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As a result of the Safety Equipment Institute becoming a subsidiary of ASTM International on April 19, SEI is expanding its offerings beyond its existing product certifications to include personnel certifications and environmental declaration programs. The SEI Board Standing Committee on Certification Programs met for the first time yesterday. It approved operating manuals and procedures for SEI’…, Media Inquiries:, Dan Bergels, tel. +1.610.832.9602; dbergels@astm.org, SEI Staff Contact:, Pat Gleason, tel. +1.703.442.5732; pgleason@seinet.org Release #10101
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ASTM International Committee F12 on Security Systems and Equipment (F12) has presented its top annual award – the Award of Merit – to Julia Schimmelpenningh of Eastman Chemical Company in Springfield, Mass., U.S.A. The prestigious award, which includes the accompanying title of fellow, is ASTM’s highest recognition for individual contributions to developing standards. The committee honored…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org Release #10067
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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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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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Grainy security-camera footage capturing a car as it plunges through glass into a store is seen all too often on television and Internet news sites. The commonplace nature of such accidents signals a need for better storefront protection from errant cars. Protective barriers are becoming an increasingly important component of preventing or minimizing the damage from such accidents. Now, a new…, ASTM Committee F12 Next Meeting:, April 27-28, 2015, April committee week, Anaheim, Calif., Technical Contact:, Michael Brackin, Texas A&M Transportation Institute, Bryan, Texas, tel +1.979.845.2019; m-brackin@ttimail.tamu.edu, ASTM Staff Contact:, Joseph Hugo, tel +1.610.832.9740; jhugo@astm.org, ASTM PR Contact:, Barbara Schindler, tel +1.610.832.9603; bschindl@astm.org Release #9746