ASTM F1088 - 18

    Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation

    Active Standard ASTM F1088 | Developed by Subcommittee: F04.13

    Book of Standards Volume: 13.01


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    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.

    This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

    1. Scope

    1.1 This specification covers chemical and crystallographic requirements for 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).

    1.2 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.


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    International Organization for Standardization Document

    ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation Within a Risk Management System

    ASTM Standards

    F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices

    F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone

    American Society for Quality (ASQ) Document


    ICS Code

    ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

    UNSPSC Code

    UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)


    Referencing This Standard
    Link Here
    Link to Active (This link will always route to the current Active version of the standard.)

    DOI: 10.1520/F1088-18

    Citation Format

    ASTM F1088-18, Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation, ASTM International, West Conshohocken, PA, 2018, www.astm.org

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