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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 ###
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A proposed ASTM International standard will help in analysis for trace metals using air and wipe sampling practices. ASTM’s air quality committee ( D22 ) is developing the proposed standard ( WK72704 ). The proposed standard covers the digestion of airborne and surface dust samples (collected using air and wipe sample practices) and associated quality control samples for the determination of…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Ashley Wiand, tel +1.610.832.9551; awiand@astm.org Release #11027 ###
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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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A proposed ASTM International standard-guide could help examine the range of commercially available methods for analyzing formaldehyde concentrations in indoor air. While formaldehyde is a naturally occurring substance, chronic long-term exposure can potentially lead to health issues, according to the World Health Organization’s report on formaldehyde in indoor environments. ASTM…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Ashley Wiand, tel +1.610.832.9551; awiand@astm.org Release #10964
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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