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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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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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ASTM C1264 Addresses Origin and Source Labeling of Drywall and Other Gypsum Products, In response to the importation of contaminated drywall that caused health and safety hazards when used in home construction, the Drywall Safety Act of 2012 (PL 112-266) was signed into law by President Barack Obama on Jan. 14, 2013. The new law cites ASTM International standard C1264-11 , Specification for Sampling, Inspection, Rejection, Certification, Packaging, Marking, Shipping, Handling and…, Labeling, The Drywall Safety Act requires the CPSC to set regulations based on C1264 , which was developed by ASTM Subcommittee C11.01 on Specifications and Test Methods for Gypsum Products , part of ASTM Committee C11 on Gypsum and Related Building Materials and Systems . The standard provides the CPSC, states, suppliers and consumers with an effective tool for supply chain communication by specifying…, Up-to-Date Standards, Under the act’s provisions, ASTM International will notify the CPSC of any updates to the labeling standard within 60 days; the CPSC will then have 90 days to disapprove ASTM’s recommended changes. If the CPSC accepts the most updated version of the ASTM standard, then the new version becomes effective 180 days after ASTM’s initial notification., Sulfur Content, Because sulfur content levels in drywall have been associated with elevated corrosion rates in a home, the act requires that the CPSC issue a regulation that limits the sulfur content for drywall manufactured in the United States or imported from abroad. In lieu of issuing a federal rule, the CPSC may adopt a voluntary consensus standard, developed by C11.01, that addresses the level of sulfur…, ASTM Staff Contact:, Thomas O’Toole, Phone: 610-832-9739; totoole@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9277
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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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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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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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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…
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There are currently several uses of alloy UNS R56320 in surgical applications and implants, but the only ASTM surgical standard for the alloys covers tubing [ ASTM F2146 , Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)]. A proposed new ASTM standard will reflect the more widespread use of UNS R56320. ASTM WK34079 ,…
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Epifluorescence microscopes are used to generate fluorescence intensity images in several biology applications. A proposed new ASTM International standard will provide guidance on how to set up an experiment that uses an epifluorescence microscope to ensure that the imaging measurements are quantitative. The proposed standard will also provide guidance on how to use benchmarks to allow…, ASTM Committee F04 Next Meeting:, Nov. 15-18, 2011, November Committee Week, Tampa, Fla., Technical Contact:, John Elliot, National Institute of Standards and Technology, Gaithersburg, Md., Phone: 310-975-8551; jelliott@nist.gov, ASTM Staff Contact:, Pat Picariello, Phone: 610-832-9720; ppicarie@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8945
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A new ASTM International standard will add opportunities for metal injection molded (MIM) medical manufacturers to use materials other than castings and wrought products to develop implants with similar properties at reduced costs. ASTM F2885 , Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications, was developed by Subcommittee F04.12…