Medical Gowns

In medical settings there are different levels of protection required to provide the needed protection against infectious diseases – air and blood borne pathogens, and other hazardous fluids. The Association for the Advancement of Medical Instrumentation (AAMI) is responsible for establishing the set of standards and test methods that all medical apparel manufactures must meet specific to the AAMI level guidelines for the product’s intended use in the medical setting.

The American National Standards Institute (ANSI)/AAMI PB70:2012 is the standard that establishes a classification system (levels 1-4) for protective apparel used in healthcare facilities, including surgical gowns, based on liquid barrier performance using standardized test methods. As a personal protective equipment (PPE) gowns are used to protect the wearer from the spread of infectious agents if the wearer comes in contact with potentially infectious material. Gowns also help protect the person wearing the gown from transferring microorganisms that could potentially harm vulnerable and immune system compromised patients. Level 1 is the least protective and level 4 the most protective.

• Level 1: These gowns are used in settings where there is minimal risk, for example, during basic care, standard isolation, cover gown for visitors, or in a standard medical unit.
• Level 2: These gowns are used in settings where there is low risk, for example, during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab.
• Level 3: These gowns are used in settings where there is moderate risk, for example, during arterial blood draw, inserting an Intravenous (IV) line, in the Emergency Room, or for trauma cases.
• Level 4: These gowns are for use in high risk settings, for example, during long, fluid intense procedures, surgery, when pathogen resistance is needed for infectious diseases are suspected (non-airborne).

Criteria to Become a Level 1 Gown: Within the ANSI/AAMI PB70:2012 standard the AAMI has identified the American Association of Textile Chemists and Colorists (AATCC) 42 (Water resistance: Impact Penetration Test) as the key test requirements that a surgical gown must pass in order to be labeled AAMI Level 1 with expected barrier effectiveness of minimal water resistance (some resistance to water spray).

Criteria to Become a Level 2 Gown: Within the ANSI/AAMI PB70:2012 standard the AAMI has identified the American Association of Textile Chemists and Colorists (AATCC) 42 (Water resistance: Impact Penetration Test) and 127 (Water resistance: Hydrostatic Pressure Test) as the key test requirements that a surgical gown must pass in order to be labeled AAMI Level 3 with expected barrier effectiveness of low water resistance (resistant to water spray and some resistance to water penetration under constant contact with increasing pressure.

Criteria to Become a Level 3 Gown: Within the ANSI/AAMI PB70:2012 standard the AAMI has identified the American Association of Textile Chemists and Colorists (AATCC) 42 (Water resistance: Impact Penetration Test) and 127 (Water resistance: Hydrostatic Pressure Test) as the key test requirements that a surgical gown must pass in order to be labeled AAMI Level 3 with expected barrier effectiveness of moderate water resistance (resistant to water spray and some resistance to water penetration under constant contact with increasing pressure).

Criteria to Become a Level 4 Gown: Within the ANSI/AAMI PB70:2012 standard the AAMI has identified the American Society for Testing and Materials (ASTM) F1671 (Resistance of Materials used in Protective Clothing to Penetration by Blood Borne Pathogens) as the key test requirement that a surgical gown must pass in order to be labeled AAMI Level 4 with expected barrier effectiveness blood and viral penetration resistance (2 psi).

Resource:

https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70Class3

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