EN 13795 Certificate Guide for Medical 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. EN 13795 and Surgical Gown ProtectionDifferent surgical procedures require different levels of protection. Before choosing a gown, buyers should consider how and where they will use it. For example:
Buyers should review the actual test results and product classification. They should not assume that every EN 13795 gown offers the same level of protection. EN 13795 vs CE MarkingEN 13795 and CE marking relate to each other, but they do not mean the same thing. EN 13795 sets the technical requirements and test methods for applicable surgical clothing and drapes. CE marking shows that the manufacturer has completed the required EU conformity assessment. It allows the manufacturer to place the medical device on the EU market under the applicable legislation. Under EU MDR, meeting a relevant harmonised standard presumes compliance with its scope. The Commission just added EN 13795-1:2025 and EN 13795-2:2025 to the MDR harmonised standards list. Therefore: EN 13795 compliance ≠ CE marking and an EN 13795 test report ≠ an EU CE certificate. How to Verify an EN 13795 Test ReportMedical buyers should check several details before accepting a supplier's documents. 1. Check the standard editionConfirm that the report refers to: EN 13795-1:2025 rather than an older edition. The 2025 edition replaced the 2019 edition. 2. Check the exact productThe report must list the same product details as the supplier's gown. A report for one product should not automatically serve as proof for another product. 3. Check the test resultsReview the test items and the actual results. Do not rely only on a statement such as: “EN 13795 approved.” Ask for the complete test report when necessary. 4. Check the laboratoryReview the following information:
5. Check the regulatory documentsSelling medical devices in the EU? Check the EN 13795 docs plus the Producer other MDR compliance papers. What Should B2B Buyers Ask a Supplier?Before placing an order, buyers can use this checklist:
EN 13795 for Chinese Surgical Gown ManufacturersChinese 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:
These documents give buyers a clearer basis for evaluating suppliers and purchasing products. EN 13795 vs EN 14126Buyers 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. FAQIs 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. ConclusionEN 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. |
EN 13795 Certificate Medicine Guide
2026-01-26
