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, EN 14683
- Bacterial filter performance - BFE (DIN EN 14683 Annex B)
- Differential pressure as an indicator of breathability (DIN EN 14683 Annex C)
- Microbiological purity - bioburden (ISO 11737-1)
- Skin compatibility using cytotoxicity test for cell damaging effect (ISO 10993-5, DIN EN 10993-1)
- For masks with splash resistance: penetration test using synthetic blood (ISO 22609)
- For washable/reusable masks, we determine functionality by re-testing after defined wash cycles
- 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
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.
For a class 1 medical device, medical face masks in the EU require a CE mark (certification) per the Medical Devices Regulation (EU) 2017/745. In accordance with EN 14683 (see factsheet) , the test report from Hohenstein may be used as one of the technical documents required for EU medical product certification.
Hohenstein is a test laboratory for medical products, but not a certification body/notified body for medical products. Additional comprehensive tests and clinical evaluations are that are required for approval must be done outside of Hohenstein.
Regulations vary by country.
Germany: 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. This temporary suspension has ended. To continue advertising and selling medical face masks, manufacturers must complete the approval process for EU medical product certification.
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.