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The latest in a series of ASTM International standards developed for the characterization of mobile bearing knees prior to implementation has now been approved by ASTM International Committee F04 on Medical and Surgical Materials and Devices. The new standard, ASTM F2777 , Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion, is under the…
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Evaluating potential irritant effects to skin is an important part of the overall safety assessment of many consumer products, including feminine hygiene products, fabrics and diapers. The normal use of these products involves contact with the skin, while continuous friction through normal movement can result in mechanical irritation. A new ASTM International standard can now be used to test both…
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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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A new ASTM International standard will provide the means to quickly detect and quantify the lead concentration in toys and other children's products. The new standard, F2853 , Test Method for Determination of Lead in Paint Layers and Similar Coatings or in Substrates and Homogenous Materials by Energy Dispersive X-Ray Fluorescence Spectrometry Using Multiple Monochromatic Excitation Beams, was…
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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 presence of lead in toys and other consumer products continues to make headlines. The Consumer Product Safety Improvement Act, a United States law enacted in August 2008, addresses the lead issue and makes provisions for the use of X-ray spectrometry in testing for lead content. To aid the toy and consumer products industries in using X-ray spectrometry for lead detection and meet the…