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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 security systems and equipment committee ( F12 ) has developed and approved several standards designed to assess the performance of security screening technologies. These standards cover three different types of metal detectors: hand-worn ( F3020 ), hand-held ( F3278 ), and walk-through ( F3566 ). The committee also approved a practice for conformity assessment of metal…, Verification Program Contact, : Anna Seiple, tel +1.703.930.0971; aseiple@seinet.org Release #11650 ###
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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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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 ###
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A proposed ASTM International standard will answer the need for a standardized test method that addresses the kink resistance of endovascular stents and stent grafts. The proposed standard ( WK70150 ) is being developed by ASTM’s committee on medical and surgical materials and devices ( F04 ) and will provide detailed, standardized methods for testing kink resistance. According to ASTM…, 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 #11150 ###
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ASTM International’s committee on medical and surgical materials and devices ( F04 ) is developing a proposed standard that will provide a cleaning agent formula to clean dried blood from stainless steel medical devices. According to ASTM International member Ralph Basile, the formula described in the new standard will be tested against the relevant tests in D8179, ASTM’s guide on medical device…, 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 #11131 ###
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A proposed ASTM International standard presents methods for detecting and quantifying cleaning markers (analytes) on reusable medical devices. ASTM’s committee on medical and surgical materials and devices ( F04 ) is developing the proposed standard. The objective of the proposed standard ( WK63284 ) would help medical device manufacturers, testing laboratories, and regulatory bodies identify the…, 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 #11042 ###