Standard Specification for Calcium Phosphate Coatings for Implantable Materials

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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) 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 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: ( 1) mechanical capture, (2) plasma spray deposition, (3) dipping/sintering, (4) electrophoretic deposition, (5) porcelainizing, and (6) sputtering.
1.4 Substrates may include smooth, porous, textured, and other implantable topographical forms.
1.5 This specification excludes organic coatings that may contain calcium and phosphate ionic species.

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09-Sep-2003
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ASTM F1609-03 - Standard Specification for Calcium Phosphate Coatings for Implantable Materials
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F 1609 – 03
Standard Specification for
1
Calcium Phosphate Coatings for Implantable Materials
This standard is issued under the fixed designation F 1609; 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 (e) indicates an editorial change since the last revision or reapproval.
5
1. Scope phate Coatings and Metallic Coatings
F 1160 Test Method for Shear and Bending Fatigue Testing
1.1 This specification covers the material requirements for
ofCalciumPhosphateandMetallisMedicalandComposite
calcium phosphate coatings for surgical implant applications.
5
Calcium Phosphate Metallic Coatings
1.2 In particulate and monolithic form, the calcium phos-
F 1185 Specification for Composition of Ceramic Hydroxy-
phate materials system has been well-characterized regarding
5
2 lapatite for Surgical Implants
biological response (1,2) and laboratory characterization (2-
F 1854 Shear and Bending Fatigue Testing of Calcium
4). Several publications (5-10) have documented the in vitro
Phosphate and Metallis Medical and Composite Calcium
and in vivo properties of selected calcium phosphate coating
5
Phosphate Metallic Coatings
systems.
F 1926 Test Method for Evaluation of the Environmental
1.3 This specification includes hydroxylapatite coatings,
5
Stability of Calcium Phosphate Coatings
tricalciumphosphatecoatings,orcombinationsthereof,withor
F 2024 Practice for X-Ray Diffraction Determination of
without intentional minor additions of other ceramic or metal-
3
Phase Content of Plasma-Sprayed Hydroxylapatite Coat-
lic, and applied by methods including, but not limited to, the
5
ings
following:(1)mechanicalcapture,(2)plasmaspraydeposition,
6
2.2 Pharmacopeia Convention Documents:
(3) dipping/sintering, (4) electrophoretic deposition, (5) porce-
National Formulary XVI, Tribasic Calcium Phosphate
lainizing, and (6) sputtering.
United States Pharmacopeia:
1.4 Substrates may include smooth, porous, textured, and
U.S. Pharmacopeia XXI, Chemical Tests CaP(191), Lead
other implantable topographical forms.
<251>, Mercury <261>, Arsenic < 211>, and Heavy
1.5 This specification excludes organic coatings that may
Metals <231> Method (1)
contain calcium and phosphate ionic species.
2.3 Other Documents:
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2. Referenced Documents U.S. Geological Survey Method, Cadmium
U.S. Code of Federal Regulations Title 21 (CFR 21), Part
2.1 ASTM Standards:
8
820–Quality System Regulation
E 376 Practice for Measuring Coating Thickness by
3
X-Ray Diffraction Analyses
Magnetic-Field or Eddy-Current (Electromagnetic) Test
4
Methods
3. Terminology
F 1044 Test Method for Shear Testing of Calcium Phos-
5 3.1 Definitions:
phate Coatings and Metallic Coatings
3.1.1 amorphous calcium phosphate—a non-crystalline cal-
F 1088 Specification for Beta-Tricalcium Phosphate for
5 cium phosphate.
Surgical Implantation
3.1.2 beta tricalcium phosphate—a calcium phosphate sub-
F 1147 Test Method for Tension Testing of Calcium Phos-
stance of empirical chemical formula, Ca (PO ) (see Specifi-
3 4 2
cation F 1088).
3.1.3 calcium phosphate—anyoneofanumberofinorganic
1
This specification is under the jurisdiction of ASTM Committee F04 on
chemicalcompoundscontainingcalciumandphosphateionsas
Medical and Surgical Materials and Devices and is the direct responsibility of
its principal constituents.
Subcommittee F04.13 on Ceramic Materials.
Current edition approved Sept. 10, 2003. Published October 2003. Originally
approved in 1995. Last previous edition approved in 1995 as F 1609 – 95.
2
The boldface numbers in parentheses refer to the list of references at the end of
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this specification. Available from U.S. Pharmacopeia Convention, Inc., 12601 Twinbrook Park-
3
The Joint Committee on Powdered Diffraction has established a Powder way, Rockville, MD 20852.
7
Diffraction File. The committee operates on an international basis and cooperates Crock, J. G., Felichte, F. E., and Briggs, P. H., “Determination of Elements in
closely with the Data Commission of the International Union of Crystallinity and National Bureau of Standards Geological Reference Materials SRM 278 Obsidian
ASTM. Hydroxylapatite data can be found on file card No. 9-432; beta tricalcium and SRM 688 Basalt by Inductively Coupled Argon Plasma—Atomic Emission
phosphate data can be found on file card No. 9-169. Spectrometry,” Geostandards Newsletter, Vol 7, 1983, pp. 335–340.
4 8
Annual Book of ASTM Standards, Vol 03.03. AvailablefromStandardizationDocumentsOrderDesk,Bldg.4SectionD,700
5
Annual Book of ASTM Standards, Vol 13.01. Robbins Ave., Philadelphia, PA 19111-5098, Attn: NPODS.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United
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