Understanding EN 13795 Requirements for Surgical GownsUpdated: January 2026 When hospitals and medical distributors buy surgical gowns and drapes, they often ask suppliers: “Do your surgical gowns have an EN 13795 certificate?” This question needs some explanation. EN 13795 is the European standard for surgical gowns and drapes. It sets performance and test rules. So say “meets EN 13795” and show test reports/certs—not “EN 13795 certified.” It’s a standard, not a product certificate. Latest: EN 13795-1:2025 covers surgical gowns and drapes; EN 13795-2:2025 covers clean air suits. The EU added both to its harmonised medical-device standards in 2025. 
What Is EN 13795?EN 13795 is a European standard for surgical clothing and drapes. This covers disposable and reusable surgical gowns and drapes. They help stop germs from spreading between patients, staff, and equipment during surgery and other invasive procedures. The standard covers:
For medical buyers, EN 13795 provides a common way to compare surgical gowns and drapes. Current EN 13795 Standards
EN 13795-1:2025 replaced the 2019 edition. National standards bodies such as NEN, SIS, and DIN list the 2025 edition as the current version. Is EN 13795 a Certificate?Not exactly. This is an important point for medical PPE buyers. EN 13795 is a technical standard. Manufacturers usually show compliance through product testing, technical documents, quality systems, and the required medical-device conformity assessment process. A supplier may provide documents such as:
Instead of asking only: “Do you have an EN 13795 certificate?” buyers should ask: “Can you send valid test reports and compliance docs showing this surgical gown meets EN 13795?” This difference helps buyers avoid confusing a laboratory test report with CE certification or another regulatory certificate. What Products Does EN 13795 Cover?EN 13795-1:2025 covers surgical gowns and surgical drapes used as medical devices. Typical products include:
The standard applies to products used during surgery and other invasive procedures. It does not cover incision drapes or films. It also does not cover resistance to laser radiation. What Does EN 13795 Test?EN 13795 checks the physical strength, barrier performance, and cleanliness of surgical gowns and drapes. The tests may include the following areas, depending on the product and its claimed performance:
CDC says EN 13795 also checks things like microbial/particle cleanliness, linting, bursting strength, and tensile strength. |
| Buyer question | Why it matters |
|---|---|
| Which EN 13795 edition was used? | Confirms the correct standard |
| Is the product single-use or reusable? | Identifies the relevant product requirements |
| Can you provide the complete test report? | Allows buyers to check the actual results |
| What material was tested? | Confirms that the tested material matches the product |
| What product model was tested? | Prevents document mismatches |
| Which laboratory performed the test? | Helps confirm the reliability of the test |
| Does the report still apply to the current product? | Helps track changes in materials and design |
| Can you provide the Declaration of Conformity? | Supports regulatory review |
| Is the product CE marked where required? | Confirms EU market access requirements |
| Can you provide samples before bulk production? | Allows buyers to check the product |
EN 13795 for Chinese Surgical Gown Manufacturers
Chinese maker selling to European hospitals, distributors, or importers? EN 13795 compliance should be a key part of your product docs.
However, manufacturers should not use a general “EN 13795 certificate” as their only compliance claim.
A complete supplier documentation package may include:
- Product specification
- Material specification
- EN 13795 test report
- Laboratory information
- Product technical documentation
- Declaration of Conformity
- Applicable CE/MDR documentation
- Quality management documentation
- Packaging and labeling information
- Batch or production traceable
These documents give buyers a clearer basis for evaluating suppliers and purchasing products.
EN 13795 vs EN 14126
Buyers sometimes confuse these two standards because both relate to protective clothing.
The main difference is their intended use.
EN 13795 covers surgical gowns, surgical drapes, and related surgical clothing used as medical devices.
EN 14126 covers protective clothing against infectious agents and relates to PPE applications.
The CDC explains that EN 13795 focuses on protecting the patient in its medical-device context. PPE that protects you from infectious agents must meet the right PPE standards—including EN 14126 when it applies.
Buyers should check if suppliers supply it as a medical device or PPE.
FAQ
Is EN 13795 mandatory for surgical gowns?
The answer depends on the target market, product classification, and applicable regulations. For medical devices sold in the EU, EN 13795-1:2025 is a harmonised standard that supports MDR requirements. Compliance can provide a presumption of compliance with the requirements covered by the standard.
What is the latest EN 13795 standard?
For surgical gowns and surgical drapes, the current edition is EN 13795-1:2025. For clean air suits, the current edition is EN 13795-2:2025.
Does EN 13795 mean the product is CE certified?
No. EN 13795 is a technical standard. CE marking requires the manufacturer to complete the applicable EU conformity assessment process. Never present an EN 13795 test report as a CE certificate.
Can different surgical gowns share one EN 13795 report?
Not automatically. Sellers must ensure the tested product matches what they sell in material, design, process, and other features.
Is EN 13795 the same as AAMI PB70?
No. EN 13795 is a European standard. ANSI/AAMI PB70 is a US classification system for protective apparel and drapes. Buyers should compare the actual test methods and performance requirements instead of treating the two systems as identical.
Conclusion
EN 13795 is an important technical standard for surgical gowns and surgical drapes supplied to the European medical market.
For buyers, the key point is simple:
Do not buy a product based only on the words “EN 13795 certificate.”
Instead, check the current EN 13795 version, the product’s test report, lab info, results, DoC, and any CE/MDR docs.
For current EU projects, buyers should pay special attention to EN 13795-1:2025. This edition replaced EN 13795-1:2019 and now forms part of the EU harmonised standards framework for medical devices.
