(a) Identification. A rigid sterilization container with electronic monitoring is a device intended to be used to enclose medical devices that are to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical devices and maintain sterility of the enclosed devices until used. The device provides sterility status of the enclosed medical devices via real time electronic monitoring.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated to ensure device function and integrity during challenging use:

(i) Vent-to-volume testing must demonstrate adequate sterilant penetration.

(ii) Sterilization validation must demonstrate that the contents to be sterilized can adequately achieve the proposed Sterility Assurance Level (SAL).

(iii) Performance testing must demonstrate the device accurately informs the end-user of the sterile status of the contents.

(iv) Performance testing must demonstrate the device can maintain sterility of the enclosed medical products for a minimum 30-day storage period.

(v) Battery performance and shelf life testing must demonstrate the device maintains its function throughout its total use-life.

(vi) Battery performance and shelf life testing must demonstrate the device maintains its function during storage, throughout a minimum 30-day sterile storage period.

(vii) Moisture/sterilant ingress testing must support that the electronic components are adequately sealed and do not allow moisture/sterilant ingress.

(viii) Microbial barrier testing must support that the seals, gaskets, valves, etc. provide an adequate barrier to microbial ingress.

(ix) Seal integrity testing must demonstrate that an adequate seal is created and maintained throughout the sterile storage period.

(x) Mechanical functionality testing must demonstrate proper function of any valves, gaskets, or other components essential to the function of the device.

(xi) For devices with handles, handle strength testing must demonstrate the handles can withstand the maximum indicated load weight.

(xii) Corrosion resistance testing must demonstrate adequate function of any components susceptible to corrosion following the most challenging use.

(xiii) Dryness evaluation testing must demonstrate the contents to be sterilized are dry prior to storage.

(xiv) Simulated use testing must evaluate device performance (including maintenance of sterility and accurate sterility status monitoring) under real-world worst-case use conditions.

(2) Device components that may contact medical products must be demonstrated to be biocompatible.

(3) Performance data must validate the reprocessing instructions for the reusable components of the device.

(4) Software verification, validation, and hazard analysis must be performed.

(5) Human factors testing must be performed to demonstrate that end user(s) can safely and correctly use the device, based solely on the directions for use.

(6) Performance data must demonstrate the electromagnetic compatibility and electrical safety of the device.

(7) Labeling must include:

(i) Warnings, cautions, and limitations for safe use of the device including:

(A) A precaution that the lids/trays and any accessories should only be used with the sterilization container.

(B) A precaution that the use of nonabsorbent tray liners can cause condensate to pool.

(ii) Device operating procedures including:

(A) Instructions for closures, gaskets, type, sizes, and valve assembly weight as appropriate.

(B) Instructions for density and distribution of contents, stacking patterns, or any other recommendations pertaining to load configuration of the medical devices to be sterilized.

(iii) A description of the validated length of time sterility can be maintained.

(iv) Identification of any replaceable components, information about the expected life of these components, and instructions for procedures on replacement when needed.

(v) Identification of products intended for sterilization that are compatible for use with the device.

(vi) Description of the required preparation of products intended for sterilization in the device.

[91 FR 32351, June 1, 2026]