Purpose of usage

Medical face masks are basically designed to prevent the transmission of bacteria and similar pathogenic organisms in the wearer's body to the environment or other people (patients) in situations such as breathing, coughing, sneezing of the wearer. It is also possible to protect the wearer from pathogenic organisms in the environment. (It is the mask recommended for our people to wear in crowded environments during the Covid19 struggle.)

Product structure and production

Medical face masks are generally produced in a structure consisting of 3 layers. The 1st and 3rd layers are produced from non-woven fabric (Spunlaid - non-woven) and the filtering fabric (Meltblow) in the middle layer is designed to provide physical and water/moisture protection. The performance of the product may vary depending on the performance of these fabrics, their thickness, the general design of the product, and the technology of combining these layers. Product standard and performance: Tubbie Face Masks, which are subject to the Medical Devices Regulation, must be produced in accordance with TS EN 14683+AC:2019 standards and must have the CE mark on them, showing that they comply with this standard and the Medical Devices Regulation.

Performance of medical face masks

The TS EN 14683 standard defines the features and performance requirements of the product. The performance levels are determined by testing the products according to these requirements. The following table shows the test and performance limits used in the classification of the product. (Type I use of patients or other healthy people is considered adequate in the fight against Covid19. It is recommended for healthcare professionals to use Type II or Type III.)

The results obtained as a result of the tests outside the limits given above cannot be qualified as in accordance with this standard.

Legislation to which the product is subject

Medical face masks are defined as class I in the medical devices regulation. In order for the product to be put on the market, it must bear the CE mark, which means that the requirements in the TS EN 14683+AC:2019 standard are also met. There is no obligation to work with a notified body in the use of the CE mark. In order for the manufacturer to put the CE mark on its products, it must be a development that meets the requirements in this standard. The conformity of the products to the standard is determined by the tests given above. If this is achieved, the manufacturer must take the necessary technical and quality control measures in order to continuously produce with the same performance in mass production. A technical dossier must be prepared and an EC declaration of conformity must be published, showing that these requirements are met in accordance with the legislation.