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Subcommittee F04.25 on Spinal Devices has been proactive in developing and advancing standards that can be used by the medical community for testing prosthetic devices in their early stages of development. The latest F04.25 standard to provide this opportunity is ASTM F2790 , Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses. Subcommittee F04.25…
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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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The impact of health care related infections is a global concern, and hands are a leading means of direct or indirect transport of infectious microorganisms. A task group within Subcommittee D11.40 on Consumer Rubber Products has begun to develop standards focused on preventing that transfer through the use of antimicrobial agents on gloves. D11.40 is part of ASTM International Committee D11 on…
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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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Residual accelerator chemicals in medical gloves appear to be a leading cause of allergic contact dermatitis in health care workers. A new ASTM International standard allows rubber glove manufacturers to monitor the level of residual chemicals in their end products and to potentially make manufacturing changes to reduce allergen levels. The new standard, D7558 , Test Method for Colorimetric/…
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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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Once approved, a proposed new ASTM standard would provide the U.S. Food and Drug Administration and personal lubricant manufacturers a means to evaluate the effect of a lubricant on the physical integrity of condoms. No standard currently exists for this type of testing. Manufacturers of condoms and rubber gloves as well as personal lubricants are welcome to join in the development of ASTM…
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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…