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ASTM F2989 is a new ASTM International standard that covers unalloyed titanium components that are used for surgical implants. The new Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications was developed by Subcommittee F04.12 on Metallurgical Materials , part of ASTM International Committee F04 on Medical and Surgical Materials and Devices . …, ASTM Committee F04 Next Meeting:, May 21-24, 2013, May Committee Week, Indianapolis, Ind., Technical Contact:, Matthias Scharvogel, Element 22 GmbH, Kiel, Germany, Phone: +49-431-659-4620; matthias.scharvogel@element22.de, ASTM Staff Contact:, Pat Picariello, Phone: 610-832-9720; ppicariello@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9336
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A new ASTM International standard sets quality requirements for the manufacture, documentation and records retention for light sport aircraft designed to ASTM consensus standards. ASTM F2972 , Specification for Light Sport Aircraft Manufacturer’s Quality Assurance System, was developed by Subcommittee F37.70 on Cross Cutting , part of ASTM International Committee F37 on Light Sport Aircraft .…, ASTM Committee F37 Next Meeting:, April 22-23, 2013, Messe Friedrichshafen GmbH, Friedrichshafen, Germany, Technical Contact:, Adam J. Morrison, Streamline Designs LLC, Greenwood, Ind., Phone: 317-888-1026; adam.morrison@sportplanedesign.com, ASTM Staff Contact:, Christine DeJong, Phone: 610-832-9736; cdejong@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9315
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There has long been a need within the tissue engineering/regenerative medicine sector for three-dimensional reference scaffolds to serve as physical standards for the materials that are used as beds for the growth of cell cultures. The National Institute of Standards and Technology has created such references, which will eventually be accompanied by a proposed ASTM International standard that…, ASTM Committee F04 Next Meeting:, May 21-24, 2013, May Committee Week, Indianapolis, Ind., Technical Contact:, Carl G. Simon Jr., Ph.D., Biosystems and Biomaterials Division, National Institute of Standards and Technology, Gaithersburg, Md., Phone: 301-975-8574; carl.simon@nist.gov, ASTM Staff Contact:, Pat Picariello, Phone: 610-832-9720; ppicariello@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9298
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Many types of surgical implants and other medical devices are made of polymeric materials. A new ASTM standard covers the raw material properties for a high strength polymer used for surgical implants. ASTM F2820 , Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications, has been developed by ASTM International Subcommittee F04.11 on Polymeric Materials , part of…, ASTM Committee F04 Next Meeting:, May 21-24, 2013, May Committee Week, Indianapolis, Ind., Technical Contact:, Jon P. Moseley, Ph.D., Wright Medical Technology Inc., Arlington, Tenn., Phone: 901-867-4414; jon.moseley@wmt.com, ASTM Staff Contact:, Pat Picariello, Phone: 610-832-9720, ppicariello@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9276
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ASTM International Committee F02 on Flexible Barrier Packaging will hold its next meeting on Sept. 26-27, 2012, at the Hotel Rey Juan Carlos I in Barcelona, Spain. At this meeting, participants will have the opportunity to contribute to the development and revision of a number of standards important to the use and evaluation of flexible barrier packaging. One of the highlights of the meeting will…, Future Trends in Permeation Measurements, , presented by Franz Sturm, Lipke •, U.S. FDA Perspective: The Use of Standards in Premarket Submissions and Auditing the Medical Device Packaging Process, , presented by Pat Weixel, U.S. Food and Drug Administration •, Microbial Barrier Test Methods for Porous Sterile Barrier Materials, , presented by Thierry Wagner, DuPont Medical and Pharmaceutical Protection •, Toward a Package Durability Predictive Model, , presented by Henk Blom, Rollprint Packaging Products •, Package Integrity: Methods of Detection, , presented by Wendy Mach, Nelson Laboratories •, Use of Design Guide F2097 and U.S. FDA Recognition, , Hal Miller, PACE Solutions LLC •, Sterile Medical Device Package Performance Testing and the Nebulous Effect of Vibration in Transit, , presented by Pat Nolan, DDL •, ASTM International: ASTM Mechanics and Overview, , presented by Diane Trinsey, ASTM Committee F02 staff manager All are welcome to attend. Registration and meeting information, including abstracts describing the presentations shown above, can be found at www.astm.org/COMMIT/F02/Barcelona_Meeting_info . Committee F02 develops standards on barrier materials, their properties and package design, development and production. Typical flexible barrier…, ASTM Committee F02 Next Meeting:, Sept. 26-27, 2012, Barcelona, Spain, ASTM Staff Contact:, Diane Trinsey, Phone: 610-832-9661; dtrinsey@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9289
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A new ASTM International standard provides a much-needed methodology for determining the shelf life of various attributes of endovascular devices. The new standard, ASTM F2914 , Guide for Identification of Shelf-Life Test Attributes for Endovascular Devices, was developed by Subcommittee F04.30 on Cardiovascular Standards , part of ASTM International Committee F04 on Medical and Surgical…, ASTM Committee F04 Next Meeting:, Nov. 13-16, 2012, November Committee Week, Atlanta, Ga., Technical Contact:, Benjamin Gundale, Boston Scientific, Maple Grove, Minn., Phone: 763-494-2771; gundaleb@bsci.com, ASTM Staff Contact:, Pat Picariello, Phone: 610-832-9720; ppicarie@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9264
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ASTM International Committee F37 on Light Sport Aircraft will host the International Workshop on Electric Aircraft Standardization on March 28 at the Hilton Garden Inn in Lakeland, Fla. The workshop is being held in conjunction with Committee F37’s standards development meetings at the 38th Annual SUN ‘n FUN International Fly-In and Expo. The marketplace adoption of electric aircraft requires…
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New functionalities in a particular group of orthopedic spinal devices will be addressed in a proposed new ASTM standard. ASTM WK34549 , Test Methods for Intervertebral Body Fusion Devices with Integrated Fixation Components, is being developed by Subcommittee F04.25 on Spinal Devices , part of ASTM International Committee F04 on Medical and Surgical Materials and Devices . According to Andrew…
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On July 29, 2011, the U.S. Federal Aviation Administration announced in the Federal Register the availability of ASTM International standard F2746–09 , Specification for Pilot’s Operating Handbook (POH) for Light Sport Airplane, as well as ASTM F2245-10c , Specification for Design and Performance of a Light Sport Airplane. Manufacturers of fixed wing light sport aircraft are required to revise…
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One of the most important characteristics of a curved surgical needle is how easily it can pass through tissue. This characteristic, known as penetration force, is important for several reasons, which include minimizing scarring and dealing with highly communicable diseases such as hepatitis. ASTM International Committee F04 on Medical and Surgical Materials and Devices is currently developing a…