Mechanical testing continues to play a strategic role in the constant effort to improve performance and compatibility of new biomaterials and improved medical devices. Laboratory test machines are commonly applied to perform biomedical research and for medical device development and product validation.

Modular static and all electric fatigue test equipment produced by TestResources has enabled improvements in implant design in vitro without putting patients at risk. With our equipment, biomedical test engineers can critically evaluate ever increasingly complex designs in a controlled and repeatable manner. Modularity ensures that our test machines can be configured to meet both immediate and future needs.

TestResources innovative electrodynamic test machines are uniquely suited for biomedical research applications because of versatility:

  • They are very stable in slower speed monotonic and yet can perform fatigue tests as needed for regulatory compliance. They are used in simple tensile testing of biological tissues as well as complex cyclical biaxial fatigue applications with little or no tuning adjustments;
  • They are modular. For example, it is easy to add a torsional channel to a customers' existing test machine which has an axial channel – thus creating a bi-axial axial-torsional test machine;
  • They can be equipped with a wide variety of different specimen fixtures. TestResources recognizes the importance of serving our customers and so we build fixtures to application requirements.

Bringing a new medical device product to market often involves 3 phases of mechanical testing:

  • Initial research and proof-of-concept testing;
  • Design verification testing to confirm the product meets its engineering specifications; and
  • Formal Design Validation Testing to be included for the formal 510k submission to the FDA.

Medical device product development engineers face many challenges in successful 510k submissions. Rigorous laboratory testing is often required to confirm substantial equivalency to the predicate device. Both the new product and the predicate product must be tested. Both tests require several test specimens to ensure high statistical confidence levels. Furthermore, the product and its packaging must be validated and tested as such. If submitted test results are not rigorous, the FDA will often request additional testing. If this testing is not planned and initiated early enough, it can significantly impede a product development schedule.

TestResources has been active in supplying static and dynamic fatigue test systems to the biomedical research and production industry since 1998. We have specialized in serving the biomedical community since our inception. Take a look at our select list of medical customers from around the world. TestResources offers testing solutions that are engineered to application requirements, and so are a good and natural fit to the needs of the biomedical industry.

What Are the Common Biomedical Testing Applications?

The ASTM D412 tension test for rubber and elastomers is a standard test that was d...
The ASTM F88 standard describes the test procedure for measuring the maximum seal ...
The Luer taper is a standardized system of small-scale fluid fittings for making l...
The ASTM F543 medical bone screw torsion test is a specification for assessing th...
Noninvasive surgery is one of the fastest growing areas of medical science. Doctor...
ISO 80369-7 specified the design and performance requirements of small-bore connec...
Medical gloves are tested to ensure they have a high level of resistance to penetr...
ISO 7864 specifies the following requirements for needles of nominal outside diame...
ISO 7886-1 specifies requirements (cleanliness, limits for acidity and alkalinity,...
ISO 7206-4 Fatigue Compression Tensile Bending Hip Implants ISO 7206-4 specifies a...
ISO 8537 specifies requirements and test methods for sterile syringes, with or wit...
ISO 6872 specifies the requirements and the corresponding test methods for dental ...
A hypodermic syringe is a small syringe used with a hollow hypodermic needle for i...
The seal strength of sterile medical packages containing medical devices is highly...
ISO 11193-1 specifies requirements for packaged sterile, or bulked non-sterile, ru...
The Luer taper is a standardized system of small-scale fluid fittings for making l...
ISO 14801 is an industry standard test method that regulatory agencies use to esta...
Personal Protective Equipment (PPE) Medical gloves are primarily used to protect h...
ASTM F2258 is intended to provide a means for comparison of the adhesive strengths...
ASTM F382 covers testing methods for mechanical properties of metallic bone plates...
ISO 22675 lays out the requirements and test methods for ankle-foot devices and fo...
ASTM F383 describes a method for static bend and torsion testing of intramedullary...
Spinal implants are designed to promote arthrodesis at a given spinal motion segme...
Hip replacements fail by loosening of the mechanical components such as the acetab...
ASTM F2267 specifies the materials and methods for the axial compressive subsidenc...
ISO 6475 provides a standard test method for determining the breaking torque and r...
ISO 10334 specifies the dimensions and mechanical properties along with test metho...
ASTM and ISO have standard test methods for mechanical testing the four separate p...
ISO 4049 specifies a three point flexural bend test requirements for dental polyme...
ASTM D6319 determines the certain requirements for nitrile rubber gloves used in c...
ASTM F2255 determines the means for comparison of the adhesive strengths of tissue...
ASTM F 2458 pertains to tissue adhesives which are becoming more prevalent in surg...
Configuring test equipment for dentistry or dental product testing is a three step...
Tensile testing of the introducer guide wire helps develop a lightweight and flexi...
There is an amazing variety of soft tissues in the human body and replacement tiss...
ISO 10328 specifies procedures for static and cyclic strength tests on lower-limb ...
Dental wear testing with the orthogonal mastication stage is a mechanical simulati...
Hypodermic needles are most commonly used for injecting medication either intramus...
ASTM F1717 covers the materials and methods for the static and fatigue testing of ...
ASTM F1839 covers rigid polyurethane foam blocks or sheets used for mechanical tes...
ISO 11405 gives guidance on substrate selection, storage and handling as well as e...
Package strength tests measure the force required to separate two components of a ...
Seal Testing of Medical Device Packaging: Tyvek Lid Thermal-Sealed to Thermoform T...
Dental implant fatigue test equipment is used to test titanium implants that are a...
ASTM F384 covers specifications and test methods for angled devices used in the su...
ASTM F451 determines the self-curing resins used primarily for the fixation of int...
Luer taper and lock test equipment are specially configured to meet ISO 80369 and ...
ASTM F2606 determines the flexural creep of plastics in the form of standard test ...
Planar biaxial test systems assist with the characterization of natural biological...
Bone screws are a widely used in orthopaedic surgery for fracture fixation. Many t...
The spine is a complex joint and so research on biomechanics and flexibility remai...
ASTM D5250 details procedures for evaluating the requirements for poly(vinyl chlor...
ASTM F1781 determines the elastomeric flexible hinge finger total joint implants, ...
ASTM F2118 describes test procedures for evaluating constant amplitude, uniaxial, ...
Introducing a new dental implant design to market is a daunting task with an impre...
The linked FDA Guidance Document published in 2004 applies to plate and rod-based ...
ASTM F2193 provides a comprehensive reference for the components of systems used i...
ASTM F 2580 covers fatigue testing of metallic femoral hip prostheses used in hip ...
ISO 13356 specifies the characteristics of, and corresponding test methods for, a ...
EN ISO 4074 is a test standard for Natural Latex Condoms.  Give our test engineers...
Constitutive modeling of biological and tissue based soft biomaterials is common i...
Ampoules are packaging materials for storing pharmaceutical products until they ar...
ASTM F1264 provides specification of the design and mechanical properties associat...
ISO 11070 specifies requirements for introducer needles, introducer catheters, she...
Personal Protective Equipment (PPE) For many companies, COVID-19 has forced busine...
A prefilled syringe is an individually packaged single-dose of a vaccine sealed by...
ASTM F2028 determines how much a prosthetic glenoid component rocks or pivots foll...
ASTM F2502 covers the mechanical characterization of plates and screws for orthope...
Container seals guarantee a certain quality of the product inside. Weather the con...
ISO 9917 specifies requirements and test methods for dental cements that are inten...
ASTM F2346 specifies the materials and methods for the static and dynamic testing ...
Bone screws are a widely used in orthopaedic surgery for fracture fixation. Many t...
ISO 11193-2 specifies requirements for packaged sterile, or bulked non-sterile, po...
ISO 14879 determines the endurance properties of knee tibial trays. Fatigue fractu...
ASTM F1691 covers the test procedure for determining the axial pull-out strength o...
ASTM F1798 is the standard test method for evaluating the static and fatigue prope...
ASTM F2345 covers the evaluation of the static and cyclic fatigue strength of cera...
If you are bringing new femoral stem prostheses to market, you face many challenge...
Personal Protective Equipment (PPE) Medical gown testing is an important step in d...
ASTM F2582 is a standard test method for determining mechanical properties of the ...
ISO 20795-1 Denture Base Polymers ISO 20795-1 classifies denture base polymers and...
Medical Luers are used in a wide variety of medical device and drug delivery appli...
Testing pen injectors, insulin pens and other auto-injectors is an important step ...
Bones within the human body undergo very complex loading during everyday activitie...
ASTM F2706 is a standard test method for comparing designs of spinal implants for ...
ASTM F564 describes testing methods to determine the following mechanical properti...
Hip implants must be vigorously tested before human use. Hip implants have four se...
Bones within the human body undergo very complex loading during everyday activitie...
Degenerative disc disease is a debilitating chronic condition with a US economic c...
The linked FDA Guidance Document published in 2007 applies to intervertebral Body ...
Drug delivery requires precise intradermal and subcutaneous injections of drugs t...
Needle insertion force measurement is a critical and strategic parameter for devi...
Like any medical device, hip implants must be vigorously tested before human use. ...
The medical device industry requires extensive testing on packaging used to seal m...
Testing the mechanical properties of biological soft tissues requires specialized ...
Soft tissue test equipment is specialized in several respects. Numerous factors su...
Tissue constructs in a microfabricated bioreactor In tissue engineering, cell gro...
Like all joints in the human body, the hip experiences complicated loading profile...
Like any medical device, spinal implants must be rigorously tested before human us...
The flexible medical packaging industry relies on product sterilization. Without a...