EPX 150 Earns USP Class VI Certification, Opening New Applications in Medical Device Production
Carbon’s EPX 150 is now USP Class VI certified, the most stringent classification for biological reactivity testing under USP <88> for plastics intended for contact with the human body. The certification expands EPX 150’s role in medical device production, pairing the resin’s engineering-grade thermal and mechanical performance with biocompatibility for direct device contact. For medical device design teams, that combination addresses a category of applications that has been difficult to achieve in photopolymer 3D printing thus far: rigid, autoclavable, biocompatible components that can support production-scale manufacturing, subject to device-specific regulatory evaluation.
Why This Combination Matters
Until now, design teams choosing a biocompatible 3D printed photopolymer have often encountered trade-offs in mechanical and thermal performance, particularly for components that need to hold tight tolerances under repeated thermal and chemical stress.
EPX 150 changes that. It is an engineering-grade resin with a heat deflection temperature of 155°C and tensile strength of 76 MPa, with mechanical and chemical properties that, based on standard test data, place it in the performance comparable to high-performance thermoplastics like PEEK, PEI, and PSU. Adding USP Class VI to that profile means the material can move into reusable, sterilizable, regulatory-grade applications that traditionally required machining or molding to achieve.
What USP Class VI Actually Means
USP Class VI is the most stringent designation under USP <88>, the United States Pharmacopeia standard for biological reactivity of plastics. To earn it, a material must pass acute systemic toxicity, intracutaneous, and implantation testing in vivo. EPX 150 has also been tested against the corresponding ISO 10993 biocompatibility panel, passing ISO 10993-5 (cytotoxicity), 10993-10 (irritation and skin sensitization), 10993-11 (systemic toxicity), and 10993-23 (in vitro irritation).
USP Class VI is a widely recognized biocompatibility benchmark for materials used in medical device manufacturing. Pairing that with engineering-grade performance positions EPX 150 as a strong material selection for medical device manufacturers developing applications that require regulatory submissions. Three properties matter most when a printed component moves from prototype into a medical device, and EPX 150 brings all three:
Accuracy: The Carbon DLS process produces parts with fine features, tight tolerances, and isotropic mechanical performance, which is critical for fluidic routing, sealed assemblies, and any application where internal geometry directly affects function.
Autoclave compatibility: In internal testing, EPX 150 withstood over 400 cycles of 134°C steam autoclave sterilization with minimal property or dimensional change, meeting the sterilization standards for reusable medical devices.
USP Class VI biocompatibility: With the new certification, EPX 150 can be used for applications where material biocompatibility is required.
Together, these properties hold up across sterilization cycles, chemical exposure, and time, which is what reusable device applications demand.
How to Access EPX 150
Teams already running Carbon printers are already using EPX 150 for product development and production. For OEMs that do not yet subscribe to Carbon printers, EPX 150 is also available through select ISO 13485-certified partners in the Carbon Production Network, which lets medical device manufacturers scale into Carbon DLS production without bringing a printer in-house first.
The Missing Piece
USP Class VI certification gives engineering teams the confidence they need to explore using EPX 150 for device production, not just prototyping. With it, the combination of accuracy, autoclavability, and biocompatibility is primed for reusable medical device applications.
To explore Carbon’s medtech materials, hardware, software, and partner network, visit carbon3d.com/industries/medtech.
USP Class VI qualifies the material, in its printed, cured form, under standardized test conditions, not any specific finished device. See the Technical Data Sheet for EPX 150. All medical devices are subject to independent biocompatibility evaluations, risk assessments, and regulatory submissions depending on classification and intended use. Device manufacturers are solely responsible for determining suitability of any material for their specific application and for obtaining all necessary regulatory clearances or approvals. Nothing in this post constitutes a guarantee of regulatory compliance for any particular device or application.