What is a medical or surgical mask?
A medical or surgical mask is a medical device. It traps droplets of saliva and airway secretions when the wearer breathes out. It is a single-use device. Worn by the healthcare professional: it protects the patient, the operating site or the equipment. Worn by somebody who is contagious: it protects those around them.
What do you need to check on a medical or surgical mask?
In Europe, a single-use medical or surgical mask must be marked with a reference to the EN 14683: 2019 + AC: 2019 standard, and the type of mask it is supposed to be (see below).
What performance requirements does this medical or surgical mask meet?
As mentioned above, it complies with the EN 14683: 2019 + AC: 2019 standard, which specifies the requirements.
4 performance criteria are expected to confirm the quality of medical or surgical masks:
- Bacteria filtering effectiveness (BFE)
- Determination of breathability by measuring differential pressure
- Microbial cleanliness
- Splash resistance pressure
Are there different levels of performance for medical or surgical masks?
Yes, the EN 14683: 2019 + AC: 2019 standarddistinguishes between 3 kinds of masks:
Tableau 1 – Exigences de performance des maques à usage médical
|Test||Type I*||Type II||Type IIR|
|Bacteria filtering effectiveness (BFE), (%)||≥ 95||≥ 98||≥ 98|
|Determination of breathability by measuring differential pressure (Pa/cm²)||< 40||<40||< 60|
|Splash resistance pressure (kPa)||Not required||Not required||≥ 16,0|
|Microbial cleanliness (ufc/g)||≤ 30||≤ 30||≤ 30|
Extrait §5.2.7 de la norme EN 14683 : 2019 + AC : 2019
Does HeX carry out its tests in accordance with EN 1468 : 2019 + AC?
Yes, HeX carries out its tests on medical and surgical masks in accordance with the requirements of EN 14683: 2019 + AC: 2019 standard
Table summarising the tests offered by HeX and compared with the requirements of the EN 14683 : 2019 + AC : 2019 standard
|Test||Type I||Type II||Type IIR||Offered by HeX|
|Bacteria filtering effectiveness (BFE)||Required||Required||Required|
|Splash resistance pressur||NOT required||NOT required||Required|
How can HeX guarantee the quality of the results of these tests?
Like most of the (over 40) tests that HeX offers its clients in the pharmaceutical and hospital industries, HeX carries out these tests in accordance with the requirements of the ISO 17025 standard expected of testing, calibration and analysis laboratories.
Do I have to have these tests done in an accredited laboratory?
There is no regulatory or legal obligation in Europe that says that performance tests on medical or surgical masks have to be carried out by ISO 17025 accredited laboratories.
What tests are available within the context of the COVID-19 pandemic?
HeX offers all of the 3 tests described above, namely bacteria filtering effectiveness, differential pressure and microbial cleanliness. In Belgium, a simplified protocol called ATP has been introduced by FAMHP (Belgium’s Federal Agency for Medicines and Health Products). In fact, the FAMHP’s inspection services have found that the surgical face masks available do not have any declarations, certificates and test reports required to unequivocally demonstrate that they meet the requirements of the applicable European standard (EN 14683: 2019 + AC:2019) (extract from the FAMHP website)
This ATP protocol is therefore based on the completion of one or two tests depending on the results. Only one laboratory is currently recognised as being qualified to carry out these tests within the context of the simplified ATP protocol.
How useful are the results of the tests carried out by HeX compared with the results produced by Belgium’s ATP protocol?
By definition, the ATP protocol is a simplified version of the EN 14683: 2019 + AC: 2019 standard (inferior or simplified number of tests and testing conditions), so results from a test report that satisfies all of the requirements of the EN 14683: 2019 + AC: 2019 standard could not be opposed from a legal perspective.