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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…
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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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ASTM International Committee F40 on Declarable Substances in Materials has approved its first test method, F2617 , Test Method for Identification and Quantification of Chromium, Bromine, Cadmium, Mercury and Lead in Polymeric Material Using Energy Dispersive X-ray Spectrometry. The new standard is under the jurisdiction of Subcommittee F40.01 on Test Methods. ASTM F2617 describes a method for…
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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 will assist industry with a communication tool in order to comply with the European Union's Registration, Evaluation and Authorization of Chemicals, more commonly referred to as REACH. ASTM F2725, Standard Guide for European Union's Registration, Evaluation and Authorization of Chemicals (REACH) Supply Chain Information Exchange, was developed by Subcommittee F40…