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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…
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The growing number and severity of healthcare association infections has increased interest in standardization efforts for antimicrobial gloves. In order to explore this area, ASTM International Committee D11 on Rubber has created a new task group on antimicrobial medical gloves. Glove suppliers, manufacturers and distributors, as well as contract test labs, government agency…
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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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Responding to requests from the food service industry, ASTM International Committee D11 on Rubber has developed and approved a new standard, D7329 , Specification for Food Preparation and Food Handling (Food Service) Gloves. The new standard, under the jurisdiction of Subcommittee D11.40 on Consumer Rubber Products, will serve as a referee and guide to glove manufacturers, distributors and the…
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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…
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Testing for potent allergens in rubber is the purpose of a proposed new ASTM standard. WK16334 , Test Method for the Immunological Measurement of Four Principal Allergenic Protein (Hev b 1, 3, 5 and 6.02) in Natural Rubber and Its Products, is being developed by Subcommittee D11.40 on Consumer Rubber Products, part of ASTM International Committee D11 on Rubber. According to Timo Palosuo and…
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Technical advancements in both tissue engineering and bone substitute materials have resulted in a great increase in the number of tissue-engineered medical products available on the market. Many of these new products are mineral-based, often using calcium phosphate scaffolds. While there are some general standards on scaffolds in tissue-engineered medical products, a comprehensive standard on…
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ASTM International Committee F04 on Medical and Surgical Materials and Devices is developing a proposed new standard that will help the medical device industry with the measurement and reporting of vascular stent radial stiffness and strength. The proposed standard, WK15227 , Test Methods for Radial Stiffness and Strength of Balloon Expandable Stents, is under the jurisdiction of Subcommittee F04…