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Jiali Self-Tapping Screws in Biocompatibility & Seal Validation for Medical Devices
ZHUHAI JIALI HARDWARE CO., LTD.
Jiali Self-Tapping Screws in Biocompatibility & Seal Validation for Medical Devices
Medical electronic devices impose strict requirements on fastener biocompatibility and environmental sealing. Jiali PMS-ST-MED series self-tapping screws pass ISO 10993-5 cytotoxicity testing (negative), ISO 10993-10 sensitization testing (no reaction), and meet IP67 ingress protection rating.
1. Biocompatibility Test Data (Report: SZ2026-ST-MED-01)
| Test Item | Standard | Result | Pass/Fail |
|---|---|---|---|
| Cytotoxicity | ISO 10993-5 | Cell viability ≥ 98.5% | ✅ Non-toxic |
| Sensitization | ISO 10993-10 | Dermal sensitization rate ≤ 0.5% | ✅ Non-sensitizing |
| Intracutaneous Reactivity | ISO 10993-23 | Irritation Index = 0.2 (pass limit ≤ 0.5) | ✅ Non-irritating |
2. IP67 Sealing Performance Validation
• Test Conditions:
- Dust: 5.5 hours, dust concentration 2 kg/m³
- Water: 1 meter depth, 30 minutes immersion
• Housing Material: PC+ABS blend (2.8mm thick)
• Result: Zero leakage, zero functional failure, zero cosmetic damage
3. Jiali PMS-ST-MED Series Advantages
✓ Medical-grade raw material: USP Class VI PC/PEEK (SGS Report SZ2026-MED-001)
✓ Surface Finish: Nickel-free eco-friendly black-grey oxidation (RoHS/REACH/FDA compliant)
✓ Smart Packaging: EO-sterilized individual pouches (ISO 11135)
✓ Certifications: ISO 13485, FDA 510(k) Letter of Substantial Equivalence
All Jiali medical-grade self-tapping screws undergo full-spectrum biocompatibility testing by third-party labs. A Biocompatibility