Medical face masks (for the mouth and nose) are usually worn by doctors and care staff to protect patients from pathogens spread by the medical staff. These “surgical masks” or “oronasal masks,” can provide some protection for medical staff from splashes during surgical procedures.
- Medical Device Regulation (EU) 2017/745, European standard EN 14683
- Protection of environment from contaminated droplets from potentially infected wearer, particularly in medicine and caretaking.
- Protection of wearer from splashes of infectious bodily fluids, e.g. during surgery. (With appropriate additional application)
- Restricted protection of wearer from smear infection from contaminated hands touching the mouth and nose.
- Regulation (EU) 2016/425 for Personal Protective Equipment, DIN EN 149, CE certification label
- Protection of wearer (for example, medical and care staff) from breathing in infectious aerosols (airborne pathogens) or dust from patients or the environment
- Protection levels for respiratory masks (FFP 1-3) depend on how well they protect from dust, liquid or solid particles and pathogens
Yes. We test FFP masks that protect the wearer from breathing in possible pathogens from aerosols or from solid or liquid particles.
Medical masks sold in the EU must comply with the European Medical Devices Regulation 2017/745 and must meet the requirements for medical products in Class 1 and the technical specifications of European Standard EN 14683.
Medical face masks in the EU require a CE mark (certification). In accordance with EN 14683, the test report from Hohenstein may be used as one of the technical documents required for EU medical product certification. Other comprehensive tests and clinical evaluations are also required for approval.
At the beginning of the COVID-19 pandemic, the German Federal Ministry of Health temporarily suspended the requirement for medical face masks to be approved as medical products before being put into circulation as long as they had a successful test report in accordance with EN 14683 (see factsheet) and indicated that their tested products do not have a CE mark, thus were not yet approved medical products. This temporary suspension has ended. To continue advertising and selling medical face masks, manufacturers must complete the approval process for EU medical product certification.
Regulations vary by country.
Hohenstein's certification/notified body status is not for medical products. In the EU, there are currently 12 medical certification/notified bodies.
Current estimated delivery time for the whole process is 6 - 9 months.
Functionality Testing for Product Development and Quality
Hohenstein tests the microbiological-hygienic and physical functionality of medical face masks (not N95 masks). We can also test the material quality and certify to STANDARD 100 by OEKO-TEX®.
We support producers in providing technical documentation as proof of effectiveness and safety, a requirement for medical product approval in accordance with the EU Medical Device Regulation 2017/745.
Hohenstein does not provide the additional tests and documents required for final approval as a medical device.
In accordance with European Standard EN 14683, we test face masks for:
- Bacterial filter performance
- Differential pressure as an indicator of breathability
- Microbiological purity (in accordance with ISO 11737-1)
- Skin compatibility using cytotoxicity test (cell damaging effect per ISO 10993-5)
- For masks with splash resistance: penetration test using synthetic blood (in accordance with ISO 22609).
For washable/reusable masks, we determine functionality by re-testing after defined wash cycles.
The normal lead time for complete testing to EN 14683 is about 3 - 4 weeks. Lead times increase with increased demand.
No. At the moment, we only carry out the above tests and deliver a corresponding test report. We do not currently offer medical product certification.
Face masks that do not meet the requirements of the Medical Device Regulation (MDR) and are not identified as personal protective equipment with the CE mark are simply clothing items without a proven protective function.
Depending on the material they are made from and whether they are worn correctly, masks of this type do demonstrate a certain barrier effect. They can provide a certain level of protection from larger droplets from coughing/sneezing persons or from infection due to potentially contaminated hands coming into accidental contact with the face.
However, the key factor regarding proof of functionality of such masks is that the performance of the material has been tested in a standardized test procedure by a specialized test laboratory.
This applies to products from manufacturers shifting to face mask production because of the COVID-19 pandemic and to individuals sewing community masks at home. If the material used is too thick and not breathable enough, there is a risk of the wearer collapsing if they do not get enough air. If the material is not thick enough, it has no protective function.