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Description of ASTM-F1609 2008ASTM F1609-08Historical Standard: Standard Specification for Calcium Phosphate Coatings for Implantable MaterialsASTM F1609Scope 1.1 This specification covers the material requirements for calcium phosphate coatings for surgical implant applications. 1.2 In particulate and monolithic form, the calcium phosphate materials system has been well-characterized regarding biological response (1,2) and laboratory characterization (2-4). Several publications (5-10) have documented the in vitro and in vivo properties of selected calcium phosphate coating systems. 1.3 This specification includes hydroxylapatite coatings, tricalcium phosphate coatings, or combinations thereof, with or without intentional minor additions of other ceramic or metallic, and applied by methods including, but not limited to, the following: (1) mechanical capture, (2) plasma spray deposition, (3) dipping/sintering, (4) electrophoretic deposition, (5) porcelainizing, and (6) sputtering. 1.4 Substrates may include smooth, porous, textured, and other implantable topographical forms. 1.5 This specification excludes organic coatings that may contain calcium and phosphate ionic species. 1.6 Warning—Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law. Keywords bone implant; calcium phosphate; coating; dental implant materials; hydroxylapatite; mechanical tests; orthopedic medical devices; physical characterizations; tricalcium phosphate; Calcium phosphate coatings--specifications; Coatings (surgical implants)--specifications; Orthopaedic medical devices--specifications; Surgical implants--specifications ICS Code ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics) DOI: 10.1520/F1609-08 The following editions for this book are also available...This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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