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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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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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ASTM International Committee E11 on Quality and Statistics has approved a new practice that describes methods for proficiency testing providers to use in analyzing laboratory results obtained in their programs. The standard, E 2489 , Practice for Statistical Analysis of One-Sample and Two-Sample Interlaboratory Proficiency Testing Programs, is under the jurisdiction of Subcommittee E11.20 on Test…
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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 F16 on Fasteners has recently approved an important new standard that deals with coated threaded fasteners and washers by hot-dip zinc galvanizing. The standard, F 2329, Specification for Zinc Coating, Hot-Dip, Requirements for Application to Carbon and Alloy Steel Bolts, Screws, Washers, Nuts and Special Threaded Fasteners, is under the jurisdiction of Subcommittee…
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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 Committee F16 on Fasteners has developed a new standard, F 2329, Specification for Zinc Coating, Hot-Dip, Requirements for Application to Carbon and Alloy Steel Bolts, Screws, Washers, Nuts, and Special Threaded Fasteners. The standard, which is under the jurisdiction of Subcommittee F16.03 on Coatings on Fasteners, covers the requirements for hot-dip zinc coating applied to…
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A former military standard has become the basis for a new ASTM standard developed by Committee E11 on Quality and Statistics. The new standard, E 2234, Practice for Sampling a Stream of Product by Attributes Indexed by AQL, will be the first in a series based on a now-withdrawn set of military documents on sampling. Practice E 2234, presently under the jurisdiction of Subcommittee E11.10 on…
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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…