ASTM WK70830

    Revision of F1983 - 14 Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications

    (What is a Work Item?)

    Active Standard: F1983 - 14

    Developed by Subcommittee: F04.16 | Committee F04 | Contact Staff Manager



    WK70830


    Keywords

    absorbables; biocompatibility; degradables; implantation;;

    Rationale

    Revisions needed for clarity, consistency and to include additional important details related to the study methodology. In addition, we updated the list of references to indicate the standard that were withdrawn and include relevant additional regulation, policies and guidance documents that focus on animal care and welfare. Through the document we included edits to clarify the language used. We also revised the language for consistency with the scope of the document: -Section 4 and section 6: specify the test material can be the material or final device, Section 4: absorption within 3 years, the final finished form or the article also include the packaging, if applicable). -Section 5: specify that the choice of animal model should consider the clinical use, device absorption kinetics. For consistency throughout the document (for example in Section 6) instead of rodent and non-rodent, we use small laboratory animals and non-rodent larger animals, including rabbits. Also, throughout the document we changed euthanasia time with termination time points, which we believe is a more appropriate term. Through the document we recommend that the test subject species is changed to animal models because this is a more appropriate term and requires careful selection to mimic the implantation in humans. Section 7 has several revisions to clarify the language use and for consistency. The implantation site and all observations and abnormal clinical findings should be recorded. Infection and animal deaths should be reported and justified. To capture the degradation profile, the termination time point is based on the degradation rate and should include early, intermediate and late stages of degradation. Because some materials may have unknown target organs, the tissue and organ harvesting should include not only include the target organs but also other organs and distant tissue Section 8, Histological evaluation should be performed by a veterinary pathologist with adequate training and experience. The semi-quantitative scoring should be based on widely recognized grading system such as the one described in ISO 10993-6. Section 9, the report should include the necropsy, gross observation or tissue and organs, condition and integrity of the test specimen, any imaging documentation prior to tissue sampling. The animal report forms should be kept and made available upon request. The appendix X1 specifies that in situations when the material can not be fully absorbed during the animal study, an appropriate scientific justification can be included for ending the study early but the appropriate percentage of absorbable material should be reported. Additionally, in vitro degradation characterization through complete degradation may support ending the implantation study prior to complete absorption if an in vitro-in vivo degradation correlation can be established.

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    Work Item Status

    Date Initiated:
    11-26-2019

    Technical Contact:
    Simona Bancos

    Status:
    Draft Under Development