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Surgical masks in Europe and the USA

The European Centre for Disease Prevention and Control (ECDC) has estimated, that on average, healtchare associated infuctions occur in one hospitalised patient in 20; that is to say 4.1 million patients a year in the European Union, and that 37.000 deaths are caused every year as a result of such infections [Council Recommendation of 9 June 2009 on patient safety, including the prevention and control of healthcare associated infections (2009/C 151/01).]

These infections are often caused by the introduction of pathogens within patients during surgical procedures. Infective agents can be transmitted during surgical procedures in operating theatres and other medical settings in several ways. One of the important sources are the noses and mouths of the surgical team. When breathing, speaking, coughing or sneezing, a person releases smaller or larger amounts of droplets of secretions from the mucous membranes in the mouth and nose. Those droplets quickly evaporate and leave nuclei suspended in the air. Nuclei can subsequently spread through the air to a susceptible site such as an open operating wound or sterile equipment, or can be inhaled if dimensions are very small.
A surgical mask is a medical device covering the mouth, nose and chin ensuring a barrier that limits the transition of an infective agent between the hospital staff and the patient. It was originally developed to contain and filter large droplets of microorganisms expelled from the mouth and nasopharynx of healthcare workers during surgery, thereby providing protection for the patient.
The main objective of wearing a surgical mask is to protect the direct environment of the wearer from contamination.

How are surgical masks evaluated in Europe and in the United States?

EUROPE

In Europe, surgical masks must wear a CE-mark and comply with the requirements defined in EN 14683. Thes requirements concern the construction, design and technical performances as described in EN 14683 "Surgical masks - requirements and test methods".

The standard defines surgical masks as : medical devices, covering the mouth, nose and chin ensuring a barrier that limits the transition of an infective agent between the hospital staff and the patient.

In respect of the performances, the mask is tested as a final product and has to comply with different requirements. Based on the test results, the mask is classified in a certain class. The required performance level depends on the end use.

The present version of EN4683 includes 3 tests to classify the masks in 4 types:

  • bacterial filtration efficiency (BFE)
  • breathability (delta P)
  • splash resistance (synthetic blood)

Click here for the table "requirements and classification of surgical masks for the European market according to EN 14683 - 2005"

Note: in 2013 a revision of EN 14683 will be published. The standard will be completed with microbial cleanliness of masks and biocompatibility tests. IR type masks will be removed. ISO standard 22609 will replace the ASTM F1862 method.

Because surgical masks are considered medical devices of class I, the manufacturer has to run a risk analysis and additional tests if needed to respond to the European Medical Directive (2007/47/EC, MDD 93/42/EEC).

There are no requirements regarding barrier against inert particles.

UNITED STATES

The FDA (Food and Drug Administration) is the organism that regulates medical devices on the USA market. Surgical masks are considered medical devices class 2.

The FDA has drafted standards to which manufacturers have to comply in order to receive a licence to sell the products on the market. The same standards apply to surgical masks, procedures, isolation, dental interventions and laser treatments.
The FDA strongly recommends that the manufacturer clearly indicates the use of the product on the package.

The masks are submitted to the same tests as the ones described in the European standard EN14683, except that the FDA also prescribes the measurement of filtration efficiency regaring inert particles (latex), fire tests and tests to measure biocompatibility.

The US standard ASTM F2100-11 “Standard specification for performance of material used in medical face masks” describes the tests and requirements with which the materials have to comply that are used to produce the masks. Several tests are not run on the final product, but on the different materials have to be tested together in the way they will be used in the final mask.

The performances of the materials composing the mask are evaluated by five tests :

  • bacterial fitlration efficiency
  • breathability (delta P)
  • splash resistance
  • particle filtration efficiency
  • fire test

According to the results, the masks are classified in three levels.
Click here to open the table "Requirements and classification of surgical masks for the US market -ASTM F2100 - 2011"

At this moment, the manufacturer has to be able to characterise and classify his masks in type I or II for the European market and in level 1, 2 ot 3 for the American one.

CENTEXBEL has the equipment and knowledge to help the industry in both markets and is actively involved in the harmonisation effort of both standardisation systems.

CENTEXBEL's surgical masks test equipment

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Bacterial filtration efficiency (BEF)
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Breathability (Delta P)
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Splash resistance