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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 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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ASTM International Committee E11 on Quality and Statistics has approved the last in a series of ASTM standards that preserve military sampling standards that were originally under the jurisdiction of the U.S. Department of Defense. The new standard, ASTM E2910 , Guide for Preferred Methods for Acceptance of Product, preserves MIL-STD-1916 in its original form. ASTM E2910 is under the jurisdiction…, ASTM Committee E11 Next Meeting:, May 8-10, 2013, ASTM International Headquarters, West Conshohocken, Pa., Technical Contact:, Dean V. Neubauer, Corning, Inc., Corning, N.Y., Phone: 607-974-6777; neubauerdv@corning.com, ASTM Staff Contact:, Katerina Koperna, Phone: 610-832-9728; kkoperna@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9317
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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
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Many types of surgical implants and other medical devices are made of polymeric materials. A new ASTM standard covers the raw material properties for a high strength polymer used for surgical implants. ASTM F2820 , Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications, has been developed by ASTM International Subcommittee F04.11 on Polymeric Materials , part of…, ASTM Committee F04 Next Meeting:, May 21-24, 2013, May Committee Week, Indianapolis, Ind., Technical Contact:, Jon P. Moseley, Ph.D., Wright Medical Technology Inc., Arlington, Tenn., Phone: 901-867-4414; jon.moseley@wmt.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 #9276
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A new ASTM International standard provides a much-needed methodology for determining the shelf life of various attributes of endovascular devices. The new standard, ASTM F2914 , Guide for Identification of Shelf-Life Test Attributes for Endovascular Devices, was developed by Subcommittee F04.30 on Cardiovascular Standards , part of ASTM International Committee F04 on Medical and Surgical…, ASTM Committee F04 Next Meeting:, Nov. 13-16, 2012, November Committee Week, Atlanta, Ga., Technical Contact:, Benjamin Gundale, Boston Scientific, Maple Grove, Minn., Phone: 763-494-2771; gundaleb@bsci.com, ASTM Staff Contact:, Pat Picariello, Phone: 610-832-9720; ppicarie@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9264
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In many testing laboratories, it can be necessary to qualify a new test method, instrument or lab itself with respect to one or more performance characteristics. One such key characteristic is bias, or mutual agreement of average test results run on the same material. A proposed ASTM standard will aid in the determination of bias equivalency. ASTM WK37659 , Guide for Testing for Bias Equivalency…
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For several years, ASTM International Committee E11 on Quality and Statistics has been preserving military sampling standards no longer supported by the U.S. Department of Defense. The latest ASTM standard to emerge from this program is ASTM E2819 , Practice for Single- and Multi-Level Continuous Sampling of a Stream of Product by Attributes Indexed by AQL. “The reason for preserving military…