The information given on this page is provided as a guide to buyers who are importing surgical gowns to the EU during the coronavirus pandemic and beyond. It includes the regulatory and certification information you need to know about in order to assure that you are purchasing safe and compliant gowns and their closely-related drapes.
Page last updated: 1/6/20
1. What are surgical gowns and drapes?
Surgical gowns are a type of protective clothing used in healthcare environments such as hospitals or clinics.
- They need to be roomy, breathable, and resistant to liquids and solids.
- Both reusable and disposable types are available.
- They may also be known as ‘medical gowns, isolation gowns, surgical isolation gowns, nonsurgical gowns, procedural gowns, and operating room gowns.’
- They are classified as ‘Medical Devices’ (MD) in Europe.
Below is an image of how a surgical gown may look, although exact styles may vary from manufacturer to manufacturer:
Surgical drapes (also patient covers) are shaped material barriers that are laid onto the patient or over the operating table or other equipment during various medical procedures such as C-section deliveries or coronary artery bypass surgery.
They are usually made from the same/similar materials as surgical gowns, hence are tested in the same way and are also classed as MD in Europe requiring a CE mark.
You can see an operating room scene with surgical drapes in use below:
2. Types of surgical gowns and drapes in the EU
Surgical gowns and drapes can be classified as either:
- Sterile (Class II MD) – gowns and drapes
- Non-sterile (Class I MD) – gowns*
The difference in classification will impact testing as class I MD do not require the mandatory involvement of a notified body (third party testing body) prior to being placed on the market (*unless they are also sterile). The manufacturer must certify that the product complies with the applicable requirements. This regime is essentially one of self-certification. If such devices are supplied in a sterile condition they are however classified in a higher risk class and a conformity assessment by a Notified Body is required.
3. The CE Certification process for surgical gowns & drapes being imported into the EU
The process to gain the CE mark which allows gowns and drapes to be imported and sold in Europe according to EU MD legislation is as follows:
- Determine medical device (MD) classification (Class I or II)
- Choose conformity assessment procedure conforming with harmonised European standards (EN 13795-1:2019) OR another verified technical specification
- Select Notified Body (not required for Class I MD unless sold as sterile) – this organisation will perform the lab testing
- Implement Quality Management System (QMS) – If the manufacturer is ISO 13485 certified for medical devices this will assure safety & quality, however an appropriate but non-certified QMS is acceptable, too.
- Prepare Technical File (TF) or Design Dossier – Includes bill of materials (BOM), design drawings, label files, packaging files, list of applicable EN standards or directives (such as EN 13795-1:2019), laboratory test reports, product QC inspection reports, risk assessment
- Appoint an Authorized EC Designated Representative (for non-European suppliers)
- Audit by Notified Body of QMS and TF (not required for Class I MD unless sold as sterile)
- Register medical device – the product must be registered with the national authority of the country where it is to be imported to and sold because it is a medical device
- Manufacturer prepares Declaration of Conformity (DoC) – This self-declaration includes SKU, product features, user manual, contact details of manufacturer/importer, list of applicable EN standards or directives (such as EN 13795-1:2019), manufacturing location, name of responsible individual.
The EU provides a thorough guide to drawing up your EC DoC.
- Affix CE mark – This will be on the product labelling and its packaging. You can read CE marking regulations here.
- (IF the product is STERILE) – the product’s labelling and packaging will also include the word STERILE and the product MUST be tested by a notified body regardless of whether it is a Class I or Class II MD.
4. EU surgical gown & drapes testing and performance standards
In Europe, Surgical gowns and drapes are classified as ‘Medical Devices’ and must comply with EU MD legislation and the harmonised standard EN 13795-1:2019 Surgical clothing and drapes – Requirements and test methods – Part 1: Surgical drapes and gowns. This standard is for gowns and drapes which are intended to prevent the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures.
Included tests for BOTH gowns and drapes are:
- Evaluation of dry microbial penetration (EN ISO 22612) – the dry gown fabric is tested for its ability to resist the penetration of bacteria-carrying particles.
- Evaluation of wet microbial penetration (EN ISO 22610) – resistance of barrier material to the penetration of bacteria carried by a donor, when subjected to mechanical rubbing and wetting.
- Evaluation of liquid penetration (EN 20811) – a method for determining the resistance of fabrics to penetration by water under increasing hydrostatic pressure.
- Evaluation of cleanliness microbial/bioburden (ISO 11737-1:2018 Sterilization of Healthcare Products) – estimates the number of microorganisms on the materials before sterilization with a limit of 300 CFU.
- Evaluation of particle release & linting (ISO 9073-10) – estimates linting of the fabric in a dry state before and after twisting and compressing.
- Evaluation of bursting strength in dry and wet state (EN 13938-1) – determines the resistance of a fabric to be punctured by fluid pressure under dry and wet conditions.
- Evaluation of tensile strength in dry and wet state (EN 29073-3) – determines the ability of a fabric to withstand tearing under dry and wet conditions. Should withstand ≥20 Newtons of force.
The gown or drape should also be evaluated to ISO 10993-1:2018 biological evaluation of medical devices which assess the risk of the wearer’s body being in contact with the gown or drape’s material and becoming irritated.
The following tables courtesy of Afnor demonstrate the testing standards and requirements for gowns:
Importers should be aware that surgical drapes undergo the same testing, however, the performance requirements do differ in some areas relevant to the specific usage of drapes:
Laser resistance of surgical drapes
Surgical drapes will also comply with EN ISO 11810:2015 which is the test method and classification for the laser resistance of surgical drapes and/or patient protective covers. They are tested for primary ignition, penetration, flame spread, and secondary ignition.
5. FAQs when importing surgical gowns and drapes into the EU
Even if you can’t run new lab tests, you can focus on paperwork, auditing, and inspections to reduce risks:
- Due diligence on suppliers before placing orders – are they legitimate manufacturers, are they legal?
- Certificate verification – is their certification real? Are the documents they provide for the correct products?
- Factory audits – this may be more effective if you are placing very large orders (millions of pieces), but they will allow you to know that the factory is capable of producing the products you need at the right standards.
- Product inspections – gives you the security that your products are good quality before they are shipped.
No. Before placing an order, you need to perform due diligence on the vendor to check that CE certification and testing certificates are not fake, as there have been many fakes recently which could place your products’ users in danger.
- BSI has warned that there are fake testing certificates in circulation.
- Fake CE certificates have also been seen regularly recently.
Since the responsibility for any problems falls on you, the importer, here’s how we can help you reduce risks and import safe, good quality medical products and PPE.
Probably not. Due to the demand, testing labs are swamped and are giving lead times of several months for certain tests. During the coronavirus pandemic when you need goods now, running new lab tests is probably unrealistic.
The EU has created this helpful guide demonstrating how to legally place medical devices and PPE on the EU market, and therefore safely purchase and use them, too.
It explains the procedure for legally placing markets for sale, what a certificate of conformity should include, what testing reports are, and much more.
Remember, importers of medical devices and PPE can be held responsible for illness or injury caused when using the products if it’s found that they were not compliant with the correct EU regulations, therefore understanding the legalities is important.
Sofeast’s indemnity and notes for the reader
- We are not legal professionals and any information provided here about the regulations and standards is only given for your reference. We do not accept responsibility for any issues you may face after using this information.
If you are unsure about the validity of your products, please refer to the EU’s official documentation, an accredited testing body, or a local legal professional for assurance before importing PPE from China to Europe.
- This page will be updated periodically as we find useful new information. If you have a suggestion for a change or an addition, please contact us.