ASTM F543 Metallic Medical Bone Screws Test Driving Torque, Pullout Load Self-Tapping

Information on the most widely used ASTM standards within the materials testing industry

Descriptions of the most prominent lSO standards within the materials testing industry

Standards including EN, DIN, JlS, and more

Mechanical testing of polymer materials in the automotive industry is directly related to the safety of components and the reliability of the entire vehicle. UnitedTest can cover mechanical performance testing for automotive interior and exterior parts, as well as functional components, adapting to automaker standards and providing comprehensive testing solutions including tensile, impact, and fatigue tests.

Mechanical testing in the battery industry determines the tensile and puncture resistance of core components such as separators and electrodes, directly affecting battery safety and cycle life. UnitedTest can cover full-dimensional mechanical testing of battery materials, compatible with national and international standards, and provide customized testing solutions.

Mechanical testing in the consumer goods industry determines product durability and safety, such as impact resistance for toys and fatigue resistance for home appliances, making it core to compliance and quality. UnitedTest can cover mechanical tests for all categories of consumer goods, including tensile, impact, and hardness tests, compatible with national and international standards, and offers customized testing solutions.

In the field of medical and biomedical sciences, mechanical testing determines the safety and compatibility of implanted devices and biomaterials, making it a core part of regulatory approval. UnitedTest can cover a full range of tests including tensile, fatigue, and wear tests, compatible with national and international standards, and provides customized biomechanical testing solutions.

Material strength is a course that most engineering fields are required to study in university education. This interesting course is very practical and makes use of testing equipment in the materials laboratory.

Mechanical testing of industrial products and components is essential to ensure their load-bearing, fatigue resistance, and impact resistance, directly preventing production accidents and ensuring stable operation of equipment. UnitedTest can cover a full range of tests including tensile, hardness, and fatigue, complying with national and international standards, and provides customized industrial mechanical testing solutions.

Mechanical testing in the plastic pipe industry determines ring stiffness, impact resistance, and tensile performance, directly preventing pipe bursts and deformation risks. UnitedTest can cover full-dimensional mechanical testing of pipes, complies with ISO,ASTM,EN et.c, international standards, and provides customized testing solutions.

In the construction engineering and building materials industry, mechanical testing determines the compressive and tensile properties of materials such as concrete and steel, which is core to ensuring the safety and durability of buildings. UnitedTest can cover the full range of building material mechanical tests, complies with ISO, ASTM international standards, and provides customized testing solutions for compressive, tensile, and other properties.

Mechanical testing in the food and beverage industry involves the compressive and tensile performance of packaging and the safety of food texture, directly ensuring storage, transportation safety, and the eating experience. UnitedTest can cover all-dimensional mechanical testing for packaging and food texture, comply with national and international standards, and provide customized testing solutions.

Mechanical testing in the packaging industry determines the packaging's resistance to compression, impact, and tension, directly ensuring the safety of contents during storage and transportation. UnitedTest can cover comprehensive mechanical testing for packaging, complying with ISO, ASTM Standards, and provides customized testing solutions for compression, drop, tear, and more.

Mechanical testing in the transportation industry concerns the load-bearing and fatigue resistance performance of core components such as vehicles, tracks, and containers, directly ensuring transport safety and equipment durability. UnitedTest can cover mechanical testing for all types of transportation materials, complying with national and international standards, and provides customized testing solutions including tensile, fatigue, and impact tests.

Metallurgical testing examines the properties of metallic materials to determine if a particular metal is appropriate for its intended use.

Testing of polymer materials covers mechanical, thermal, and chemical properties, verifying strength, heat resistance, composition, and ensuring product quality and compliance.

UnitedTest offer world-class testing solution in testing for polymeric materials, including elastomers, thermoplastics, composites, coatings, and structural adhesives in a variety of industries.

Testing of rubber and elastomers is used to assess the various properties and performance of materials under different conditions. This is crucial for ensuring the safety, functionality, and quality of rubber and elastomer products used in industries such as automotive, construction, consumer goods, and aerospace.

Conduct adhesive testing using various testing methods to determine their performance and characteristics in applications across multiple industries such as aerospace, automotive, construction, packaging, industrial, medical, and energy, thereby supporting application development and quality assurance.

UnitedTest supply machine and testing solution for tension, compression, fracture toughness, direct shear, triaxial and ultrasonic velocity are common concrete and rock testing applications.

UnitedTest has helped a number of companies involved in the wood, paper, cardboard, and corrugated industry with their testing needs. Our materials testing systems are capable of testing raw materials, components, and finished products.

UnitedTest testing system is trusted by leading medical device manufacturers, universities, and medical research laboratories worldwide. Whether testing tissues or bioresorbable materials, stents, or sutures, UnitedTest offers a variety of single-actuator and dual-actuator systems to meet your biomedical testing needs.

Mechanical testing in the textile fabric industry determines core properties such as fabric tensile strength, tear resistance, and wear resistance, directly affecting product durability and safety. UnitedTest can cover comprehensive mechanical tests for textiles, complying with national standards / ISO standards, and provides customized testing solutions including tensile, tear, and puncture tests.

The mechanical testing of industrial components directly determines the load-bearing, fatigue resistance, and wear resistance of the parts, helping to avoid equipment failure risks. UnitedTest can cover a full range of tests including tensile, hardness, and fatigue, is compatible with ISO/ASTM/GB standards, and provides customized mechanical testing solutions for industrial components.

Mechanical testing in the glass-ceramics industry determines core properties such as flexural strength, hardness, and fracture toughness, directly helping to avoid brittleness and failure risks. UnitedTest can cover comprehensive testing for flexural strength, hardness, and fracture toughness, compatible with national and ISO/ASTM standards, and provides customized testing solutions.

Tensile test evaluates material resistance to stretching, measuring strength/elongation critical for quality control. UnitedTest offers universal tensile testers (10-600KN) compliant with ASTM/ISO standards, providing tailored solutions for metals, polymers, medical & industrial materials.

Compression test assesses material resistance to compressive loads, measuring strength/deformation critical for quality validation. UnitedTest offers compression testing machines compliant with ASTM/ISO standards, providing tailored solutions for concrete, plastics, metals and industrial components.

Flexural & Bend tests evaluate material resistance to bending forces, measuring strength, stiffness and ductility for quality assurance. UnitedTest provides flexural testing machines (3-point/4-point bend) compliant with ASTM/ISO standards, offering tailored solutions for composites, plastics, metals and construction materials.

Torsion Test evaluates material resistance to rotational forces, measuring torsional strength/ductility critical for fasteners, insulators, shafts. UnitedTest offers torsion testers compliant with ASTM A938/ISO 16047, providing tailored solutions for automotive, aerospace, fastener industries.

Fatigue Test assesses material durability under cyclic loading, critical for predicting service life of industrial components. UnitedTest offers fatigue testing systems (axial/bending/torsion) compliant with ASTM E466/ISO 12106, providing tailored solutions for automotive, aerospace and manufacturing sectors.

Peel Test measures material adhesion strength by evaluating resistance to peeling forces, critical for adhesives, films, packaging. UnitedTest offers peel testers compliant with ASTM D903/ISO 8510, covering 90°/180° peel tests, and tailored solutions for packaging, automotive, textile industries.

Impact Test evaluates material resistance to sudden shock loads, critical for assessing toughness and fracture risk. UnitedTest offers impact testers (Charpy/Izod/fall weight) compliant with ASTM E23/ISO 148, providing tailored solutions for metals, plastics, glass and industrial components.

Tear & Shear Test evaluates material resistance to tearing and shearing forces, measuring critical strength parameters for quality control. Tear tests (Elmendorf/trouser/trapezoidal) assess resistance to crack propagation in films/fabrics, while shear tests measure resistance to parallel forces in joints/bolts. UnitedTest provides universal testing machines (10KN-600KN) with specialized fixtures for both tests, compliant with ASTM D624/D3164 and ISO standards, serving automotive, packaging and construction industries.

Hardness test measures material's resistance to permanent indentation, critical for quality control. UnitedTest offers universal hardness testers (Rockwell/Brinell/Vickers) compliant with ASTM/ISO standards, plus tailored hardness testing solutions for diverse industrial needs.

Biaxial/triaxial tests evaluate material performance under multi-axis loads, critical for biomaterials, metals and composites. UnitedTest provides compliant testing machines (ASTM/ISO) for planar biaxial, static/fatigue triaxial tests, with tailored solutions for industrial & biomedical needs.

Friction and wear tests assess material resistance to friction, abrasion and wear, critical for industrial material performance validation. UnitedTest offers tribometers compliant with ASTM G99/ISO standards, covering pin-on-disk, four-ball tests, and tailored friction & wear testing solutions for diverse industries.

Pressure test evaluates material/component resistance to static/dynamic pressure, critical for sealing, strength and safety validation. UnitedTest offers pressure testing machines compliant with ASTM/ISO standards, covering burst, hold-pressure tests, and tailored solutions for industrial, automotive & medical sectors.

Fire test assesses material flammability, heat resistance and fire-retardant performance, critical for safety compliance across industries. UnitedTest offers fire testing equipment compliant with ASTM/ISO/UL standards, providing tailored fire test solutions for building materials, plastics and industrial components.

Non-destructive Test (NDT) evaluates material/component integrity without damage, critical for safety & quality across industries. UnitedTest offers ultrasonic/X-ray/magnetic particle NDT equipment compliant with ASTM/ISO standards, plus tailored NDT solutions for aerospace, automotive & manufacturing sectors.

ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws

ASTM F543 is a testing standard used in the biomedical industry that defines specifications for metallic medical bone screws. Bone screws are used in surgical procedures for securing implants, osteosynthesis devices, and fracture fixation plates to the skeletal system. In normal clinical use, a surgeon applies combined axial and torsional forces to implant a bone screw into the body. Bone screws are designated Class 2 FDA devices, requiring significant testing and analysis of mechanical properties prior to approval and release. It provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.

ASTM F543 Metallic Medical Bone Screws Test Driving Torque, Pullout Load Self-Tapping

ASTM F543 includes multiple annexes which stipulate the properties related to the functional use of bone screws and the axial torsion forces associated with their use. The standard also includes geometric specifications for the design of these devices. The annexes include both purely torsional as well as biaxial testing for a complete evaluation of these devices. The specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone.

The Metallic Medical Bone Screws key test are included as below:

ASTM F543 Annex 1 Torsional Properties of Bone Screws
ASTM F543 Annex 1 measures the uniformity of bone screw products and enables comparison to other different, yet similarly sized, products. Measures torsional yield strength, maximum torque, and breaking angle of the bone screw. Torsional yield strength is an important engineering parameter to prevent screws from breaking during insertion or removal. Breaking angle is a measure of screw ductility as it undergoes a torsional moment. A large break angle provides an early warning to the surgeon that the screw is reaching its maximum strength. UnitedTest torsion testing machine meets the requirements of ASTM F543 Appendix 1 (ASTM F543-A1). The capacity ranges from 10 Nm (90 in lbf) to over 30 Nm (270 in lbf) and supports both clockwise and counterclockwise modes. Each system includes a test controller, software, test bench, angular displacement sensor, and torque sensor. The specimen fixture seat or mechanical fixture fixes the bone screw to prevent it from rotating under force. The software continuously records the relationship between torque and rotation angle. The angular displacement scale has the sensitivity to accurately measure the offset of 2 ° angular displacement. Draw the relationship between torque and angle in the graphical test report.
ASTM F543 Annex 2 Driving Torque for Medical Bone Screws
ASTM F543 Appendix 2 measures the torque required to drive the bone screw into the defined standard material of the simulated bone. This testing method helps maintain the uniformity of the product. Test steps: Use the matching tool to screw the sample into the test block. Apply torque to the screw head at a speed of 3r/min using a torsion testing machine. Record the maximum torque for the first 4 turns as the screw in torque, and for the reverse rotation of 4 turns, record the maximum torque as the spin out torque. Apply an axial load not exceeding 11.17N during the process of screwing in and out. Insertion torque testing helps prevent screw failure during insertion. The insertion torque is much smaller than the torsional yield strength of the screw and its screwdriver head. The disassembly torque test helps to prevent screw failure during the disassembly process. The disassembly torque is also much smaller than the torsional yield strength of the screw and its screwdriver head. In both tests, the torque motor was driven at a rate of 1 to 5 RPM.
ASTM F543 Appendix 3 Axial Tensile Strength of Medical Screws
Appendix 3 measures the axial tensile force required to disable or remove bone screws from their application. If the screw is subjected to axial tension, or if the screw is fixed in poor quality or osteoporotic bone, axial tensile strength testing is very important. Axial Tensile Strength of Medical Screws test requires the use of a basic universal testing machine that can withstand the force required to pull out or break medical screws. UnitedTest provides universal/tensile testing machinesorbone screw test machine for this application, each of which meets the ASTM E4 force measurement accuracy requirements. Use our controller to record the displacement data of the load and fixture. For axial pull-out testing, a customized fixture is required to grip the head of the screw and pull it out after reaching the desired depth of thread engagement.
ASTM F543 Annex 4 Performance of Self tapping Medical Bone Screws
ASTM F543 Annex 4 test the axial compression force required for the self tapping function of engaging self tapping medical bone screws. The self attack force testing method helps ensure that surgeons can easily insert screws, especially when screws are screwed into low-quality or osteoporotic bones. Self tapping performance refers to the ability of screws to be directly inserted and fixed in bone tissue without the need for pre drilling. This performance is crucial for internal fixation in orthopedic surgery. When conducting self tapping performance tests, it is usually necessary to prepare a set of bone screw samples that meet the specifications, which should have different variables such as size, material, and surface treatment, in order to comprehensively evaluate the influence of different factors on self tapping performance. Next, insert the samples into materials that simulate bone tissue and simulate the operating conditions in actual surgery. During the experiment, it is necessary to record parameters such as the force, speed, and depth of screw insertion, as well as the stability and firmness of the screw after fixation. At the same time, it is necessary to observe the deformation and damage of the screw during insertion, as well as the microstructural changes after fixation, in order to evaluate its self tapping performance. Test procedure: Pre drill guide holes on a uniform test block and apply a constant axial force of 2 N/s. Drive the screw at a speed of 30r/min and monitor the torque and axial displacement. Once the torque and axial displacement significantly increase, it is considered that the screw has started self tapping. Maintain the axial load force at the beginning of the self attack and complete 5 rotations. Record the maximum axial force obtained at the beginning of a self tapping, defined as self attack force.

Annex A5-Specifications for Type HA and Type HB Metallic Bone Screws.

Annex A6-Specifications for Type HC and Type HD Metallic Bone Screws.

Annex A7-Specifications for Metallic Bone Screw Drive Connections.

This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.

In the R&D phase, this standard enables researchers to compare the performance differences between different materials and structural designs of bone plates, thus guiding the optimization of product schemes. In the mass production stage, it serves as a key quality control tool to ensure that each batch of bone plates meets the unified mechanical performance standards. For manufacturers, test data compliant with this standard is also an important basis for applying for FDA approval of their products, which is crucial for the products to enter the market smoothly and be used clinically.

We offer customization to meet your specific needs. Our expert team will collaborate with you to develop the perfect product for you