Material Analysis
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COC Performance Deterioration After Sterilization
Problembeschreibung
COC medical parts show yellowing, embrittlement or dimensional changes after gamma or ethylene oxide sterilization, and the sterilization verification batch is unqualified.
Ursachenanalyse
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.
Lösung
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.
Wichtigste Erkenntnis
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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