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A proposed ASTM standard aims to protect children from accidentally ingesting liquids from containers such as medicine bottles through the use of restrictive delivery systems. Each year, approximately 60,000 emergency department visits are made after young children find and ingest medicines while their parents/caregivers aren’t looking. Restricted delivery systems are designed to limit access by…, ASTM Committee D10 on Packaging Next Meeting:, Oct. 25-28, 2015, October Committee Week, Tampa, Fla., Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Daniel Budnitz, M.D., Centers for Disease Control and Prevention, Atlanta, Ga., tel +1.404.639.4096; dbudnitz@cdc.gov, ASTM Staff Contact:, Diane Lake, tel +1.610.832.9661; dlake@astm.org Release #9842 ###
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A proposed ASTM standard guide will cover a heavily used procedure used for assessing bone-grafting technologies in pre-clinical models. Specifically, the standard (WK49454, Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model) describes the process for implanting bone void filler and bone graft extender products into rabbits to test their effectiveness in…, ASTM Committee F04 on Medical and Surgical Materials and Devices Next Meeting:, Nov. 17-20 2015, November Committee Week, Tampa, Fla., Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Jeffrey L. Scifert, Ph.D., Medtronic Spinal, Memphis, Tenn., tel +1.901.344.0844; jeffrey.scifert@medtronic.com, ASTM Staff Contact:, Pat Picariello, tel +1.610.832.9720; ppicariello@astm.org Release #9833 ###
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An ASTM International committee is encouraging more participation as it makes major revisions to a standard that tests packaging for many consumer products and other goods. “The general public benefits from this standard every day,” says ASTM member Bryan Williams. “Many consumer goods, including food and beverages, electronics, healthcare products and more, are tested using this standard.”…, ASTM Committee D10 on Packaging Next Meeting:, April 26-29, 2015, Anaheim, Calif., Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Bryan Williams, Lansmont Corp., Monterey, Calif. tel +1.831.655.6605; bryan_williams@lansmont.com, ASTM Staff Contact:, Diane Lake, tel +1.610.832.9661; dlake@astm.org Release #9790 ###
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A proposed new ASTM guide will provide a standardized method for measuring the safety and effectiveness of hip replacements while also fostering a less-burdensome approach to the design, review and FDA approval of clinical trials and insurance coverage decisions involving these products. Specifically, the new standard will bring more consistency and credibility to the information flowing from…, ASTM Committee F04 Next Meeting:, May 19-22, 2015, May committee week, Anaheim, Calif., Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Gregory A. Brown, M.D., Olympia Orthopaedic Associates, Olympia, Wash., tel +1.360.491.4211; gbrown@olyortho.com, ASTM Staff Contact:, Pat Picariello, tel +1.610.832.9720; ppicariello@astm.org Release #9786 ###
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Although regulatory bodies, including the U.S. Food and Drug Administration, frequently request information from manufacturers on the potential for ion release from surgical implants containing metal, there has not been a standard method for performing this evaluation. A proposed new ASTM standard, ASTM WK47808 , Test Method for Ion Release Evaluation of Medical Implants, will provide such a…, ASTM Committee F04 Next Meeting:, May 19-22, 2015, May Committee Week, Anaheim, Calif., Technical Contact:, Matthias Frotscher, Cortronik, Rostock-Warnemuende, Germany, tel +49.381.8173.7251; matthias.frotscher@biotronik.com, ASTM Staff Contact, : Pat Picariello, tel +1.610.832.9720; ppicariello@astm.org, ASTM PR Contact:, Barbara Schindler, tel +1.610.832.9603; bschindl@astm.org Release #9758
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Keeping the cap tight on a bottle of children’s cough medicine is essential, not only to keep children out of the medicine, but also to keep the medicine fresh. Understanding the degree of torque needed for cap tightness is the subject of a new ASTM International standard, D7860 , Test Methods for Measurement of Torque Retention for Child Resistant and Non-Child Resistant Packages with…, ASTM Committee D10 Next Meeting:, April 26-29, 2015, April Committee Week, Anaheim, Calif., Technical Contact:, Simon Freed, Simon Freed Consultant LLC, Providence, R.I., tel +1.908.240.4567; simon@smfpkg.com, ASTM Staff Contact:, Diane Lake, tel +1.610.832.9661; dlake@astm.org, ASTM PR Contact:, Barbara Schindler, tel +1.610.832.9603; bschindl@astm.org Release #9728
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Catheter manufacturers have found that properties of their devices can influence performance of delivered cell therapy products. However, there is wide variability in how delivery device effects on cell performance are evaluated. A proposed new ASTM International standard will help eliminate this confusion and provide guidance to manufacturers on how to measure the effects of their devices on…, ASTM Committee F04 Next Meeting:, Nov. 11-13, November committee week, New Orleans, La., Technical Contact:, Carl Simon, Jr., National Institute of Standards and Technology, Gaithersburg, Md., tel +1.301.975.4977; carl.simon@nist.gov, ASTM Staff Contact:, Pat Picariello, tel +1.610.832.9720; ppicariello@astm.org, ASTM PR Contact:, Barbara Schindler, tel +1.610.832.9603; bschindl@astm.org Release #9707
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People suffering from cardiovascular disease may have another option for treatment: drug-coated balloons. Merging established angioplasty balloon catheter technology with active drug coatings, this evolving medical technology will be covered in a proposed new ASTM standard, ASTM WK46148, Guide for Acute Durability of Drug-Coated Balloons. “Drug-coated angioplasty balloon catheters are intended to…, ASTM Committee F04 Next Meeting:, Nov. 10-14, 2014, November Committee Week, New Orleans, La., Technical Contact:, Gary Binyamin, TriReme Medical LLC, Kensington, Calif., Phone 650-823-0710; gbinyamin@yahoo.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 #9641
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Strength and penetration are key attributes needed for surgical needles. A new ASTM International standard, ASTM F3014 , Test Method for Penetration Testing of Needles Used in Surgical Sutures, focuses on penetration testing of such needles. ASTM F3014 was developed by Subcommittee F04.33 on Medical/Surgical Instruments , part of ASTM International Committee F04 on Medical and Surgical Materials…, ASTM Committee F04 Next Meeting:, Nov. 10-14, 2014, November Committee Week, New Orleans, La., Technical Contact, : Eric Hinrichs, Ethicon Inc., Somerville, N.J., Phone: 908-218-3177; ehinrich@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 #9654
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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