“Guidel!ne” is a High Strength ISO 10993 PETG Based Material.
Guidel!ne is a unique high strength PETG based material with excellent high temperature printing capabilities. Users know that printing small features of some parts can be difficult due to thermal build-up. guidel!ne is much less susceptible to these thermal issues allowing for finer detail without distortion. guidel!ne is also released as a starting point for individuals and companies wishing to obtain eventual FDA/CE certification for a device knowing that the raw material itself is listed with the FDA and has already passed specific FDA testing.
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. In addition, pH and ORP levels are monitored and adjusted to maintain acceptable levels.
Of course, printing an item with guidel!ne does not mean the item is certified. The certification process for medical/surgical equipment and components is on a part by part/usage certification process with the applicable agency.
Information provided to the user will be in sync with the FDA’s “Technical Considerations for Additive Manufactured Devices Draft Guidance for Industry and Food and Drug Administration Staff”. Section “C” “Material Controls”. While COA’s will be the responsibility of the end user, taulman3D will provide information to support such efforts. End users will be able to “register” their spool/s with taulman3D. (To register your spool/s of guidel!ne, send an email to email@example.com and include your serial # in the subject line. In the body, include any info you wish to provide as to your use of guidel!ne.). As with other materials from taulman3D, the clarity of guidel!ne allows for visual non-destructive evaluation of the printed part.
When 3D Printed, guidel!ne has a tensile strength higher than TECH-G, coming in at 6,850PSI. Elongation is 5.9 and a modulus of 281,469PSI. Heat distortion temp is 70C. Softening temperature is 100C. A key feature of guidel!ne is that one can easily print small hollow tubes without the issue of heat build-up deforming the tube.
Another feature of guidel!ne is that it’s higher print temperature allow it to be used as a support material for medical grade Nylon. guidel!ne used as a zero-gap support material works extremely well on Nylon with just enough adhesion to form mechanical support yet easy to remove from parts where mechanical removal is accessible.
guidel!ne meets the following:
- ISO 11607-1: 2006
- ISO 10993
- USP Class VI
- USP <661>
- DMF (Drug Master File) number 16525
STORAGE: One large resealable bag with slider + an extra desiccant pack are included with every spool. The bag and extra desiccant are a great way to safely store your filament spool when not in use. It keeps your filament bone dry & free from any dust or dirt particles, so it's always ready for your next print.
NET WEIGHT: 0.45 KG (1.1 LB)
|245°C - 252°C
- very easy to print needing only a small amount of retraction.