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Air permits from regulatory agencies, such as the U.S. Environmental Protection Agency (USEPA), often require the measurement of a plume's opacity as the plume is emitted from a stationary point source (for example, smokestacks) in the outdoor ambient environment. While such opacity is often visually measured by human observers as “certified smoke readers,” an opacity measurement method using…
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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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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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The measurement of acid mist is becoming increasingly important due to recent actions taken by the U.S. Environmental Protection Agency on fine particles (2.5 micrometers in diameter and smaller) that are unhealthy to breathe. ASTM International Committee D22 on Air Quality is currently working on a proposed standard for measuring acid mists that come from combustion sources, WK22846 , Test…
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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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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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A new ASTM International standard provides guidance for using data generated by ASTM standards in testing for asbestos in surface dust. ASTM D 7390 , Guide for Evaluating Asbestos in Dust on Surfaces by Comparison Between Two Environments, was approved by ASTM International Committee D22 on Air Quality, part of Subcommittee D22.07 on Sampling and Analysis of Asbestos. According to James Millette…
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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…