The correct answer is option A – Class I Autoclave sterilizer is classified as a class I device. Class I devices are medical devices that have the lowest amount of control by the FDA. This class of medical devices exposes a patient or user to little or no potential as a result of usage of the device.
Most often than not, class I devices are very simply tools that are easy to use with less complicated designs. The higher the risk associated with a medical device the high the class and requlatory control. Other examples of Class I devices include tongue depressors, and arm slings.
M. Porter, Senior Executive, Master of Art, San Jose
Answered May 01, 2019
Autoclaves are machines used to sterilize medical equipment with the combination of high heat, steam, and vacuum. Instruments are prepared by scrubbing and or soaking in the cleaning solution and then packed in bags and sealed. The autoclave is packed with the instruments in the bags and then sealed. There is also distilled water inside the machine.
First, the machine runs for 15 minutes to bring to temperature and create the vacuum and then is run for another 15 minutes at high temperature. When complete, the environment inside the sealed bag is sterile until opened. There is no class of autoclave; however, there are different kinds such as vacuum or no vacuum.