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A new ASTM International standard aims to help determine the safety of surgical implants and prevent potentially adverse effects on patients. ASTM’s committee on medical and surgical materials and devices (F04) developed the standard (soon to be published as F3306). The new test method assesses metal and other ions released from single-use, metallic, implantable medical devices and components of…, 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 #10740
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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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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 will help manufacturers classify discarded materials from their factories and facilities. This will help meet an important need for companies that value corporate responsibility and the environment. “This standard provides a system based on classification, location, disposition, and treatment,” says ASTM International member Amy Costello, a sustainability…, 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 #10476
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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 sustainability ( E60 ) has developed a new guide that will help companies set reasonable, realistic operational objectives for reducing the environmental impact of their own manufacturing processes. The standard (soon to be published as E3096, Guide for the Definition, Selection, and Organization of Key Performance Indicators for Environmental Aspects of…, Media Inquiries:, Dan Bergels , tel +1.610.832.9602 , Committee Contact:, Travis Murdock , tel +1.610.832.9826 R elease #10376
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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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Pending approval from its board of directors, ASTM International announced yesterday the launch of a new committee focused on creating technical standards and guidance materials for cannabis and its products and processes. Yesterday, about 60 industry representatives, associations, and others convened at ASTM International’s global headquarters near Philadelphia and decided to create a volunteer…, Media Inquiries:, Nate Osburn, tel +1.610.832.9603; nosburn@astm.org, Committee Contact:, Robert Morgan, tel +1.610.832.9732; rmorgan@astm.org Release #10266