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  • ASTM
    F1609-23 Standard Specification for Calcium Phosphate Coatings for Implantable Materials (Redline)
    Edition: 2023
    $93.60
    Unlimited Users per year

Description of ASTM-F1609 2023

ASTM F1609-23

Redline Standard: Standard Specification for Calcium Phosphate Coatings for Implantable Materials




ASTM F1609

Scope

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)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 covers hydroxylapatite coatings, other calcium phosphate (for example, octacalcium calcium phosphate, amorphous calcium phosphate, dicalcium phosphate dihydrate) coatings, or a coating containing a combination of two or more calcium phosphate phases, with or without intentional minor additions of other elements or compounds (for example, fluorine, manganese, magnesium, carbonate),3 and applied by methods including, but not limited to, the following: (1) plasma spray deposition, (2) solution precipitation, (3) dipping/sintering, (4) electrophoretic deposition, and (5) sputtering.

1.4 For a coating containing two or more calcium phosphate phases, one or more of which will be a major phase or major phases in the coating, while the other phase(s) may occur as a second or minor phases, the phase composition(s) of the coating should be determined against each corresponding crystalline phase, respectively. See X1.2.

1.5 Substrates may include smooth, porous, textured, and other implantable topographical forms.

1.6 This specification excludes organic coatings that may contain calcium and phosphate ionic species.

1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.


Keywords

bone implant; calcium phosphate; coating; dental implant; hydroxylapatite; mechanical tests; orthopedic medical devices; physical characterizations; tricalcium phosphate;


ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)


DOI: 10.1520/F1609-23

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About ASTM

ASTM 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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