May 12, 2016 | By Kira
3D printing filament manufacturer Taulman3D has been listening to its clients over the years, developing a range of high-strength, high-performance materials for their ever expanding needs. From low-temperature Nylon 230, to flexible PCTPE nylon, to stronger-than-ABS t-glase, they’ve got a specialized material for nearly any 3D printing application.
The latest addition to their portfolio is guidel!ne (pronounced guideline), which was created specifically to answer the call of their clients in the medical and clinical fields. These individuals and companies have been in search of an FDA-registered, ISO 10993 class material for developing biocompatible 3D printed medical devices, including surgical tools and even implants.
With guidel!ne, Taulman3D introduces a clear, high-strength, PETG based material with excellent high temperature printing capabilities. Because of its unique thermal profile, guidel!ne can retain fine 3D printed features without the distortion that usually effects high-temperature prints. Additionally, users can easily 3D print watertight, hollow tubes.
For the medical and clinical 3D printing community specifically, however, guidel!ne comes with a few uniquely targeted advantages.
First and most importantly, guidel!ne has already passed specific FDA testing, and is therefore ideal for individuals for companies wanting to obtain eventual FDA/CE certification for a 3D printed medical device.
“[Guidel!ne is] 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,” explains the developers. “In addition, pH and ORP levels (Oxidation-reduction potential) are monitored and adjusted to maintain acceptable levels.”
Taulman3D rightly points out that although the raw material is FDA-tested, does not guarantee that the device it is made from will be approved, as the certification process for medical or surgical equipment is done on a part/usage process, and requires stringent testing.
However, they suggest that using guidel!ne can help simplify the process, as designers and engineers can confidently move forward with their certification applications knowing the raw material they’ve used to design their medical device is already on the FDA’s list.
A final advantage of using guidel!ne is that because of its higher 3D printing temperature, it can effectively be used as a support material for medical grade Nylon, providing just enough adhesion to form mechanical support, while still being easy enough to remove.
Taulman3D has provided the following specs for its new guidel!ne filament:
- Tensile strength: 6,850PSI (higher than their strongest TECH-G)
- Elongation: 5.9, with a modulus of 281,469PSI
- Heat distortion temp: 70C
- Softening temperature: 100C
- Printing temperature: 250C
Guidl!ne will soon be available via the Taulman3D webstore. The 3D printing filament comes in 1-pound spools of either 2.85mm or 1.75mm. Each spool also comes with an identification number and a ‘traceability and batch key’.
Posted in 3D Printing Materials
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