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ASTM International’s committee on medical and surgical materials and devices (F04 ) is developing a standardized guide for pre-clinical testing considerations for materials used to regenerate muscle. This guide (WK64460 ) will provide scientifically-based information concerning repairing and regenerating muscle when defects are caused by trauma, such as blast injuries. “These types of injuries…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Kathleen Chalfin, tel +1.610.832.9717; kchalfin@astm.org Release #10615
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Hany Demian, the U.S. Food and Drug Administration’s standards executive, will receive the 2018 Robert J. Painter Award which honors a standards leader who has given outstanding service in any field. The award will be jointly given by ASTM International and the Society for Standards Professionals (SES) at the SES annual conference in August in Nashville, Tennessee (USA). ASTM International and…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org Release #10609
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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 proposed ASTM International standard aims to promote a shared understanding of the science and engineering behind pharmaceutical freeze-drying. The proposed standard ( WK63507 ) is being developed by ASTM’s committee on the manufacture of pharmaceutical and biopharmaceutical products ( E55 ). According to ASTM member Arnab Ganguly, uncertainty over the best practices in these areas of freeze-…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Travis Murdock, tel +1.610.832.9826; tmurdock@astm.org Release #10571
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ASTM International’s committee on medical and surgical materials and devices ( F04 ) presented its top annual award – the Award of Merit – to Dr. William M. Mihalko, University of Tennessee and the Campbell Clinic, Memphis, Tennessee, USA. The prestigious award, which includes the accompanying title of fellow, is ASTM’s highest recognition for individual contributions to developing standards. …, Media Inquiries:, Dan Bergels, tel+1.610.832.9602; dbergels@astm.org, , Release #10562
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A new ASTM International subcommittee will focus on the process of lyophilization, often referred to as freeze-drying, in the pharmaceutical industry. The group (E55.05) will be part of the committee on pharmaceutical and biopharmaceutical products (E55). The Advanced Lyophilization Technology Hub (LyoHub), a group of manufacturers, researchers, and others in the pharmaceutical and food…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Travis Murdock, tel +1.610.832.9826; tmurdock@astm.org Release #10500
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Today, ASTM International, one of the world’s leading developers of technical standards, released a white paper entitled, “Standards Development: Enabling Manufacturing Innovation and Accelerating Commercialization.” The free paper provides a high-level vision for optimal partnership and interaction between the global standardization and innovation communities. In particular, it emphasizes how…, Media Inquiries:, Nate Osburn, tel +1.610.832.9603; nosburn@astm.org , Innovation Initiatives Contact:, Brian Meincke, tel +1.610.832.9613; bmeincke@astm.org Release #10499
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Terry O. Woods, Ph.D., leader of the Solid Mechanics Laboratory at the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) in Silver Spring Maryland, USA, will serve a three-year term on the ASTM International board of directors. CDRH focuses on ensuring that patients and providers have access to safe and effective medical devices and radiation-emitting products…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org Release #10459
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After receiving inquiries from industry and academia, ASTM International announced today that it is extending deadlines by one week for letters-of-intent and full proposals for a new center of excellence in additive manufacturing. Many interested parties throughout the world have asked for more time to respond to the RFP. “We are receiving a strong and enthusiastic response to our request for…
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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