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ASTM International’s committee on medical and surgical materials and devices (F04) approved a new guide that seeks to improve the cleaning of medical devices. The standard provides methods for simulated soiling of reusable medical devices for the purpose of improving cleaning instructions. The guide (F3293) offers methods for how to identify clinically relevant areas of the device to soil, time…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Kathleen Chalfin, tel +1.610.832.610-8329717; kchalfin@astm.org Release #10572
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A new ASTM International standard covers a high- strength alloy that could be used for cardiovascular stents as well as trauma, spinal, and face-related surgical implants. “This powder-metallurgy alloy has a good combination of high strength and high ductility when compared to other metallic implant materials,” said ASTM International member John Disegi, a consultant at Advanced Biomaterial…, Standardization News, magazine. Also see this overview: Standards for Healthcare Services, Products, and Technology To purchase standards, contact customer relations (tel +1.877.909.ASTM; sales@astm.org )., Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Kathleen Chalfin, tel +1.610.832.9717; kchalfin@astm.org
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ASTM International’s committee on medical and surgical materials and devices ( F04 ) has updated its standard on elbow prostheses to include testing guidance. This is the first time that any standards organization in the world has incorporated testing into a specification for these products, according to the committee. The revision to the specification for total elbow prostheses ( F2887 ) will…, ASTM Committee on Medical and Surgical Materials and Devices (F04) Next Meeting:, Nov. 14-17, 2017, November Committee Week, Atlanta, Ga., Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Technical Contact:, Brian Kincaid, Zimmer Biomet, Warsaw, Ind., +1.574.372.3922; brian.kincaid@zimmerbiomet.com, ASTM Staff Contact:, Kathleen Chalfin, +1.610.832.9717; kchalfin@astm.org R elease #10322
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A proposed ASTM International standard could help manufacturers improve designs for total disc replacements of diseased discs in the spine. The proposed standard (WK33006, Guide for Impingement Testing of Total Disc Prostheses) is being developed by ASTM’s committee on medical and surgical materials and devices ( F04 ). Specifically, the standard will guide manufacturers through the process of…, ASTM Committee F04 on Medical and Surgical Materials and Devices Next Meeting:, May 9-11, 2017, May Committee Week, Toronto, Ontario, Canada, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Technical Contact:, Ryan Siskey, Exponent, Philadelphia, Pa., tel +1.215.594.8800 ext. 8896, rsiskey@exponent.com, ASTM Staff Contact:, Kathleen Chalfin, tel +1.610.832.9717; kchalfin@astm.org R elease #10285
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A new ASTM International guide will help the medical industry create and select artificial materials used to test the cleanliness of reusable medical devices. The guide provides formulas for preparing artificial “test soils” that resemble blood, feces, and other biological matter that simulates contamination of the devices. Prior to this standard, there were few formulations available, according…, ASTM Committee F04 on Medical and Surgical Materials and Devices Next Meeting:, May 9-11, 2017, May Committee Week, Toronto, Ontario, Canada, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Technical Contact:, Stephen Spiegelberg, Cambridge Polymer Group, Boston, Mass., tel +1.617.629.4400; stephen.spiegelberg@campoly.com, ASTM Staff Contact:, Kathleen Chalfin, tel +1.610.832.9717; kchalfin@astm.org R elease #10280
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A proposed ASTM International standard will support the growing potential for small “scaffolds” to regrow tissue around the knee joint after a meniscus injury. The standard (WK54939, Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction) is being developed by ASTM’s committee on medical and surgical…, ASTM Committee F04 on Medical and Surgical Materials and Devices Next Meeting:, May 9-12, 2017, May Committee Week, Toronto, Ontario, Canada, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Technical Contact:, Suzanne Maher, Hospital for Special Surgery, New York, New York, tel +1.212.606.1083; mahers@hss.edu, ASTM Staff Contact:, Kathleen Chalfin, tel +1.610.832.9717; kchalfin@astm.org Release #10250
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ASTM International’s committee on medical and surgical materials and devices ( F04 ) is developing two standards to help evaluate performance of brushes that clean medical devices. One is focused on brush parts that clean internal channels and the other is focused on brush parts that clean external surfaces. Additional related standards may follow. The committee welcomes anyone who wants to help…, ASTM Committee F04 on Medical and Surgical Materials and Devices Next Meeting:, May 9-12, 2017, May Committee Week, Toronto, Ontario, Canada, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Technical Contact:, Ralph J. Basile, Healthmark Industries Co., Fraser, Mich., tel +1.248.238.8435; ralphjb@usa.net, ASTM Staff Contact:, Kathleen Chalfin, tel +1.610.832.9717; kchalfin@astm.org Release #10248
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Yesterday, more than 50 government and industry officials decided to launch a new ASTM International committee dedicated to developing standards in the area of commercial spaceflight. The Committee on Commercial Spaceflight (F47) will focus on standards development in areas such as occupant safety of orbital and suborbital vehicles, launch and reentry vehicles, and spaceports. James Thomas,…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, ASTM Staff Contact:, Kristy Straiton, tel +1.610.832.9640; kstraiton@astm.org Release #10195
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With support from industry and government leaders, ASTM International will host an organizational meeting to potentially create a new technical committee that develops voluntary consensus standards for commercial spaceflight. This meeting comes in part as a result of the updated U.S. Commercial Space Launch Competitiveness Act of 2015 (CSLCA). The U.S. Federal Aviation Administration’s…, ASTM Commercial Spaceflight Meeting:, Oct. 24, 2016, RTCA, Inc.; 1150 18th St. NW, 4th Floor, Washington, DC 20036, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, ASTM Staff Contact:, Christine DeJong, tel +1.610.832.9736; cdejong@astm.org Release #10170
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A proposed ASTM International test method will educate implant designers on the material properties and capabilities of implants, specifically those used in unicondylar knee joint replacements. The proposed standard ( WK45235 , Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements) is being developed by ASTM Committee F04 on Medical and…, ASTM Committee F04 on Medical and Surgical Materials and Devices Next Meeting:, Nov. 16-18, 2016, November Committee Week, Orlando, Fla., Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Technical Contact:, Gokce Yildirim, Stryker Orthopaedics, tel +1.973.946.6994; gokce.yildirim@strykers.com, ASTM Staff Contact:, Kate Chalfin, tel +1.610.832.9717; kchalfin@astm.org Release #10149