ASTM F1185-03(2009)
(Specification)Standard Specification for Composition of Hydroxylapatite for Surgical Implants
Standard Specification for Composition of Hydroxylapatite for Surgical Implants
ABSTRACT
This specification covers chemical and crystallographic requirements for hydroxylapatite intended for surgical implants. Elemental analysis for calcium and phosphorus will be consistent with the expected stoichiometry of hydroxylapatite. The calcium and phosphorus contents shall be determined using a suitable method such as ion chromatography. A quantitative X-ray diffraction analysis shall indicate a minimum hydroxylapatite content of 95 %. The concentration of trace elements such as arsenic, cadmium, mercury, and lead shall be determined for hydroxylapatite derived from natural resources. The analysis of other trace elements may be required, based on the conditions, apparatus, or environments specific to the manufacturing techniques and raw materials. Either inductively coupled plasma/mass spectroscopy (ICP/MS), atomic absorption (AAS), or the methods mentioned shall be used.
SCOPE
1.1 This specification covers chemical and crystallographic requirements for hydroxylapatite intended for surgical implants. For a material to be called hydroxylapatite, it must conform to this specification. (See Appendix X1.)
1.2 The biological response to hydroxylapatite in soft tissue and bone has been characterized by a history of clinical use (1-3) and by laboratory studies (4-6).
1.3 This specification includes powder, particulate, and forms intended for use as surgical implants, components of surgical implants, or as raw materials for manufacturing processes such as thermal spray coating, electrophoretic deposition, physical vapor deposition, and so forth.
1.4 This specification specifically excludes hydroxylapatite coatings, amorphous calcium phosphate, ceramic-glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. (See Specification F 1088.)
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This 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 and health practices and determine the applicability of regulatory limitations prior to use.
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Designation:F1185 −03(Reapproved 2009)
Standard Specification for
Composition of Hydroxylapatite for Surgical Implants
This standard is issued under the fixed designation F1185; 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 F981 Practice for Assessment of Compatibility of Biomate-
rials for Surgical Implants with Respect to Effect of
1.1 This specification covers chemical and crystallographic
Materials on Muscle and Bone
requirements for hydroxylapatite intended for surgical im-
F1088 Specification for Beta-Tricalcium Phosphate for Sur-
plants. For a material to be called hydroxylapatite, it must
gical Implantation
conform to this specification. (See Appendix X1.)
F2024 PracticeforX-rayDiffractionDeterminationofPhase
1.2 The biological response to hydroxylapatite in soft tissue
Content of Plasma-Sprayed Hydroxyapatite Coatings
and bone has been characterized by a history of clinical use
2.2 Code of Federal Regulations:
(1-3) and by laboratory studies (4-6).
Title 21, Part 820.
1.3 This specification includes powder, particulate, and
2.3 National Formulary:
forms intended for use as surgical implants, components of
Tribasic Calcium Phosphate
surgical implants, or as raw materials for manufacturing 6
2.4 United States Pharmacopeia:
processes such as thermal spray coating, electrophoretic
Identification Tests for Calcium and Phosphate <191>
deposition, physical vapor deposition, and so forth.
Lead < 251>
1.4 This specification specifically excludes hydroxylapatite
Mercury <261>
coatings, amorphous calcium phosphate, ceramic-glasses, Arsenic <211>
tribasic calcium phosphate, whitlockite, and alpha- and beta-
Heavy Metals <231> Method 1
tricalcium phosphate. (See Specification F1088.)
2.5 U. S. Geological Survey Method:
Cadmium
1.5 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this 2.6 American Society for Quality:
standard. C1 Specification of General Requirements for a Quality
Program
1.6 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
3. Terminology
responsibility of the user of this standard to establish appro-
3.1 Definitions of Terms Specific to This Standard:
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use. 3.1.1 hydroxylapatite—the chemical substance having the
empirical formula Ca (PO ) OH.
5 4 3
2. Referenced Documents
4. Chemical Requirements
2.1 ASTM Standards:
4.1 Elemental analysis for calcium and phosphorus will be
F748 PracticeforSelectingGenericBiologicalTestMethods
consistent with the expected stoichiometry of hydroxylapatite.
for Materials and Devices
Available from U.S. Government Printing Office, N. Capitol and H St., NW,
This specification is under the jurisdiction of ASTM Committee F04 on Washington, DC 20402.
Medical and Surgical Materials and Devices and is the direct responsibility of National Formulary XVI.Available from U.S. Pharmacopeia Convention, Inc.,
Subcommittee F04.13 on Ceramic Materials. 12601 Twinbrook Parkway, Rockville, MD 20852.
Current edition approved June 15, 2009. Published July 2009. Originally United States Pharmacopeia XXI. Available from U.S. Pharmacopeia
approved in 1988. Last previous edition approved in 2003 as F1185 – 03. DOI: Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852.
10.1520/F1185-03R09. Crock, J. G., Felichte, F. E., and Briggs, P. H., “Determination of Elements in
The boldface numbers in parentheses refer to the list of references at the end of National Bureau of Standards Geological Reference Materials SRM 278 Obsidian
this specification. and SRM 688 Basalt by Inductively Coupled Argon Plasma—Atomic Emission
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Spectrometry,” Geostandards Newsletter, Vol 7, 1983, pp. 335-340.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
Standards volume information, refer to the standard’s Document Summary page on Milwaukee, WI 53203, http://www.asq.org.
the ASTM website. Chemical Abstracts Service Registry Number [1306-06-5].
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1185−03 (2009)
The calcium and phosphorus contents shall be determined equivalent. Sample preparation will be identical to that for
using a suitable method such as ion chromatography. tribasic calcium phosphate as specified in the National Formu-
lary (2.3) except that approximately1gof material will be
4.2 Aquantitative X-ray diffraction analysis shall indicate a
dissolved in approximately 30 mL of 5 % HCl and boiled.
minimum hydroxylapatite content of 95 % as determined in
accordance with Practice F2024. Analysis of relative peak 4.5 It is recommended that all metals or oxides not detected
intensities shall be consistent with published data. as lead present in concentrations equal to or greater than 0.1 %
be listed on the package insert.
4.3 For hydroxylapatite derived from natural sources, the
concentration of trace el
...
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.
´1
Designation:F1185–88 (Reapproved 1993) Designation: F 1185 – 03 (Reapproved 2009)
Standard Specification for
Composition of Ceramic Hydroxylapatite for Surgical
Implants
This standard is issued under the fixed designation F 1185; 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.
´ NOTE—Keywords were added and Section 3 editorially corrected in March 1993.
1. Scope
1.1 This specification covers material chemical and crystallographic requirements for ceramic hydroxylapatite intended for
surgical implants. For a material to be called ceramic hydroxylapatite, it must conform to this specification. (See Appendix X1.)
1.2 The biological response to ceramic hydroxylapatite in soft tissue and bone has been characterized by a history of clinical
use (1-3) and by laboratory studies (4-6) .
1.3This specification specifically excludes hydroxylapatite coatings, non-ceramic hydroxylapatite, ceramic-glasses, tribasic
calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. (See Specification F1088
1.3 This specification includes powder, particulate, and forms intended for use as surgical implants, components of surgical
implants,orasrawmaterialsformanufacturingprocessessuchasthermalspraycoating,electrophoreticdeposition,physicalvapor
deposition, and so forth.
1.4 This specification specifically excludes hydroxylapatite coatings, amorphous calcium phosphate, ceramic-glasses, tribasic
calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. (See Specification F 1088.)
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This 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 and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2.1 ASTM Standards:
F 748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F 981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
F 1088 Specification for Beta-Tricalcium Phosphate for Surgical Implantation
2.2 Specification for Beta-Tricalcium Phosphate for Surgical Implantation
F 2024 Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
2.2 Code of Federal Regulations:
Title 21, Part 820.
2.3 National Formulary:
Tribasic Calcium Phosphate
2.4 United States Pharmacopeia:
Identification Tests for Calcium and Phosphate <191>
Lead < 251>
Mercury <261>
This specification is under the jurisdiction ofASTM Committee F-4 F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.13 on Ceramic Materials.
Current edition approved Oct. 31, 1988. Published December 1988.
Current edition approved June 15, 2009. Published July 2009. Originally approved in 1988. Last previous edition approved in 2003 as F 1185 – 03.
The boldface numbers in parentheses refer to the list of references at the end of this specification.
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
, Vol 13.01.volume information, refer to the standard’s Document Summary page on the ASTM website.
Available from U.S. Government Printing Office, Washington, DC 20402.
Available from U.S. Government Printing Office, N. Capitol and H St., NW, Washington, DC 20402.
National Formulary XVI. Available from U.S. Pharmacopeia Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852.
United States Pharmacopeia XXI. Available from U.S. Pharmacopeia Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 1185 – 03 (2009)
Arsenic <211>
Heavy Metals <231> Method 1
2.5 U. S. Geological Survey Method:
Cadmium
2.6 American Society for Quality:
C1 Specification of General Requirements for a Quality Program
3. Terminology
3.1 Descriptions of Terms Specific to This Standard:
3.1.1 calcining—the heat treatment of a ceramic precursor for the purpose of eliminating volatile constituents. Calcining is also
accompanied by some surface area and bulk volume reductions. Increases in mechanical properties are not usually significant.
3.1.2ceramic hydroxylapatite—hydroxylapatite which has been fired at sintering temperatures. Firing time is mass dependent,
and should be sufficiently long to cause significant densification and formation of a biologically stable form.
3.1.3hydroxylapatite—the chemical substance having the empirical formula Ca (PO ) OH.
5 4 3
3.1.4sintering—an integration of time and temperature of a ceramic precursor which develops a coherent body with useful
properties. Sintering is a non-melting process accompanied by significant surface area and bulk volume reductions (densification),
grain growth, and increases in mechanical properties.
4. Chemical Requirements
4.1Elemental analysis for calcium and phosphorus will be consistent with the expected stoichiometry of hydroxylapatite.
4.2A quantitative X-ray diffraction analysis shall indicate a minimum hydroxylapatite content of 95% (7)
4.1 Elemental analysis for calcium and phosphorus will be consistent with the expected stoichiometry of hydroxylapatite. The
calcium and phosphorus contents shall be determined using a suitable method such as ion chromatography.
4.2 A quantitative X-ray diffraction analysis shall indicate a minimum hydroxylapatite content of 95 % as determined in
accordance with Practice F 2024. Analysis of relative peak intensities shall be consistent with published data.
4.3The concentration of trace elements in the hydroxylapatite shall be limited as follows:
4.3 For hydroxylapatite derived from natural sources, the concentration of trace elements shall be limited as follows:
Element ppm, max
As 3
Cd 5
Hg 5
Pb 30 total heavy metals
(as lead)
For referee purposes, methods in
Either inductively coupled plasma/mass spectroscopy (ICP/MS), atomic absorption (AAS), or the methods listed in 2.4 and 2.5
shall be used.
4.4The maximum allowable limit of all heavy metals determined as lead will be 50 ppm as described in
4.3.1 The analysis of other trace elements may be required, based on the conditions, apparatus, or environments specific to the
manufacturing techniques and raw materials.
4.4 Th
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