According to the ISO EN 14683:2019+AC:2019, surgical masks and medical face masks in general should fulfil defined safety standards before being placed on the European market.
To fulfil these criteria Tentamus offers the following testing strategies in compliance with ISO 14683:
- Bacterial filtration efficiency (BFE)
- Splash resistance
Medical face masks represent medical devices classified for prolonged contact (24h – 30d) with the skin or the mucosal membrane. Therefore, in compliance with ISO 14683 as well as ISO 10993 Tentamus offers a profound Biocompatibiliy testing strategy including the following tests:
- Biocompatibility testing of Medical face masks:
- Determination of cytotoxicity (ISO 14683 Ch. 5.2.6 / ISO 10993-5)
- Determination of skin irritation (ISO 14683 Ch. 5.2.6 / ISO 10993-10 / OECD TG 439)
- Determination of skin sensitization (ISO 14683 Ch. 5.2.6 / OECD TG 442d/e)
- Microbiological safety
- Biological burdens
- Medical face masks have to be free of microbial contaminants including bacteria and yeast. In this context we determine the Bioburden as the total number of contaminating bacteria (TAMC) and yeast (TYMC) with a boundary of ≤ 30 CFU / g.
- Tests are performed according to the EN ISO 11737-1: 2018
- Product specific Pyrogenicity
Medical face masks should not only be free of microbiological contamination. They also have to be free of microbiological compounds inducing fever and or inflammatory reactions. In this context Tentamus offers a sophisticated and accredited in-vitro testing strategy for the detection / exclusion of Bacterial Pyrogens (BEPs), Non Endotoxin Pyrogens (NEPs) and material dependent pyrogenicity according to the European Pharmacopoeia.
- Determination of Bacterial Endotoxin Pyrogens (BEP) using the LAL-Test (Ph. Eur. 2.6.14)
- Determination of BEPs, Non Endotoxin Pyrogens (NEPs) and material dependent pyrogenicity: Monocyte Activation Test (Ph. Eur. 2.6.30)
If you wish to learn more, please contact our expert:
Dr. Wolfgang Rudy
Chief Scientific Officer Tentamedix
+49 721 957 919 550