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A proposed ASTM International standard aims to improve quality of life for patients who have had total knee replacement surgery due to conditions such as osteoarthritis. The proposed standard (WK49175, Practice for Finite Element Analysis (FEA) of Metallic Orthopedic Total Knee Femoral Components Under Closing Conditions) outlines how to evaluate the strength of knee replacement femoral…, ASTM Committee F04 on Medical and Surgical Materials and Devices Next Meeting:, Nov. 17-20, November Committee Week, Tampa, Fla., Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Walter Schmidt, Stryker Orthopaedics, Mahwah, N.J., tel +1.201.831.5386; walter.schmidt@stryker.com, ASTM Staff Contact:, Pat Picariello, tel +1.610.832.9720; ppicariello@astm.org Release #9854 ###
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A proposed ASTM standard guide will cover a heavily used procedure used for assessing bone-grafting technologies in pre-clinical models. Specifically, the standard (WK49454, Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model) describes the process for implanting bone void filler and bone graft extender products into rabbits to test their effectiveness in…, ASTM Committee F04 on Medical and Surgical Materials and Devices Next Meeting:, Nov. 17-20 2015, November Committee Week, Tampa, Fla., Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Jeffrey L. Scifert, Ph.D., Medtronic Spinal, Memphis, Tenn., tel +1.901.344.0844; jeffrey.scifert@medtronic.com, ASTM Staff Contact:, Pat Picariello, tel +1.610.832.9720; ppicariello@astm.org Release #9833 ###
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ASTM International recently published two standards that will educate existing and future workers in nanotechnology. Educators will use the new standards to develop and refine curricula at the undergraduate level. At the same time, industries and businesses may use the standards as a basis for hiring new graduates as well as for upgrading skills of current employees. The Nanotechnology…, ASTM Committee E56 on Nanotechnology Next Meeting:, Nov. 16-17, 2015, November Committee Week, Tampa, Fla., Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contacts:, (E2996) Robert Ehrmann, Pennsylvania State University, State College, Pa., tel +1.814.404.0127; rke2@psu.edu ; (E3001) Raymond Tsui, Ph.D., Arizona State University, Tempe, Ariz., tel +1.480.206.4736; raymond.tsui@asu.edu, ASTM Staff Contact:, Kathleen McClung, tel +1.610.832.9717; kmcclung@astm.org Release #9816 ###
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Additional Standard on Silver Nanomaterials Underway, The U.S. Food and Drug Administration has added two ASTM International standards to its List of Recognized Standards, meaning that the FDA advises referring to listed documents for points to consider when assessing whether an FDA-regulated product involves the application of nanotechnology. Specifically, ASTM recently published a standard that describes one of the few techniques that measure…, ASTM Committee E56 on Nanotechnology Next Meeting:, April 9-10, National Institute for Standards and Technology, Gaithersburg, Md., Media Inquiries:, Nathan Osburn, tel +1.610.832.9603, nosburn@astm.org, Technical Contact:, Aleksandr Stefaniak, NIOSH, Morgantown, W.V., tel +1.304.285.6302; Boq9@cdc.gov, ASTM Staff Contact:, Kathleen McClung, tel +1.610.832.9717, kmcclung@astm.org Release #9809 ###
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A proposed new ASTM guide will provide a standardized method for measuring the safety and effectiveness of hip replacements while also fostering a less-burdensome approach to the design, review and FDA approval of clinical trials and insurance coverage decisions involving these products. Specifically, the new standard will bring more consistency and credibility to the information flowing from…, ASTM Committee F04 Next Meeting:, May 19-22, 2015, May committee week, Anaheim, Calif., Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Gregory A. Brown, M.D., Olympia Orthopaedic Associates, Olympia, Wash., tel +1.360.491.4211; gbrown@olyortho.com, ASTM Staff Contact:, Pat Picariello, tel +1.610.832.9720; ppicariello@astm.org Release #9786 ###
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Although regulatory bodies, including the U.S. Food and Drug Administration, frequently request information from manufacturers on the potential for ion release from surgical implants containing metal, there has not been a standard method for performing this evaluation. A proposed new ASTM standard, ASTM WK47808 , Test Method for Ion Release Evaluation of Medical Implants, will provide such a…, ASTM Committee F04 Next Meeting:, May 19-22, 2015, May Committee Week, Anaheim, Calif., Technical Contact:, Matthias Frotscher, Cortronik, Rostock-Warnemuende, Germany, tel +49.381.8173.7251; matthias.frotscher@biotronik.com, ASTM Staff Contact, : Pat Picariello, tel +1.610.832.9720; ppicariello@astm.org, ASTM PR Contact:, Barbara Schindler, tel +1.610.832.9603; bschindl@astm.org Release #9758
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Catheter manufacturers have found that properties of their devices can influence performance of delivered cell therapy products. However, there is wide variability in how delivery device effects on cell performance are evaluated. A proposed new ASTM International standard will help eliminate this confusion and provide guidance to manufacturers on how to measure the effects of their devices on…, ASTM Committee F04 Next Meeting:, Nov. 11-13, November committee week, New Orleans, La., Technical Contact:, Carl Simon, Jr., National Institute of Standards and Technology, Gaithersburg, Md., tel +1.301.975.4977; carl.simon@nist.gov, ASTM Staff Contact:, Pat Picariello, tel +1.610.832.9720; ppicariello@astm.org, ASTM PR Contact:, Barbara Schindler, tel +1.610.832.9603; bschindl@astm.org Release #9707
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People suffering from cardiovascular disease may have another option for treatment: drug-coated balloons. Merging established angioplasty balloon catheter technology with active drug coatings, this evolving medical technology will be covered in a proposed new ASTM standard, ASTM WK46148, Guide for Acute Durability of Drug-Coated Balloons. “Drug-coated angioplasty balloon catheters are intended to…, ASTM Committee F04 Next Meeting:, Nov. 10-14, 2014, November Committee Week, New Orleans, La., Technical Contact:, Gary Binyamin, TriReme Medical LLC, Kensington, Calif., Phone 650-823-0710; gbinyamin@yahoo.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 #9641
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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