What are the AAMI Levels of Protection?

The AAMI levels of protection are a system used to classify medical devices according to their level of invasiveness. There are four levels, with Level I being the least invasive and Level IV being the most invasive. Devices that are classified as Level I have little or no potential for harm to the patient, while those classified as Level IV have a high potential for harm.

The standard ANSI/AAMI PB70:2012 covers surgical gowns, isolation gowns, and many other items. These standards are required by the FDA for all medical textile manufacturers.

Level 1 : Minimal risk, to be used, for example, during basic care, standard isolation, a cover gown for visitors, or in a standard medical unit

Level 2 : Low risk, to be used, for example, during the blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab

Level 3 : Moderate risk, to be used, for example, during the arterial blood draw, inserting an intravenous (IV) line, in the Emergency Room, or for trauma cases

Level 4 : High risk, to be used, for example, during long, fluid intense procedures, surgery, when pathogen resistance is needed, or infectious diseases are suspected (non-airborne)

Protective apparel must conform to a set of standards and undergo a specific set of tests to determine “the liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.”

HEALEECARE manufactures 4 levels surgical gown and isolation gown. Welcome to contact us for further detail!