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A new ASTM International standard provides an easy-to-perform test method for growing different strains of Clostridium difficile spores, which are used by microbiologists to evaluate antimicrobial drugs. Spore crops grown using the test method (soon to be published as E3011, Test Method for in vitro Production of Clostridium Difficile Spores) will be used in laboratories to test the efficacy of…, ASTM Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents Next Meeting:, Oct. 26-29, 2015, October Committee Week, Tampa, Fla., Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Lisa Hellickson, Ecolab, Eagan, Minn, tel+1.651.795.5709; lisa.hellickson@ecolab.com , ASTM Staff Contact:, Brian Milewski, tel +1.610.832.9619; bmilewski@astm.org Release #9884
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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 new ASTM International standard details the procedures for testing pre-wetted towelettes with a mechanized device called “the wiperator.” Manufacturers would use the standard (soon to be available as E2967, Test Method for Assessing the Ability of Pre-Wetted Towelettes to Remove and Transfer Bacterial Contamination on Hard, Non-Porous Environmental Surfaces Using the Wiperator) to test…, ASTM Committee E35 on Pesticides, Antimicrobials and Alternative Control Agents Next Meeting:, Oct. 26-29, 2015, October Committee Week, Tampa, Fla., Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Syed Sattar, Ph.D., University of Ottawa, Ottawa, Ontario, Canada., tel +1.307.399.1345; ssattar@uottawa.ca, ASTM Staff Contact:, Brian Milewski, tel +1.610.832.9619; bmilewski@astm.org Release #9834 ###
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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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There are all kinds of textiles treated with antimicrobial agents, and a variety of ways in which each can be tested for their performance response to antimicrobial activity. A proposed new ASTM International standard, WK31901, Guide for Standard Test Methods and Practices for Evaluating Antibacterial Activity on Textiles, will help tie all of this information together. “Many of the…, ASTM Committee E35 Next Meeting:, April 27-30, 2015 April committee week, Anaheim, Calif., Technical Contact:, Robert A. Monticello, Ph.D., International Antimicrobial Council, Midland, Mich., tel +1.989.615.0031; ramphd@amcouncil.org, ASTM Staff Contact:, Jennifer Rodgers, tel +1.610.832.9694; jrodgers@astm.org, ASTM PR Contact:, Barbara Schindler, tel +1.610.832.9603; bschindl@astm.org Release #9727
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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