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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 Committee E10 on Nuclear Technology and Applications has approved two new ASTM standards, ASTM E2628 , Practice for Dosimetry for Radiation Processing, and ASTM E2701 , Guide for Performance Characterization of Dosimeters and Dosimetry Systems for Use in Radiation Processing. Both standards are under the jurisdiction of Subcommittee E10.01 on Radiation Processing: Dosimetry and Applications…, ASTM Committee E10 Next Meeting:, Jan. 24-27, January committee week, San Antonio, Texas, Technical Contact:, (E2628) John Logar, Ethicon Inc., Somerville, N.J., Phone: 908-218-5638; jlogar8@its.jnj.com ; (E2701) Rod Chu, Ottawa, Ontario, Canada, Phone: 613-565-2305; rodchu@rogers.com, ASTM Staff Contact:, Joe Koury, Phone: 610-832-9804; jkoury@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #84 58/Jan2010
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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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New ASTM Committee E58 to Develop Standards That Support Engineering Investigations and Assist the Court, ASTM International, one of the largest voluntary standards development organizations (SDO) in the world, today announced the formation of ASTM Committee E58 on Forensic Engineering . Committee E58 will develop standards that promote awareness of the scientific, engineering, ethical and legal considerations inherent in forensic engineering investigations, reporting and testimony., Bringing Engineering Reason to the Dispute Resolution Process, Forensic engineering focuses on the investigation of alleged defects in materials, products, structures and components. These cases are litigated on the premise that the defects cause personal injury or damage to property. Forensic engineering investigations may help determine the causes of these events and assist the disputing parties or the court in resolving the case. Today, forensic…, Assisting the Court through Consensus Standards, ASTM Committee E58 comes together to create important standards and guides that will support the judicial process by facilitating an improved understanding of forensic engineering practices and associated technical issues. This will better enable the court to resolve disputes in a more well-informed and efficient manner, relying on deeper knowledge of the technical data presented and the sound…, E58 Standards: Guiding Forensic Engineering Practice, E58 standards will help guide forensic engineers in conducting investigations in a robust manner while protecting overall public safety. The initial scope of Committee E58 activities will be driven by subcommittees on Product Defect Incidents, Vehicular Incidents, Electrical Incidents and Industrial Processes. ASTM Committee E58 will build upon the body of work of former subcommittee E30.05 on…, Foundation Standard for the Forensic Engineering Profession, Other E58 standards will bolster the role of forensic engineering professionals in the eyes of the court and other users of these services. Consistent with this objective, Committee E58 has recently drafted a general practice document for the forensic engineering profession, titled Standard Guide for the Practice of Forensic Engineering. The goal of this standard is to further educate the court…
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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 proposed new standard is being developed for the industrial radiation processing industry and irradiation research facilities where absorbed-dose measurement is critical. The proposed standard, WK15409 , Practice for Dosimetry in Radiation Processing, is under the jurisdiction of Subcommittee E10.01 on Radiation Processing: Dosimetry and Applications, which is part of ASTM International…