Product Catalog - AAMI PB70 Classification System

About the ANSI/AAMI PB70:2003 Standard and Classification System

This standard establishes a system of classification for protective apparel and drapes used in health care facilities based on their liquid barrier performance and specifies related labeling requirements and standardized test methods for determining compliance. By specifying a consistent basis for testing and labeling protective apparel and drapes and providing a common understanding of barrier properties (e.g., efficacy against liquid or liquid-borne microorganism penetration) based on this new classification system, the standard is intended to ultimately assist end-users in determining the type(s) of protective product most appropriate for a particular task or situation.¹

The AAMI PB70 standard defines four levels of classification that are based on standard tests to define a drape or gowns' barrier performance. The following table summarizes the test involved for each level of classification.

Source: Suzanne Pear, The AAMI Protective Barrier Standard, Managing Infection Control. November 2006. Available online at www.manageinfection.com/database/dms/MIC1108Q_28.pdf

Levels 1 through 3 have different require different ranges for the tests listed. Level 4 test results are designated pass or fail.

Barrier properties increase with each level.

• Level 1 gowns are generally isolation gowns and are not used for surgical procedures.
• Level 2 gowns offer the most basic protection. Gowns in this category are useful for procedures where the gown is exposed to small amounts of fluids for relatively short amounts of time.
• Level 3 gowns offer increased barrier properties and resistance to strike through.
• Level 4 gowns offer the highest level of barrier properties. Gowns in this category are useful for procedures involving large amounts of fluids. Equine colic surgery is an example procedure where this level of protection would be required.

Summary of Test

Details of each test may be found by following links below the summary to the appropriate standard organization.

• AATCC 42

  The AATCC 42 test is a fluid impact penetration test. Defined by the American Association of Textile Chemists and Colorists (AATCC) the AATCC 42 test measures the resistance of fabrics to the penetration of water by impact, and thus can be used to predict the probable resistance of fabrics to rain penetration resistance of garment fabrics.²

• AATCC 127

  The AATCC 127 test is hydrostatic pressure test. This test method measures the resistance of a fabric to the penetration of water under hydrostatic pressure.³

• ASTM F1670

  The ASTM F1670 is used to evaluate the resistance of materials used in protective clothing to penetration by synthetic blood under conditions of continuous liquid contact. Protective clothing pass/fail determinations are based on visual detection of synthetic blood penetration.⁴ When a drape material passes this test it is considered Level 4 material. Gowns are further tested with the ASTM F1671 test.

• ASTM F1671

  The ASTM F1671 is used to measure the resistance of materials used in protective clothing to penetration by blood-borne pathogens using a surrogate microbe under conditions of continuous liquid contact. Protective clothing material pass/fail determinations are based on the detection of viral penetration.⁵

About the AAMI

The Association for the Advancement of Medical Instrumentation (AAMI), a nonprofit organization founded in 1967, is a unique alliance of nearly 6,000 members from around the world united by one mission — to increase the understanding and beneficial use of medical instrumentation through effective standards and educational programs, and publications.⁶

1. http://marketplace.aami.org/eseries/scriptcontent/index_productinfo.cfm?Product_Code=pb70
2. http://www.aatcc.org/technical/Test_Methods/scopes/tm42.cfm
3. http://www.aatcc.org/technical/Test_Methods/scopes/tm127.cfm
4. http://www.astm.org/Standards/F1670.htm
5. http://www.astm.org/Standards/F1671.htm
6. http://www.aami.org/about/index.html