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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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, 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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