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A new guide proposed by ASTM International’s cannabis committee (D37) will help organizations in the industry to develop their own internal Corrective Action/Preventive Action (CAPA) processes and procedures. CAPA systems are a key part of quality management, according to committee members. Specifically, CAPA systems focus on investigating, understanding, and correcting discrepancies to prevent…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Robert Morgan, tel +1.610.832.9732; rmorgan@astm.org Release #10586
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ASTM International’s cannabis committee ( D37 ) is developing a proposed standard that will provide recommendations for laboratories involved in the industry. According to members, the standard (WK63913) will outline best lab practices, recommended certifications, various types of analyses, and the quality assurance functions for labs working with cannabis. Cary Black, consultant for Orion GMP,…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Robert Morgan, tel +1.610.832.9732; rmorgan@astm.org Release #10581
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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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ASTM International’s recently formed committee on cannabis ( D37 ) has approved its first two standards. Both deal with the aspects of moisture in cannabis. According to committee members, cannabis is generally sold by weight, with a large measure of its quality determined by the amount of moisture it contains. The standards provide a procedure to determine the water activity in a cannabis sample…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Robert Morgan, tel +1.610.832.9732; rmorgan@astm.org Release #10556
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A new ASTM International standard covers a high- strength alloy that could be used for cardiovascular stents as well as trauma, spinal, and face-related surgical implants. “This powder-metallurgy alloy has a good combination of high strength and high ductility when compared to other metallic implant materials,” said ASTM International member John Disegi, a consultant at Advanced Biomaterial…, Standardization News, magazine. Also see this overview: Standards for Healthcare Services, Products, and Technology To purchase standards, contact customer relations (tel +1.877.909.ASTM; sales@astm.org )., Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Kathleen Chalfin, tel +1.610.832.9717; kchalfin@astm.org
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A proposed ASTM International standard will help guide the development of detergents that clean medical devices, helping support patient safety and health. The practice for characterizing detergents for the cleaning of medical devices ( WK58652 ) is being created by the organization’s committee on soaps and other detergents ( D12 ). “Currently, there are no consensus methods for characterizing…
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ASTM International’s committee on medical and surgical materials and devices ( F04 ) has updated its standard on elbow prostheses to include testing guidance. This is the first time that any standards organization in the world has incorporated testing into a specification for these products, according to the committee. The revision to the specification for total elbow prostheses ( F2887 ) will…, ASTM Committee on Medical and Surgical Materials and Devices (F04) Next Meeting:, Nov. 14-17, 2017, November Committee Week, Atlanta, Ga., Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Technical Contact:, Brian Kincaid, Zimmer Biomet, Warsaw, Ind., +1.574.372.3922; brian.kincaid@zimmerbiomet.com, ASTM Staff Contact:, Kathleen Chalfin, +1.610.832.9717; kchalfin@astm.org R elease #10322
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A proposed ASTM International standard could help manufacturers improve designs for total disc replacements of diseased discs in the spine. The proposed standard (WK33006, Guide for Impingement Testing of Total Disc Prostheses) is being developed by ASTM’s committee on medical and surgical materials and devices ( F04 ). Specifically, the standard will guide manufacturers through the process of…, ASTM Committee F04 on Medical and Surgical Materials and Devices Next Meeting:, May 9-11, 2017, May Committee Week, Toronto, Ontario, Canada, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Technical Contact:, Ryan Siskey, Exponent, Philadelphia, Pa., tel +1.215.594.8800 ext. 8896, rsiskey@exponent.com, ASTM Staff Contact:, Kathleen Chalfin, tel +1.610.832.9717; kchalfin@astm.org R elease #10285
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A new ASTM International guide will help the medical industry create and select artificial materials used to test the cleanliness of reusable medical devices. The guide provides formulas for preparing artificial “test soils” that resemble blood, feces, and other biological matter that simulates contamination of the devices. Prior to this standard, there were few formulations available, according…, ASTM Committee F04 on Medical and Surgical Materials and Devices Next Meeting:, May 9-11, 2017, May Committee Week, Toronto, Ontario, Canada, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Technical Contact:, Stephen Spiegelberg, Cambridge Polymer Group, Boston, Mass., tel +1.617.629.4400; stephen.spiegelberg@campoly.com, ASTM Staff Contact:, Kathleen Chalfin, tel +1.610.832.9717; kchalfin@astm.org R elease #10280
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A proposed ASTM International standard will support the growing potential for small “scaffolds” to regrow tissue around the knee joint after a meniscus injury. The standard (WK54939, Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction) is being developed by ASTM’s committee on medical and surgical…, ASTM Committee F04 on Medical and Surgical Materials and Devices Next Meeting:, May 9-12, 2017, May Committee Week, Toronto, Ontario, Canada, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Technical Contact:, Suzanne Maher, Hospital for Special Surgery, New York, New York, tel +1.212.606.1083; mahers@hss.edu, ASTM Staff Contact:, Kathleen Chalfin, tel +1.610.832.9717; kchalfin@astm.org Release #10250