ASTM F1088-04ae1

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 This 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).

General Information

• Status: Historical
• Publication Date: 30-Apr-2004
• 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 F1088-04a - Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
• Effective Date: 01-May-2004
• Replaced By: ASTM F1088-04a(2010) - Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
• Effective Date: 01-Sep-2010
• Referred By: ASTM F2502-17 - Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
• Effective Date: 01-May-2004
• Referred By: ASTM F1926/F1926M-14(2021) - Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings
• Effective Date: 01-May-2004
• Referred By: ASTM F1609-23 - Standard Specification for Calcium Phosphate Coatings for Implantable Materials
• Effective Date: 01-May-2004
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 01-May-2004
• Referred By: ASTM F2224-09(2020) - Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
• Effective Date: 01-May-2004
• Referred By: ASTM F1185-23 - Standard Specification for Composition of Medical-Grade Hydroxylapatite for Surgical Implants
• Effective Date: 01-May-2004

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
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Designation: F1088 – 04a
Standard Specification for
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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.
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´ NOTE—Subsection 3.2 was editorially corrected in June 2006.
1. Scope 2.5 Other Reference:
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U.S. Geological Survey Method
1.1 This specification covers chemical and crystallographic
requirements for biocompatible beta-tricalcium phosphate (b-
3. Chemical Requirements
TCP) for surgical implant applications. For a material to be
3.1 Elemental analysis for calcium and phosphorus will be
identified as medical grade beta-tricalcium phosphate, it must
consistent with the expected stoichiometry of beta-tricalcium
conform to this specification (see Appendix X1).
phosphate (Ca (PO ) . The calcium and phosphorus content
3 4 2
2. Referenced Documents shall be determined using a suitable method such as USP
2 <191> (see 2.4) or X-ray fluorescence.
2.1 ASTM Standards:
3.2 Aquantitative X-ray diffraction analysis shall indicate a
F748 Practice for Selecting Generic Biological Test Meth-
minimum beta-tricalcium phosphate content of 95 % as deter-
ods for Materials and Devices
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mined using Powder Diffraction File #550898 and a method
F981 Practice forAssessment of Compatibility of Biomate-
8 9,10
equivalent to Forman or Rietveld.
rials for Surgical Implants with Respect to Effect of
3.3 For beta-tricalcium phosphate, the concentration of
Materials on Muscle and Bone
trace elements shall be limited as follows:
2.2 American Society for Quality (ASQ) Document:
Element
C1 Specification of General Requirements for a Quality
ppm, max
Other Metals
3
Program
Pb 30
2.3 International Organization for Standardization Docu- Hg 5
As 3
ment:
Cd 5
4
ISO 10993 Biological Evaluation of Medical Devices
5
Inductively coupled plasma/mass spectroscopy (ICP/MS),
2.4 United States Pharmacopeia (USP) Documents:
Identification Tests for Calcium and Phosphate <191> atomic absorption spectroscopy (AAS), or the methods listed
in 2.4 and 2.5 shall be used.
Lead <252>
3.3.1 The analysis of other trace elements may be required,
Mercury <261>
based on the conditions, apparatus, or environments specific to
Arsenic <211>
the manufacturing techniques and raw materials.
Heavy Metals <231> Method 1
3.4 The maximum allowable limit of all heavy metals
determined as lead will be 50 ppm as described in 2.4 or
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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 May 1, 2004. Published June 2004. Originally National Bureaus of Standards Geological Reference Materials SRM 278 Obsidian
approved in 1987. Last previous edition approved in 2004 as F1088 – 04. DOI: and SRM 688 Basalt by Inductively Coupled Plasma—Atomic Emission Spectrom-
10.1520/F1088-04AE01. 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 [e-mail]. 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-
5
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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F1088 – 04a
equivalent. Sample preparation will be identical to that for 5. Keywords
tribasic calcium phosphate as specified in the National Formu-
5.1 advanced ceramics; b-TCP; beta-tricalcium phosphate;
la
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