ASTM F1088-04a

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Designation: F 1088 – 04a
Standard Specification for
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Beta-Tricalcium Phosphate for Surgical Implantation
This standard is issued under the fixed designation F 1088; 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.
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1. Scope U.S. Geological Survey Method
1.1 This specification covers chemical and crystallographic
3. Chemical Requirements
requirements for biocompatible beta-tricalcium phosphate (b-
3.1 Elemental analysis for calcium and phosphorus will be
TCP) for surgical implant applications. For a material to be
consistent with the expected stoichiometry of beta-tricalcium
identified as medical grade beta-tricalcium phosphate, it must
phosphate (Ca (PO ) . The calcium and phosphorus content
3 4 2
conform to this specification (see Appendix X1).
shall be determined using a suitable method such as USP
2. Referenced Documents <191> (see 2.4) or X-ray fluorescence.
2 3.2 Aquantitative X-ray diffraction analysis shall indicate a
2.1 ASTM Standards:
minimum beta-tricalcium phosphate content of 95 % as deter-
F 748 Practice for Selecting Generic Biological Test Meth-
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mined using Powder Diffraction File #0901695 and a method
ods for Materials and Devices
,
8 9 10
equivalent to Forman or Rietveld.
F 981 Practice for Assessment of Compatibility of Bioma-
3.3 For beta-tricalcium phosphate, the concentration of
terials (Non-porous) for Surgical Implants with Respect to
trace elements shall be limited as follows:
Effect of Materials on Muscle and Bone
Element
2.2 American Society for Quality (ASQ) Document:
ppm, max
Other Metals
C1 Specification of General Requirements for a Quality
Pb 30
3
Program
Hg 5
As 3
2.3 International Organization for Standardization Docu-
Cd 5
ment:
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Inductively coupled plasma/mass spectroscopy (ICP/MS),
ISO 10993 Biological Evaluation of Medical Devices
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atomic absorption spectroscopy (AAS), or the methods listed
2.4 United States Pharmacopeia (USP) Documents:
Identification Tests for Calcium and Phosphate <191> in 2.4 and 2.5 shall be used.
3.3.1 The analysis of other trace elements may be required,
Lead <252>
Mercury <261> based on the conditions, apparatus, or environments specific to
the manufacturing techniques and raw materials.
Arsenic <211>
3.4 The maximum allowable limit of all heavy metals
Heavy Metals <231> Method 1
determined as lead will be 50 ppm as described in 2.4 or
2.5 Other Reference:
equivalent. Sample preparation will be identical to that for
tribasic calcium phosphate as specified in the National Formu-
latory (see 2.4).
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This specification is under the jurisdiction of ASTM Committee F04 on
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Medical and Surgical Materials and Devices and is the direct responsibility of Crock, J. G., Felichte, F. E., and Briggs, P. H., “Determination of Elements in
Subcommittee F04.13 on Ceramic Materials. National Bureaus of Standards Geological Reference Materials SRM 278 Obsidian
Current edition approved May 1, 2004. Published June 2004. Originally and SRM 688 Basalt by Inductively Coupled Plasma—Atomic Emission Spectrom-
approved in 1987. Last previous edition approved in 2004 as F 1088 – 04. etry,” Geostandards Newsletter, Vol 7, 1983, pp. 335-340.
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or International Centre for Diffraction Data, 12 Campus Blvd, Newtown Square,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM PA 19073-3273.
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Standards volume information, refer to the standard’s Document Summary page on Forman, D. W. and Metsger, D. S., “The Determination of Phase Composition
the ASTM website. of Calcium Phosphate Ceramics by X-Ray Diffraction,”TransactionsoftheSeventh
3
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Annual Meeting of the American Society for Bone and Mineral Research,
Milwaukee, WI 53203-3005. Kelseyville, CA, 1985 p. 391.
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Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St., Jackson,L.E.,Barralet,J.E.,andWright,A.J.,“RietveldAnalysisinSintering
4th Floor, New York, NY 10036. Studies of Ca-Deficient Hydrxyapatite,” Bioceramics 16, Key Engineering Materi-
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Available from U.S. Pharmacopeia (USP), 12601Twinbrook Pkwy., Rockville, als, Vols 254-256, 2004, pp. 297-300.
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MD 20852. Rietveld, H. M., Acta Crystallogr., Vol 22, 1967, p. 151.
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F 1088 – 04a
3.5 It is recommended that all metals or oxides present in 5. Keywords
concentrations equal or greater than 0.1 % be noted in m
...