surgical material News
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ASTM F629 - 11 standard practice for radiography of cast metallic surgical implants
The requirements in this practice are intended to control the quality of the radiographic image of cast metallic surgical implants and related weldments. 1. Scope 1.1 This practice covers the procedure for radiographic testing of cast metallic surgical implants and related weldments. 1.2 The values ...
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ASTM F1160 - 05(2011)e1 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
The shear and bending fatigue tests are used to determine the effect of variations in material, geometry, surface condition, stress, and so forth, on the fatigue resistance of coated metallic materials subjected to direct stress for up to 107 cycles. These tests may be used as a relative guide to the selection of coated materials for service under condition of repeated stress. In order ...
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ASTM F1147 - 05(2011) standard test method for tension testing of calcium phosphate and metallic coatings
The tensile test method is recommended for tension testing of calcium phosphate/substrate or porous metal coating/substrate combinations and can provide information on the adhesive or cohesive strength of coatings under (uniaxial) tensile stress. The test method may be useful for comparative evaluation of adhesive or cohesive strengths of a variety of types of coatings. Coatings may be ...
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Withdrawn Standard: ASTM F1251-89(2003) Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012)
This terminology covers polymeric biomaterials in medical and surgical devices. Terms are defined as they are used relative to medical and surgical materials and devices. Terms that are generally understood and in ...
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ASTM F1044 - 05(2011)e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
The shear test method is recommended for shear testing of calcium phosphate and metallic/substrate combinations and can provide information on the adhesive or cohesive strength of coatings under a uniaxial shear stress. The test method may be useful for comparative evaluation of adhesive or cohesive strengths of a variety of types of coatings. Information developed using this test method may be ...
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Withdrawn Standard: ASTM F1612-95(2005) standard practice for cyclic fatigue testing of metallic stemmed hip arthroplasty femoral components with torsion (Withdrawn 2011)
Withdrawn Rationale: This practice covers a method for the fatigue testing of metallic stemmed femoral components used in hip arthroplasty. The described method is intended to be used for evaluation in comparisons of various designs and materials used for stemmed femoral components used in the ...
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ASTM F2038 - 00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
4.1 This guide is intended to provide guidance for the specification and selection of silicone materials for medical device applications. Silicone manufacturers supplying materials to the medical device industry should readily provide information regarding non-proprietary product formulation to their customers either directly, or ...
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BioPoly Granted Another US Patent
FORT WAYNE, IN – BioPoly LLC has announced that another U.S. patent has been granted for its innovative BioPoly® material, which is currently being used to replace damaged cartilage in joints. Where some of the other BioPoly patents address the design of the implants, this patent family focuses on the material itself. This most recent patent, regarding material derivatives, adds to the ...
By BioPoly, LLC
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ASTM F2066 - 11 standard specification for wrought titanium-15 molybdenum alloy for surgical implant applications (UNS R58150)
This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-15 molybdenum alloy to be used in the manufacture of surgical implants. The product shall be classified as: strip; sheet; plate; ...
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ASTM F1855 - 00(2011) Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
This specification covers polyoxymethylene (acetal) resin for medical applications. This specification provides requirements and associated test methods for a form of this thermoplastic which is intended for use in manufacturing medical devices, instrumentation or components thereof. Physical and mechanical properties of medical grade ...
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ASTM F2180 - 02(2011) standard specification for metallic implantable strands and cables
This specification covers the materials, dimensional tolerances, constructions, and mechanical properties for standard metallic implantable strands and cables. Materials shall be manufactured using equivalent size wires in the cold-worked and stress-relieved or annealed condition. Standard strand constructions shall be 1×3, 1×7, and 1×19 ...
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ASTM F2180 - 02(2011)e1 Standard Specification for Metallic Implantable Strands and Cables
This specification covers the materials, dimensional tolerances, constructions, and mechanical properties for standard metallic implantable strands and cables. Materials shall be manufactured using equivalent size wires in the cold-worked and stress-relieved or annealed condition. Standard strand constructions shall be 1×3, 1×7, and 1×19 strand. Cabling ...
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ASTM F2267 - 04(2011) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
Intervertebral body fusion devices are generally simple geometric shaped devices, which are often porous or hollow in nature. Their function is to support the anterior column of the spine to facilitate arthrodesis of the motion segment. This test method is designed to quantify the subsidence characteristics of different designs of intervertebral body fusion devices since ...
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BioPoly Granted US Patent for Its Implant Technology
FORT WAYNE, IN – BioPoly LLC has announced that another U.S. patent has been granted for its partial resurfacing implants which protects the innovative implant designs. The Company’s intellectual property portfolio also consists of patents that address its unique BioPoly® material. This most recent patent further adds to the Company’s IP portfolio, providing assurance that ...
By BioPoly, LLC
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BioPoly Granted an International Patent for Its Implant Technology
FORT WAYNE, IN – BioPoly LLC has announced that the Company has further expanded its intellectual property portfolio. The Company was granted another international patent for its partial resurfacing implants which protects the innovative implant designs. In addition to patents that cover the design of its implants, several U.S. and international patents have also been granted that address ...
By BioPoly, LLC
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ASTM F2042 - 00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
This guide is intended to provide guidance for the specification and selection of fabrication methods for silicones used in medical devices. It also provides guidance relative to testing that might be done to qualify lots of acceptable material, based on desired performance properties. Silicone manufacturers supplying material ...
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ASTM F1980 - 07(2011) standard guide for accelerated aging of sterile barrier systems for medical devices
The loss of sterile barrier system integrity may occur as a result of physical properties of the materials and adhesive or cohesive bonds degrading over time and by subsequent dynamic events during shipping and handling. ISO 11607–1:2006, clause 6, states that “the packaging system shall provide physical protection and maintain integrity of the sterile barrier system. The sterile ...
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ASTM F136 - 11 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401) to be used in the manufacture of surgical implants. The products are classified into: strip, sheet, plate, bar, forging bar, and wire. The heat analysis shall conform to the ...
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ASTM F1378 - 12 Standard Specification for Shoulder Prostheses
This specification covers shoulder prostheses for total or hemiarthroplasty used to provide functioning articulation by employing glenoid and humeral components. The prostheses may be constrained, partially constrained, or unconstrained. Modular prostheses are included in this ...
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TISSIUM to present study results at the 76th Annual Meeting of the American Society for Surgery of the Hand
TISSIUM, a privately-owned medtech company developing biomorphic programmable polymers for tissue reconstruction, has announced its research has been selected for presentation within the scientific program at the 76th Annual Meeting of the American Society for Surgery of the Hand. The event is scheduled to be held virtually and in-person from September 30 – October 2, 2021 in San Francisco, ...
By TISSIUM
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