Biocompatible. Sterilizable. Medical-grade.
Material selection for medical devices. Biocompatibility, sterilization compatibility, regulatory acceptance — different requirements vs industrial.
Material selection for medical devices
Different. USP VI: implant biocompatibility testing. FDA 21 CFR: food/medical contact materials. Application-dependent.
Key principles.
Implants
Extra-low interstitial titanium. Spinal, orthopedic, dental implants.
Surgical instruments
Vacuum-melted 316L. Surgical instruments, temporary implants.
Joint replacements
CoCr alloys for hip/knee replacements. High wear resistance.
Spinal cages
USP Class VI PEEK. Radiolucent, biocompatible.
Tubing, seals
USP Class VI silicone elastomer. Drug-contact tubing.
Bioprocess
Electropolished 316L for biopharmaceutical processing.
Disposables
FDA-grade PETG for disposable medical packaging.
USP VI plastic
Cost-effective USP VI plastic. Syringes, containers.
Vials, syringes
USP type I borosilicate glass for parenteral packaging.
FAQ
Different. USP VI: implant biocompatibility testing. FDA 21 CFR: food/medical contact materials. Application-dependent.
Each material/method match. Steam autoclave 121°C: most metals OK. Gamma: most plastics OK with verified material grade. EtO: most materials OK.
FDA 510(k) required for new implants. Material selection per intended duration. ISO 10993 biocompatibility testing.
Final assembly in ISO 7/8 cleanroom for sterile products. Particle-controlled manufacturing.
Mill cert through finished part. Lot traceability. 25-year retention typical for permanent implants.
"Surgical grade", "implant grade", "USP VI" — verify exact testing performed. Generic material may not be suitable.
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