Surgical gowns AAMI Levels 3 and 4
Front chest
Sleeve seam
Sleeve
Front belt
There are typically four different areas that must pass the test within the critical zones: front chest, sleeve seam, sleeve and front belt attachment point.
Level 4
Level 1
Level 2
Level 3
• Simple excision biopsies
• Excision of “lumps and bumps”
• Ophthalmological procedures
• Simple ear, nose and throat (ENT) procedures
Minimal
• Tonsillectomies and adenoidectomies
• Endoscopic gastrointestinal procedures
• Open hernia repair
• Minimally invasive surgery (MIS)
• Interventional radiology or catheter laboratory procedures
Low
• Mastectomies
• Arthroscopic orthopedic procedures
• Endoscopic urological procedures (such as transurethral prostate resections [TURP])
Moderate
• Any procedure in which the surgeon’s hands and arms are in a body cavity
• Orthopedic procedures during which tourniquets are not used
• Open cardiovascular or thoracic procedures
• Trauma procedures
• Cesarean sections
High
Examples of procedures with anticipated exposure risks
ANSI/AAMI PB70 barrier
Risk of exposure: Fluid amount, fluid spray or splash and pressure on gown
Click numbers 1 through 4 to view AAMI level details
4
1
2
3
Minimal protection
Low protection
Moderate protection
High protection
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 healthcare 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 PB70:2022 as the standard by which all surgical gown manufacturers must abide.
Relationships between barrier performance and anticipated risks of exposure*