This standard is issued under the fixed designation F1609; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon (ε) indicates an editorial change since the last revision or reapproval.

1. 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.

2. Referenced Documents

2.1 ASTM Standards:4

2.2 U.S. Pharmacopeia Convention Documents:5

2.3 Other Documents:

3. Terminology

3.1 Definitions:

4. Chemical or Crystallographic Requirements, or Both

4.1 Chemical:

4.2 Crystallographic Characterization:

4.3 Environmental Stability

4.4

5. Physical Characterization

5.1 Coverage of Substrate:

5.2 Thickness

5.3 Porosity

5.4 Color

5.5 Surface Topography

6. Mechanical Characterization

6.1

7. Test Specimen Fabrication

7.1

7.2

8. Contact with Calcium Phosphate Coatings

8.1

9. Quality Program Requirements

9.1

10. Keywords

10.1 REFERENCES

RELATED MATERIAL

ASTM F1609 - 23

Standard Specification for Calcium Phosphate Coatings for Implantable Materials

Current

Published:

1 Jul 2023

1. Scope