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  • ASTM
    F1926/F1926M-14 Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings
    Edition: 2014
    $93.60
    Unlimited Users per year

Description of ASTM-F1926/F1926M 2014

ASTM F1926/F1926M-14

Historical Standard: Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings




ASTM F1926/F1926M

Scope

1.1 This test method covers calcium phosphate materials intended for use in surgical implant applications.

1.2 The material(s) shall be representative of that produced for sale. It shall have been produced and processed under standard manufacturing conditions.

1.3 The materials may be in the form of powders, granules, spall material, fabricated forms or coatings; and may be porous, nonporous, textured, and other implantable topographical substrate form representative of the end-use product.

1.4 The calcium phosphate material may constitute the only material in a substrate or it may be one of multiple materials so long as all other materials present do not dissolve under the test conditions described in this test method.

1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.

1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.


Keywords

calcium-phosphate; coating; dissolution rate; fabricated form; granule


ICS Code

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


DOI: 10.1520/F1926_F1926M-14

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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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