Tibial Tray Fatigue Testing Machine | ISO 14243 Knee Implant Tester
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Whats/App: +86 156 1874 6768
Web: standard-groups.com
Standards
(1)YY/T 0810 (China): Specifies fatigue testing protocols for tibial trays in total knee arthroplasty, focusing on support and protection of plastic bearing surfaces.
(2)ASTM F1800 (International): Defines methodologies for evaluating the fatigue strength of tibial components under cantilever loading conditions.
(3)ISO 14879-1: Additional compliance for general fatigue testing of total knee joint prostheses.
Product Advantages
(1)Cantilever Loading Precision: Advanced actuator design ensures uniform stress distribution per ASTM F1800 requirements.
(2)5 Million Cycle Endurance: Proven capability to complete YY/T 0810’s 5×10⁶-cycle fatigue test without calibration drift.
(3)Dynamic Load Control: Closed-loop system maintains R=0.1 stress ratio during sinusoidal/random loading (0.1–10 Hz).
(4)Real-Time Fracture Detection: AI-powered acoustic emission monitoring identifies micro-cracks at sub-millisecond intervals.
(5)Intuitive Workflow: 21.5” capacitive touchscreen with gesture control and pre-loaded SOPs for 10+ implant geometries.
(6)Modular Environmental Chambers: Quick-swap pods for simulated physiological (-20°C to +50°C) and corrosive environment testing.
Product Features
(1)Electromagnetic Actuator: 3.000 N peak force capacity with programmable load ratios (R=0.1–10).
(2)Cantilever Loading System: Simulates physiological knee joint moments with ±20 mm axial displacement.
(3)Dynamic Load Control: 0.1–10 Hz frequency range with programmable waveforms (sine, square, random, custom).
(4)Thermal-Mechanical Chamber: ±0.3°C temperature stability with integrated humidity control (10–95% RH).
(5)High-Speed Imaging Ready: Syncs with external cameras for full-field strain mapping (DIC optional upgrade).
(6)Safety First: Triple-redundant emergency stop, overload clutches, and laser-based specimen breakage detection.
Accessories
(1)Tibial Tray Test Fixture Kit:
Self-centering collet system (28–40 mm tibial tray compatibility)
Laser-aligned loading anvils with diamond-like carbon (DLC) coating
(2)Thermal-Mechanical Chamber:
15L capacity with rapid cooling/heating (15°C/min)
316L stainless steel interior with HEPA filtration
(3)TestMaster Ultimate Software:
Automated S-N curve generation and fatigue limit calculation
21 CFR Part 11-compliant audit trail with blockchain timestamping
Remote monitoring via dedicated iOS/Android app
(4)Operator Kit:
Calibrated torque wrench set (0.5–50 Nm)
Specimen alignment gauges (ASTM F1800 compliant)
(5)Calibration Bundle:
NIST-traceable force calibration weights
Temperature/humidity verification probe
(6)Safety Kit:
Laser safety curtains
Acoustic enclosure with 30 dB noise reduction
Technical Parameters
| Parameter | Specification |
|---|---|
| Max. Dynamic Force | ±3.000 N (6.000 N peak optional) |
| Frequency Range | 0.1–10 Hz (0.01 Hz increments) |
| Load Ratio (R) | 0.1–10 (adjustable) |
| Axial Displacement | ±20 mm (0.1 μm resolution) |
| Torque Capacity | ±20 Nm (0.01 Nm resolution) |
| Temperature Range | -20°C to +50°C (environmental chamber) |
| Humidity Control | 10–95% RH (non-condensing) |
| Data Sampling Rate | 100 kHz (synchronized across 16 channels) |
| Power Requirements | 220V/110V ±10%, 50/60Hz, 2.000W |
| Dimensions (W×D×H) | 1.500 × 1.000 × 2.000 mm |
| Weight | 750 kg (including environmental chamber) |
| Noise Level | <65 dB (A-weighted) |
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