Medical Face Masks
Medical Face Masks
Purpose of Use: Medical Face Masks are basically designed to prevent bacteria and similar pathogenic organisms in the wearer's body from infecting the environment or other people (patients) with breathing, cough, sneezing.
It is possible to protect the wearer from pathogenic organisms in the environment. (These are the masks that our people are recommended to wear in crowded environments during the fight against Covid19.)
Structure and Production of Face Mask
Medical Face Masks are generally produced in a structure consisting of 3 layers. The 1st and 3rd layers are produced from nonwoven fabric (Spunlaid - Nonwoven), it is designed to physically protect the fabric (Meltblow), which is in the middle layer and functions as a filter, against water / moisture. The performance of the product may vary according to the performance and thickness of these fabrics used, the general design of the product, and the combination technology of these layers.
Product Standard and Performance: Medical Face Masks, which are subject to the Medical Devices Regulation, must be produced in accordance with the TS EN 14683 + AC: 2019 standard and must have a CE mark showing that they comply with this standard and the Medical Devices Regulation.
Performance of Medical Face Masks
TS EN 14683 standard defines the features and performance requirements of the product. Products are subjected to tests according to these requirements and their performance levels are determined. The table below shows the test and performance limits used in the classification of the product. (In the fight against Covid19, the use of patients or other healthy people is considered to be Type I. Healthcare professionals are recommended to use Type II or Type IIR.)
Legislation Governing the Product
The results obtained in the experimental result outside the limits given above should be considered not conform to this standard.
Medical Face Masks are defined as Class I in the Medical Devices Regulation. In order for the product to be placed 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 using the CE mark. In order for the manufacturer to put CE mark on its products, it must be a development that meets the requirements of this standard. The conformity of the products to the standard must be determined by the tests given above. If this is achieved, the manufacturer should take the necessary technical and quality control measures to be able to produce with the same performance continuously in mass production. It should prepare a technical file showing that these requirements are fulfilled as required by the legislation and issue an EC Declaration of Conformity.