Shanghai Hengyi HY-0580UIMIK Universal Testing Machine for Cardiovascular Biomaterials and Soft Tissue Mechanics

Overview

The Shanghai Hengyi HY-0580UIMIK Universal Testing Machine is an electromechanical materials testing system engineered for high-precision mechanical characterization of soft biological tissues, cardiovascular biomaterials, and medical devices under controlled uniaxial loading conditions. Based on servo-controlled electromechanical actuation and closed-loop feedback architecture, the system implements force, displacement, strain, and stress control modes in accordance with ISO 5832, ASTM F2129, ISO 13314, ISO 6892-1, and GB/T 16491–2008 standards. Designed specifically for low-force biomechanical applications—particularly tensile, compression, peel, tear, and relaxation testing of membranes, valves, sutures, hydrogels, and native or engineered soft tissues—the HY-0580UIMIK delivers traceable, reproducible measurements across a full load range from 5 N to 5,000 N. Its modular frame architecture supports interchangeable fixtures—including pneumatic clamps, custom tissue grips, and micro-test platens—enabling seamless adaptation to specimen geometries ranging from sub-millimeter vascular grafts to macro-scale implant packaging films.

Key Features

• Electromechanical drive system with precision ball-screw transmission and AC servo motor, enabling speed control from 0.001 to 500 mm/min with ±0.5% speed accuracy
• High-resolution load cell with dual-range capability (5 N to 5,000 N selectable), offering ±0.5% full-scale accuracy and internal resolution up to 500,000 counts
• Closed-loop control algorithms supporting four independent modes: force control, displacement control, strain control, and stress control
• Integrated electronic limit protection, overload cutoff (>110% FS), real-time self-diagnostic monitoring of drive and sensor subsystems
• Adjustable crosshead travel (800 mm effective stroke) with dual-speed manual/electric positioning and programmable return-to-start functionality
• Rigid aluminum alloy frame with dual-layer baked enamel finish, optimized for long-term dimensional stability and vibration damping
• Compliant with GLP documentation requirements: audit-trail-enabled test logging, timestamped raw data export (CSV, XML), and report generation per ISO/IEC 17025 workflows

Sample Compatibility & Compliance

The HY-0580UIMIK accommodates diverse specimen types common in biomedical R&D and regulatory testing, including but not limited to: native cardiac valve leaflets, synthetic heart valve membranes (e.g., polyurethane, bovine pericardium), suture threads (absorbable/non-absorbable), vascular stent coatings, hydrogel-based tissue scaffolds, collagen membranes, surgical meshes, catheter tubing, IV bag films, blister packaging laminates, and orthopedic soft-tissue fixation components. All test protocols align with internationally recognized standards: ASTM D882 (tensile properties of thin plastic sheeting), ASTM F963 (toy safety—tensile strength of elastics), ISO 10993-12 (sample preparation for biocompatibility), USP (mechanical testing of pharmaceutical packaging), and EN ISO 11607-2 (sterile barrier systems). System calibration certificates are traceable to NIM (National Institute of Metrology, China) and support FDA 21 CFR Part 11 compliance when paired with validated software modules.

Software & Data Management

The embedded Windows-based control software provides real-time acquisition at up to 1 kHz sampling rate, synchronized force–displacement–time data streaming, and automated calculation of standard mechanical parameters—including ultimate tensile strength (UTS), yield point (0.2% offset), elastic modulus (secant/tangent), elongation at break, tear propagation resistance, 90°/180° peel adhesion, and stress relaxation half-life. Curve overlay, differential analysis, and statistical batch reporting are supported natively. Raw datasets export in vendor-neutral formats (CSV, TXT) compatible with MATLAB, Python (NumPy/Pandas), and JMP. Optional IQ/OQ documentation packages and 21 CFR Part 11-compliant user access controls (role-based permissions, electronic signatures, immutable audit logs) are available upon request for regulated laboratory environments.

Applications

• Mechanical evaluation of bioprosthetic heart valve membranes under cyclic and static loading
• Tensile and creep behavior assessment of decellularized myocardial patches and engineered cardiac constructs
• Peel strength quantification of medical device pouch seals and sterile barrier systems
• Compression testing of hydrogel-based wound dressings and dermal fillers
• Three-point bending of bioresorbable polymer pins and plates per ISO 13314
• Micro-tensile characterization of suture knots and needle attachment integrity
• Relaxation and hysteresis profiling of elastomeric catheter shafts and balloon materials
• Quality control of raw material batches for ISO 13485-certified medical device manufacturers

FAQ

What is the maximum test speed and its accuracy specification?
The system achieves speeds from 0.001 to 500 mm/min, with speed accuracy maintained within ±0.5% of setpoint across the entire range.
Does the machine support ASTM F2129-compliant pitting corrosion test sample mounting?
While primarily designed for mechanical testing, custom fixture adapters can be supplied to accommodate ASTM F2129 specimen holders for combined electrochemical–mechanical studies.
Is third-party calibration certification included with delivery?
Yes—each unit ships with a factory calibration certificate traceable to national metrological standards; optional UKAS-accredited calibration is available pre-delivery.
Can the software generate GLP-compliant test reports with electronic signatures?
When configured with the Validation Package, the system supports 21 CFR Part 11 and Annex 11 compliance, including role-based access, audit trails, and digitally signed PDF reports.
What is the minimum resolvable force at the 5 N load cell setting?
With 500,000 internal counts and no auto-ranging, the effective resolution is 0.01 mN at full scale—equivalent to 10 µN per count.