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A proposed ASTM International standard will help develop “test soils” that validate cleaning methods for reusable medical devices. This will help companies that make endoscopes, clamps, suction tubes, arthroscopic shavers and other devices, as well as companies that provide cleaning systems for those products. Reusable medical devices are often exposed to biological materials such as blood,…, 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:, Stephen Spiegelberg, Cambridge Polymer Group, Boston, Mass, tel +1.617.629.4400 ext. 12; stephen.spiegelberg@campoly.com , ASTM Staff Contact:, Pat Picariello, tel +1.610.832.9720; ppicariello@astm.org Release #9885
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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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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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More than a decade after the post-Sept. 11 anthrax mail scares, rapidly screening and identifying potential biological agents in suspicious powders remains a challenge. A proposed ASTM International standard, ASTM WK46895 , Specification for Hand Portable Biodetection Instruments for Homeland Security Applications, will prove to be helpful in this area. “It is important that testing requirements…, ASTM Committee E54 Next Meetings:, Jan. 26-18, 2015, January Committee Week, New Orleans, La.; June 15-17, 2015, June Committee Week, Anaheim, Calif., Technical Contact:, Richard Ozanich, National Security Directorate, Pacific Northwest National Laboratory, Richland, Wash., tel +1.509.375.4586; richard.ozanich@pnnl.gov, ASTM Staff Contact:, Robert Morgan, tel +1.610.832.9732; rmorgan@astm.org, ASTM PR Contact:, Barbara Schindler, tel +1.610.832.9603; bschindl@astm.org Release #9755
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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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A proposed ASTM specification will fill a need for a standard ensuring that protective helmets, particularly those used in law enforcement, are tested consistently. Once approved, ASTM WK46152, Specification for Ballistic-Resistant Head Protection for Law Enforcement Applications, will provide law enforcement and other public safety agencies with a means of establishing minimum performance…, ASTM Committee E54 Next Meeting:, Jan. 26-28, 2015, January Committee Week, New Orleans, La., Technical Contact:, John Cronin, HP White Laboratory Inc., Cortland, N.Y., Phone: 603-933-3768; john.cronin@hpwhite.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 #9633
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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