| Orthopedic devices implanted in
the body must undergo static and fatigue tests that mimic ten
years of product life to be considered acceptable. Spinal implants
and constructs are tested according to various ASTM and ISO standards
and typically require static tension, compression and torsion
testing, and fatigue tests. The typical medical device developer
needs a versatile proven test system that can do both types of
tests and one that can expand to combined axial torsional loading.
800LE test systems are servo-all-electric systems that are rated
to produce the high loads needed for static tests and the high
(to 20 Hz) speeds needed for fatigue testing of materials, devices
and components. They require single phase 110V or 220V electric
power. No special utilities such as pneumatic air, hydraulics
or water are needed. TestResources configures each system to match
required load and speed requirements.
Static and Fatigue Test Systems - Single Channel
- Axial or Torsional - Static & Fatigue - Expands to Multistation
or Multiaxis as needed. Fatigue Testers are required when first
testing devices, because developers must generate the required
5 to 10 million compression-compression cycles at speeds to 20
Hz. We also offer servohydraulic load frames - including axial
torsional test systems
Servo-all-electric Static and Fatigue Test Systems
for Spinal Implants -- Download
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Torsion Fatigue Test Systems - More
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Saline baths
More Info - Biobath Product Line
Biaxial tests on spine fixators, spinal constructs,
spine segments and other components require combined axial and
torsional tests. Setups can apply static or dynamic forces while
acquiring test data. Load bearing activities can be simulated
on subsections of the spine such as functional spine units or
lumbar and cervical sections. All spinal products require extensive
mechanical tests due to the consequences of potential catastrophic
failure. Simple static testing is required to evaluate the compressive,
tensile and torsional loading required to fracture a spinal device.
Fatigue life tests are critical because fatigue failure is more
common than catastrophic failure. Loading test samples with load-controlled
sinusoidal waveforms is most common, and tests last in excess
of five million (10 MM) cycles.
Standard
test methods are evolving within the industry for spinal
products. ASTM F1717 relies on ultra high molecular weight polyethylene
(UHMWPE) blocks rather than vertebrae to eliminate variances that
bone properties and geometry introduce.
TestResources testers are configured to match specific customer
requirements and typically perform static and fatigue tensile,
compression and torsion tests. With the capabilities of our 2350
Servocontroller, lumbar spine non-fusion spinal preclinical spine-
astm spinal- biomechanical artificial fda guidance tester torsional
loads test disc replacement testing thoracic devices iso tests
flexible collagen, orthopedic, bone In Vivo bone formation scaffold
into the paraspinal muscle Lumbar posterolateral spine fusion
chondrocytes, osteocytes, and granulation tissue prosthetic spinal
disc nucleus degenerative disc disease of the lumbar spine prosthetic
device loading implant environment durability fatigue stress loading
compression/shear fatigue cycling hydrogel load cycling hydrogel
nucleus replacement compressive stiffness Materials ering
Chemical ering Orthopaedic Surgery mechanical behavior mechanical
test rate hz displacement strain Load bend testing-plate; bend
testing-rod; bend testing-screw; bend testing-surgical implants;
fatigue test-plate; fatigue test-rod; fatigue test-screw; fatigue
test-surgical implants; orthopedic medical device-plate; orthopedic
medical device-rod; orthopedic medical device-screw; orthopedic
spinal devices; performance; spinal arthrodesis; surgical devices;
terminologydevices and biological tissues. The mechanical tests
or simulations may involve joint or organ kinematics and load
deformation characteristics of soft tissues. The biomechanics
involved in the motion of the joints are complex and require an
ability to simulate the contraction and antagonistic relaxation
of the involved muscle groupsmechanical testing; biomechanics;
material properties; structural behavior; tension; compression;
bending ; test methods-surgical implants; bone screw; dimensions;
insertion; performance requirements; pullout; static; test methods;
torsion; ASTM F543 bend testing-surgical implants; fatigue test;
bone plate; orthopedic medical devices-bone plates; surgical devices;
test methods-surgical implants ASTM F382 F1839 bone; cellular
plastic; medical devices; polyurethane; rigid foam ASTM F1798
ASTM F2193 Surgical Fixation of the SPINAL Skeletal System ASTM
F1717 SPINAL Implant Constructs in a Vertebrectomy Model ASTM
F1556 SPINAL Immobilization and Extrication (SPINE) Device Characteristics
ASTM F1798 Static Fatigue Properties of Interconnection Mechanisms
and Subassemblies Used in SPINAL Arthrodesis Implants ASTM F1559
Cervical Spine Immobilization Collar(s) (CSIC) ASTM F1558 Adjunct
Cervical Spine Immobilization Devices (ACSID) ASTM F1557 Full
Body SPINAL Immobilization Devices (FBSID) Characteristics ASTM
F2031 Arrow Shaft Static Spine (Stiffness) ASTM F2346 Static and
Dynamic Characterization of SPINAL Artificial Discs ASTM F2267
Load Induced Subsidence of an Intervertebral Body Fusion Device
Under Static Axial Compression ASTM F2077 Intervertebral Body
Fusion Devices ASTM F1582 SPINAL Implants Standard Guide for Evaluating
the Static and Fatigue Properties of Interconnection Mechanisms
and Subassemblies Used in Spinal Arthrodesis Implants uniaxial
static and fatigue strength, and resistance to loosening of the
component interconnection mechanisms of spinal arthrodesis implants.
These test methods cover the materials and methods for the static
and fatigue testing of spinal implant assemblies in a vertebrectomy
model. The test materials for most combinations of spinal implant
components can be specific depending on the intended spinal location
and intended method of application to the spine. corpectomy model;
fatigue test methods; spinal impant assembly; spinal implant construct;
static test methods F1582 Terminology Relating to Spinal Implants
F2077 Test Methods For Intervertebral Body Fusion Devices Displacement
curve specimens, in axial compression biomechanics Resorbable
Bone Graft Substitute Spinal Fusion autograft bone allograft bone
polymer Spinal Implant System fusion implants ASTM F1717 systems
axial-torsional torsion fusion implant 6 dof products axial torsion
testeur dynamic testers posterior load standards saline bath functional
corrosion ASTM F1798 machine stability hook stabilization fusion
actuator screw fatigue rotation disc integrity pedicle axial-torsion
rehabilitation combined mode biomechanical requirements disk constructs
prostheses cadaveric durability static failure modes anchoring
gauge length Spinal Device Components Functional Spinal Devices
Artificial Discs high accuracy and flexible control of multiple
channels of actuators are now possible. Software records load-displacement
curves and performs calculations required by the standard.
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