Cleaning and Sterilization Validation of Reusable Medical Devices

Medical devices need to be cleaned thoroughly and effectively to ensure their safety in use.  Reusable devices (such as surgical tools etc.) require reprocessing (cleaning and disinfection/sterilization) between each use.  To ensure the effectiveness of such reprocessing methods, manufacturers are required to validate their cleaning and disinfection/sterilization processes as part of the device instructions for use (IFU).  The webinar will focus on key factors that should be considered when developing and validating the cleaning process.

Lucideon’s chemical and microbiological testing facilities coupled with our long-standing experience working with medical devices make us the ideal partner for such validations.  We work in accordance with the following standards and guidance documents, AAMI TIR30:2011, AAMI TIR12:2010, ISO 17665-1, ISO 11138-1, ASTM E1766-15 among others so you can be confident that our experts can assist you with your regulatory submissions.

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Resources

  • White paper

    Additive Manufacturing - A Metallurgical Perspective

    pdf 4 MB

  • Newsletter

    Pharmaceutical Newsletter

    pdf 418 KB

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