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A new ASTM International standard responds to a recent emphasis by regulatory agencies that firms manufacturing drug products demonstrate the efficacy of disinfectants used in controlled environments. The standard, ASTM E2614 , Guide for Evaluation of Cleanroom Disinfectants, was developed by Subcommittee E35.15 on Antimicrobial Agents, part of ASTM International Committee E35 on Pesticides and…
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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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Plastic pipe and components are used with low pressure oxygen and enriched air for a variety of applications, including medical and healthcare, agriculture (fish farming), welding and fabrication, waste water treatment and others. Despite this widespread use, there are currently no standards that help in the materials selection and design features of these systems. ASTM International Committee…
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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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A new ASTM International standard describes a variety of methods that can be used to determine the index of refraction and dispersion of glass. The standard, C 1648 , Guide for Choosing a Method for Determining the Index of Refraction and Dispersion of Glass, will be useful to manufacturers of glass and glass products as well as designers of products in which glass is a critical component. C 1648…
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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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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…
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ASTM International Committee G04 on Compatibility and Sensitivity of Materials in Oxygen Enriched Atmospheres originally developed the standard, G 88, Guide for Designing Systems for Oxygen Service, in 1984. Since that time, G 88 has been regarded as one of the leading design guides for oxygen systems throughout all industries that use oxygen. While the original version of the standard contained…
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ASTM International Committee F04 on Medical and Surgical Materials and Devices is now developing a proposed new standard, WK8619, Test Method for the Measurement of Crystallinity and Melting Point of Ultra High Molecular Weight Polyethylene via Differential Scanning Calorimetry. The proposed test method, under the jurisdiction of Subcommittee F04.15 on Material Test Methods, will focus on the…