ASTM F1609-23

Standard Specification for Calcium Phosphate Coatings for Implantable Materials

ABSTRACT
This specification covers the material requirements for calcium phosphate coatings for surgical implant applications. In particulate and monolithic form, the calcium phosphate materials system has been well-characterized regarding biological response and laboratory characterization. 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: mechanical capture, plasma spray deposition, dipping/sintering, electrophoretic deposition, porcelainizing, and sputtering. Substrates may include smooth, porous, textured, and other implantable topographical forms. This specification excludes organic coatings that may contain calcium and phosphate ionic species. Materials shall be tested and the individual grades shall conform to chemical requirements such as elemental analysis for calcium and phosphates, and intentional additions, trace element analysis for hydroxylapatite and beta tricalcium phosphate; crystallographic characterization such as Fourier Transform infrared spectroscopy, and environmental stability; physical characterization such as coverage of substrate, thickness, porosity, color, surface topography, and density; and mechanical characterization such as tensile bond strength, shear strength, and fatigue strength. The test specimen fabrication and contact with calcium phosphate coatings are also detailed.
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.

General Information

• Status: Published
• Publication Date: 30-Jun-2023
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.13 - Ceramic Materials

Standards Content (Sample)

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.
Designation: F1609 − 23
Standard Specification for
1
Calcium Phosphate Coatings for Implantable Materials
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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.7 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1.1 This specification covers the material requirements for
ization established in the Decision on Principles for the
calcium phosphate coatings for surgical implant applications.
Development of International Standards, Guides and Recom-
1.2 In particulate and monolithic form, the calcium phos-
mendations issued by the World Trade Organization Technical
phate materials system has been well characterized regarding
Barriers to Trade (TBT) Committee.
2
biological response (1, 2) and laboratory characterization
(2-4). Several publications (5-10) have documented the in vitro
2. Referenced Documents
and in vivo properties of selected calcium phosphate coating
4
2.1 ASTM Standards:
systems.
E376 Practice for Measuring Coating Thickness by
1.3 This specification covers hydroxylapatite coatings, other
Magnetic-Field or Eddy Current (Electromagnetic) Test-
calcium phosphate (for example, octacalcium calcium
ing Methods
phosphate, amorphous calcium phosphate, dicalcium phos-
F1044 Test Method for Shear Testing of Calcium Phosphate
phate dihydrate) coatings, or a coating containing a combina-
Coatings and Metallic Coatings
tion of two or more calcium phosphate phases, with or without
F1088 Specification for Medical-Grade Beta-Tricalcium
intentional minor additions of other elements or compounds
Phosphate Raw Material for Implantable Medical Devices
3
(for example, fluorine, manganese, magnesium, carbonate),
F1147 Test Method for Tension Testing of Calcium Phos-
and applied by methods including, but not limited to, the
phate and Metallic Coatings
following: (1) plasma spray deposition, (2) solution
F1160 Test Method for Shear and Bending Fatigue Testing
precipitation, (3) dipping/sintering, (4) electrophoretic
of Calcium Phosphate and Metallic Medical and Compos-
deposition, and (5) sputtering.
ite Calcium Phosphate/Metallic Coatings
F1185 Specification for Composition of Medical-Grade Hy-
1.4 For a coating containing two or more calcium phosphate
droxylapatite for Surgical Implants
phases, one or more of which will be a major phase or major
F1854 Test Method for Stereological Evaluation of Porous
phases in the coating, while the other phase(s) may occur as a
Coatings on Medical Implants
second or minor phases, the phase composition(s) of the
F1926 Test Method for Dissolution Testing of Calcium
coating should be determined against each corresponding
Phosphate Granules, Fabricated Forms, and Coatings
crystalline phase, respectively. See X1.2.
F2024 Practice for X-ray Diffraction Determination of Phase
1.5 Substrates may include smooth, porous, textured, and
Content of Plasma-Sprayed Hydroxyapatite Coatings
other implantable topographical forms.
5
2.2 U.S. Pharmacopeia Convention Documents:
1.6 This specification excludes organic coatings that may
National Formulary XVI Tribasic Calcium Phosphate
contain calcium and phosphate ionic species.
USP <191> Chemical Tests—Calcium and Phosphorous
USP <211> Arsenic
USP <232> Elemental Impurities—Limits
1
This specification is under the jurisdiction of ASTM Committee F04 on
USP <233> Elemental Impurities—Procedures
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.13 on Ceramic Materials. USP <251> Lead
Current edition approved July 1, 2023. Published July 2023. Originally approved
USP <261> Mercury
in 1995. Last previous edition approved in 2014 as F1609 – 08 (2014). DOI:
10.1520/F1609-23.
2
The boldface numbers in parentheses refer to the list of references at the end of
4
this specification. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
3
The Joint Committee on Powdered Diffraction has established a Powder contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Diffraction File. The committee operates on an international basis and cooperates Standards volume information, refer to the standard’s Document Summary page on
closely with the Data Commission of the International Union of Crystallinity and the ASTM website.
5
ASTM. Hydroxylapatite data can be found on file card No. 9-432; beta tricalcium Availa
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F1609 − 08 (Reapproved 2014) F1609 − 23
Standard Specification for
1
Calcium Phosphate Coatings for Implantable Materials
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 (´) 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 well characterized
2
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 includescovers hydroxylapatite coatings, tricalcium phosphate coatings, or combinations thereof, 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
3
additions of other ceramic or metallic,elements or compounds (for example, fluorine, manganese, magnesium, carbonate), and
applied by methods including, but not limited to, the following: (1) mechanical capture, plasma spray deposition, (2) plasma spray
deposition, solution precipitation, (3) dipping/sintering, (4) electrophoretic deposition, and (5) porcelainizing, and (6) 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.
1.6 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.
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.13 on Ceramic Materials.
Current edition approved March 1, 2014July 1, 2023. Published March 2014July 2023. Originally approved in 1995. Last previous edition approved in 20082014 as
F1609 – 08.F1609 – 08 (2014). DOI: 10.1520/F1609-08R14.10.1520/F1609-23.
2
The boldface numbers in parentheses refer to the list of references at the end of this specification.
3
The Joint Committee on Powdered Diffraction has established a Powder Diffraction File. The committee operates on an international basis and cooperates closely with
the Data Commission of the International Union of Crystallinity and ASTM. Hydroxylapatite data can be found on file card No. 9-432; beta tricalcium phosphate data can
be found on file card No. 9-169.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F1609 − 23
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
4
2.1 ASTM Standards:
E376 Practice for Measuring Coating Thickness by Magnetic-Field or Eddy Current (Electromagnetic) Testing Methods
F1044 Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
F1088 Specification for Medical-Grade Beta-Tricalcium Ph
...