Production & Quality
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PSU Failure Under High-temperature Sterilization
Problembeschreibung
PSU medical devices show performance degradation and appearance changes after repeated high-temperature steam sterilization; failures accumulate with sterilization cycles.
Ursachenanalyse
Although PSU resists high-temperature steam, repeated sterilization still has cumulative effects; internal stress is released and deforms during thermal cycling; material grades differ in sterilization resistance levels; sterilization temperature and time exceeded limits.
Lösung
①Select sterilization-resistant grades; ②Low-stress molding; ③Verify according to the number of sterilization cycles; ④Execute sterilization parameters per specifications.; After adjustment, continuously sample to verify the effect, and resume mass production only after confirming stability
Wichtigste Erkenntnis
The sterilization resistance of PSU medical parts requires cyclic verification; grade selection and process quality jointly determine life; parameter specification is a basic requirement.; After confirming effectiveness, solidify the parameters and practices into the work instructions to prevent recurrence
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