Material Analysis
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COC Performance Deterioration After Sterilization
Fenómeno del problema
COC medical parts show yellowing, embrittlement or dimensional changes after gamma or ethylene oxide sterilization, and the sterilization verification batch is unqualified.
Análisis de la causa
High-energy radiation causes COC molecular chain scission or crosslinking, and grades with insufficient radiation stabilizer deteriorate significantly; ethylene oxide residue and temperature also have effects; sterilization doses exceeding the limit aggravate the damage.
Solución
①Select radiation-stabilized medical grades; ②execute the sterilization dose at the verified minimum effective value; ③retest all performance items after sterilization; ④verify different sterilization methods separately.
Conclusión clave
The sterilization adaptability of COC medical parts is guaranteed by dedicated grades; the dose minimization principle reduces damage; changes in sterilization methods must be re-verified.; After confirming effectiveness, fix the parameters and practices into the work instruction to prevent recurrence
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