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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 ASTM standard will meet the need for a method that labs can follow when testing samples for mold. The proposed standard (WK17177, Test Method for Examination of Fungal Structures on Tape Lift Samples by Optical Microscopy) will provide labs with an approach based on quality and science. The primary users of the standard will be labs that provide services in the fields of occupational…, Committee D22 on Air Quality Next Meeting:, April 26-May 1, 2015, April committee week, Anaheim, Calif., Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Terri L. Williams, Wisconsin Occupational Health Laboratory, University of Wisconsin, Madison, Wis., tel +1.608.224.6261; terri.williams@slh.wisc.edu, ASTM Staff Contact:, Jeffrey Adkins, tel +1.610.832.9738; jadkins@astm.org Release # 9797 March 17, 2015 ###
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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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Taking a tape-lift sample is one of the main practices used by indoor environmental quality investigators for detecting whether mold structures (for example, spores and hyphae) have either settled onto or colonized the surface. Despite the popularity of the method, there can be significant inconsistency in how tape lifts are collected. A new ASTM standard, ASTM D7910 , Practice for the Collection…, ASTM Committee D22 Next Meeting:, Oct. 5-8, 2014, October Committee Week, New Orleans, La., Technical Contact:, John M. Neville, Ph.D., Bureau Veritas North America Inc., Novi, Mich., Phone: 248-344-3042; john.neville@us.bureauveritas.com, ASTM Staff Contact:, Jeffrey Adkins, Phone: 610-832-9738; jadkins@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9655
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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 new standard, ASTM D7886 , Practice for Asbestos Exposure Assessments for Repetitive Maintenance and Installation Tasks, will aid those testing asbestos exposures by quantifying such exposure levels. Regulations set forth by the U.S. Occupational Safety and Health Administration require that worker exposure to asbestos be determined with a “high level of certainty.” “ASTM D7886 overcomes the…, ASTM Committee D22 Next Meeting:, Oct. 5-8, 2014, October Committee Week, New Orleans, La., Technical Contact:, Andrew F. Oberta, MPS, CIH, The Environmental Consultancy, Austin, Texas, Phone: 512-266-1368; andyobe@aol.com , ASTM Staff Contact:, Jeffrey Adkins, Phone: 610-832-9738; jadkins@astm.org , ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9639