Filament biocompatibility for FFF/FDM - legislation/certification

[Florian_De_Boec]

Hi all,

I am currently starting a project in the biomedical field with the 3D printing technology.

As everyone knows, the medical field is highly regulated!

That is why I am looking for filament already certified biocompatible (specially ISO10993-1, but also USP VI, and why not FDA). I just need to be sure that the filament respect the class 1 of the medical devices classification. I have found so much brands of filaments on the web (Stratasys, Taulmann, Colorfabb, … and if you are aware of better brands, feel free to share them).

But I still have some questions and I don’t know where to find the answers:

- if I have a certificated filament but then I use my FDM 3D printer (that is not), will the filament be still certificate and with no risk for the patient ? or should I certificate the 3D printer too ?

The material will still be the same, but just heated and molded… Until what point can we “modify/transform” the material to keep the certification valid?

- What is the difference between a machine certification (3D printer) and a material certification (filament) ?

- if I have to certificate the whole process, should I follow the ISO13485 norm?

Thank you very much for your help

Florian

[Perry_1]

Contact Taulman directly so they can discuss your needs. They are experienced in this field, can guide you on the best approach.

[Florian_De_Boec]

Yes, I already did but they answered me :

"Florian,
We understand your interest, but can only provide the information located on our site. There are too many rules/regs for us to go further.
Thanks Tom
We want to thank everyone for their incredible interest in
our High Strength 3D Printing Materials!

www.taulman3d.com"

So I don’t really know where to find the information that I need…