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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 wildland-urban interface is a transitional zone between unoccupied land and human development. There are currently more than 40 million homes located within WUI areas throughout the United States. A proposed new ASTM standard will be used to alleviate the issue of fire conditions that exist due to eaves and other projections in structures that exist in WUI areas. ASTM WK37414, Test Method for…, ASTM Committee E05 Next Meeting:, June 23-26, 2014, June Committee Week, Toronto, Ontario, Canada, Technical Contact:, John Simontacchi, Firefree Coatings Inc., San Rafael, Calif., Phone: 415-459-6488; jsimontacchi@firefree.com , ASTM Staff Contact:, Thomas O’Toole, Phone: 610-832-9739; totoole@astm.org , ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9529
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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
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, ASTM to Partner with ASC to Foster EPD Development, ASTM International will be collaborating with industry to develop Environmental Product Declarations (EPDs) across the 90+ industry markets they support, including sealants. The Adhesive and Sealant Council (ASC) will be partnering with ASTM International to raise awareness of this effort, educate industry on the value of Type III EPDs, and proactively engage industry in developing Product…, ASTM Staff Contact:, Tim Brooke, Phone: 610-832-9729; tbrooke@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9370
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ASTM F2989 is a new ASTM International standard that covers unalloyed titanium components that are used for surgical implants. The new Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications was developed by Subcommittee F04.12 on Metallurgical Materials , part of ASTM International Committee F04 on Medical and Surgical Materials and Devices . …, ASTM Committee F04 Next Meeting:, May 21-24, 2013, May Committee Week, Indianapolis, Ind., Technical Contact:, Matthias Scharvogel, Element 22 GmbH, Kiel, Germany, Phone: +49-431-659-4620; matthias.scharvogel@element22.de, 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 #9336
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There has long been a need within the tissue engineering/regenerative medicine sector for three-dimensional reference scaffolds to serve as physical standards for the materials that are used as beds for the growth of cell cultures. The National Institute of Standards and Technology has created such references, which will eventually be accompanied by a proposed ASTM International standard that…, ASTM Committee F04 Next Meeting:, May 21-24, 2013, May Committee Week, Indianapolis, Ind., Technical Contact:, Carl G. Simon Jr., Ph.D., Biosystems and Biomaterials Division, National Institute of Standards and Technology, Gaithersburg, Md., Phone: 301-975-8574; carl.simon@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 #9298