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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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Biofilm, self-organized communities of bacteria that can have both positive and negative effects in a variety of industries, is the subject of a new ASTM International standard, E 2562 , Test Method for Quantification of Pseudomonas aeruginosa Biofilm Grown with High Shear and Continuous Flow Using CDC Biofilm Reactor. The new standard is under the jurisdiction of Subcommittee E35.15 on…
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Responding to a new emphasis by regulatory agencies that firms manufacturing drug products demonstrate the efficacy of disinfectants used in controlled environments, ASTM International Committee E35 on Pesticides and Alternative Control Agents has begun to develop a proposed new standard, WK12880 , Guide for Evaluation of Clean Room Disinfectants. WK12880 is under the jurisdiction of Subcommittee…
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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 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…
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ASTM International Subcommittee F04.35 has recently undergone a name change. Formerly known as F04.35 on GI Endoscopes, the subcommittee, which is under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, is now known as Gastroenterolgy (GI). The name change indicates a broadening of the scope of activities for the subcommittee. James Bardwell, Leading Medical…