We custom-design 3D resin systems for biomedical-device development and other specialised printing applications. Where biological-evaluation requirements apply, materials are designed to support the relevant requirements after appropriate printing and post-processing; final-part compliance must be validated by the user/device manufacturer.
Material development for biological-evaluation workflows
Examples of 3Dresyns® material systems and development routes used in biological-evaluation and biomedical workflows:
Quality considerations and printer-specific tuning
Custom-designed 3Dresyns® can be tuned for the intended printer and workflow. Where relevant, development can take into account quality-management and biological-evaluation considerations associated with standards such as ISO 13485 and ISO 10993, without implying certification of the resin or final device.
Resin selection and tuning can be aligned with your own development process for biomedical devices across different device classes. Final qualification, testing and regulatory compliance remain the responsibility of the device manufacturer.
Monomer-free systems with MSDS
3Dresyns develops monomer-free (as supplied) resin systems and process auxiliaries supplied with the applicable Safety Data Sheets. Hazard classification and biological suitability are product- and workflow-specific and must not be inferred from a monomer-free designation or from the use of an auxiliary.
Broad performance range for biomedical development
Custom-designed resin systems can be tuned across a broad range of physical properties, from hard and tough grades to flexible and elastic systems, for biomedical-development workflows. Final properties and suitability depend on the selected formulation and validated process.
Reduced extractables, leachables, and cross-contamination potential
Extractables, leachables and cross-contamination potential should be evaluated for the specific formulation, printed specimen and complete workflow. No general reduction relative to monomer-based systems is assumed without like-for-like analytical evidence.
Learn more about potential health problems of monomer-based 3D resins .
Recommended cure verification and purification protocol
For added process control, our Cure Tester & Purification protocol is recommended:
Contact
Contact us to discuss our customisation services for materials designed to support biological-evaluation requirements and your specific performance goals at: info@3dresyns.com
