En10204 / fda?

Hello Community,
im wondering if there is any Resin, that has been approved for Engineering in medical production machines?

Im working as an engineer for special-purpose machines and were facing lots of difficult parts for medical Treatment etc. These parts ooften have some wiered geometries and there for i tried to print some vacuum grippers.

it really works great and offers a whole new manufacturing process to the Company. but unfortunately the materilas
being used by formlabs are not approved by EN10204 or the FDA.

So if anyone has some ideas or knows Resins, which got the approval i would be very grateful if he can spread his knowledge.

Just throwing out an idea here…You could use the printed part as a positive for a silicone mold then find a FDA approved elastomer to mold the part out of.


1 Like

Had this in mind also. but it´s obvious more work to get the product, what will be okay to do if theres no other Option. Problems i see in this case is for spare parts. The effort for later casts would be pretty high, and we would Need some room to store the molds if we dont want to make them again every time we Need a spare part.

And another ver important Point: were totally not familiar with casting :smiley:

Formlabs has some resins that have been tested for biocompatibility. Check out their Dental resins.

The FDA does not approve materials (unfortunately). The preclinical testing you need to perform should come from your risk and hazard analysis and any applicable testing standards (ASTM, etc) if they have been defined for your product. If your application requires biocompatibility, it is possible you can avoid expensive testing by using Formlabs’ master file - but again it depends on your risk and hazard analysis and any standards.