What does it take to become
an AAMI Level 3 surgical gown?
Protective apparel, including surgical gowns, are governed by a set of standards
and test methods that all manufacturers must meet.
These standards are established by AAMI (The Association for the Advancement of Medical
Instrumentation). Specifically, ANSI (American National Standards Institute)/AAMI PB70:2012
is the standard that establishes a classification system (Levels 1-4) for protective apparel used
in health care facilities, including surgical gowns, based on liquid barrier performance using
standardized test methods. The U.S. Food and Drug Administration (FDA) has adopted ANSI/
AAMI PB70:2012 as the standard by which all surgical gown manufacturers must abide.
Within that standard, AAMI has identified AATCC (American Association of Textile Chemists
and Colorists) 42 and AATCC 127 as the key test requirements that a surgical gown
must pass in order to be labeled AAMI Level 3.
What is AATCC 42?
This test is called the “Water resistance: Impact Penetration Test.” It indicates how the fabric will
resist strikethrough when fluids splash or spray onto the fabric.
What is AATCC 127?
This test is called the “Water resistance: Hydrostatic Pressure Test”. It indicates how
the fabric will resist strikethrough when water pressure is applied to the surface of the fabric.
Testing the gown
AAMI standards call for a surgical gown to meet the requirements mentioned above for AATCC 42
and AATCC 127 in the critical zones in order to be labeled an AAMI Level 3 surgical gown.
What areas are included in the critical zones? There are typically 4 diff rent areas that must pass
within the critical zones, including two in the front chest and two on the sleeves. If a product passes
AATCC 42 and AATCC 127 in all applicable areas, then it qualifies as an AAMI Level 3 surgical gown.
What should you look at when researching
AAMI Level 3 surgical gowns
When you are looking for an AAMI Level 3 surgical gown, you should always look
for AAMI Level 3 on the label.
What are some common questions you might have as you look
at different surgical gowns?
? Does Bodygard offer AAMI Level 3 surgical gowns?
Yes. The BodygardTM Fabric Reinforced Surgical Gowns all meet the AATCC 42 and AATCC
127 AAMI Level 3 requirements in all four areas within the critical zones.
? Does Bodygard offer any surgical gowns without an AAMI Level rating?
No. All Bodygard ™ Surgical Gowns are AAMI rated and the AAMI Level is clearly
identifiable on the product’s label. Bodygard currently offers surgical gowns with
either an AAMI Level 3 or AAMI Level 4 rating.
? All surgical gowns on the market today have an AAMI Level rating, correct?
No. Always look for the AAMI Level rating on the surgical gown packaging to determine
the AAMI Level rating.
? If a surgical gown isn’t rated AAMI Level 4, then it is an AAMI Level 3
surgical gown, correct?
No. Surgical gowns can be rated AAMI Level 1, AAMI Level 2, AAMI Level 3 or AAMI Level 4.
Always look for the AAMI Level rating on the label to determine the AAMI Level rating.
? Reinforced means it is an AAMI Level 4 gown, correct?
Not necessarily. Within the surgical gown market there are two typical types of reinforced
surgical gowns; fabric reinforced and poly reinforced. Always look for the AAMI Level rating
on the label, but typically fabric reinforced surgical gowns are AAMI Level 3, while poly
reinforced surgical gowns are AAMI Level 4.
When you are looking for an AAMI Level 3 surgical gown, look for AAMI Level 3 on
the label. If you cannot find the AAMI Level rating, talk to the surgical gown supplier.
Want to know more
standards? Ask your
representative for more
information and a
detailed explanation of
the requirements.28 Eylül 2021