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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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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 E57 Will Meet Important Industry Need for Consensus Standards, ASTM International, one of the largest voluntary standards development organizations (SDO) in the world, has announced the formation of ASTM Committee E57 on 3D Imaging Systems. The new standards initiative was driven by the cooperative efforts of the National Institute of Standards and Technology (NIST) and stakeholders within the 3D imaging systems sector. Committee E57 will focus on the…, Powerful Tools for Measurement and Information Capture, 3D imaging systems are used to rapidly capture three-dimensional information of a scene or object. This information is often provided in the form of “point clouds” (grouping of points) with associated color and intensity data. Usage of 3D imaging systems has steadily increased during the past 10 years as the devices have become important measuring tools in industrial sectors such as construction…, Dynamic, Growing Technology in Need of Consensus Standards, 3D imaging technology has been in existence for several decades. Current systems include laser scanners, 3D optical scanners, 3D range cameras, and 3D flash laser radars (LADARs). Although these systems have become more established during the last decade, there are presently no standards for evaluating the performance of 3D imaging systems or the related end projects derived from the data they…, ASTM International: Meeting the Call for a Comprehensive Standards Program, Following a NIST workshop of stakeholders from the 3D imaging systems sector held in March, ASTM International was chosen in a competitive bid process to be home of the new standards initiative. With a proven consensus process and state-of-the-art standards development infrastructure, ASTM is well suited to meet the 3D imaging industry’s need for comprehensive standards. ASTM Committee E57 will…
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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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Dried blood represents the greatest challenge to cleaning surgical instruments. To meet this challenge, ASTM International Committee D12 on Soaps and Other Detergents has developed a new standard, D 7225 , Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors. The new guide is under the jurisdiction of Subcommittee D12.16 on Hard Surface Cleaning. Water-soluble components of…
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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…