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ASTM International’s committee on medical and surgical materials and devices (F04) has approved the third in a series of standards that help evaluate effective cleaning procedures for medical devices. The new guide, which focuses on extraction of test soils to validate cleaning methods, will soon be published as F3321. According to ASTM International member Ralph Basile, the guide is an important…, 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 #10894
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A new ASTM International standard will provide performance requirements for designers and manufacturers of eye protectors for racket sports. ASTM’s committee on sports equipment, playing surfaces, and facilities ( F08 ) developed the new standard ( F3164 ). The new standard covers both prescription and non-prescription eye protective devices for racquetball, squash, and/or tennis. Requirements…, , Media Inquiries: , Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact: , Joe Koury, tel +1.610.832.9804; jkoury@astm.org Release #10875
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Global standards organization ASTM International has signed a memorandum of understanding (MOU) with the Standardization, Metrology and Certification Agency of Uzbekistan (UZSTANDART Agency), bringing the total number of MOUs to 112. The MOU program supports the use of ASTM International standards while also encouraging global participation in the ongoing development of new and revised standards…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org Release #10779
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A new ASTM International standard will help manufacturers of surgical implants inspect their products for potential mechanical failure. “The objective of this standard was to prescribe uniform inspection practices that would apply to all existing spinal device testing standards so that end users can reliably inspect parts for mechanical failure,” says ASTM International member Brad Estes, Ph.D…, 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 #10764
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Two new ASTM International standards help describe methods for characterizing the performance of brush parts that clean medical devices. The new standards (one available as F3275 and one soon to be published as F3276) were developed by ASTM International’s committee on medical and surgical materials and devices ( F04 ). According to committee member Ralph Basile, the standards describe how…, 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 #10752
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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 test method will support the growing use of roofing membranes that contain ketone ethylene ester (KEE) polymer blends that are more flexible and chemical resistant and thus less susceptible to some types of damage. In the early 2000s, members of ASTM International’s committee on roofing and waterproofing ( D08 ) developed a specification ( D6754 ) that required the…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Joseph Hugo, tel +1.610.832.9740; jhugo@astm.org Release #10528
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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