Two standards dominate the conversation about gown barrier performance, and they answer different questions. EN 13795 covers surgical gowns, drapes and clean air suits as a device category, with requirements for performance, manufacturing and processing. The AAMI PB70 levels describe barrier performance in ascending categories that most Canadian buyers already recognise from gown labels.
For a clinic buying isolation gowns or procedure gowns, the practical question is not which standard is better. It is which performance level the task requires, and whether the paperwork behind the product can show it.
What does EN 13795 verify for surgical gowns and drapes?
EN 13795 defines performance requirements for surgical gowns, drapes and clean air suits used as medical devices, covering material performance and the requirements for the manufacturing process. It separates product categories by whether they are single-use or reusable, and it addresses both the critical product areas — where the barrier matters most — and the less critical areas of the same garment.
The practical distinction buyers feel is the critical zone concept: a gown's barrier performance is not a single number for the whole garment, because the front panel and sleeves are held to a different expectation than the back.
How does EN 13795 compare with the AAMI PB70 barrier levels?
PB70 gives a four-level ladder from Level 1 through Level 4 based on barrier performance testing, and it is the framing most North American buyers see on packaging. EN 13795 approaches the same problem through a device standard with performance and manufacturing requirements attached.
| Frame | What it describes | Where you meet it |
|---|---|---|
| AAMI PB70 Level 1 | Minimal barrier performance | Basic care environments, low fluid exposure |
| AAMI PB70 Level 2 | Low barrier performance | Standard clinical procedures, routine care |
| AAMI PB70 Level 3 | Moderate barrier performance | Procedures with moderate fluid exposure |
| AAMI PB70 Level 4 | Highest barrier performance, with seam and viral penetration testing | High-fluid procedures and surgical settings |
| EN 13795 | Device standard for gowns, drapes and clean air suits, including critical zones | Procurement specifications and price lists for gown and drape programs |
| ASTM F1670 / F1671 | Blood and viral penetration resistance test methods | The test evidence behind higher PB70 levels |
What about clean air suits?
Clean air suits sit in the same EN 13795 family and add a different purpose: limiting particle shedding from the wearer into the environment rather than protecting the wearer from fluid. That is why a clean air suit and a surgical gown are specified by different criteria, even though they are frequently bought by the same department.
The purchasing consequence is straightforward. Asking for "the same gown as last year" without stating whether the requirement is wearer protection, environment protection, or both, is how a department ends up with a suit that meets neither specification cleanly.
Which gown should a Canadian clinic buy?
Start from the task and the fluid exposure it involves, not from the lowest unit price. Isolation and routine care in a clinic, a retirement residence or a food facility usually need a light fluid-resistant gown; procedure rooms with visible splash risk move up a level; and any activity specified as requiring higher barrier performance should be met with tested evidence rather than a heavier-looking fabric.
Then check the supply-side basics before placing a case order: the stated performance level, the critical-area construction, the size range that fits your actual staff, and whether the gown is single-use or reusable with a documented reprocessing route. For high-volume departments, the purchasing decision usually comes down to two ranges and a written level, held on a standing order.
Ordering for a clinic, lab or care home? Wholesale and multi-site ordering covers case pricing and account setup, and the B2B wholesale collection lists the lines stocked for institutional buyers.
Not sure which monitoring consumable fits your cycles? Start with the BI 5-pack trial (CA $12.99, shipping included), or request a quote for volume pricing.
Related reading
Gown blood penetration testing: ASTM F1670, F1671 and EN 13795; AAMI Level 2 isolation gowns: what the rating means; Level 2 fluid-resistant gowns vs standard gowns; isolation gowns and protective apparel.
Frequently Asked Questions
Is EN 13795 the same as AAMI Level 2?
No. EN 13795 is a device standard covering performance and manufacturing for gowns, drapes and clean air suits; AAMI PB70 is a barrier performance ladder. A product can reference both, and a specification should state the level required for the task.
Do reusable gowns meet EN 13795?
Reusable gowns can meet the standard, provided the manufacturer's reprocessing instructions are followed and the gown is inspected before each use. Performance that degrades with laundering cycles is exactly what the reusable route has to control.
What is the difference between a surgical gown and a clean air suit?
A surgical gown is specified primarily for barrier protection of the wearer and the field; a clean air suit is specified to limit particles shed by the wearer into the environment. Some specifications require both properties, which is why the intended use should be stated on the purchase requisition.
Last updated: September 2025. CliniEco Medical is a licensed medical device establishment (MDEL #35334).
0 commentaire