Are you #3dprinting insoles? Not all filaments are created equal! ⚠ Some filaments are definitely not suitable for the production of 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲𝘀. Especially if you see the warning sign as shown here. However, not all manufacturers have the courtesy of providing you with such a warning... As a result, filaments without such a sticker can't automatically be deemed safe! Make sure you use 𝗯𝗶𝗼𝗰𝗼𝗺𝗽𝗮𝘁𝗶𝗯𝗹𝗲 filament!
Robert Joyce
1mo
Nice catch. Important label. I would comment - not all polymer filaments are biocompatible - harmful to cells and tissue, yet can meet California requirements.
Staff Biomedical Engineer, 3D printing at Johnson & Johnson
4wI would start with the materials outlined in annex G of fda document - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".