ANSI/AAMI ST72:2019 update & key learnings on BET

    Sterilization Validation

    ANSI/AAMI ST72:2019 provides guidance for BET/LAL of implantable medical devices.

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    Product Adoption for Sterilization Validation

    Product Adoption for Sterilization Validation

    Medical Device, Technical Expertise, Bioburden, Regulatory Expertise, Sterilization Validation

    When your product has had a material change, a component added, or a new size developed, does this necessarily mean you must complete the sterilization validation of each?

    There is another...

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