Key principles.
Adhesives
Food contact adhesives. Specific approval list.
Food contact
Food contact materials. Most plastics here.
Additives
Food additive materials. Specific list.
Implants
Implant biocompatibility testing. PEEK-OPTIMA, USP silicone.
Premium
Some materials cover both — premium documentation.
Per heat lot
Material cert traceable to mill heat.
FAQ
FDA 21 CFR: food contact materials. USP VI: implant biocompatibility testing. Different applications.
Invibio PEEK-OPTIMA USP Class VI. Standard for spinal cages, orthopedic implants.
Systemic toxicity, intracutaneous reaction, intramuscular implantation per USP.
Material certificates, processing records, inspection per AS9102 or PPAP.
Most USP VI materials autoclave-compatible. Verify per material grade and method.
USP VI materials 1.5-3× standard equivalent. Documentation adds 10-20%.
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