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A proposed ASTM International standard will be used to determine the fatigue strength of metallic components used in the development and manufacture of cardiovascular medical devices. Such devices include stents, heart valves, inferior vena cava (IVC) filters, endovascular prostheses, and other cardiovascular devices with metallic components. The proposed standard ( WK88773 ) will aid in the…, Media Inquiries:, Gavin O’Reilly, tel +1.610.832.9618; goreilly@astm.org, Committee Contact:, Kate Chalfin, tel +1.610.832.9717; kchalfin@astm.org Release #11803 ###
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ASTM International’s medical and surgical materials and devices committee ( F04 ) is currently working on a proposed standard on locking mechanisms for locking plate and screw systems. The systems described in the proposed standard ( WK88483 ) aid in the healing of bone fractures. The proposed standard will be used to evaluate and compare the mechanical properties of locking mechanisms used with…, Media Inquiries:, Gavin O’Reilly, tel +1.610.832.9618; goreilly@astm.org, Committee Contact:, Kate Chalfin, tel +1.610.832.9717; kchalfin@astm.org Release #11792 ###
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ASTM International’s medical and surgical materials and devices committee ( F04 ) has developed standard test methods to serve as a basis for mechanical comparison of small bone plates. Small bone plates, as detailed in this standard, are metallic plates used to fix far extremities in the human body, like fingers, toes, and areas in the cranium and upper face. According to ASTM member Joe Turner…, Media Inquiries:, Gavin O’Reilly, tel +1.610.832.9618; goreilly@astm.org, Committee Contact:, Kate Chalfin, tel +1.610.832.9717; kchalfin@astm.org Release #11665 ###
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ASTM International’s manufacture of pharmaceutical and biopharmaceutical products committee ( E55 ) has approved a new standard that will help advance the use of continuous manufacturing (CM) technologies in the biopharmaceutical industry. In a CM process, individual unit operations are integrated into a connected flow which provides multiple efficiencies in terms of scale and productivity. “…, 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 #11543 ###
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A new ASTM International standard seeks to coordinate terminology relating to microphysiological systems. The standard, soon to be published as F3570, was developed by ASTM’s committee on medical and surgical materials and devices ( F04 ). Microphysiological system (MPS) models simulate the physiologic activities of organs and organ systems at the microscale, and use of this technology can ease…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Kate Chalfin, tel +1.610.832.9717; kchalfin@astm.org Release #11484 ###
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A new ASTM International standard will provide a test method related to sacroiliac joint fusion devices. The standard ( F3574 ) was developed by the committee on medical and surgical materials and devices ( F04 ). According to ASTM International member Nathan Wright, prior to this standard, sacroiliac (SI) joint fusion devices have not had standardized test methods. “Sacroiliac (SI) joint fusion…, 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 #11477
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A proposed ASTM International standard will help advance the concept of lyophilization (freeze-drying) as it is used in the pharmaceutical and biotechnology industries. ASTM’s committee on manufacture of pharmaceutical and biopharmaceutical products ( E55 ) is developing the proposed standard. “The proposed standard will promote a deeper understanding of the science and engineering of…
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A proposed ASTM International standard will be used to aid physical integrity testing of single-use systems (SUS) in the pharmaceutical and biopharmaceutical industries. SUS equipment has become a popular alternative to stainless steel equipment that has been generally used for biopharmaceutical manufacturing processes. ASTM International’s committee on manufacture of pharmaceutical and…
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A new ASTM International standard will aid the pharmaceutical industry by describing best practices in monitoring process and product condition during freeze-drying. ASTM’s committee on manufacture of pharmaceutical and biopharmaceutical products (E55) developed the standard, which focuses on methods that apply to both laboratory and production environments. “The new standard provides guidance on…, Media Inquiries:, Jaime Martorana, tel +1.610.832.9796; jmartorana@astm.org , Committee Contact:, Travis Murdock, tel +1.610.832.9826; tmurdock@astm.org Release #11246 ###
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ASTM International’s committee on medical and surgical materials and devices ( F04 ) invites all interested parties to participate in the revision of the terminology standard ( F2312 ) for tissue-engineered medical products (TEMP). “The value in this standard is that it allows for clearer communication between different facets of the field helping to get products developed more efficiently and…, Media Inquiries:, Jaime Martorana, tel +1.610.832.9796; jmartorana@astm.org , Committee Contact:, Kathleen Chalfin, tel +1.610.832.9717; kchalfin@astm.org Release #11191 ###