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ASTM International Committee F04 on Medical and Surgical Materials and Devices is developing two new proposed standards that will be used in the field of arthroplasty. Arthroplasties are surgical procedures that resurface, remodel, rebuild or replace arthritic or dysfunctional sites of the body with optimal goals including pain alleviation, a return to full range of motion, improvement in…
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In order to address highly variable labeling within the orthopedic implant industry, ASTM International Committee F04 on Medical and Surgical Materials and Devices is developing a proposed new standard that will create a uniform labeling system for implant manufacturers. The proposed new standard, ASTM WK27458 , Guide for Presentation of End-User Information on Implant Package Labeling, is under…
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Being able to complement marketing claims in advertising and promotions with third-party certification or verification is important in any industry. A new ASTM subcommittee will be working on standards for such verification in the livestock and meat industry. The new subcommittee, F10.60 on Livestock, Meat and Poultry Marketing Claims, is part of ASTM International Committee F10 on Livestock,…
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There has been a renewed interest in instrumental qualification and standardization by the fluorescence community over the last 10 years, driven by the increasing number of quantitative chemical assays that use fluorescence detection and the presence of regulations in some of these areas. After revising three test methods for fluorescence instruments, stakeholders decided that a standard guide…
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Hydrogels are highly hydrated polymer networks that can be used in the regenerative medicine field as “scaffolding” for the repair of tissue. A proposed new ASTM standard will provide those working in regenerative medicine with a means of characterizing hydrogels. The work item, ASTM WK21927 , Guide for Characterization of Hydrogels Used in Regenerative Medicine, is under the jurisdiction of…
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Each year, approximately 400,000 healthcare workers (HCW) in the United States suffer accidental injury from needles and other medical sharps while tending to patients. These injuries can result from injections, drips, infusions, blood-taking, surgery, biopsy and research, among other causes. Each of these accidents carries a small but documented risk of transmitting more than 60 blood-borne…
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Participation is welcome in a task group that is developing a proposed new ASTM International standard for manufacturers of vascular graft tissue engineered medical products. WK21657 , Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs), is being developed by a task group under the jurisdiction of subcommittee F04.04 on Tissue Engineered Medical…
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Subcommittees F04.41 - F04.46 , which deal with Tissue Engineered Medical Products (TEMPs), part of ASTM International Committee F04 on Medical and Surgical Materials and Devices, will meet Oct. 27-28 at the National Physical Laboratory in Teddington, United Kingdom. The meeting will focus on the ongoing development of several proposed TEMPs-related standards. Several TEMPS standards are…
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ASTM Committee F10 on Livestock, Meat and Poultry Evaluation Systems has approved a new standard, F2717 , Guide for the Development of Independent Third-Party Verification. The standard, which was developed by Subcommittee F10.20 on Device Performance Criteria, provides an internationally recognized set of guidelines for companies that test the accuracy of livestock, meat and poultry evaluation…
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A new ASTM International standard provides testing procedures for devices that can be used to treat spinal disorders while allowing for continued joint movement. The standard, ASTM F2624 , Test Method for Static, Dynamic and Wear Assessment of Extra-Discal Spinal Motion-Preserving Implants, was developed by Subcommittee F04.25 on Spinal Devices, part of ASTM International Committee F04 on Medical…