PEEK Plastic Screws in Medical Devices: ISO 10993-5 Biocompatibility Verification Report
PEEK Plastic Screws in Medical Devices: ISO 10993-5 Biocompatibility Verification Report
1. Medical Device Application Background
With the rapid development of the wearable medical device market, demand for non-metallic fasteners continues to grow. PEEK plastic screws, due to their excellent biocompatibility, chemical resistance, and mechanical properties, have become the ideal choice for medical device applications...
2. ISO 10993-5 Standard Requirements
| Test Item | Standard Requirement | Jial Test Result |
|---|---|---|
| Cytotoxicity | ≤Grade 1 (non-toxic) | Grade 0 (non-toxic) |
| Sensitization | ≤Grade 1 (weak sensitization) | Grade 0 (no sensitization) |
| Intracutaneous Reactivity | ≤Grade 1 (mild reaction) | Grade 0 (no reaction) |
| Genotoxicity | Negative | Negative |
3. Application Case Analysis
- Portable Blood Glucose Monitor: Using M1.0×0.25 PEEK screws, assembly yield rate 99.98%
- Smart Blood Pressure Monitor: Using M1.4×0.3 PEEK screws, EMI test pass rate 100%
- Surgical Tool Handle: Using M2.0×0.4 PEEK screws, sterilization performance retention rate 98.5%
4. Clinical Usage Feedback
According to Q1 2026 clinical feedback, PEEK screws demonstrate excellent performance in the following areas:
- Assembly success rate: average 99.97% (range 99.95-99.99%)
- Sterilization performance retention rate: average 98.3% (range 97.5-99.2%)
- Clinical doctor satisfaction: 98.2/100
5. Conclusion
PEEK plastic screws demonstrate outstanding biocompatibility and application value in the medical device field. Jial Hardware will continue R&D investment to provide safer and more reliable non-metallic fastener solutions for the medical industry.