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ASTM F1088-23

Current Revision

Standard Specification for Medical-Grade Beta-Tricalcium Phosphate Raw Material for Implantable Medical Devices

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1.1 This specification covers chemical and crystallographic requirements for beta-tricalcium phosphate (β-TCP) raw materials intended for use in medical device applications. For a material to be identified as medical-grade beta-tricalcium phosphate, it must conform to this specification (see Appendix X1).

1.2 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.


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.


SDO ASTM: ASTM International
Document Number F1088
Publication Date April 15, 2023
Language en - English
Page Count 4
Revision Level 23
Supercedes
Committee F04.13
Publish Date Document Id Type View
April 15, 2023 F1088-23 Revision
Nov. 15, 2018 F1088-18 Revision
May 1, 2004 F1088-04AE01 Revision
May 1, 2004 F1088-04A Revision
Jan. 1, 2004 F1088-04 Revision
Jan. 1, 1992 F1088-87R92E01 Revision
Sept. 1, 2010 F1088-04AR10 Reaffirmation