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A new ASTM International standard will help medical device manufacturers collect sufficient data to demonstrate that they consistently clean medical devices to a safe and effective level. The new standard (soon to be published as F3127 , Guide for Validating Cleaning Lines for Medical Devices) is the result of a November 2011 symposium sponsored by ASTM on Cleaning Validation of Medical Devices.…, ASTM Committee F04 on Medical and Surgical Materials and Devices Next Meeting:, May 3-5, 2016, May Committee Week, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Technical Contact:, Randall J. Thoma, Ph.D., VeeSquared Consulting Services, Round Rock, Texas, tel +1.512.924.3832; randy.thoma@VeeSquared.com, ASTM Staff Contact:, Pat Picariello, tel +1.610.832.9720; ppicariello@astm.org Release #10050
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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 new ASTM specification will help manufacturers optimize and expand the use of high-silicon molybdenum iron (SiMo) castings, which are used in high-temperature car parts such as exhaust systems and turbocharger housings. These castings are also used for components of power plants. “This standard helps produce lighter, more heat-resistant and more consistent iron castings for auto and related…, ASTM Committee A04 on Iron Castings Next Meeting:, May 3-4, 2016, May Committee Week, San Antonio, Texas, Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Delin Li, CanmetMATERIALS, Hamilton, Ontario, Canada, tel +1.905.645.0778; delin.li@canada.ca, ASTM Staff Contact:, Kathleen Chalfin, tel +1.610.832.9717; kchalfin@astm.org Release #9966
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A new ASTM International standard will help oil spill responders evaluate the stability of water-in-oil mixtures. Specifically, the new standard (soon to be published as F3045, Test Method for the Evaluation of the Stability of Water-in-Oil Mixtures Formed from Crude Oil and Petroleum Products Mixed with Saline Water) provides a laboratory test method to determine the tendencies of emulsions and…, ASTM Committee F20 on Hazardous Substances and Oil Spill Response Next Meeting, : Oct. 25-26, 2016, October Committee Week, Orlando, Fla., Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Mervin Fingas, Edmonton, Alberta, Canada, tel +1.780.989.6059; fingasmerv@shaw.ca , ASTM Staff Contact:, Jeffrey Adkins, tel +1.610.832.9738; jadkins@astm.org Release #9936
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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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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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A proposed new ASTM standard will provide a lab test to determine how various types of oil will interact with water in oil spill situations. Information gleaned from such testing will ultimately lead to more effective oil spill recovery. All interested parties are welcome to join in the ongoing development of the standard ( WK41247 , Test Method for the Evaluation of the Stability of Water-in-Oil…, ASTM Committee F20 on Hazardous Substances and Oil Spill Response Next Meeting:, Oct. 27-28, 2015, October committee week, Tampa, Fla., Technical Contact:, Mervin Fingas, Edmonton, Alberta, Canada, tel +1.780.989.6059; fingasmerv@shaw.ca, ASTM Staff Contact:, Jeffrey Adkins, tel +1.610.832.9738; jadkins@astm.org, ASTM PR Contact:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org Release #9772