SEM MicroscopyHigh magnification microscopy provides visual interpretation of the individual fibers that make up a fabric swatch. Low-vacuum backscatter allows for clear visualization of non-conductive materials such as polymers. | |
Material and Mechanical TestingOIC's broad array of mechanical testing equipment provides full capability for material properties characterization including tensile strength, elongation, and tear propagation. | |
Cleaning, Reprocessing, Sterilization TrialsA customized cleaning and/or sterilization protocol can be developed with input from the client to determine best-practices for reprocessing of re-usable PPE products. | |
Inline Ventilator FilterFilters for ventilator and respiratory systems are challenged with sub-micron salt particles to determine the percent efficiency of filtration. | |
Dry Bacterial PenetrationMedical gowns are placed in contact with a bacterial culture under dry conditions to determine the degree of penetration through the material. | |
Wet Bacterial PenetrationMedical gowns placed in contact with a bacterial culture under wet conditions to determine the degree of penetration through the material. | |
Exhalation Valve LeakageRespirators equipped with exhalation valves are leak tested to ensure a very low level of backflow during inhalation. | |
Strap TestingRespirator head or ear straps are challenged with a specified tension load to ensure no breakage occurs. | |
Synthetic Blood Penetration (Respirators – Suffix “F”)Medical masks are challenged to resist penetration by increasing velocities of 2mL of synthetic blood disbursed by an air pressure source, simulating arterial blood splatter. | |
Exhalation and Inhalation resistance (Levels 100Pa, 175Pa, 343Pa)Respirators are tested for resistance to exhalation air flow by measuring the differential pressure across the filter with airflow moving from inside to outside of the mask. | |
Particle Filtration EfficiencyNon-powered respirators are challenged with sub-micron salt (NaCl) particles at an airflow rate of 85 L/min to determine the percent efficiency of filtration. | |
Barrier Face CoveringNon-medical masks are challenged with sub-micron salt particles to determine the percent efficiency of filtration at the most challenging particle size. This test method differs from ASTM F2299 as it does not use polystyrene latex particles. | |
Synthetic Blood Penetration (Gowns)Medical gowns are challenged to resist penetration of synthetic blood disbursed at increasing velocities to simulate blood spatter. | |
Synthetic Blood Penetration (Masks)Medical masks are challenged to resist penetration by increasing velocities of 2mL of synthetic blood disbursed by an air pressure source, simulating arterial blood splatter. | |
Accelerated shelf-agingMedical packaging and devices are exposed to increased temperature for an extended period of time to simulate real-time shelf aging. | |
Bacterial Filtration Efficiency (BFE)Medical masks are challenged with aerosolized bacteria to determine the percent efficiency of filtration. Bacterial colonies are counted in a 6-stage cascade impactor after incubation. | |
Particulate Filtration Efficiency (PFE)Medical masks are challenged with sub-micron polystyrene latex particles to determine the percent efficiency of filtration at the most challenging particle size. | |
Breathing resistance (per ASTM F2100)Medical masks are tested for breathing resistance by measuring the differential pressure across the mask at an airflow rate of 8L/min. | |
Exhalation resistance (42 CFR Part 84.172)Respirators are tested for resistance to exhalation air flow by measuring the differential pressure across the filter with airflow moving from inside to outside of the mask. OIC utilizes the Dwyer 475-00-FM Digital Manometer for high-precision pressure measurement. | |
Inhalation resistance (42 CFR Part 84.172)Respirators are tested for resistance of inhalation air flow by measuring the differential pressure across the filter with airflow moving from outside to the inside of the mask. OIC utilizes the Dwyer 475-00-FM Digital Manometer for high-precision pressure measurement. | |
Particle Filtration Efficiency (42 CFR Part 84.174)Non-powered respirators are challenged with sub-micron salt (NaCl) particles at an airflow rate of 85 L/min to determine the percent efficiency of filtration. OIC utilizes the ATI 100x system to perform this test. | |
Flammability of TextilesMedical masks are elevated to a 45 degree angle, subjected to an ignition source and the burn time is recorded and classified into 3 levels. | |
Respirator Fit TestingRespirators are donned by personnel and the quality of fit to the person's face is assessed while performing several activities. A fit factor is reported for each activity and each person tested to determine pass/fail. Fit testing can also be performed on a bivariate panel of up to 25 volunteers to determine to ensure broad applicability of the respirator. | |
Test Method for Metallic Bone PlatesDescribes single cycle bending test and fatigue test methods of metallic bone plates. Depending on the application of the bone plate, certain tests may be applied to evaluate different strength characteristics required for in vivo efficacy. | |
Test Method for Metallic Angled Devices used in Internal Fixation of Skeletal SystemDescribes a test method specifying mechanical tests of metallic angled devices important to in vivo performance, such as, single cycle compression bending and bending fatigue methods. Depending on the application of the angled device, certain tests may be applied to evaluate different strength characteristics required for in vivo efficacy. | |
Bone Screw Testing for Torsional PropertiesMedical bone screws are tested for torsional yield strength, maximum torque, and breaking angle. The bone screw is placed in a holding device such as a split collet. The associated driver instrumentation is used to apply a torque at a constant rate of rotation until failure. Torque and rotation data is collected. | |
Bone Screw Testing for Driving TorqueMedical bone screws are tested for the torque required to drive the screw into a standardized bone-analogue test block. The bone screw is inserted into the test block using appropriate driver instrumentation at a constant rate of rotation until reaching a specified depth. Torque and rotation data is collected. Testing the removal torque is optional. | |
Bone Screw Testing for Axial Pullout LoadMedical bone screws are tested to determine the load required to pull the screw out from a standardized bone-analogue. A fixture is used to apply an axial tensile load on the screw at a constant rate of displacement until screw pullout or failure. | |
Bone Screw Testing for Self-Tapping PerformanceSelf-tapping bone screws are tested to determine the load required to engage the self-tapping feature of the bone screw. The self-tapping screw is inserted into a standardized bone-analogue test block at a constant rate of rotation and steady rate of axial compression until the self-tapping feature engages with the test block. | |
Specifications of Bone ScrewsDescribes the classifications of different varieties of medical bone screws based on major and minor dimensions, thread forms, thread pitch, and driver connections. | |
Specification and Test Method for Metallic Bone StaplesConstant amplitude bending fatigue, pull-out fixation strength, soft tissue fixation strength, and elastic static bending are the four available test methods for evaluating metallic bone staples used in the internal fixation of the musculoskeletal system. Specifications on the characterization and mechanical function of metallic bone staples are also covered. | |
Test Methods for External Skeletal Fixation DevicesIdentifies several test methods for testing both individual components, such as external fixator connectors and skeletal fixator joints, subassemblies such as ring elements, and full external fixation devices. | |
Test Methods for Intramedullary Fixation DevicesDescribes four standard test methods: static four-point bend, static torsion, bending fatigue test, bending fatigue test for locking screws. Not all tests outlined in this standard are applicable/required, but based on the intent of the device, certain tests may be applied to evaluate different strength characteristics required for in vivo efficacy. | |
Fretting Corrosion of Plates and ScrewsDescribes the method to determine material loss due to cyclic fretting corrosion between screw head and plate hole countersink junctions of devices used for osteosynthesis. Mass loss of the plates and screws and chemical analysis of the solutions are evaluated to determine the amount of fretting corrosion that occurred. | |
Test Methods for Absorbable Plates and ScrewsDescribes the mechanical characterization and test methods for absorbable plates and screws made from hydrolytically degradable polymer resins or resin composites for orthopaedic internal fixation. Test methods aim to assess the performance-related mechanical properties when applied to conditions of pretreatment, temperature, humidity, and testing machine speed. The standard may not be applicable to all forms of absorbable plates and screws. | |
Tensile Properties of PlasticsDescribes a method for testing tensile properties of standard dumbbell-shaped specimens under defined conditions for pre-treatment, temperature, humidity and testing machine speed. Five samples of isotropic materials are tested or ten samples of anisotropic materials (five normal to, and five parallel with, the principle axis of anisotropy). | |
Wear Testing of Polymeric MaterialsDescribes methodology for wear testing of various materials using OIC’s AMTI OrthoPOD. Pin rotation, disc rotation, and dynamic pin loading are all independently controlled. Track patterns and loads can be customized and are fully programmable, ensuring an accurate representation of the cross-shear motion experienced by prostheses in vivo. Testing can be performed dry or in various lubricants. POD testing can be used for screening candidate biomaterial couples and for optimizing design performance prior to cost-intensive joint simulator wear tests. | |
Shear Strength of CoatingsDescribes methodology for assessing adhesive and cohesive strength of coatings determined via shear tests. Bending fatigue tests can also be performed to provide further information, such a cracking resistance, adhesion, and the relationship between the coating and substrate. | |
Tensile Strength of CoatingsEvaluates the adhesion and cohesion of coatings to specific materials. Testing is performed by applying tensional loads to both coated and uncoated metal substrates. The internal cohesion of the coatings normal to the surface of samples may also be determined during this test. | |
Accelerated Aging of UHMWPE (Ultra-high-molecular-weight polyethylene)Accelerated aging evaluates the material’s chemical and mechanical stability in an extended shelf-aged condition. Components are aged in a temperature and pressure regulated oxygen chamber to verify experimental conditions are within tolerance during aging. Two individually regulated pressure tanks are available for use at OIC. Accelerated aging may be applied prior to wear testing, pin-on-disc testing, or mechanical testing. | |
Bone Cement Fatigue TestSimilar to ISO 16402, this test method describes a variety of tests for evaluating the static and fatigue strength of acrylic resin-based bone cement. Constant amplitude, uniaxial, and tension-compression tests are performed to generate an S-N curve using dumbbell-shaped samples. | |
Strength Testing of Tissue AdhesivesThree standard test methods for measuring the adhesive performance of tissue adhesives intended for surgical application with soft tissue are described. Including, strength properties of tissue adhesives in T-peel by tension loading (ASTM F2256) and in tension (F2258), and wound closure strength of tissue adhesives and sealants (F2458). | |
Standard Guide for Characterizing Properties of Metal Powders Used for Additive Manufacturing ProcessesParticle characterization on metal particles such as additive manufacturing powders using methodology similar to ASTM F1877. Metal powder morphology and particle size are reported using custom automated particle characterization software. | |
Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed FusionThis standard provides a guide for validating cleaning processes performed on additive manufactured parts. Techniques we offer include extraction of residual particles, morphological characterization, composition analysis and total particulate quantity estimation. Samples are processed through ultra-sonication in an appropriate extraction fluid to loosen and remove any manufacturing particulate. This extraction fluid is then filtered to isolate the particles for further analysis. Using custom, automated particle characterization, particle parameters (area, aspect ratio, form factor, roundness, length, perimeter, ferret average and equivalent circular diameter) are measured. Using SEM-EDS, a compositional analysis may be performed on a selection of particles to verify composition. Quantity of total particulate can also be estimated by performing counts on the filtered particles. | |
Characterization of Particles and Retrieval and Analysis of Test FluidsSimilar to ISO 17853, in these standards, samples of test fluid are digested and filtered for polyethylene, ceramic or metal particles resulting from wear, fretting, or corrosion. Filtered particles are coated and carefully examined using a scanning electron microscope (SEM), where high definition images are taken for custom automated particle characterization. Particle characterization may include measurements of area, aspect ratio, form factor, roundness, length, perimeter, ferret average, and equivalent circular diameter. Energy-dispersive x-ray spectroscopy (EDS) can also be performed for verification of elemental composition of particles. | |
Wear of Implant Materials – Polymer and Metal Wear ParticlesSimilar to ASTM F1877 and ASTM F561, in this standard, samples of test fluid are digested and filtered for polyethylene, ceramic or metal particles resulting from wear, fretting, or corrosion. Filtered particles are coated and carefully examined using a scanning electron microscope (SEM), where high definition images are taken for custom automated particle characterization. Particle characterization may include measurements of area, aspect ratio, form factor, roundness, length, perimeter, ferret average, and equivalent circular diameter. Energy-dispersive x-ray spectroscopy (EDS) can also be performed for verification of elemental composition of particles. | |
Bone Cement Fatigue TestSimilar to ASTM F2118, this test method describes a variety of tests for evaluating the static and fatigue strength of acrylic resin-based bone cement. Constant amplitude, uniaxial, and tension-compression tests are performed to generate an S-N curve using dumbbell-shaped samples. | |
Standard Specification for Shoulder ImplantsProvides general specifications for total shoulder replacement (TSR) and defines minimum surface finish specifications of the articulating surfaces. | |
Static Test of Glenoid Locking MechanismDescribes a method for testing the static shear disassembly force of glenoid TSR components. A constant displacement rate is applied to five samples in the inferior-superior position, and five samples in the anterior-posterior direction until disassembly occurs. | |
Evaluation of Glenoid LooseningTest method for evaluating the displacement of a glenoid TSR component after cyclic loading applied to the opposing rims of the glenoid component. Test is applicable to both standard and reverse shoulder implants and also evaluates the locking mechanism of modular glenoid or humeral components. | |
Total Knee Replacement Constraint TestingThis test method measures the constraint on total knee replacements under specific loading conditions. These include constraint determination in: antero-posterior draw, medio-lateral shear, rotary laxity, valgus-varus rotation, and distraction. Samples are loaded in the specified directions and displacement is measured. | |
Standard Patellar Component SpecificationsThis standard describes the materials, geometries, and performance requirements for patellar resurfacing devices. The standard lists relevant failure modes that should be tested and considered when determining the safety and efficacy of the knee device. The OIC can perform a series of static and dynamic testing for shear and stress analysis, and to evaluate contact area and pressure distributions. Additionally, the durability of the patellofemoral device can be tested according to ISO 14243-5. | |
Tibial Tray Fatigue TestingSimilar to ISO 14879, this standard describes cyclic fatigue testing for tibial trays. To simulate worst-case loading conditions where the medial side becomes unsupported by bone, the tibial tray is fixed unilaterally down the center line and the medial side is left unsupported. Cyclic loading is applied to the medial side for 10 million cycles or until failure. | |
Modular Knee Implant Testing GuideThis guide suggests areas of modular hip and knee implants for design evaluation and testing. The modular connections may be tested in static to measure forces during assembly (axial and torsional) and disassembly (axial, shear, bending, and torsional). Modular connections shall also be tested in cyclic fatigue to assess how the design withstands and is affected by cyclic loading while considering other factors such as sterilization, corrosion, and fretting. Our team can help determine and perform the applicable test methods on the modular connections of your total knee system. | |
Standard Specifications for Knee DevicesThis standard describes the generic types of knee devices including total knee replacements (TKR) and unicondylar knee replacements (UKR) for both fixed and mobile bearing varieties, and for primary and revision surgeries. The OIC can perform the various test methods referenced in this standard to assess knee device performance, such as: ASTM F1800, ASTM F2777, ASTM F1223, ASTM F2724, ASTM F1814, ASTM F2722, ASTM F2723, and ISO 14243-1/-3. The standard also includes contact area and contact pressure distribution testing to examine the area and magnitude of stresses applied between the femoral component and tibial insert of a total knee replacement at various flexion angles through mapping on pressure films. | |
Tibial Baseplate/Insert Resistance to Dynamic DisassociationTest method for evaluating the potential of mobile TKR bearing disassociation under repeated forces at high flexion. Five samples are tested for a total of 220,000 cycles, equivalent to 30 extreme motions per day for 20 years, or until failure of the retention mechanism. | |
Test Method for Evaluating Mobile Bearing Knee DislocationTest method to determine the dislocation resistance (constraint) of mobile-bearing TKR designs with regards to femoral component disassociation and behavior of the knee insert. Testing is performed at 4 different flexion angles and the mode of failure (either spin-out or spit-out) is reported for each angle. | |
Tibial Insert Endurance and Performance Under High FlexionTest method describing fatigue testing of tibial inserts at high-flexion angles of the femoral component. Five TKR samples are tested for 220,000 cycles or until failure. Pre- and post-test analysis of material deformation and damage are performed using a Coordinate Measuring Machine (CMM). Inserts shall be artificially aged according to ASTM F2003. | |
Fatigue Testing of Unicondylar Tibial Tray ComponentsTest method describing fatigue testing of unicondylar tibial tray components supported at only anterior and posterior edges by thin rollers. Cyclic loading is applied to the midline of the tibial tray using a spherical indenter and polymer spacer for 10 million cycles or until device failure. | |
Total Knee Replacement Loading ProfilesProvides a guide for waveforms and loading profiles that approximate activities of daily living to be applied in a TKR joint simulator. Profiles are described for: straight walking gait, stair ascent, stair descent, sit to stand to sit, pivot turn, and crossover turn. These profiles can be used in OIC’s AMTI Knee Simulator. | |
Fatigue Testing of TKR Femoral Components Under Closing ConditionsFatigue testing applied to the medial condyle of a femoral TKR component in an inverted position to simulate single condyle loading at 90° knee flexion. The femoral component is potted to a defined depth which leaves the regions of highest stress exposed to the test. Cyclic loading is applied until run-out is achieved or device failure. This standard is still in development. | |
Endurance Properties of Tibial TraysSimilar to ASTM 1800, this standard describes cyclic fatigue testing of tibial trays for 10 million cycles, or until failure. The tibial tray is mounted at the center line, with the medial side left unsupported, and the load applied on the unsupported region. | |
ISO 14243-1 Load-Control Knee Wear Test and ISO 14243-3 Displacement-Control Knee Wear TestJoint simulator wear testing evaluates the wear performance of TKR prosthesis design and bearing materials under physiological conditions for device optimization and to meet regulatory requirements. Up to 6 TKR implants can be assessed on OIC’s AMTI Knee Simulator. Samples complete 5 million cycles of testing under force-controlled (ISO 14243-1) or displacement-controlled (ISO 14243-3) kinematics. Wear is measured through gravimetric analysis following ISO 14243-2. Typical additions for this test are accelerated aging of polyethylene components (ASTM F2003), wear particle characterization (ASTM F1877), surface roughness characterization, and CMM measurement to evaluate dimensional changes resulting from the test. Adverse condition testing is also commonly performed to evaluate TKR device performance under non-ideal conditions such as increased load, high range of motion, and roughened or pre-damaged articular surfaces. | |
ISO 14243-5 Durability Performance of the Patellofemoral JointDurability of the patellar and femoral components are tested through joint wear simulation that follows a squatting sub-cycle and two low flexion sub-cycles. Loading and displacement waveforms are applied for 50,000 cycles or until patellofemoral joint failure occurs in the form of delamination, cracking or other mechanical failure. It is recommended to test the largest femur with the smallest patella to achieve the highest contact stress and subsurface shear for worst-case conditions. | |
Specification for Surface Finish of Knee ReplacementsDefines the measurement procedure for assessing surface roughness at multiple locations on a knee replacement component. This standard applies to partial and total knee replacements made of metallic, ceramic, and polymeric materials. | |
Anatomical Total Shoulder Prostheses Wear TestWear performance of anatomical total shoulder replacements can be tested on OIC's AMTI hip simulator. An ISO working draft remains under development, awaiting an official release. | |
Reverse Total Shoulder Prostheses Wear TestWear performance of reverse total shoulder replacements is tested on OIC's AMTI hip simulator. Force and displacement parameters suitable for reverse total shoulder prostheses are applied to completion of 2.5 million cycles or until mechanical failure of the articulating surfaces is observed. An ISO working draft remains under development, awaiting an official release. | |
Resistance to Static Load of Ceramic Humeral Heads and GlenospheresA humeral head is assembled onto the humeral stem taper using the specified assembly force. Load is applied to the humeral head at a user-specified angle to the humeral stem taper until the humeral head fractures or the maximum specified load is reached. | |
Resistance to Torque Off Head Fixation of Modular Humeral ProsthesesA humeral head is assembled onto the humeral stem taper using the specified assembly force. Torsion is applied to the humeral head while holding the stem rigid until movement of the head occurs. The peak torsion is recorded as the loosening torque. | |
Water Resistance: Impact Penetration TestA flow of water is dropped onto a gown material sample from a specified height and blotting paper is used to determine if water has penetrated the sample. | |
Test Method for Water Resistance: Hydrostatic PressurePressurized water pushing against a gown material sample for a specified period of time to determine if and when penetration occurs. |
Device Testing
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