Cleaners for Medical Device Classes

Q. What classes of medical devices are Alconox brand cleaners formulated to clean?

A. Alconox brand cleaners are formulated to clean Class I, II, and III medical devices. For further information please visit the Medical Device Cleaning section of the Alconox website.

According to www.fda.gov , the FDA classifies medical devices into three categories.

Class I devices are subject to the least regulatory control. They present minimal potential for harm to the user.

Class II are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. In addition to complying with general controls, Class II devices are also subject to special controls. Special controls may include special labeling requirements, mandatory performance standards and post market surveillance.

Class III is the most stringent regulatory category for devices. Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls. Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.

For additional technical information, please Download our Medical Device Cleaning Validation References PDF.  And if you have a question for our experts about critical cleaning, please visit Ask Alconox.