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Sterilization for Medical Devices | FDA

    https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices
    Medical devices are sterilized in a variety of ways including using moist heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, and other sterilization methods (for ...

Sterilization | Disinfection & Sterilization Guidelines

    https://www.cdc.gov/infectioncontrol/guidelines/disinfection/sterilization/index.html
    This section reviews sterilization technologies used in healthcare and makes recommendations for their optimum performance in the processing of medical …

Sterilization of implantable polymer-based medical …

    https://pubmed.ncbi.nlm.nih.gov/29274370/
    This review article is focused on the sterilization techniques used for polymer-based implantable medical devices as well as the regulatory aspects governing …

Sterilization of Medical Devices: A Review - Donald J.

    https://journals.sagepub.com/doi/10.1177/088532828800300303
    Glaser, Z.R. "Ethylene Oxide: Toxicology Review and Field Study Results of Hospital Use," J. Environ. Pathol. and Toxic., 2:173-208 (1979). ... Evaluation of …

Gamma Sterilization of Medical Devices - Food and …

    https://www.fda.gov/media/132374/download
    Typical gamma sterilization applications . Healthcare products including (but not limited to): Syringes, vacutainers Bandages, gauze Implantable devices (e.g., stents, orthopedics)

Ethylene oxide sterilization of medical devices: a review

    https://pubmed.ncbi.nlm.nih.gov/17980234/
    Ethylene oxide (EO) is a well-known sterilizing agent. However, only recently has its use significantly emerged, based on its range of applications in the field of new medical …

Sterilization Process Controls | FDA

    https://www.fda.gov/sterilization-process-controls
    If review of the Device History Records (including process control and monitoring records, acceptance activity records, etc.) reveals that the sterilization process is outside the firm's tolerance ...

Medical Device Sterilization: Methods Explained, Compared

    https://esenssys.com/methods-of-medical-sterilization/
    The medical device sector established the first commercial application of electron beams for sterilization in 1956. The sterilized objects are placed on a conveyor …

Terminal sterilization of medical devices using …

    https://ami-journals.onlinelibrary.wiley.com/doi/10.1111/jam.14412
    This review focuses on technologies employed in both the contract sterilization and in-house sterilization, specifically the terminal sterilization of medical devices. Terminal sterilization …

Sterilization of medical devices: a review - PubMed

    https://pubmed.ncbi.nlm.nih.gov/2654354/
    Sterilization of medical devices: a review J Biomater Appl. 1989 Jan;3(3):454-523. doi: 10.1177/088532828800300303. Authors D J Dempsey 1 , R R Thirucote. Affiliation 1 Thermedics Inc., Woburn, MA 01888. PMID: 2654354 DOI: 10.1177/088532828800300303 No abstract available ...



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