Hengyi HY-0580FGTY Cardiovascular & Orthopedic Tensile Testing Machine

Overview

The Hengyi HY-0580FGTY Cardiovascular & Orthopedic Tensile Testing Machine is a precision-engineered electromechanical universal testing system designed specifically for biomechanical evaluation of soft and hard biological tissues, medical devices, and implantable biomaterials. Built upon a single-column load frame architecture, it delivers high reproducibility in static and quasi-static mechanical characterization—including uniaxial tensile, compression, flexure, peel, tear, and cyclic loading modes—under controlled displacement or force-rate conditions. Its core measurement principle relies on closed-loop servo-controlled actuation combined with high-fidelity load cell transduction (up to 5 kN) and sub-micron displacement feedback, enabling compliance with ISO 5832, ASTM F2129, ISO 178, ISO 527, ASTM D638, ASTM F1717, and ISO 14879-1 for orthopedic and cardiovascular device validation. The system supports both manual and programmable test protocols, making it suitable for R&D laboratories, regulatory submission studies, and quality control environments operating under GLP or GMP-aligned workflows.

Key Features

• Single-column rigid aluminum alloy frame with integrated vertical travel guide and anti-rotation column for enhanced axial alignment and minimal parasitic bending during specimen loading.
• High-resolution digital encoder-based displacement measurement (0.001 mm resolution) with real-time feedback and automatic calibration traceability.
• Modular load cell selection (5 N to 5000 N), all factory-calibrated to ISO/IEC 17025-accredited standards; dual-range capability ensures optimal signal-to-noise ratio across low-force soft-tissue and high-force metallic implant testing.
• Programmable crosshead speed from 0.001 to 500 mm/min with ±0.5% speed accuracy over full range, supporting strain-rate-sensitive protocols per ASTM F2193 (tendon testing) and ISO 13314 (compressive behavior of porous biomaterials).
• Comprehensive safety architecture: electronic limit switches, overload protection at 110% of maximum rated load, emergency stop circuitry, and automatic return-to-home function post-test.
• Integrated environmental readiness: compact footprint (0.99 m³), 220 V / 750 W single-phase operation, and EMI-shielded control electronics compliant with IEC 61326-1 for laboratory electromagnetic compatibility.

Sample Compatibility & Compliance

The HY-0580FGTY accommodates a broad spectrum of specimen geometries and mechanical behaviors relevant to translational biomedical engineering. Validated test configurations include native and decellularized vascular grafts, synthetic polymer stents, nitinol wires, titanium spinal rods, PEEK interbody cages, hydroxyapatite-coated screws, suture anchors, biodegradable sutures, collagen scaffolds, cortical bone cores, and polymeric wound dressings. Specimen gripping options include pneumatic, wedge, and custom-designed clamps with surface-textured jaws to minimize slippage during high-strain-rate testing. All hardware and firmware comply with essential requirements of the EU Medical Device Regulation (MDR 2017/745) Annex I for ancillary equipment used in mechanical validation of Class IIa–III devices. Data acquisition meets ALCOA+ principles, and audit trail functionality supports FDA 21 CFR Part 11 readiness when paired with validated software modules.

Software & Data Management

The system operates with Hengyi’s proprietary BioTestSuite™ v4.2 software—a Windows-based platform engineered for ISO 13485-aligned documentation workflows. It enables automated parameter derivation per ASTM E8/E8M and ISO 6892-1, including Rp0.2 (0.2% offset yield strength), Rm (ultimate tensile strength), A5 (elongation at break), E-modulus (secant and tangent), and fracture energy integration. Real-time curve overlay, multi-channel synchronized data logging (load, displacement, extensometer strain), and customizable report templates (PDF/Excel) are standard. Raw data export is in ASCII CSV format with embedded metadata (operator ID, timestamp, calibration certificate ID, environmental conditions). Optional add-ons include GLP-compliant electronic signatures, role-based user access control, and secure network deployment via TLS 1.2 encrypted API endpoints.

Applications

• Mechanical qualification of vascular grafts and heart valve leaflets per ISO 7198 and ASTM F1241.
• Tensile fatigue assessment of orthopedic fixation plates and intramedullary nails under ISO 14801 and ASTM F1160.
• Compression testing of vertebral body replacement implants and dental abutments per ISO 14801 and ISO 14801-2.
• Peel strength evaluation of medical adhesive tapes and wound closure strips per ASTM D903.
• Dynamic mechanical analysis (DMA-mode equivalent) of hydrogels and electrospun nanofibers using programmed ramp-hold sequences.
• Regulatory submission support for 510(k), IDE, and CE Technical Documentation packages requiring traceable, repeatable mechanical performance data.

FAQ

Does the HY-0580FGTY support ASTM F2193-compliant tendon testing protocols?

Yes—the system includes preconfigured test methods for human and animal tendon specimens, with adjustable preload, strain-rate ramping, and stress-relaxation hold segments aligned with the standard’s annexes.
Can the machine perform simultaneous load and extensometer-controlled tests?

Yes—dual-closed-loop control allows independent regulation of force and axial strain using optional non-contact video extensometry or clip-on mechanical extensometers.
Is calibration documentation provided with each unit?

Each system ships with a factory-issued calibration certificate traceable to NIM (China National Institute of Metrology), including uncertainty budgets for force, displacement, and speed channels.
What is the warranty coverage and service response time?

Standard warranty is 24 months parts-and-labor; extended service plans include on-site preventive maintenance and remote diagnostics with ≤72-hour SLA for critical issues within APAC regions.
Are custom grips or fixtures available for specialized implants?

Yes—Hengyi maintains an engineering support team capable of rapid prototyping and validation of application-specific fixtures, subject to NDA and design transfer agreements.