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Testing Machines for Biomedical Devices and Medical Equipment

In the biomedical sector, the safety and performance of materials and devices are critical. Italsigma develops custom testing machines for biomedical applications, designed to test medical devices, prostheses, biomaterials and components for the healthcare and pharmaceutical industries.

Our solutions enable advanced mechanical testing, including tensile, compression, fatigue and durability tests, ensuring high precision, repeatability and compliance with applicable standards and regulations.

Each system is designed to ensure data traceability, automated testing processes and integration with international medical standards, supporting research and development activities in the biomedical sector.

Why Choose Italsigma for Biomedical Testing

Italsigma is a technology partner for the development of high-precision biomedical testing systems, designed to simulate real-world biomechanical conditions.

Our solutions integrate:

  • Precision mechanics
  • Advanced servo-hydraulics
  • Data acquisition systems
  • Automation and digital control

We develop custom medical testing equipment to deliver reliable and traceable results, supporting innovation in healthcare and the safety and validation of medical devices.

PROJECTS

  • FPF100 Servo-Hydraulic Testing Machine

    Two-column testing machine equipped with a servo-hydraulic actuator mounted beneath the lower crosshead and a slotted support base.

    The load cell can be mounted either on the actuator or on the upper crosshead.
  • FPF50 Servo-Hydraulic Testing Machine

    Two-column testing machine equipped with a hydrostatically supported servo-hydraulic actuator mounted above the upper crosshead and a slotted support base.

    The load cell can be mounted either on the actuator or on the lower crosshead.
  • Three- and Four-Point Bending Test System

    Testing system designed to perform three- and four-point bending tests using adjustable supports and loading noses.

    The system is manufactured from high-strength steel and features graduated scales on the sliding bases, allowing precise positioning of the supports and loading noses. The rollers are interchangeable and manufactured from high-hardness steel. Main features:
    • Maximum static and dynamic force: 10 kN
    • Adjustable loading-nose span: 40 to 200 mm
    • Contact roller width: 50 mm
    Italsigma has also developed bending test systems with capacities of up to 500 kN.
  • LM10 – LOAD FRAME

    LM10 – LOAD FRAME FOR TENSILE/COMPRESSION TESTING Two-column testing machine equipped with an electric actuator mounted on the upper crosshead and a slotted lower support base. The load cell can be mounted either on the actuator or on the support base. The machine consists of the following main components:
    • Special compact two-column load frame designed to withstand a dynamic axial load of 10 kN
    TECHNICAL SPECIFICATIONS
    • Maximum height (with motor at the top): 2,700 mm
    • Overall footprint: 1,050 × 600 mm
    • Clear distance between columns: 450 mm
    • Actuator working stroke: 100 mm
    • Maximum specimen height: 600 mm
    • Machine weight: 750 kg
    • Maximum dynamic …
  • FPF 30 MN Testing Machine

    Uniaxial load frame designed to withstand maximum loads of 30 MN in both compression and tension for testing structural components.

    The frame is equipped with a fixed lower crosshead and a movable upper crosshead, allowing adjustment of the available test clearance. The upper crosshead is moved by four servo-hydraulic actuators rigidly connected to the two crossheads. These actuators also apply the test load to the specimen by controlling the displacement of the upper crosshead.
  • Compression Platen System

    System consisting of circular steel compression platens made of 38NiCrMo3 steel, complete with a spherical joint to compensate for minor misalignments.

    The upper platen, equipped with a spherical joint, is directly connected to the actuator piston rod. Four elastic retaining rings keep the spherical joint assembly in position. The lower platen is connected to the load cell, which is in turn secured to the frame base. TECHNICAL SPECIFICATIONS
    • Compression platen diameter: 125 mm
  • Hip Prosthesis Fatigue Testing System

    Testing system designed to perform static and fatigue tests on hip prostheses, consisting of:

    • A lower fixation fixture onto which the prosthesis stem is cemented
    • An upper loading fixture equipped with two orthogonal low-friction slides
    • A temperature-controlled fluid bath in which the entire system is immersed, allowing tests to be performed in physiological solutions or other fluids while maintaining the temperature within a range close to ambient or body temperature.
  • MU26 – Ultrasonic VHCF Testing Machine

    Ultrasonic Testing Machine

    Electromechanical testing machine equipped with an ultrasonic system for generating cyclic loads and a load frame with an electromechanical actuator for applying static loads. Test control, monitoring and data management are performed via personal computer.
  • Mechanical Gripping System for Tensile Testing

    Mechanical grips for flat and/or round specimens, operating on a screw-clamping principle.

    The grips are manufactured from 39NiCrMo3 quenched and tempered steel with a blued surface treatment, making them suitable for fatigue testing with loads of up to 20 kN. The gripping surfaces feature a knurled clamping system. Maximum gripping width: 30 mm Supplied with:
    • 2 pairs of knurled grip plates for flat specimens from 0 to 8 mm thick
    • 2 pairs of knurled grip plates for round specimens from 6 to 12 mm in diameter
    These grips are suitable for installation inside an environmental chamber and for tensile testing of …
  • Hydraulic Gripping System for Tensile Testing

    Self-centering hydraulic wedge grips with a one-piece steel body, suitable for tensile and compression testing as well as load cycles around zero, with forces of up to 100 kN.

    Supplied with:
    • 2 pairs of wedges for flat specimens from 0 to 10 mm thick
    • 2 pairs of wedges for cylindrical specimens from 10 to 25 mm in diameter
  • Ortho 3 – 3-Axis Biomechanical Simulator

    Three-axis biomechanical simulator for orthopaedic prostheses.

    The machine features a four-column frame with an electric actuator mounted beneath the lower crosshead. The load cell can be mounted either on the lower or upper test surface. Equipped with a 6-axis load cell measuring Fx, Fy, Fz, Mx, My and Mz. TECHNICAL SPECIFICATIONS
    • Vertical force: 10 kN
    • Axial moment: 100 Nm horizontal / 100 Nm vertical
    • Very high dynamic performance in the vertical direction
  • Torsion Testing Machines

    High-stiffness frame designed for torsion testing of femoral prostheses.

    The torsional load is generated by an electronically controlled motor, with precise control of the angle of rotation. The lower test platform rotates and can apply a preload to the prosthesis.
  • LM10 – Linear Testing Machine

    Two-column testing machine equipped with an electric actuator mounted on the upper crosshead and a slotted lower support base.

    The load cell can be mounted either on the actuator or on the support base. The machine provides very high dynamic performance, with frequencies of up to 80 Hz.
  • Plane Bending – MINI FP2

    The MINI FP2 is a fatigue testing machine featuring a novel approach based on specimen miniaturization and cyclic plane bending loading.

    The machine operates at a selectable test frequency of up to 50 Hz. MINI FP2 generates S/N curves for uniform test configurations and correlates the results with those obtained using standard-sized specimens.
  • Rotating Bending – RB35

    Constant-load rotating bending testing machine.

    The testing system generates four-point bending with a constant bending moment along the specimen axis, while allowing continuous adjustment of the rotational speed around the longitudinal axis. The electromechanical testing machine is integrated into a tubular steel base and equipped with a protective polycarbonate enclosure. Test operation, control and data management are performed from a dedicated control console.
  • FPF25 – SERVO-HYDRAULIC TESTING MACHINE

    Two-column testing machine equipped with a servo-hydraulic actuator mounted above the upper crosshead and a slotted support base.

    The load cell can be mounted either on the actuator or on the lower crosshead.
  • FPF500 – SERVO-HYDRAULIC TESTING MACHINE

    Four-column testing machine equipped with lateral column reinforcements, designed to withstand test loads up to 500 kN without significant deformation.

    The base features a slotted test surface for securing testing fixtures and equipment.
    • Support surface: 2,900 × 1,500 mm
    • Hydraulic lifting of the upper crosshead

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