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ASTM International Committee F04 on Medical and Surgical Materials and Devices has approved a new standard for a metallurgical implant material that is useful in a variety of surgical applications. ASTM F3046 , Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy for Surgical Implant Applications (UNS R56320), was developed by Subcommittee F04.12 on Metallurgical Materials . Mark…, ASTM Committee F04 Next Meeting:, May 6-9, 2014, May Committee Week, Toronto, Ontario, Canada, Technical Contact:, Mark Ransick, Ethicon Surgical Care, Cincinnati, Ohio, Phone: 513-337-8069; mransick@its.jnj.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 #9644
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Events Include USTDA-Sponsored Workshop, Rare Earth Materials Workshop and RoHS Roundtable, ASTM International Committee F40 on Declarable Substances in Materials conducted its biannual standards development meetings on March 10-11, 2014, at Thermo Fisher Scientific’s facilities in Shanghai, China. The meeting included both standards development work and special presentations. ASTM staff and F40 members participated in other events related to declarable substances in China, including…, F40 Meeting, Committee F40 is currently developing three proposed new standards, which were discussed in the Shanghai meeting: • ASTM WK26792, Guide for Identification of Declarable Substances in Polymeric Materials; • ASTM WK21957, Test Method for Identification and Quantification of Lead in Paint and Other Coatings Using Energy Dispersive X-Ray Spectrometry (EDXRF); and • ASTM WK44003, Test Method for…, New Chemical Substance Workshop, Members of F40 participated in the U.S.-China Provisions on the Environmental Administration of New Chemical Substances workshop held in Shanghai on March 12. The workshop was organized by ASTM International in cooperation with the American National Standards Institute on behalf of the U.S. Trade and Development Agency. More than 30 participants from different regions of China, as well as from…, Rare Earth Materials Workshop, On March 13, F40 held a Rare Earth Materials workshop. Gao Lan, secretary general, Standardization Administration of China’s TC229 on Rare Earth Metals, provided an overview of TC229’s work, while Taco van der Marten, chairman of ASTM Subcommittee F40.04 on Rare Earth Materials, described the history and current activities of the subcommittee. The workshop also featured a presentation by Kevin…, RoHS Roundtable, Alyson Fick, ASTM staff manager for F40, spoke at a March 17 event held by the American Chamber of Commerce, China division, in Beijing. The roundtable on restriction of hazardous substances (RoHS) standards provided the opportunity for China-based U.S.-funded companies to understand ASTM standards that consider RoHS issues. Also speaking at that roundtable were Weibing Xing, chief engineer,…, Sinopec Visit, In addition to the F40 meetings and events, Fick, along with ASTM China office representatives Liu Fei and Nancy Hu, visited the polymers and plastic building product division of Sinopec Petroleum in Beijing. This division uses many standards under the jurisdiction of ASTM International Committee D20 on Plastics . The ASTM staff provided an overview of ASTM and D20 to 20 attending engineers. A…, ASTM Committee F40 Next Meeting:, Nov. 12-14, 2014, New Orleans, La., ASTM Staff Contact:, Alyson Fick, Phone: 610-832-9710; afick@astm.org , ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9634
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A proposed new ASTM International standard will cover fatigue testing of metallic tibial trays, which are components used in partial knee joint replacement. ASTM WK45235 , Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements, is being developed by Subcommittee F04.22 on Arthroplasty , part of ASTM International Committee F04 on Medical and…, ASTM Committee F04 Next Meeting:, May 6-9, 2014, May Committee Week, Toronto, Ontario, Canada, Technical Contact:, Gokce Yildirim, Stryker MAKO, Jersey City, N.J., Phone: 973-946-6994; gyildirim@makosurgical.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 #9630
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Patients with blockages in their coronary vasculature have historically been treated with permanent metallic stents, metal mesh tubes that open clogged blood vessels, restore blood flow and keep the vessel open over time. Certain patients can now be treated with an absorbable stent, otherwise known as a vascular scaffold, available in international markets. Absorbable stents are designed to open…, ASTM Committee F04 Next Meeting:, May 6-9, 2014, May Committee Week, Toronto, Ontario, Canada, Technical Contact:, Julia Fox, Ph.D., Abbott Vascular, Santa Clara, Calif., Phone: 408-845-0719; julia.fox@av.abbott.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 #9561
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ASTM Committee F40 on Declarable Substances in Materials will convene its next business meetings in the People’s Republic of China in March 2014. The four-day session will include participation from 20 to 25 international technical committee experts who represent global manufacturers of products that incorporate identified hazardous materials restricted by legislation. Representatives from 15…, F40.01 Test Methods:, The development of standard test methods related to declarable substances in materials and products to assist manufacturing supply chains in various industries with compliance requirements. Key standards include: • ASTM F2617 , Test Method for Identification and Quantification of Chromium, Bromine, Cadmium, Mercury and Lead in Polymeric Material Using Energy Dispersive X-Ray Spectrometry (EDXRF…, F40.02 Management Practices and Guides, : Establish standards for the management of information for the declaration via paper or electronic means of substances in materials. Key Standards include: • ASTM F2577 , Guide for Assessment of Materials and Products for Declarable Substances • ASTM F2931 , Guide for Analytical Testing of Substances of Very High Concern in Materials and Products, F40.03 Monitoring and Research of Legislation and Regulations, F40.04 Rare Earth Materials, : Development of standards for rare earth materials, with an initial focus on material recycling, reuse and recapture as well as physical characterization and terminology. Key Work Items include: • ASTM WK44003, Test Method for Identification and Quantification of Rare Earth Elements (REEs) in Rare Earth Materials (REMs) by X-Ray Fluorescence Spectrometry ASTM encourages all interested…, ASTM Committee F40 Next Meeting:, March 10-13, 2014, Shanghai, China, ASTM Staff Contact:, Alyson Fick, Phone: 610-832-9710; afick@astm.org , ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9545
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Determining the mechanical performance and biocompatibility of an implantable medical device are crucial steps in evaluating the device’s safety and efficacy. A proposed new ASTM International standard will be used to help assess device performance by examining the potential for galvanic corrosion of implants. ASTM WK19883 , Test Method for Conducting and Evaluating Galvanic Corrosion Tests of…, ASTM Committee F04 Next Meeting:, May 6-9, 2014, May Committee Week, Toronto, Ontario, Canada, Technical Contact:, Shari Nathanson Rosenbloom, Ph.D., Corrosion Testing Laboratories Inc., Newark, Del., Phone: 302-454-8200; shari@corrosionlab.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 #9537
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An ASTM International symposium on metal-on-metal total hip replacement devices held in May 2012 identified unmet standardization needs. One such need was for a standard that deals with the collection and analysis of explanted hip implants in order to understand their in-vivo performance. In addition, the U.S. Food and Drug Administration Order 522 mandates orthopaedic companies to carry out…, ASTM Committee F04 Next Meeting:, May 6-9, 2014, May Committee Week, Toronto, Ontario, Canada, Technical Contact:, Richard Underwood, Ph.D., Exponent, Philadelphia, Pa., Phone: 215-594-8800, ext. 8875; runderwood@exponent.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 #9524
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Rare earth elements and rare earth materials are common in a wide variety of products, from cell phones to electric cars and beyond. Thus, REEs and REMs have become a critical component in the economies of many developing countries. Specifications and test methods are needed to determine if the purchased quality of REEs and REMs meets the specified quality. One such proposed standard is ASTM…, ASTM Committee F40 Next Meeting:, March 10-13, 2014, Shanghai, China, Technical Contact:, Taco van der Maten, PANalytical, Almelo, The Netherlands, Phone: +31-546-534-372; taco.van.der.maten@panalytical.com, ASTM Staff Contact:, Alyson Fick, Phone: 610-832-9710; afick@astm.org , ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9527
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A proposed new ASTM International standard will be used in the design, development, quality control and comparison of a variety of collagen-based medical products, including surgical implants, delivery vehicles for therapeutic cells or molecules and substrates for tissue engineered medical products. ASTM WK43011 , Specification for Characterization and Standardization of Polymerizable Collagen-…, ASTM Committee F04 Next Meeting:, Nov. 12-14, 2013, November Committee Week, Jacksonville, Fla., Technical Contact:, Sherry Voytik-Harbin, Weldon School of Biomedical Engineering and Department of Basic Medical Sciences, Purdue University, Phone: 765-496-6128; harbins@purdue.edu ; Tetsuro Wakatsuki, InvivoSciences Inc., Phone: 608-713-0149; tetsuro@invivosciences.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 #9490
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All interested parties are welcome to join in the development of a proposed new ASTM International standard that will provide guidance on how to conduct axial, bending and torsional fatigue testing of stents. The proposed new standard, ASTM WK23330 , Guide for in Vitro Axial, Bending and Torsional Durability Testing of Vascular Stents, is being developed by Subcommittee F04.30 on Cardiovascular…, ASTM Task Group F04.30.06 Next Meeting:, Nov. 21, 2013, FDA White Oak Campus, Silver Spring, Md., Technical Contact:, Brian Choules, MED Institute Inc., West Lafayette, Ind., Phone: 765-463-7537; choules@medinst.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 #9471