issue journal on 3D printing during covid-19, and most recently acquired 3D printing consultancy firm Wohlers Associates and, by extension, the revered state-of-the-industry Wohlers Report.
Aiding PBF for medical device 3D printing
ASTM’s F42 additive manufacturing technologies committee has carried out a lot of work on developing standards for the PBF 3D printing process in the past. This latest standard will provide guidance to medical device manufacturers on the use of powder reuse in PBF manufacturing processes.
The new F3456 standard explains seven broad reuse schema that will give manufacturers information important to regulatory bodies that are wishing to understand how powder reuse schemes affect medical device performance.
F3456 is the first standard to be developed by the F42’s additive manufacturing subcommittee regarding medical and biological standards.
The subcommittee is also welcoming wider engagement in developing standards on the use of 3D printing material specifications for medical applications.
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Featured image shows ASTM’s Additive Manufacturing Center of Excellence aims to accelerate additive manufacturing standardization. Photo via ASTM International.