21 CFR 880.6855 — Rigid Sterilization Container With Software

General Hospital (HO) · Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices · § 880.6855

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.

Classification Rationale

Class II (special controls). The device is classified as Class II because the probable benefits outweigh the probable risks, and the risks can be mitigated by the use of general controls and the identified special controls.

Product Codes