ASTM WK38520

    Work Item: ASTM WK38520 - Revision of F2064 - 00(2006)e1 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application

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    Active Standard: F2064 - 00(2006)e1

    Developed by Subcommittee: F04.42 | Committee F04 | Contact Staff Manager



    1. Rationale

    1. Revisions to the general text have been done to coincide with other ASTM documents, i.e. TEMPS has been changed to TEMPs. 2. Additional ASTM Standards relating to alginate have been included in 2.1 ASTM Standards. The added Standards are: F2259, F2315 and F2605. 3. The reference to USP/NF has been updated. The most current USP/NF is USP 35 NF 30. 4. The FDA Guideline on Validation of LAL has been removed as this document has been removed by the U.S. FDA. 5. Other references have been updated as appropriate. 6. G and M have been added to 3.1 Definitions 7. Molecular weight has been revised to the SI unit of molar mass. 8. Section 5.1.2 FT-IR identity of alginate has been amended to include FT-IR ATR of alginate powder. A typical FT-IR ATR spectrum of sodium alginate is appended as Fig. 1. Consequently the NMR spectrum is now Fig. 2. 9. Reference to ASTM F2259 is made in section 5.2.1 and reference to F2605 is made in section 5.2.2.2. 10. Reference to prEN 12442 is removed in both Referenced documents and in the text (section 7.3.2) since these documents relate to animal-derived products. 11. Several typographical errors are corrected in X2. Background (including Table X2.1). It is recommended that F2064 be balloted at the sub-committee level with the suggested revisions.


    Keywords

    alginates; biomedically engineered; tissue-engineered medical products; Chemical characterization; Degradation--surgical devices/applications; Depolymerization; Engineered medical products; Functionality; Impurities--medical/surgical materials/applications; Molecular mass average; Performance--surgical materials/applications; Physical analysis/characterization; TEMPs (tissue engineered medical products); Alginates; Characteristics/characterization--surgical implants/applications;
    Citing ASTM Standards
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    Work Item Status

    Date Initiated:
    07-26-2012

    Technical Contact:
    Michael Dornish

    Item:
    001

    Ballot:
    F04.42 (12-02)

    Status:
    Negative Votes Need Resolution