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ASTM F 1926/F1926M : 2014 : R2021

Current

Current

The latest, up-to-date edition.

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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

09-06-2021

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

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

1.3The 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.

1.4The 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.

1.5The 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.

1.6This 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.7This 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.

Committee
F 04
DocumentType
Test Method
Pages
5
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

ASTM F 1185 : 2023 Standard Specification for Composition of Medical-Grade Hydroxylapatite for Surgical Implants
ASTM E 691 : 2020 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM F 1088 : 2023 Standard Specification for Medical-Grade Beta-Tricalcium Phosphate Raw Material for Implantable Medical Devices
ASTM E 691 : 2023 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2022 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2021 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM F 1185 : 2003 : R2014 Standard Specification for Composition of Hydroxylapatite for Surgical Implants
ASTM F 1088 : 2018 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation

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