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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 provides a new way to test for water vapor transmission through flexible barrier materials using electrolytic detection sensors. According to ASTM International member Victor Kofman, technical manager of R&D at Illinois Instruments, water vapor transmission can have a negative impact on food, pharmaceuticals, and other products in the package. “Historically…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Jimmy Farrell, tel +1.610.832.9661; jfarrell@astm.org Release #10566
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A new ASTM International test method helps identify leaks in packages, which is important for supporting quality and safety of various medical, pharmaceutical, and food products. According to ASTM International member Larry Bishop, the “Mass extraction container closure integrity test method” allows manufacturers to identify very small packaging defects without affecting a package’s contents (…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, James Farrell, tel +1.610.832.9661; jfarrell@astm.org Release #10516
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ASTM International’s committee on primary barrier packaging (F02) has approved a new guide that will help validate test methods for packaging on medical devices. This will help professionals who specify certain packaging as well as those who regularly test packaging, ultimately helping support quality and safety of products. According to ASTM International member Daniel Burgess of Boston…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, James Farrell, tel +1.610.832.9661; jfarrell@astm.org Release #10494
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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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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