AAMI PB70 is the American classification for the liquid barrier of protective apparel. EN 13795 is the European standard for surgical gowns, drapes and clean air suits. They cover the same garments and are often treated as interchangeable. They are not, and a gown labelled to one does not automatically satisfy the other.
Structure
AAMI PB70 has four levels, 1 to 4, based on liquid barrier tests in a critical zone. EN 13795 has two performance classes, standard performance and high performance, and defines critical and less critical product areas, with requirements for each.
Tests Compared
| Property | AAMI PB70 | EN 13795 |
|---|---|---|
| Liquid penetration | AATCC 42 impact, AATCC 127 hydrostatic | EN ISO 811 hydrostatic pressure |
| Microbial penetration, dry | Not required | EN ISO 22612 |
| Microbial penetration, wet | Not required | EN ISO 22610 |
| Viral penetration | ASTM F1671 at Level 4 only | Not required |
| Cleanliness, microbial | Not required | EN ISO 11737-1, bioburden limit |
| Cleanliness, particulate and linting | Not required | EN ISO 9073-10 |
| Bursting strength, dry and wet | Not required | EN ISO 13938-1 |
| Tensile strength, dry and wet | Not required | EN 29073-3 |
Rough Equivalence
A gown built for AAMI Level 3 usually meets EN 13795 standard performance in the critical area. A gown built for AAMI Level 4 usually meets high performance. Usually is the word: EN adds strength, linting and microbial tests that AAMI does not ask for, so the equivalence has to be shown with EN test reports, not assumed from the AAMI level.
What to Ask For
- Selling in the US: the AAMI level, with AATCC 42 and 127 or ASTM F1670 and F1671 reports.
- Selling in Europe: the EN 13795 performance class, with the full EN test set and CE marking under the MDR.
- Selling in both: one gown, both report sets, both on the Trust ID. Our surgical gown lines are built and tested this way because most of our buyers sell into more than one market.
Where to Go from Here
Every gown and drape on our protective apparel page is listed with its level, tests and construction. The tariff page carries the current duty picture for US buyers, and the quotation request takes a spec, a SKU or a competitor's item.