3D printing has opened up concrete possibilities in the medical sector: from custom prostheses to orthopedic aids, from anatomical models for surgical planning to Class I and II medical devices. Each application requires a material with specific, verified and documented characteristics.
Biocompatibility is the primary requirement: the material must not release toxic substances when in contact with tissues, blood or bodily fluids. The reference standard is ISO 10993 for medical devices. Not all generic PLAs or PETGs meet this requirement: medical-grade formulations, free of unapproved anti-UV additives and colorants, are needed.
Medical-grade PEEK is the reference material for implants and components in contact with bone tissue: elastic modulus similar to cortical bone (3–5 GPa), resistance to autoclave sterilization at 134°C, radiotransparency to X-rays. The PEEK filaments in this collection are specific formulations for biomedical use with ISO 10993 or ASTM F3091 certification where applicable.
Biocompatible PLA is suitable for aids, orthoses, and aesthetic prostheses in contact with skin. Medical-grade TPU offers softness and comfort for padding, orthopedic footwear, and parts in prolonged contact with skin.
Note: The presence of a biocompatible filament is a necessary but not sufficient condition for the production of a regulated medical device. CE marking requires a qualification process that goes beyond material selection. Strato3D provides materials and technical documentation—the regulatory process is the responsibility of the device manufacturer.