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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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ASTM International Subcommittee E34.50 on Health and Safety Standards for Metalworking Fluids has developed three new standards. Two of the recently approved ASTM standards cover aspects of water-miscible metalworking fluids, while the third concerns prevention of dermatitis in the wet metal removal fluid environment., Prevention of Dermatitis, Dermatitis is an inflammatory response of the skin to a chemical or physical agent. While redness, swelling and itching are typical signs of dermatitis, symptoms can be more severe as well. A new ASTM standard, ASTM E2693 , Practice for Prevention of Dermatitis in the Wet Metal Removal Fluid Environment, discusses dermatitis and its causes and presents a comprehensive approach to dermatitis…, Metalworking Fluids, Two new E34.50 standards address the detection of microbial contamination in metalworking fluids: ASTM E2657 , Test Method for Determination of Endotoxin Concentrations in Water-Miscible Metalworking Fluids, and ASTM E2694 , Test Method for Measurement of Adenosine Triphosphate in Water-Miscible Metalworking Fluids. Both ASTM E2657 and ASTM E2694 measure biological contamination in metalworking…, Participation Invited, The subcommittee is currently looking for participants for an interlaboratory study for ASTM E2657 and ASTM E2694 . “We plan to use a single set of MWF for both standards, so labs who are interested in either or both are welcome to participate,” says Passman. “A few labs will run both the ILS’s for both standards, while most will run one or the other.” Subcommittee E34.50 is part of ASTM…
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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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All interested parties in the glass industry are invited to participate in the development of a proposed new standard guide for the safe handling of annealed glass. The new standard will be developed by a task group within ASTM Committee E34 on Occupational Health and Safety. A small group from industry and OSHA met in Rossford, Ohio, in March to discuss this new activity. The task group plans to…
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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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Information and product destruction services is a rapidly growing industry. In order to develop standards to serve the needs of this industry, ASTM International Committee E34 on Occupational Health and Safety has formed Subcommittee E34.25 on Mobile and Plant-Based Security Destruction Equipment Safety Requirements. All interested parties are invited to participate in the standards developing…