CRCST Practice Exam

What class of medical devices are sterilizers?

1. Class 1

2. Class 2

3. Class 3

4. Class 4

The correct answer is: Class 2

Sterilizers are classified as Class 2 medical devices. Class 1 devices are considered low-risk, while Class 3 devices are high-risk devices, and Class 4 does not exist in the typical classification system for medical devices. Class 2 devices require more stringent regulatory controls to provide assurance of their safety and effectiveness, making them appropriate for devices like sterilizers that are critical for ensuring patient safety in healthcare settings.