Present and future of standardization of additive manufacturing in the medical field

Abstract

This chapter presents how standards in additive manufacturing (AM) can support the regulation and certification of medical devices and implants made by these technologies. There are some specific issues of AM technologies such as anisotropy, multi-material, graded material, process parameters, etc., which need to be addressed to ensure the final quality of the product. The chapter shows how standards in additive manufacturing are developed by international bodies (ASTM, ISO, CEN), and how the medical field requires specific standards. There are some gaps in the existing international regulations for medical devices/implants (MD/I) when this digital manufacturing is involved, for example, the issue of custom-made product /mass production. Future needs and priorities of standardization of AM for MD/I are proposed to fill the existing gap.