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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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A new ASTM standard consolidates six current standards on structural fasteners. With hundreds of millions of fasteners produced to ASTM specifications each year, industry will benefit from the streamlined approach provided by the new ASTM standard ( F3125 : Specification for High Strength Structural Bolts, Steel and Alloy Steel, Heat Treated, 120 ksi (830 MPa) and150 ksi (1040 MPa) Minimum…, ASTM Committee F16 Next Meeting:, May 17-19, 2015, May committee week, Anaheim, Calif., Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Chad Larson, LeJeune Bolt Co., Burnsville, Minn., tel +1.952.890.7700; clarson@lejeunebolt.com, ASTM Staff Contact:, Jennifer Rodgers, tel +1.610.832.9694; jrodgers@astm.org Release #9785 ###
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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
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A proposed new ASTM International standard will cover fatigue testing of metallic tibial trays, which are components used in partial knee joint replacement. ASTM WK45235 , Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements, is being developed by Subcommittee F04.22 on Arthroplasty , part of ASTM International Committee F04 on Medical and…, ASTM Committee F04 Next Meeting:, May 6-9, 2014, May Committee Week, Toronto, Ontario, Canada, Technical Contact:, Gokce Yildirim, Stryker MAKO, Jersey City, N.J., Phone: 973-946-6994; gyildirim@makosurgical.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 #9630
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Performance tests of potential personnel are becoming more commonly used as predictors of on-the-job performance. A new ASTM International standard is focused on 42 issues that are specific to personnel performance test development and implementation. ASTM E2849 , Practice for Professional Certification Performance Testing, was developed by Subcommittee E36.80 on Personnel Performance Testing and…, ASTM Committee E36 Next Meeting:, June 23-24, 2014, June Committee Week, Toronto, Ontario, Canada, Technical Contact:, Wallace Judd, CertNT LLC, Leesburg, Va, Phone: 703-884-2222 (ext. 802); wallace@wallacejudd.com, ASTM Staff Contact:, Rick Lake, Phone: 610-832-9689; rlake@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9565