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 | Less than or equal to 4.5g |
2 | AATCC-42: Water Resistance: Impact Penetration AATCC-127: Water Resistance: Hydrostatic Pressure | Less than or equal to 1.0g Greater than or equal to 20cm |
3 | AATCC-42: Water Resistance: Impact Penetration AATCC-127: Water Resistance: Hydrostatic Pressure | Less than or equal to 1.0g Greater than or equal to 50cm |
4 | ASTM F1671: Viral Penetration | Pass |
Wuhan Youfu company have got PP plus 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!
