ASTM F1088-04
(Specification)Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
SCOPE
1.1 This specification covers material requirements for biocompatible beta tricalcium phosphate (-TCP) for surgical implant applications. For a material to be called beta-tricalcium phosphate, it must conform to this specification (see Appendix X1).
1.2 Beta-tricalcium phosphate is used in medical devices which have been cleared for marketing by the U.S. Food and Drug Administration.
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Designation: F 1088 – 04
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 material requirements for bio-
3. Chemical Requirements
compatible beta tricalcium phosphate (b-TCP) for surgical
3.1 Elemental analysis for calcium and phosphorus will be
implant applications. For a material to be called beta-tricalcium
consistent with the expected stoichiometry of b-tricalcium
phosphate, it must conform to this specification (see Appendix
phosphate (Ca (PO ) . The calcium and phosphorus content
3 4 2
X1).
shall be determined using a suitable method such as USP
1.2 Beta-tricalcium phosphate is used in medical devices
<191> (see 2.4) or ion chromatography.
which have been cleared for marketing by the U.S. Food and
3.2 A quantitative X-ray diffraction analysis shall indicate a
Drug Administration.
minimum b-tricalcium phosphate content of 95 % as deter-
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2. Referenced Documents mined using Powder Diffraction File #0901695 and a method
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2
equivalent to Balmain and Forman.
2.1 ASTM Standards:
3.3 For b-tricalcium phosphate derived from natural
F 748 Practice for Selecting Generic Biological Test Meth-
sources, the concentration of trace elements shall be limited as
ods for Materials and Devices
follows:
F 981 Practice for Assessment of Compatibility of Bioma-
Element
terials (Non-porous) for Surgical Implants with Respect to
ppm
Other Metals
Effect of Materials on Muscle and Bone
Pb #30
2.2 American Society for Quality (ASQ) Document: Hg #5
As #3
C1 Specification of General Requirements for a Quality
Cd #5
3
Program
Total Heavy Metals (as Pb) #50
2.3 International Organization for Standardization Docu-
Either inductively coupled plasm/mass spectroscopy (ICP/
ment:
4 MS), atomic absorption (AAS), or the methods listed in 2.4 and
ISO 10993 Biological Evaluation of Medical Devices
5 2.5 shall be used.
2.4 United States Phamacopaeia (USP) Documents:
3.3.1 The analysis of other trace elements may be required,
Identification Tests for Calcium and Phosphate <191>
based on the conditions, apparatus, or environments specific to
Lead <252>
the manufacturing techniques and raw materials.
Mercury <261>
3.4 The maximum allowable limit of all heavy metals
Arsenic <211>
determined as lead will be 50 ppm as described in 2.4 or
Heavy Metals <231> Method 1
equivalent. Sample preparation will be identical to that for
2.5 Other Reference:
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
Medical and Surgical Materials and Devices and is the direct responsibility of
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Subcommittee F04.13 on Ceramic Materials. Crock, J. G., Felichte, F. E., and Briggs, P. H., “Determination of Elements in
Current edition approved Jan. 1, 2004. Published February 2004. Originally National Bureaus of Standards Geological Reference Materials SRM 278 Obsidian
e1
approved in 1987. Last previous edition approved in 1992 as F 1088 – 87 (1992) . and SRM 688 Basalt by Inductively Coupled Plasma—Atomic Emission Spectrom-
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or etry,” Geostandards Newsletter, Vol 7, 1983, pp. 335-340.
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contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM International Centre for Diffraction Data, 12 Campus Blvd, Newtown Square,
Standards volume information, refer to the standard’s Document Summary page on PA 19073-3273.
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the ASTM website. Balmain, N., et al, “X-Ray Diffraction of Calcined Bone Tissue: A Reliable
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Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Method for the Determination of Bone Ca/P Molar Ratio,” Calcified Tissue
Milwaukee, WI 53203-3005. International, Vol 34, Supplement 2, 1982, pp. S93-98.
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Available from American National Standards Institute (ANSI), 25 W. 43rd St., Forman, D. W. and Metsger, D. S., “The Determination of Phase Composition
4th Floor, New York, NY 10036. of Calcium Phosphate Ceramics by X-Ray Diffraction,” Transactions of the Seventh
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Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, Annual Meeting of the American Society for Bone and Mineral Research,
MD 20852. Kelseyville, CA, 1985 p. 391.
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