Active standard | Published: 15/04/2023

ASTM F1088-23

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

Available languages: English

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Detail information

Designation: ASTM F1088-23

Publication date: 15/04/2023

Pages: 4

Country: American technical standard

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Anotation

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.

Keywords:
advanced ceramics, ?-TCP, beta-tricalcium phosphate, calcium phosphate material, ceramic, surgical implant,, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

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