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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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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…
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ASTM International Committee F04 on Medical and Surgical Materials and Devices is developing a proposed new standard that will help the medical device industry with the measurement and reporting of vascular stent radial stiffness and strength. The proposed standard, WK15227 , Test Methods for Radial Stiffness and Strength of Balloon Expandable Stents, is under the jurisdiction of Subcommittee F04…
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Two proposed new ASTM standards will serve as guides for laboratories around the world in establishing a minimum basis of practice for validation and sampling of seized drugs. The proposed standards, WK12734 , Guide for Sampling Seized Drugs for Qualitative and Quantitative Analysis, and WK12735 , Practice for Validation of Seized Drug Analytical Methods, are under the jurisdiction of…
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A proposed new standard being developed by ASTM International Committee B09 on Metal Powders and Metal Powder Products offers a solution to the challenge of handling and characterizing very fine powders. Subcommittee B09.02 on Base Metal Powders is developing the proposed standard, WK13023 , Test Method for Determination of Tap Density of Metallic Powders by a Constant Volume Measuring Method. …
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Understanding how blood within a human body will interact with any substance with which it comes in contact is a crucial part of any medical process. A new practice recently approved by ASTM International Committee F04 on Medical and Surgical Materials and Devices is one of a series of standards that evaluates the complement activating properties of solid materials intended for use in contact…
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Conventionally processed powder metallurgy materials often exhibit open microporosity at the surface. While it is a natural part of the process, this microporosity can affect the measurement of surface finishes. To cover this and other issues that arise from measuring the surface finish of powder metallurgy, ASTM International Committee B09 on Metal Powders and Metal Powder Products has developed…
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A new standard, developed by ASTM International Committee F04 on Medical and Surgical Materials and Devices, establishes performance requirements for single-use, enteral feeding devices with retention balloons. These devices are used by medical professionals to provide nutrition or administer medication to patients through a natural orifice (nasal, oral, transluminal) or through a surgically…