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Surgical Gown Barrier Standards: AAMI PB70 and EN 13795 Explained for Buyers
A buyer's overview of the two main surgical gown and drape standards, ANSI/AAMI PB70 and EN 13795: what they cover, how they classify products, and how to check a supplier's barrier claims.
The two standards you will meet most often for surgical gowns and drapes are ANSI/AAMI PB70, which classifies protective apparel and drapes into four levels of liquid barrier performance, and EN 13795, the European standard that sets requirements and test methods for surgical drapes, gowns and clean air suits. Neither is a quality stamp a supplier can simply quote: each depends on specific tests on specific products, and a buyer should ask which standard, which edition, which level or performance class, which areas were tested and whether the documentation can be shared.
This article explains, in plain terms, what each standard covers and how to question a supplier's barrier claims. It is a buyer's overview, not a substitute for the standards themselves or for your infection-control team's judgement.
Why barrier standards matter
Surgical gowns and drapes sit between the sterile field and everything that could contaminate it, and between the surgical team and the patient's blood and body fluids. How well a textile resists liquids and micro-organisms depends on the material, the construction and the seams, and it can change with use and reprocessing. Standards give manufacturers and buyers a shared way to describe that performance.
For buyers, the practical value is comparison. Two gowns described as "fluid resistant" may perform very differently. Two gowns documented to the same standard and level are much easier to compare.
ANSI/AAMI PB70
What it covers
According to the US Centers for Disease Control and Prevention (CDC) summary, ANSI/AAMI PB70 establishes a system for classifying protective apparel and drapes used in healthcare facilities by their liquid barrier performance. It covers protective apparel such as surgical gowns and isolation gowns, as well as surgical drapes, and applies to products labelled with liquid barrier or liquid-borne microbial barrier claims. It also sets labelling requirements and standardised test methods. The CDC page lists the 2022 edition and notes that the US Food and Drug Administration (FDA) recognised the standard in 2004; earlier editions, such as 2012, are still widely cited, so check which edition a supplier's report refers to.
The four levels
PB70 defines four barrier performance levels, from Level 1 (lowest) to Level 4 (highest). A summary published by the Government of Ontario describes them as follows:
| Level | Risk described | Testing described |
|---|---|---|
| 1 | Minimal | A single test of water impacting the surface of the material |
| 2 | Low | Water impact plus a test that puts the material under pressure |
| 3 | Moderate | The same two tests, with higher performance than Level 2 |
| 4 | High | The earlier tests plus a test with simulated blood containing a virus |
A few points buyers often miss:
- The level applies to the critical zones of the product. For surgical gowns, the same Ontario summary describes these as the front of the body from the top of the shoulders to the knees and the arms from the wrist cuff to above the elbow; the back of a surgical gown may be non-protective.
- A level is a claim about a product as labelled. Ask for the test report, not just the level number.
- In the US, surgical gowns are regulated as medical devices, and the FDA's approach considers how a gown is labelled and marketed as well as its barrier level. If your facility follows US-based guidance, your infection-control team will know how this applies.
EN 13795
What it covers
EN 13795 is the European standard for surgical clothing and drapes. According to Centexbel, a Belgian textile testing centre, it covers woven and nonwoven surgical drapes, gowns and clean air suits used as medical devices, and is intended to apply the same safety and performance levels to single-use and reusable products, over the whole life of the product. Part 1 covers surgical drapes and gowns. A 2019 edition of Part 1 is widely cited, and a later edition appears in national standards catalogues, so confirm which edition a supplier's testing refers to.
Performance classes and areas
EN 13795 distinguishes between:
- Standard performance and high performance products, chosen according to factors such as exposure to fluids, mechanical stress and the length of the procedure
- Critical areas (for gowns, typically the front and sleeves, closest to the surgical site) and less critical areas of each product
What is tested
Centexbel lists properties evaluated under EN 13795, including:
| Property | What it tells you |
|---|---|
| Resistance to dry microbial penetration | How well the material resists bacteria carried on dry particles |
| Resistance to wet microbial penetration | How well it resists bacteria carried through liquid under contact and pressure |
| Resistance to liquid penetration | How well it resists water under pressure |
| Microbial cleanliness | How many micro-organisms are on the product as supplied |
| Particulate cleanliness and linting | How many particles it carries and sheds |
| Bursting strength, dry and wet | Resistance to bursting under pressure |
| Tensile strength, dry and wet | Resistance to tearing apart under tension |
Patient protection versus staff protection
Centexbel also notes that EN 13795 is aimed at preventing transmission of infectious agents to the patient. Where a manufacturer claims a gown protects staff, the product falls under the European personal protective equipment regulation and related standards. This is a useful reminder that "surgical gown" and "protective gown" are not automatically the same claim.
How the two standards compare
| ANSI/AAMI PB70 | EN 13795 | |
|---|---|---|
| Origin | United States | Europe |
| Main focus | Liquid barrier performance | Range of properties including microbial penetration, cleanliness, linting and strength |
| Classification | Levels 1 to 4 | Standard and high performance, critical and less critical areas |
| Products | Protective apparel and drapes | Surgical drapes, gowns and clean air suits |
| Reusable products | Ask whether testing reflects processing | Intended to apply over the product's life |
Facilities in the UAE may see either standard, depending on where products are made and which guidance the facility follows. Your infection-control team should decide which, if any, it requires for each item.
Questions to ask a supplier
- Which standard? PB70, EN 13795, another, or none.
- Which edition? Standards are revised; the edition should be on the report.
- Which level or performance class? And for which areas of the product.
- Fabric or finished product? Fabric testing alone does not show how seams and construction perform.
- New or processed? For reusables, was the product tested after laundering and sterilisation, and after how many cycles?
- Who tested it? The laboratory's name and the report reference.
- Can we see the report? Not just a certificate or a sentence in a brochure.
- What changes would invalidate it? A different fabric, finish or construction may need new testing.
If the answers are vague, treat the product as having no documented barrier performance.
Where woven reusable textiles fit
Many woven reusable theatre textiles are not certified to a barrier standard at all. That does not make them useless, but it does mean infection control should decide where they are appropriate. MISHAREN does not claim barrier-standard certification for its reusable OT gowns and drapes; what the fabric is tested to is confirmed in the quotation, with documentation shared where available, and otherwise the items should be treated as reusable theatre textiles rather than certified barrier products.
For fabric options, see our guide to surgical gown fabrics, and for the wider decision, reusable vs disposable surgical gowns. To discuss your requirements, see our OT gowns and drapes page or get in touch through our contact page.