Key principles.
USP VI grade
PEEK-OPTIMA, USP VI silicone, FDA-compliant 316L. Specify by USP VI compliance, not just material.
From mill
Material certificate from mill heat through finished part. Required for medical traceability.
Pure substrate
Avoid coatings, fillers, additives unless specifically USP VI rated. Each adds compliance burden.
Cleanability
Smooth surfaces (Ra 0.8 µm or better) for cleaning. Crevices harbor bacteria.
Drainable design
Drainable, cleanable design. Sanitary 3-A standard for some applications.
Material-process
Specify sterilization method (gamma, EtO, autoclave). Material compatibility matters.
FAQ
Systemic toxicity, intracutaneous reaction, intramuscular implantation testing per USP. Materials passing become Class VI rated.
FDA 21 CFR 177 covers food contact materials. USP VI covers medical device implantation testing. Different applications.
Invibio PEEK-OPTIMA is USP Class VI certified for implants. Standard for spinal cages, orthopedic. Premium over industrial PEEK.
Medical-grade documentation adds 10-20% to part cost. Includes mill certs, processing records, inspection per AS9102.
Yes. Gamma may degrade some plastics. Repeated autoclave fatigues materials. Specify sterilization compatibility for chosen material.
Medical device development requires regulatory expertise. We manufacture per spec; customer responsible for FDA submission, 510(k), etc.
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