ASTM WK65476

    New Guide for Characterizing Fiber-Based Constructs for Tissue Engineered Medical Products

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



    WK65476

    1. Scope

    A Workshop on Characterization of Fiber-Based Scaffolds was held on August 10, 2018 in Manchester NH. The event was jointly sponsored by ASTM and ARMI BioFabUSA with participation from the Standards Coordinating Body (SCB). Many companies that are manufacturing fiber-based constructs for tissue engineering applications were represented at the workshop. Discussion focused on fiber-based scaffold characterization, batch to batch variability, measurement validation and release criteria. At the workshop, there was strong support to form a working group to write an ASTM standard guide for characterizing fiber-based scaffolds. This guide will focus on fiber-based constructs made by methods including, but not limited to, electrospinning, forcespinning, meltspinning, pneumatospinning and extrusion. The guide will focus on the fiber diameter range of 10 nm to 100 m. It is anticipated that the guide will provide a list of common measurements and discuss caveats, best practices, controls, reference standards if available and reasons for doing the measurement. The guide may include a table that presents all the measurements in a systematic fashion. The guide may also include a long section on porosity since there was a lot say about this topic at the workshop.


    Keywords

    medical device

    Rationale

    A Workshop on Characterization of Fiber-Based Scaffolds was held on August 10, 2018 in Manchester NH. The event was jointly sponsored by ASTM and ARMI BioFabUSA with participation from the Standards Coordinating Body (SCB). Discussion focused on fiber-based scaffold characterization, batch to batch variability, measurement validation and release criteria. At the workshop, there was strong support to form a working group to write an ASTM standard guide for characterizing fiber-based scaffolds. the majority of companies that are currently manufacturing fiber-based constructs for tissue engineering applications were represented at the workshop and there was strong support and

    The title and scope are in draft form and are under development within this ASTM Committee.

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    Work Item Status

    Date Initiated:
    10-22-2018

    Technical Contact:
    Carl Simon

    Status:
    Draft Under Development