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Association for the Advancement of Medical Instrumentation (AAMI)

"Liquid barrier performance and classification of protective apparel and drapes in health care facilities"


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.

Standard Type(s)

An explicit set of requirements to be satisfied by a material, product, system, or service: Examples of specifications include, but are not limited to, requirements for; physical, mechanical, or chemical properties, and safety, quality, or performance criteria. A specification identifies the test methods for determining whether each of the requirements is satisfied.

Test Method

A definitive procedure that produces a test result: Examples of test methods include, but are not limited to: identification, measurement, and evaluation of one or more qualities, characteristics, or properties. A precision and bias statement shall be reported at the end of a test method.

Personal Protective Equipment
Body Protection

All items of clothing and/or accessories (whether or not detachable) designed and manufactured to provide specific protection. This includes bullet-proof clothing, general protective clothing and full body ensembles that protect from cuts, radiation, temperature extremes, hot splashes from molten metals and other hot liquids, potential impacts from tools, machinery and materials and hazardous chemicals. Examples of body protection include laboratory coats, coveralls, vests, jackets, aprons, surgical gowns and full body suits

  • Medical protective clothing
  • Biological

In the United States, ANSI/AAMI PB70 establishes a system of classification for protective apparel (including surgical gowns and isolation gowns) used in healthcare facilities, based on their liquid barrier performance. It also specifies labeling requirements and test methods for determining the compliance of protective apparel labeled with liquid barrier claims or liquid-borne microbial barrier claims. The ANSI/AAMI PB70 was accepted by the FDA in 2004.


The ANSI/AAMI PB70 standard includes four standard tests to evaluate the barrier effectiveness of surgical gowns, isolation gowns, and surgical drapes. Based on the results of these standardized tests, four levels of barrier performance are defined, with Level 1 being the lowest level of protection, and Level 4 being the highest level of protection. Table 3 summarizes the requirements of ANSI/AAMI PB70:2012 regarding the classification of barrier performance of surgical gowns, isolation gowns, and surgical drapes.


For more information please follow the link:

Testing Laboratories
Nelson Laboratories, Inc. - Salt Lake City, UT, 84123

FDA Registered and ANSI-ASQ National Accreditation Board/ACLASS


Phone Number: (801) 290-7500


ISO 17025

Scope of Accreditation

ASTM D5151 - 19 , ASTM D6124 - 06(2017) , ANSI/AAMI PB70:2012 , ASTM F1342 / F1342M - 05(2013)e1 , ASTM F1670 / F1670M - 17a , ASTM F1671 / F1671M - 13 , ASTM F1862 / F1862M - 17 , ANSI/AAMI PB70 - Class 3 , ASTM F2100 - 21 , ASTM F2101 - 19 , ASTM F1819 - 19 , ANSI/AAMI PB70 - Class 4


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