The FDA recognizes guidelines from the American National Standards Institute/Association of the Advancement of Medical Instrumentation (ANSI/AAMI) PB70:2003, which specify tests and results necessary to verify and validate that gown provide specific levels of protection.
AAMI PB70:2012 details specific test methods and passing criteria in order to label an isolation gown as AAMI 1, 2, 3, or 4 rated. A summary of the required testing is in the list below:
AAMI Level | Test Method | Standard |
1 | AATCC-42: Water Resistance: Impact Penetration | ≤ 4.5g |
2 | AATCC-42: Water Resistance: Impact Penetration AATCC-127: Water Resistance: Hydrostatic Pressure | ≤ 1.0g ≥ 20cm |
3 | AATCC-42: Water Resistance: Impact Penetration AATCC-127: Water Resistance: Hydrostatic Pressure | ≤ 1.0g ≥ 50cm |
4 | ASTM F1671: Viral Penetration | Pass |
Wuhan Youfu company have got PP+PE, SMS, CPE isolation gown AAMI test reports. Please feel free to contact us if you are interested to check them, we will send to you once received your contact!
