Standard
- ASTM F543: Standard specification for metallic medical bone screws (dynamic loading protocols).
- ISO 12172: Implants for surgery—Partial and total hip joint prostheses (fatigue testing methodologies).
- YY/T 0342: Chinese standard for surgical implant testing (cutout resistance evaluation).
- Adaptive Compliance: Customizable protocols for emerging regulatory frameworks.
Product Advantages
- Dynamic Load Simulation: Replicates physiological gait-cycle forces (0–1,500 N at 5 Hz) for real-world failure prediction.
- Dual-Axis Measurement: Simultaneous tracking of cutout force (N) and angular displacement (°) during cyclic testing.
- Failure Prediction Algorithm: Proprietary software identifies pre-failure indicators using machine learning.
- High-Speed Imaging Integration: Syncs with external cameras for real-time deformation visualization (optional upgrade).
- Ergonomic Workflow: Touchscreen interface with pre-loaded ASTM/ISO templates and customizable test sequences.
- Modular Design: Quick-swap fixtures for testing various nail designs (helical blades, lag screws, etc.).
Product Features
- Electrodynamic Actuator: Delivers sinusoidal, triangular, or custom waveforms up to 10 Hz.
- 6-DoF Load Cell: Measures axial/torsional forces and moments with 0.1% FS accuracy.
- High-Resolution Motion System: ±5° angular resolution for tracking nail migration paths.
- Thermal Stability Chamber: Controls test environment (-20°C to +50°C) for material property analysis.
- AI-Powered Analytics: Auto-generates failure mode maps comparing historical/current implant designs.
- Remote Access: Cloud-connected system for real-time collaboration and audit trails.
Műszaki paraméterek
| Paraméter | Specifikáció |
|---|
| Max. Dynamic Load | ±1,500 N (axial) / ±50 Nm (torsional) |
| Frequency Range | 0.1–10 Hz (sinusoidal) |
| Angle Measurement | ±5° (0.001° resolution) |
| Data Sampling Rate | 10 kHz (synchronized across 8 channels) |
| Test Duration | 1–10⁶ cycles (programmable) |
| Sample Compatibility | 8–16 mm diameter nails, 100–500 mm length |
| Power Requirements | 220V/110V ±10%, 50/60Hz, 1,200W |
| Dimensions (W×D×H) | 1,200 × 800 × 1,800 mm |
| Súly | 450 kg (including safety enclosure) |
Accessories
- Dynamic Test Fixture Kit:
- Self-centering bone analog holder
- Adjustable nail insertion guide (0–45° varus/valgus)
- 6-Channel Load Cell: Calibrated to ISO 376 standards.
- TestMaster Pro Software:
- Real-time hysteresis loop visualization
- Fatigue life prediction (S-N curve generation)
- 21 CFR Part 11 compliance module
- Safety Enclosure: Acrylic chamber with interlock system and LED lighting.
- Calibration Bundle:
- NIST-traceable weights (100g–1kg)
- Angular verification jig
- Operator Kit:
- Torque wrench set (0.1–10 Nm)
- Sterilizable bone cement spatulas
- ISO international standards: The design, manufacturing, and testing process of the equipment should meet the requirements of ISO international standards to ensure the international recognition of the test results.
- National/regional standards: Different countries and regions may formulate specific standards for the mechanical property testing of orthopedic implants. When conducting tests, appropriate national/regional standards should be selected according to the actual situation.
- Industry standards: The orthopedic implant industry may also have formulated relevant testing standards and specifications internally. These standards may include provisions on testing methods, testing conditions, testing equipment, etc.
Felelősségi nyilatkozat: A fenti tartalom kizárólag az iparági belső személyek közötti hivatkozásra és kommunikációra szolgál, és nem garantálja pontosságát vagy teljességét. A vonatkozó törvények és előírások, valamint a weboldal előírásai szerint a kapcsolódó cikkeket vásárló egységeknek vagy egyéneknek érvényes képesítést és képesítési feltételeket kell megszerezniük.
