Description

An all-in-one pressure vessel design intended to be used in pressure decay testing. The purpose is to generate evidence that the components fabricated during an additive manufacturing build may be sufficiently free from air leakage. These are STL files for a Regulatory Science Tool (RST) from the U.S. Food and Drug Administration (FDA) / Center for Devices and Radiological Health (CDRH) / Office of Science and Engineering Laboratories (OSEL). The demonstration pressure vessel incorporates the outer geometry of the medium size Stopgap Face Mask (SFM), https://3d.nih.gov/entries/3DPX-014168 (https://3d.nih.gov/entries/3DPX-014168). This vessel design is the result of peer-reviewed literature from: Ibarra, B., Schwerin, M., Hasani, A. et al. Leak verification method for additively manufactured medical devices. Int J Adv Manuf Technol 140, 1427–1440 (2025). https://doi.org/10.1007/s00170-025-16362-5 (https://doi.org/10.1007/s00170-025-16362-5)