Process Capabilities · 06
What ceramic CIM can and cannot do in medical devices
Medical Device-Specific CapabilityEO Sterilization
Both materials compatible, no risk.
Gamma (50kGy)
Both zirconia and alumina show discoloration (alumina slightly yellows); performance unaffected, reversible at 300°C. Measured: zirconia C-ring, 325N before sterilization, 320N after, density 6.05g/cm³ both before and after.
Autoclave (Steam)
Alumina can be reused across multiple cycles; zirconia requires dedicated validation (risk of low-temperature degradation, LTD).
Biocompatibility
Y-TZP zirconia: over 30 years of clinical use in medical devices, fully validated under ISO 10993. Alumina: also has a track record of medical use, with good biocompatibility.
Production environment disclosure: our production environment is a standard industrial-grade facility, not ISO cleanroom-certified. After ceramic parts are delivered, the medical device manufacturer performs cleaning, disinfection, and sterile packaging in their own cleanroom - the standard division of labor in the medical device supply chain. If you need final assembly and packaging of a single-use sterile device completed directly in a cleanroom environment, we currently cannot serve as a direct supplier for that step.