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A proposed ASTM International standard aims to make it easier to use tissue engineered medical products to repair cartilage. The proposed standard ( WK55272 Test Method for Tissue Engineering Medical Products – Preclinical Assessment of Engineered Cartilage Tissue Growth Using an MRI) could help with efforts to use regenerative medicine for damaged knee cartilage. The standard is being developed…, ASTM Committee F04 on Medical and Surgical Materials and Devices Next Meeting:, Nov. 15-18, 2016, November Committee Week, Orlando, Fla., Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Technical Contact:, Mrignayani Kotecha, University of Illinois, tel +1.773.324.1072; mkotecha@uic.edu, ASTM Staff Contact:, Kathleen Chalfin, tel +1.610.832.9717; kchalfin@astm.org Release #10144
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A new ASTM International standard will provide structured guidance in deciphering whether silver nanoparticles are present in certain products. Committee E56 on Nanotechnology developed the standard ( E3025 , Guide for Detection and Characterization of Manufactured Silver Nanomaterials in Textiles). It will make it possible to compare measurements and data that can be crucial for manufacturers,…, Committee E56 on Nanotechnology Next Meeting:, Nov. 14-15, 2016. November Committee Week. Orlando, FL., Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Technical Contact:, Aleksandr Stefaniak, National Institute for Occupational Safety and Health; tel +1.304.285.6302; boq9@cdc.gov, ASTM Staff Contact:, Kathleen Chalfin, tel +1.610.832.9717; kchalfin@astm.org Release #10131
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A proposed ASTM International standard seeks to define terminology for description of cellular and/or tissue-based products (CTPs) for skin wounds based on their composition. The proposed standard (WK43184, Classification of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds) will provide a much-needed common language for healthcare providers, payers, researchers and manufacturers, and…, ASTM Committee F04 on Medical and Surgical Materials and Devices Next Meeting:, May 3-6, 2016, May Committee Week, San Antonio, Texas, Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Charles Drueck, M.D., Swedish Covenant Hospital Wound Center, Glenview, Ill., tel +1.847.612.8335; cdrueck@msn.com , ASTM Staff Contact:, Pat Picariello, tel +1.610.832.9720; ppicariello@astm.org Release #9963
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A proposed ASTM International standard will provide a common way to describe platelet-rich plasma (PRP), which is used in orthopedics, sports medicine and other medical fields, to promote healing and tissue regeneration. According to ASTM member Henry Speich, Ph.D., “platelet-rich plasma” is a general term applied to a broad range of platelet concentrates, but there is no standardized way to…, ASTM Committee F04 on Medical and Surgical Materials and Devices Next Meeting:, Nov. 17-19, 2015, November Committee Week, Tampa, Fla., Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Henry Speich, Ph.D., Zimmer Biomet, Warsaw, Ind., tel +1.901.848.3741; henry.speich@zimmerbiomet.com , ASTM Staff Contact:, Pat Picariello, tel +1.610.832.9720; ppicariello@astm.org Release #9924
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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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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 ###