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ASTM International’s cannabis committee ( D37 ) is developing a guide for quality management systems (QMS) that provide a framework for organizations dealing with cannabis consumer products. The standard ( WK61355 ) provides a guideline to show an organization’s ability to provide cannabis-related products or services that meet consumer safety standards along with local and state regulatory…, 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 #10617
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ASTM International’s committee on medical and surgical materials and devices (F04 ) is developing a standardized guide for pre-clinical testing considerations for materials used to regenerate muscle. This guide (WK64460 ) will provide scientifically-based information concerning repairing and regenerating muscle when defects are caused by trauma, such as blast injuries. “These types of injuries…, 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 #10615
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A new ASTM International subcommittee will focus on industrial hemp. The group (D37.07) will be part of ASTM’s newly formed cannabis committee ( D37 ). According to organizers, the subcommittee plans to develop practices and guides relevant to industrial hemp, a variety of the cannabis sativa plant species. Industrial hemp is used for many applications including food, natural health products,…, 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 #10608
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ASTM International’s cannabis committee (D37) is working to develop a voluntary standardized practice ( WK63546 ) that will outline how producers can respond when products need to be recalled or removed from the market. ASTM International member Cary Black, a consultant at Orion GMP, notes that many cannabis products are designed for human consumption, so product safety and quality are critical…, 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 #10589
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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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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