Our Level 1, 2 and 3 gowns are intended to be used when minimal, low, and moderate fluid barrier protection is needed. Level 4 gowns are prepared for the highest fluid and microbial barrier protection to protect the user against lengthy, fluid-intensive procedures and reduce the risk of potential blood-borne pathogens.
Test
Description
Our Level 1, 2 and 3 gowns are intended to be used when minimal, low, and moderate fluid barrier protection is needed. Level 4 gowns are prepared for the highest fluid and microbial barrier protection to protect the user against lengthy, fluid-intensive procedures and reduce the risk of potential blood-borne pathogens.
AAMI PB70 GUIDELINES
Level | Test Method | Test Definition | Requirement | Expected Barrier Effectiveness | Anticipated Fluid Exposure |
---|---|---|---|---|---|
AAMI Level 1 | AATCC 42 Impact Penetration | Measures the ability of a material to resist water penetration under spray impact | Water impact < 4.5g | Minimal water resistance (some resistance to water spray) | Minimal Fluid Levels |
AAMI Level 2 | AATCC 42 Impact Penetration | Measures the ability of a material to resist water penetration under spray impact | Spray impact < 1.0g | Low water resistance (resistant to water spray and some resistance to water penetration under constant contact with increasing pressure) | Low Fluid Levels |
AATCC 127 Hydrostatic Pressure | Measures the ability of a material to resist water penetration under constant contact with increasing pressure | Hydrostatic pressure > 20cm | |||
AAMI Level 3 | AATCC 42 Impact Penetration | Measures the ability of a material to resist water penetration under spray impact | Spray impact < 1.0g | Moderate water resistance (resistant to water spray and some resistance to water penetration under constant contact with increasing pressure) | Moderate Fluid Levels |
AATCC 127 Hydrostatic Pressure | Measures the ability of a material to resist water penetration under constant contact with increasing pressure | Hydrostatic pressure > 20cm | |||
AAMI Level 4 | ASTM F1671 Viral Penetration Test | Measures the resistance to penetration by blood borne pathogens using a surrogate microbe under conditions of continuous liquid contact | Pass | Blood and viral penetration resistance (2 psi) | High Fluid Levels |
The Association for the Advancement of Medical Instrumentation (AAMI) standards are designed to help medical-device companies meet global standards for the safe use of medical devices. ANSI/AAMI PB70:2012