Surgical face mask testing

Testing of face masks according to standard EN 14683:2019 + AC:2019. Testing is done in an accredited laboratory. Passing the test grants the manufacturer permission to attach a CE marking to the product if other requirements are met.

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In order to attach a CE marking to the product, manufacturers need to test the performance of the medical face masks they produce. The requirements of the standard EN 14683 include three tests for type I and type II masks.

Bacterial filtration efficiency (BFE): Efficiency of the medical face mask material(s) as a barrier to bacterial penetration.

Breathability (differential pressure): Air permeability of the mask, measured by determining the difference of pressure across the mask under specific conditions.

Microbial cleanliness (Bioburden): Microbiological cleanliness is the amount of viable micro-organisms on a product.

For type IIR masks there is also an additional test: blood splash resistance.

The standard EN 14683 also requires that the manufacturer needs to assess the biocompatibility of the face masks. If the materials have been previously tested and accepted for use as face masks, the biocompatibility reduces to a manufacturer’s risk assessment, and does not need any testing services.

The manufacturer also needs to have a quality control system and write other documents, such as the Declaration of Conformity.

Measur offers the accredited face mask testing services that are required for the CE marking of the product.

Suitable sample matrices

  • Face masks intended for medical use

Ideal uses of surgical face mask testing

  • CE-marking and surgical grade acceptance for surgical face masks

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Frequently asked questions

What is surgical face mask testing commonly used for?

This test is used for CE-marking and hospital grade use acceptance for surgical face masks.

What are the limitations of surgical face mask testing?

The bioburden test is very accurate and is often failed due to poor hygiene during the manufacturing or packaging of the mask. The test only gives the total number of viable micro-organisms and does not give any information on what kind of microbes they are.

What kind of samples can be analyzed with surgical face mask testing?

The testing is for medical grade face masks of type I, type II and type IIR. The tests can also be done to non-medical grade masks, but these do not often pass the test.

What is Measurlabs?

Measurlabs offers a variety of laboratory analyses for product developers and quality managers. We perform some of the analyses in our own lab, but mostly we outsource them to carefully selected partner laboratories. This way we can send each sample to the lab that is best suited for the purpose, and offer high-quality analyses with more than a thousand different methods to our clients.

How does the service work?

When you contact us through our contact form or by email, one of our specialists will take ownership of your case and answer your query. You get an offer with all the necessary details about the analysis, and can send your samples to the indicated address. We will then take care of sending your samples to the correct laboratories and write a clear report on the results for you.

How do I send my samples?

Samples are usually delivered to our laboratory via courier. Contact us for further details before sending samples.