Which class of devices is associated with the use of chemical indicators in the sterilization process?

Chemical indicators are specifically utilized in the sterilization process to monitor the exposure of instruments and materials to the sterilization conditions. They provide a straightforward way to confirm that the sterilization process has occurred effectively.

Devices classified under FDA Class II are generally those that require special controls to ensure their safety and effectiveness. This classification includes many medical devices involved in procedures that are more complex and carry some risk, such as sterilization indicators that ensure the sterility of surgical instruments.

Thus, the association of chemical indicators with FDA Class II devices makes sense because these indicators are pivotal in ensuring that a device has undergone proper sterilization, which is essential for patient safety in healthcare settings.