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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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Signing Occurs Just Prior to National Manufacturing Day, In advance of the recently celebrated National Manufacturing Day on Friday, Oct. 4, last month ASTM International and the National Additive Manufacturing Innovation Institute signed a memorandum of understanding that outlines a framework of cooperation between ASTM and NAMII for the development of ASTM standards in the area of additive manufacturing. Signed by Katharine Morgan, vice president,…, Technical Contact:, Rob Gorham, National Additive Manufacturing Innovation Institute, Phone: 330-599-6474; rob.gorham@ncdmm.org , ASTM Staff Contact:, Pat Picariello, 610-832-9720; ppicariello@astm.org , ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9479
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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 proposed new ASTM International standard will serve as a guide to determine specific mechanical properties of materials made with an additive manufacturing process. ASTM WK43112 , Guide for Evaluating Mechanical Properties of Materials Made via Additive Manufacturing Processes, is being developed by Subcommittee F42.01 on Test Methods , part of ASTM International Committee F42 on Additive…, ASTM Committee F42 Next Meeting:, Jan. 27-28, 2014, ASTM International Headquarters, West Conshohocken, Pa., Technical Contact:, John A. Slotwinski, Ph.D., National Institute of Standards and Technology, Gaithersburg, Md., Phone: 301-975-2171; johnslot@nist.gov , 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 #9470
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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 standard covers a popular material used to make parts for the aerospace and medical components industries through the additive manufacturing process. The new standard, ASTM F3001 , Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion, was developed by Subcommittee F42.05 on Materials and Processes ,…, Technical Contact:, Nik Hrabe, Medical Modeling Inc., Golden, Colo., Phone: 303-273-5344; nik.hrabe@medicalmodeling.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 #9457
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The first two standards to be approved through a Partner Standards Development Organization cooperation agreement between ASTM International Committee F42 on Additive Manufacturing and ISO Technical Committee 261 on Additive Manufacturing have now been approved. The two standards are: • ISO/ASTM 52921: 2013 E, Terminology for Additive Manufacturing—Coordinate Systems and Test Methodologies (…, ASTM Committee F42 Next Meeting:, July 10-11, 2013, Nottingham Belfry, Nottingham, Great Britain. Meeting arranged by the International Conference on Additive Manufacturing, 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 #9389
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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