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Material Drying 5 views

PA66 medical device boundaries

Problem Phenomenon
PA66 medical parts have sharp strength drop and dimension out of control after repeated steam sterilization
Cause Analysis
PA66's moisture absorption characteristic makes it absorb water, swell, and hydrolyze during high-temperature steam sterilization, and performance cumulatively deteriorates with repeated sterilization; medical scenarios have higher requirements for batch consistency and traceability
Solution
①For repeated steam sterilization scenarios, switch to hydrolysis-resistant or other materials; ②Verify disposable products by single sterilization; ③Batch traceability of medical-grade grades; after adjustment, take continuous samples to verify the effect, confirm stability before resuming mass production
Key Takeaway
PA66's moisture absorption nature limits its medical sterilization applications; grade hydrolysis resistance level and usage count limitation are the feasible boundaries; after confirming effectiveness, fix the parameters and practices into the work instructions to prevent recurrence
PA66;medical;steam sterilization;hydrolysis;traceability

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