Medical Appareal AAMI Standard (U.S. Standard)
The AAMI PB70 standard was developed to set reference points by which institutions can evaluate protective gowns and surgical drapes.
These objective criteria allow large organizations to easily standardize the selection of protective gowns as well as allow the user to choose the most appropriate protection at a glance.
Level 1 Gowns and Drapes
Describes surgical gowns, other protective apparel, surgical drapes and drape accessories that demonstrate the ability to resist liquid penetration in a laboratory test, AATCC 42 (Water resistance: Impact penetration test).
Level 2 Gowns and Drapes
Describes surgical gowns, other protective apparel, surgical drapes and drape accessories that demonstrate the ability to resist liquid penetration in two laboratory tests, AATCC 42 (Water resistance: Impact penetration test) and AATCC 127 (Water resistance: Hydrostatic pressure test).
Level 3 Gowns and Drapes
Describes surgical gowns, other protective apparel, surgical drapes and drape accessories that demonstrate the ability to resist liquid penetration in two laboratory tests, AATCC 42 (Water resistance: Impact penetration test) and AATCC 127 (Water resistance: Hydrostatic pressure test). For Level 3, the test criterion for AATCC 127 performance is set at a higher value than for Level 2.
Level 4 Gowns
Describes surgical gowns and protective apparel that demonstrate the ability to resist liquid and viral penetration in a laboratory test, ASTM F1671 (Standard test method for resistance of materials used in protective clothing to penetration by blood-borne pathogens using Phi-X174 bacteriophage penetration as a test system).
Level 4 Drapes
Describes surgical drapes and drape accessories that demonstrate the ability to resist liquid penetration in a laboratory test, ASTM F1670 (Standard test method for resistance of materials used in protective clothing to penetration by synthetic blood).
AAMI Level Requirement
| ANSI/AAMI PB 70 Barrier Performance |
Test method | Requirement |
|---|---|---|
| Level 1 | Impact Penetration AATCC 42 | <= 4.5g |
| Level 2 | Impact Penetration AATCC 42 | <= 1.0g |
| Hydrostatic Pressure AATCC 127 | >= 20cm | |
| Level 3 | Impact Penetration AATCC 42 | <= 1.0g |
| Hydrostatic Pressure AATCC 127 | >= 50cm | |
| Level 4 | Blood Penetration ASTM F1670 | Pass |
| Viral Penetration ASTM F1671 | Pass |
