ASTM F1609-03e1

Standard Specification for Calcium Phosphate Coatings for Implantable Materials

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) 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.
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.

General Information

• Status: Historical
• Publication Date: 09-Sep-2003
• 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

Relations

• Replaces: ASTM F1609-03 - Standard Specification for Calcium Phosphate Coatings for Implantable Materials
• Effective Date: 10-Sep-2003
• Replaced By: ASTM F1609-08 - Standard Specification for Calcium Phosphate Coatings for Implantable Materials
• Effective Date: 01-May-2008
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 10-Sep-2003

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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
e1
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.
1
e NOTE—Mercury warning was editorially added in April 2008.
1. Scope 2. Referenced Documents
4
1.1 This specification covers the material requirements for 2.1 ASTM Standards:
calcium phosphate coatings for surgical implant applications. E 376 Practice for Measuring Coating Thickness by
1.2 In particulate and monolithic form, the calcium phos- Magnetic-Field or Eddy-Current (Electromagnetic) Test
phate materials system has been well-characterized regarding Methods
2
biological response (1,2) and laboratory characterization (2- F 1044 Test Method for Shear Testing of Calcium Phos-
4). Several publications (5-10) have documented the in vitro phate Coatings and Metallic Coatings
and in vivo properties of selected calcium phosphate coating F 1088 Specification for Beta-Tricalcium Phosphate for
systems. Surgical Implantation
1.3 This specification includes hydroxylapatite coatings, F 1147 Test Method for Tension Testing of Calcium Phos-
tricalciumphosphatecoatings,orcombinationsthereof,withor phate Coatings and Metallic Coatings
without intentional minor additions of other ceramic or metal- F 1160 Test Method for Shear and Bending Fatigue Testing
3
lic, and applied by methods including, but not limited to, the ofCalciumPhosphateandMetallisMedicalandComposite
following:(1)mechanicalcapture,(2)plasmaspraydeposition, Calcium Phosphate Metallic Coatings
(3) dipping/sintering, (4) electrophoretic deposition, (5) porce- F 1185 Specification for Composition of Ceramic Hydroxy-
lainizing, and (6) sputtering. lapatite for Surgical Implants
1.4 Substrates may include smooth, porous, textured, and F 1854 Shear and Bending Fatigue Testing of Calcium
other implantable topographical forms. Phosphate and Metallis Medical and Composite Calcium
1.5 This specification excludes organic coatings that may Phosphate Metallic Coatings
contain calcium and phosphate ionic species. F 1926 Test Method for Evaluation of the Environmental
1.6 Warning—Mercury has been designated by EPA and Stability of Calcium Phosphate Coatings
many state agencies as a hazardous material that can cause F 2024 Practice for X-Ray Diffraction Determination of
central nervous system, kidney, and liver damage. Mercury, or Phase Content of Plasma-Sprayed Hydroxylapatite Coat-
its vapor, may be hazardous to health and corrosive to ings
5
materials.Cautionshouldbetakenwhenhandlingmercuryand 2.2 Pharmacopeia Convention Documents:
mercury-containing products. See the applicable product Ma- National Formulary XVI, Tribasic Calcium Phosphate
terial Safety Data Sheet (MSDS) for details and EPA’s website United States Pharmacopeia:
(http://www.epa.gov/mercury/faq.htm) for additional informa- U.S. Pharmacopeia XXI, ChemicalTests CaP(191), Lead
tion. Users should be aware that selling mercury or mercury- <251>, Mercury <261>, Arsenic < 211>, and Heavy
containingproducts,orboth,inyourstatemaybeprohibitedby Metals <231> Method (1)
state law. 2.3 Other Documents:
6
U.S. Geological Survey Method, Cadmium
U.S. Code of Federal Regulations Title 21 (CFR 21), Part
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
4
Subcommittee F04.13 on Ceramic Materials. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Sept. 10, 2003. Published October 2003. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
approved in 1995. Last previous edition approved in 1995 as F 1609 – 95. Standards volume information, refer to the standard’s Document Summary page on
2
The boldface numbers in parentheses refer to the list of references at the end of the ASTM website.
5
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.
6
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
...

This document is not anASTM standard and is intended only to provide the user of anASTM 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.
e1
Designation:F1609–95 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.
1
e NOTE—Mercury warning was editorially added in April 2008.
1. Scope
1.1 This specification covers the material requirements for calcium phosphate coatings for surgical implant applications.
1.2 Inparticulateandmonolithicform,thecalciumphosphatematerialssystemhasbeenwell-characterizedregardingbiological
2
response(1,2) and laboratory characterization(2–42-4). Several publications(5-10–10) 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
3
without intentional minor additions (10% or less, as opposed to trace elements) of other ceramic or metallics, 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.
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.
2. Referenced Documents
2.1 ASTM Standards:
C313Test Method for Adherence of Porcelain Enamel and Ceramic Coatings to Sheet Metal
4
C501Test Method for Relative Resistance to Wear of Unglazed Ceramic Tile by the Taber Abraser C633Test Method for
Adhesion or Cohesive
Strength of Flame-
Sprayed Coatings
4
C674Test Methods for Flexural Properties of Ceramic Whiteware Materials
4
C949Test Method for Porosity in Vitreous Whitewares by Dye Penetration
E 376 Practice for Measuring Coating Thickness by Magnetic-Field or Eddy-Current (Electromagnetic) Test Methods
F 1044Test Method for Shear Testing of Porous Metal Coatings
Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
F 1088 Specification for Beta-Tricalcium Phosphate for Surgical Implantation
7
F 1147Test Method for Tension Testing of Porous Metal Coatings
Test Method for Tension Testing of Calcium Phosphate Coatings and Metallic Coatings
F 1160 Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallis Medical and Composite
Calcium Phosphate Metallic Coatings
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 Aug. 15, 1995. Published September 1995.
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 this specification.
3
Discontinued 1991—See 1990 Annual Book of ASTM Standards, Vol 15.02.
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.
4
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
, Vol 15.02.volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Har
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