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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 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 E55 on Manufacture of Pharmaceutical Products is currently developing a proposed standard that will document a set of process steps that can reproducibly inactivate or remove any potential retrovirus in new biological products, particularly antibodies and antibody-like compounds. The proposed standard, ASTM WK39883 , Practice for Process of Inactivation of Enveloped…, ASTM Committee E55 Next Meeting:, April 9-11, 2013, Genzyme-A Sanofi Company, Haverhill, Suffolk, United Kingdom, Technical Contact:, John Schreffler, Ph.D., Morphotek Inc., Exton, Pa., Phone: 610-423-6557; jschreffler@morphotek.com, ASTM Staff Contact:, Christine DeJong, Phone: 610-832-9736; cdejong@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9327
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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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A proposed new ASTM International standard will provide an important process step to be used in the manufacture of protein-based drugs, such as antibodies and fusion proteins, made to inactivate retroviruses. The proposed standard, ASTM WK36552 , Practice for Inactivation of Retrovirus by pH, is being developed by Subcommittee E55.04 on General Biopharmaceutical Standards , part of ASTM…