The American standard ASTM F3352-19 defines medical isolation gowns as protective clothing (apparel) used to protect medical personnel, visitors and patients from the transfer of microorganisms and body fluids in the case of patient isolation. Medical isolation gowns can also be used to protect visitors in the medical environment. According to the isolation and prevention guidelines of the Centers for Disease Control and Prevention, during surgery and patient care activities, wear isolation gown to protect medical staff's arms and exposed body areas when they are expected to come into contact with clothing, blood, body fluids, secretions and excreta.
What are the levels of medical isolation gowns?
The core performance of medical isolation gowns is barrier performance. The barrier performance of medical isolation gowns conforms to all levels specified in ANSI/AAMI PB 70.
Table 1 The barrier performance and physical performance requirements of single-use and multiple-use medical isolation gowns
Performance
Material type
Test method
AAMI PB 70 4 grades
Level 1
Level 2
Level 3
Level 4
Barrier performance
All
AATCC 42
≤4.5 g
≤1.0 g
≤1.0 g
N/A
All
AATCC 127
N/A
≥20 cm
≥50 cm
N/A
All
F1671/F1671M
N/A
N/A
N/A
Pass
Tensile strength
All
D5034
≥30N
≥30N
≥30N
≥30N
Tear strength
nonwoven fabric, film, nonwoven fabric and filmcomposite material
D5587
D5733
≥10 N
≥10 N
≥10 N
≥10 N
Seam strength
All
D1683/D1683M
≥30 N
≥30 N
≥30 N
≥30 N
*According to ANSI/AAMI PB70, the qualified quality level (AQL) is 4% and the unqualified quality level (RQL) is 20%.
