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