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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 ###
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A new ASTM International standard will help keep foreign particles out of biopharmaceuticals during the single use system (SUS) manufacturing process. ASTM’s committee on manufacture of pharmaceutical and biopharmaceutical products (E55) developed the standard, which will soon be published as E3230. According to ASTM International member Klaus Wormuth, over the last 10 years, single-use…, 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 #11021 ###
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In light of COVID-19 (coronavirus) and ongoing safety concerns for members and staff, ASTM International announced today that all previously scheduled in-person May standards development meetings (including independent meetings) have been canceled. Earlier this month, ASTM International announced the cancellation of all April in-person meetings . These decisions were based on several factors,…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org Release #11001 ###
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In light of COVID-19 (coronavirus) and growing safety concerns for members and staff, ASTM International announced today that previously scheduled April standards development meetings in Boston (March 29-April 3) and Prague (April 27-30) have been canceled. The decision was based on several factors, including, but not limited to: Continued review of information and recommendations from the U.S.…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org Release #10993
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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 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