BioMed Flex 80A Resin is ISO 10993 and USP Class VI tested and certified. It is rated for long-term skin contact (more than 30 days) and short-term mucosal membrane contact (less than 24 hours). Formlabs manufactures this material within a Quality Management System that is ISO 13485 and EU MDR certified, and all Medical Device Resins are appropriately registered with the FDA and CE marked according to EU MDR requirements.

The resin is produced at Formlabs' FDA-registered facility in Ohio. A dedicated team of operators and quality assurance professionals manufactures the material inside a certified ISO Class 8 clean room, under the same ISO 13485-certified Quality Management System that governs all Formlabs Medical Device Resins.

Unlike Formlabs Dental Resins, no intended uses are specified for BioMed Resins. It is the manufacturer's responsibility, along with its customers and end-users, to determine the biocompatibility and performance of all printed parts for their respective application and use. Formlabs provides biocompatibility testing data and manufacturing documentation to help instill confidence in potential users.

BioMed Flex 80A Resin has a Shore hardness of 80A, an ultimate tensile strength of 7.2 MPa, an elongation at break of 135%, a tear strength of 22 kN/m, and a compression set of 5.3% (tested at 70°C for 22 hours). These properties allow parts to deform under manipulation and return to their original shape. You can download the full Technical Data Sheet for the complete property table.

Shore 80A places BioMed Flex 80A Resin in the firm, flexible range. Parts are rigid enough to hold their shape and function as durable components, yet compliant enough to deform and recover, making the material well suited for flexible medical devices and firm tissue models.

BioMed Flex 80A Resin is designed for flexible biocompatible medical devices and components, as well as firm, transparent tissue models that can be brought directly into the operating room. Typical uses include sizing models, cartilage models, disease organ models, and medical devices requiring short-term mucosal membrane contact. Because parts are 3D printed directly, this approach eliminates the need for cumbersome molds and enables mass personalization of patient-specific parts. For more context, see the Formlabs white paper on printing soft anatomical models.

The resin is translucent, which allows surgeons and medical professionals to produce complex, clear tissue models and use them as hands-on references during procedures. This visibility can support more informed planning and decision-making in the operating room without requiring the part to be opaque.

BioMed Flex 80A Resin is compatible with the Form 4B, Form 4BL, Form 3B, and Form 3BL. It uses SLA print technology with a minimum layer thickness of 50 microns. Compatible tanks include the Form 4 Resin Tank, Form 4L Resin Tank, Form 3 Resin Tank V2.1, and Form 3L Resin Tank V3.

Yes. Two post-processing steps are required. First, parts must be washed to remove excess resin from the surface using an alcohol wash. Second, post-curing is necessary for biocompatible materials to achieve the safety standards set by regulatory agencies. Detailed settings for both steps are provided in the BioMed Flex 80A Manufacturing Guide.

The Technical Data Sheet, Safety Data Sheet, and Certificate of Analysis (COA) are all available directly from Formlabs. You can download the Technical Data Sheet and Safety Data Sheet or request a COA from the product page.