ASTM F1088-04a(2010)
(Specification)Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
ABSTRACT
This specification covers chemical and crystallographic requirements for biocompatible beta-tricalcium phosphate for surgical implant applications. Elemental analysis for calcium and phosphorus will be consistent with the expected stoichiometry of beta-tricalcium phosphate. The calcium and phosphorus content shall be determined using a suitable method such X-ray fluorescence. A quantitative X-ray diffraction analysis shall indicate a minimum beta-tricalcium phosphate content of 95 % as determined using powder diffraction method. The analysis of other trace elements may be required, based on the conditions, apparatus, or environment. It is recommended that all metals or oxides present in concentrations equal or greater than 0.1 % be noted in material descriptions.
SCOPE
1.1 Thisastm specification covers chemical and crystallographic requirements for biocompatible beta-tricalcium phosphate (β-TCP) for surgical implant applications. For a material to be identified as medical grade beta-tricalcium phosphate, it must conform to this specification (see Appendix X1).
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Standards Content (Sample)
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Designation:F1088 −04a (Reapproved 2010)
Standard Specification for
Beta-Tricalcium Phosphate for Surgical Implantation
This standard is issued under the fixed designation F1088; 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 Mercury <261>
Arsenic <211>
1.1 This specification covers chemical and crystallographic
Heavy Metals <231> Method 1
requirements for biocompatible beta-tricalcium phosphate (β-
2.5 Other Reference:
TCP) for surgical implant applications. For a material to be
U.S. Geological Survey Method
identified as medical grade beta-tricalcium phosphate, it must
conform to this specification (see Appendix X1).
3. Chemical Requirements
1.2 This international standard was developed in accor-
3.1 Elemental analysis for calcium and phosphorus will be
dance with internationally recognized principles on standard-
consistent with the expected stoichiometry of beta-tricalcium
ization established in the Decision on Principles for the
phosphate (Ca (PO ) . The calcium and phosphorus content
3 4 2
Development of International Standards, Guides and Recom-
shall be determined using a suitable method such as USP
mendations issued by the World Trade Organization Technical
<191> (see 2.4) or X-ray fluorescence.
Barriers to Trade (TBT) Committee.
3.2 Aquantitative X-ray diffraction analysis shall indicate a
minimum beta-tricalcium phosphate content of 95 % as deter-
2. Referenced Documents
mined using Powder Diffraction File #550898 and a method
2.1 ASTM Standards:
8 9,10
equivalent to Forman or Rietveld.
F748 PracticeforSelectingGenericBiologicalTestMethods
3.3 For beta-tricalcium phosphate, the concentration of
for Materials and Devices
F981 Practice for Assessment of Compatibility of Biomate- trace elements shall be limited as follows:
rials for Surgical Implants with Respect to Effect of
Element
ppm, max
Other Metals
Materials on Muscle and Insertion into Bone
Pb 30
2.2 American Society for Quality (ASQ) Document:
Hg 5
C1 Specification of General Requirements for a Quality As 3
Cd 5
Program
Inductively coupled plasma/mass spectroscopy (ICP/MS),
2.3 International Organization for Standardization Docu-
atomic absorption spectroscopy (AAS), or the methods listed
ment:
in 2.4 and 2.5 shall be used.
ISO 10993 Biological Evaluation of Medical Devices
3.3.1 The analysis of other trace elements may be required,
2.4 United States Pharmacopeia (USP) Documents:
based on the conditions, apparatus, or environments specific to
Identification Tests for Calcium and Phosphate <191>
the manufacturing techniques and raw materials.
Lead <252>
3.4 The maximum allowable limit of all heavy metals
determined as lead will be 50 ppm as described in 2.4 or
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devicesand is the direct responsibility of
Subcommittee F04.13 on Ceramic Materials. Crock, J. G., Felichte, F. E., and Briggs, P. H., “Determination of Elements in
Current edition approved Sept. 1, 2010. Published November 2010. Originally National Bureaus of Standards Geological Reference Materials SRM 278 Obsidian
ε1
approved in 1987. Last previous edition approved in 2004 as F1088 – 04a . DOI: and SRM 688 Basalt by Inductively Coupled Plasma—Atomic Emission
10.1520/F1088-04AR10. Spectrometry,” Geostandards Newsletter, Vol 7, 1983, pp. 335–340.
2 7
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.
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
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Annual Meeting of the American Society for Bone and Mineral Res
...
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