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Sterility Information for Gowns

For a device sold sterile, the FDA recommends sponsors provide the following information as detailed in the final guidance entitled Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. This information may include:

  • Sterilization method that will be used.
  • A description of the method that will be used to validate the sterilization cycle, but not the validation data itself (for established sterilization methods).
  • Reference to a standard method (e.g., AAMI Radiation Standard) usually is sufficient for established sterilization methods with FDA-recognized standards.
  • The sterility assurance level (SAL) for the device which the firm intends to meet. An SAL of 10-6 is required for surgical drapes and surgical gowns which are to be used during surgical procedures.
  • A description of the packaging’s ability to maintain the device’s sterility.
  • If sterilization involves ethylene oxide (EtO), the maximum levels of residues of ethylene oxide, ethylene chlorohydrin, and ethylene glycol which remain on the device. The levels should be consistent with the draft Federal Register Notice on EtO limits.
  • In the case of radiation sterilization, the radiation dose.

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