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 .
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➊ It is labeled as such ➋ It is described in its labeling as a surgical gown ➌ It has statements relating to moderate or high-level barrier protection ➍ It has statements that it is intended for use during sterile procedures
The FDA must perform a premarket review of all Class II gowns before these can be cleared for marketing . FDA premarket reviews will address areas such as :
● Performance testing to ensure the gowns resist blood and liquid penetration
● Safety testing for biocompatibility , sterilization method validation , flammability , physical strength , and linting
● Labeling including barrier level identification and instructions for use
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 . The ANSI / AAMI PB70 standard was accepted by the FDA in 2004 . AAMI addresses fluid protection in the critical zone , the gown area where an OR staff member is most likely to come in direct contact with potentially infectious material . In surgical gowns , it includes much of the sleeves and the front panel . Both fabric and construction ( seams ) are tested . The back of the gown is typically not protective . ANSI / AAMI PB70 Levels are defined as follows :
ANSI / AAMI PB70 Level 1 : ANSI / AAMI PB70 Level 1 gowns offer minimal protection and are intended to protect the wearer from the transfer of microorganisms and body fluids in low or minimal risk patient isolation situations . These can be used for Standard Precautions and Contact Precautions . Patient gowns and non-surgical isolation gowns are classified as ANSI / AAMI PB70 Level 1 .
ANSI / AAMI PB70 Level 2 : ANSI / AAMI PB70 Level 2 gowns offer minimal to low fluid barrier protection . These are intended only for low-fluid , minimally invasive surgical procedures such as blood draws and suturing . These can also be used for standard precautions and contact precautions . To classify as ANSI / AAMI PB70 Level 2 , the gown must undergo impact penetration testing ( AATCC 42 ) as well as hydrostatic pressure testing ( AATCC 127 ). Impact penetration testing must measure <= 1.0 g . The test indicates how the fabric will resist strikethrough when fluids splash or spray onto the fabric . Please see
https :// www . aatcc . org / impactpenetration-testing-for-textiles / for the test definition . Hydrostatic Pressure testing must measure >= 20 cm . This test indicates how the fabric will resist strikethrough when water pressure is applied to the surface of the fabric . A higher number indicates better water resistance . See https :// members . aatcc . org / store / tm127 / 535 for the test definition .
ANSI / AAMI PB70 Level 3 : ANSI / AAMI PB70 Level 3 gowns offer moderate fluid barrier protection and are used for the widest range of surgical procedures , where moderate fluid protection is necessary . Examples include arterial blood draws , IV insertions , ER staff , and trauma staff . To classify as an ANSI / AAMI PB70 Level 3 the gown must measure <= 1.0 g for AATCC 42 impact penetration testing and >= 50 cm for Hydrostatic Pressure testing .
ANSI / AAMI PB70 Level 4 : ANSI / AAMI PB70 Level 4 gowns offer the highest fluid and microbial barrier protection against bloodborne pathogens in the critical zones . These are used for long , fluid-intensive procedures or procedures where there is a high likelihood of bloodborne pathogen contamination . Open heart surgeries , C-Sections , and organ transplants are procedures where ANSI / AAMI PB70 Level 4 gowns would be typically required . Only ANSI / AAMI PB70 Level 4 gowns are tested for viral penetration resistance , and therefore only Level 4 gowns are considered impermeable to viral penetration using ASTM F1671 testing . See
https :// www . astm . org / Standards / F1671 . htm for the testing definition . To classify as ANSI / AAMI PB70 Level 4 , gowns must exhibit no penetration at 2 psi ( 13.8 kPa ) using ASTM F1671 testing .
According to the CDC , the gowns complying with the lower levels ( Level 1 , 2 and 3 ) cannot be considered impermeable . However , Level 1 – 3 gowns can provide increased resistance to liquids . ANSI / AAMI PB70 Level 1 , 2 , and 3 surgical / isolation gown-testing requirements only use water as a challenge . Because the surface tension of water is much higher than that of blood , blood can penetrate through fabrics more readily than water . Therefore , no correlation can be made between AATCC water resistance tests ( AATCC 42 and AATCC 127 ) and ASTM F1671 viral penetration tests , and consequently , protection provided by Levels 1 , 2 , 3 gowns and that of Level 4 gowns .
A common misunderstanding among many end-users is that they are protected from blood , body fluids , and other potentially infectious materials ( OPIM ) when they wear any type of fluid-resistant garment or surgical or isolation gown . Another common misunderstanding is around gown testing versus fabric testing . Many gowns are marketed with Level 2 or 3 fabric . This is vastly different from an actual Level 2 or Level 3 surgical gown . To be classified as a Level 2 or Level 3 surgical gown , the entire gown critical zones , including all seams , must pass rigorous hydrostatic testing and impact testing after the marketed number of uses . They also have thorough labeling requirements . Do not expect a