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Strength and penetration are key attributes needed for surgical needles. A new ASTM International standard, ASTM F3014 , Test Method for Penetration Testing of Needles Used in Surgical Sutures, focuses on penetration testing of such needles. ASTM F3014 was developed by Subcommittee F04.33 on Medical/Surgical Instruments , part of ASTM International Committee F04 on Medical and Surgical Materials…, ASTM Committee F04 Next Meeting:, Nov. 10-14, 2014, November Committee Week, New Orleans, La., Technical Contact, : Eric Hinrichs, Ethicon Inc., Somerville, N.J., Phone: 908-218-3177; ehinrich@its.jnj.com , ASTM Staff Contact:, Pat Picariello, Phone: 610-832-9720; ppicariello@astm.org , ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9654
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ASTM International Committee F04 on Medical and Surgical Materials and Devices has approved a new standard for a metallurgical implant material that is useful in a variety of surgical applications. ASTM F3046 , Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy for Surgical Implant Applications (UNS R56320), was developed by Subcommittee F04.12 on Metallurgical Materials . Mark…, ASTM Committee F04 Next Meeting:, May 6-9, 2014, May Committee Week, Toronto, Ontario, Canada, Technical Contact:, Mark Ransick, Ethicon Surgical Care, Cincinnati, Ohio, Phone: 513-337-8069; mransick@its.jnj.com , ASTM Staff Contact:, Pat Picariello, Phone: 610-832-9720; ppicariello@astm.org , ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9644
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A proposed new ASTM International standard will cover fatigue testing of metallic tibial trays, which are components used in partial knee joint replacement. ASTM WK45235 , Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements, is being developed by Subcommittee F04.22 on Arthroplasty , part of ASTM International Committee F04 on Medical and…, ASTM Committee F04 Next Meeting:, May 6-9, 2014, May Committee Week, Toronto, Ontario, Canada, Technical Contact:, Gokce Yildirim, Stryker MAKO, Jersey City, N.J., Phone: 973-946-6994; gyildirim@makosurgical.com , ASTM Staff Contact:, Pat Picariello, Phone: 610-832-9720; ppicariello@astm.org , ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9630
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Patients with blockages in their coronary vasculature have historically been treated with permanent metallic stents, metal mesh tubes that open clogged blood vessels, restore blood flow and keep the vessel open over time. Certain patients can now be treated with an absorbable stent, otherwise known as a vascular scaffold, available in international markets. Absorbable stents are designed to open…, ASTM Committee F04 Next Meeting:, May 6-9, 2014, May Committee Week, Toronto, Ontario, Canada, Technical Contact:, Julia Fox, Ph.D., Abbott Vascular, Santa Clara, Calif., Phone: 408-845-0719; julia.fox@av.abbott.com , ASTM Staff Contact:, Pat Picariello, Phone: 610-832-9720; ppicariello@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9561
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Determining the mechanical performance and biocompatibility of an implantable medical device are crucial steps in evaluating the device’s safety and efficacy. A proposed new ASTM International standard will be used to help assess device performance by examining the potential for galvanic corrosion of implants. ASTM WK19883 , Test Method for Conducting and Evaluating Galvanic Corrosion Tests of…, ASTM Committee F04 Next Meeting:, May 6-9, 2014, May Committee Week, Toronto, Ontario, Canada, Technical Contact:, Shari Nathanson Rosenbloom, Ph.D., Corrosion Testing Laboratories Inc., Newark, Del., Phone: 302-454-8200; shari@corrosionlab.com, ASTM Staff Contact:, Pat Picariello, Phone: 610-832-9720; ppicariello@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9537
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An ASTM International symposium on metal-on-metal total hip replacement devices held in May 2012 identified unmet standardization needs. One such need was for a standard that deals with the collection and analysis of explanted hip implants in order to understand their in-vivo performance. In addition, the U.S. Food and Drug Administration Order 522 mandates orthopaedic companies to carry out…, ASTM Committee F04 Next Meeting:, May 6-9, 2014, May Committee Week, Toronto, Ontario, Canada, Technical Contact:, Richard Underwood, Ph.D., Exponent, Philadelphia, Pa., Phone: 215-594-8800, ext. 8875; runderwood@exponent.com , ASTM Staff Contact:, Pat Picariello, Phone: 610-832-9720; ppicariello@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9524
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A proposed new ASTM International standard will be used in the design, development, quality control and comparison of a variety of collagen-based medical products, including surgical implants, delivery vehicles for therapeutic cells or molecules and substrates for tissue engineered medical products. ASTM WK43011 , Specification for Characterization and Standardization of Polymerizable Collagen-…, ASTM Committee F04 Next Meeting:, Nov. 12-14, 2013, November Committee Week, Jacksonville, Fla., Technical Contact:, Sherry Voytik-Harbin, Weldon School of Biomedical Engineering and Department of Basic Medical Sciences, Purdue University, Phone: 765-496-6128; harbins@purdue.edu ; Tetsuro Wakatsuki, InvivoSciences Inc., Phone: 608-713-0149; tetsuro@invivosciences.com , ASTM Staff Contact:, Pat Picariello, Phone: 610-832-9720; ppicariello@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9490
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All interested parties are welcome to join in the development of a proposed new ASTM International standard that will provide guidance on how to conduct axial, bending and torsional fatigue testing of stents. The proposed new standard, ASTM WK23330 , Guide for in Vitro Axial, Bending and Torsional Durability Testing of Vascular Stents, is being developed by Subcommittee F04.30 on Cardiovascular…, ASTM Task Group F04.30.06 Next Meeting:, Nov. 21, 2013, FDA White Oak Campus, Silver Spring, Md., Technical Contact:, Brian Choules, MED Institute Inc., West Lafayette, Ind., Phone: 765-463-7537; choules@medinst.com, ASTM Staff Contact:, Pat Picariello, Phone: 610-832-9720; ppicariello@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9471
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A new ASTM International standard will provide a consistent method for analyzing hip stems used in hip replacement surgery. The new standard, ASTM F2996 , Practice for Finite Element Analysis (FEA) of Nonmodular Metallic Orthopaedic Hip Femoral Stems, was developed by Subcommittee F04.22 on Arthroplasty , part of ASTM International Committee F04 on Medical and Surgical Materials and Devices . “…, ASTM Committee F04 Next Meeting:, Nov. 12-14, 2013, November Committee Week, Jacksonville, Fla., Technical Contact:, Jeffrey Sprague, Smith and Nephew, Memphis, Tenn., Phone: 901-399-5215; j eff.sprague@smithnephew.com, ASTM Staff Contact:, Pat Picariello, Phone: 610-832-9720; ppicariello@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9458
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A new ASTM International guide addresses variable labeling within the orthopedic implant industry. ASTM F2943 , Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty, was developed by Subcommittee F04.22 on Arthroplasty , part of ASTM International Committee F04 on Medical and Surgical Materials and Devices . “During an orthopedic surgery, the…, ASTM Committee F04 Next Meeting:, Nov. 12-15, 2013, November Committee Week, Jacksonville, Fla., Technical Contact:, Kent Jason Lowry, M.D., Ministry Medical Group, Rhinelander, Wis., Phone: 715-369-2300; klortho@newnorth.net , ASTM Staff Contact:, Pat Picariello, Phone: 610-832-9720; ppicariello@astm.org , ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9386