According to the Missouri company, the medical 3D printing industry has been clamoring for a material that meets ISO 10993 standards for biocompatible medical devices, and taulman3D has now delivered with a new PETG-based filament called guidel!ine. The high-strength, high-temperature material is already registered with the FDA, and users will be provided with plenty of information in sync with the agency’s “Technical Considerations for Additive Manufactured Devices Draft Guidance for Industry and Food and Drug Administration Staff: Section C: Material Controls.”
A device printed with guidel!ne isn’t automatically FDA/CE certified – the certification process is a lot more complicated than that – but it significantly speeds things along to be able to present a part made with an already tested and approved raw material.
“guidel!ne is sold as a raw material modified in form only into 3d printing line and most important, extruded in a manner that keeps contaminates out of the material during the cooling process, where contaminates and bacteria could be embedded in the soft extrusion,” states taulman3D. “In addition, pH and ORP levels are monitored and adjusted to maintain acceptable levels.”
In terms of performance, guidel!ine has excellent thermal properties and is resistant to distortion, allowing the printing of small, finely detailed parts, including watertight hollow tubes, at high temperatures without warpage. It needs only a small amount of retraction and also serves as a good support material for medical grade nylon prints – it has just enough adhesion to provide support and still be easy to remove.
Here are the fine details:
- Tensile strength: 6,850PSI – stronger than taulman3D’s strongest TECH-G material
- Elongation: 5.9, modulus 281,469PSI
- Print temperature: 250°C
- Heat distortion temperature: 70°C
- Softening temperature: 100°C
guidel!ine is now available for purchase from taulman3D’s website. Discuss further in the guidel!ine 3D Printing forum over at 3DPB.com.