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 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...
Noninvasive surgery is one of the fastest growing areas of medical science. Doctor...
ISO 14801 is an industry standard test method that regulatory agencies use to esta...
ISO 80369-7 specified the design and performance requirements of small-bore connec...
A hypodermic syringe is a small syringe used with a hollow hypodermic needle for i...
The ASTM F543 medical bone screw torsion test is a specification for assessing th...
ISO 7206-4 Fatigue Compression Tensile Bending Hip Implants
ISO 7206-4 specifies a...
Medical gloves are tested to ensure they have a high level of resistance to penetr...
Personal Protective Equipment (PPE)
Medical gloves are primarily used to protect h...
The Luer taper is a standardized system of small-scale fluid fittings for making l...
The seal strength of sterile medical packages containing medical devices is highly...
ISO 22675 lays out the requirements and test methods for ankle-foot devices and fo...
Hypodermic needles are most commonly used for injecting medication either intramus...
Seal Testing of Medical Device Packaging: Tyvek Lid Thermal-Sealed to Thermoform T...
ISO 6872 specifies the requirements and the corresponding test methods for dental ...
ISO 7886-1 specifies requirements (cleanliness, limits for acidity and alkalinity,...
Configuring test equipment for dentistry or dental product testing is a three step...
ISO 7864 specifies the following requirements for needles of nominal outside diame...
ASTM F383 describes a method for static bend and torsion testing of intramedullary...
ASTM and ISO have standard test methods for mechanical testing the four separate p...
Dental implant fatigue test equipment is used to test titanium implants that are a...
ISO 11193-1 specifies requirements for packaged sterile, or bulked non-sterile, ru...
ASTM F382 covers testing methods for mechanical properties of metallic bone plates...
There is an amazing variety of soft tissues in the human body and replacement tiss...
ASTM F2258 is intended to provide a means for comparison of the adhesive strengths...
Luer taper and lock test equipment are specially configured to meet ISO 80369 and ...
ISO 4049 specifies a three point flexural bend test requirements for dental polyme...
ISO 10328 specifies procedures for static and cyclic strength tests on lower-limb ...
ASTM F2267 specifies the materials and methods for the axial compressive subsidenc...
ASTM F384 covers specifications and test methods for angled devices used in the su...
ISO 10334 specifies the dimensions and mechanical properties along with test metho...
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 F2255 determines the means for comparison of the adhesive strengths of tissue...
ASTM F451 determines the self-curing resins used primarily for the fixation of int...
ISO 8537 specifies requirements and test methods for sterile syringes, with or wit...
ASTM F1839 covers rigid polyurethane foam blocks or sheets used for mechanical tes...
Constitutive modeling of biological and tissue based soft biomaterials is common i...
Personal Protective Equipment (PPE)
Puncture testing of protective clothing is an ...
Container seals guarantee a certain quality of the product inside. Weather the con...
ASTM D6319 determines the certain requirements for nitrile rubber gloves used in c...
The spine is a complex joint and so research on biomechanics and flexibility remai...
Dental wear testing with the orthogonal mastication stage is a mechanical simulati...
ASTM F1717 covers the materials and methods for the static and fatigue testing of ...
ASTM F 2458 (F-2458) pertains to tissue adhesives which are becoming more prevalen...
The flexible medical packaging industry relies on product sterilization. Without a...
The knee is one of the most highly stressed joints in the human body, supporting a...
A prefilled syringe is an individually packaged single-dose of a vaccine sealed by...
Introducing a new dental implant design to market is a daunting task with an impre...
Ampoules are packaging materials for storing pharmaceutical products until they ar...
ASTM F2028 determines how much a prosthetic glenoid component rocks or pivots foll...
ASTM F1264 provides specification of the design and mechanical properties associat...
ASTM F2193 provides a comprehensive reference for the components of systems used i...
Tensile testing of the introducer guide wire helps develop a lightweight and flexi...
Medical Luers are used in a wide variety of medical device and drug delivery appli...
Dental products are tested mechanically to prove their performance in various appl...
The ASTM D5250 standard details procedures for evaluating the requirements for pol...
ISO 11405 gives guidance on substrate selection, storage and handling as well as e...
ISO 9917 specifies requirements and test methods for dental cements that are inten...
ASTM F2345 covers the evaluation of the static and cyclic fatigue strength of cera...
ASTM F2346 specifies the materials and methods for the static and dynamic testing ...
ASTM F2706 is a standard test method for comparing designs of spinal implants for ...
The medical device industry requires extensive testing on packaging used to seal m...
ASTM F2118 describes test procedures for evaluating constant amplitude, uniaxial, ...
If you are bringing new femoral stem prostheses to market, you face many challenge...
ASTM F1691 covers the test procedure for determining the axial pull-out strength o...
ASTM F1781 determines the elastomeric flexible hinge finger total joint implants, ...
Soft tissue test equipment is specialized in several respects. Numerous factors su...
ISO 11193-2 specifies requirements for packaged sterile, or bulked non-sterile, po...
ASTM F2606 determines the flexural creep of plastics in the form of standard test ...
For a total knee prosthesis, FDA recommends you provide a report of fatigue testin...
EN ISO 4074 is a test standard for Natural Latex Condoms.
Give our test engineers...
ASTM F 2580 (F-2580) covers fatigue testing of metallic femoral hip prostheses use...
The linked FDA Guidance Document published in 2004 applies to plate and rod-based ...
Personal Protective Equipment (PPE)
Medical gown testing is an important step in d...
ASTM F1798 is the standard test method for evaluating the static and fatigue prope...
ISO 11070 specifies requirements for introducer needles, introducer catheters, she...
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...
Planar biaxial test systems assist with the characterization of natural biological...
Needle insertion force measurement is a critical and strategic parameter for devi...
ISO 14879 determines the endurance properties of knee tibial trays. Fatigue fractu...
ASTM F564 describes testing methods to determine the following mechanical properti...
ASTM F2502 covers the mechanical characterization of plates and screws for orthope...
Vascular catheter development is an increasingly emergent area of medical device i...
Bones within the human body undergo very complex loading during everyday activitie...
Drug delivery requires precise intradermal and subcutaneous injections of drugs t...
Tissue adhesives are used in applications such as bandages, surgical sealants, sec...
Personal Protective Equipment (PPE)
For many companies, COVID-19 has forced busine...
Testing the mechanical properties of biological soft tissues requires specialized ...
G71349 fixtures feature a manually adjustable grip fixture to pull on a variety of...
Tissue adhesives are used in bandages, wound closure and surgical sealants. Based ...
Like any medical device, spinal implants must be rigorously tested before human us...
Tissue engineered skin offers promise as an alternate wound healing treatment when...
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...
Tissue constructs in a microfabricated bioreactor
In tissue engineering, cell gro...
The linked FDA Guidance Document published in 2007 applies to intervertebral Body ...
Like any medical device, hip implants must be vigorously tested before human use. ...