Particulate Filter Half

Face Masks

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Particulate Filtered Half

Face Masks

Purpose of Use: Particle Filtered Half Face Masks are basically designed for the wearer (to cover the mouth and nose) with the aim of solid and liquid aerosols (pathogenic organisms that can be transmitted through respiration).

 

It protects the wearer from pathogenic organisms in the environment. (During the fight against Covid19, it is recommended by the World Health Organization that healthcare workers use a mask of this type with at least FFP2 protection level.)

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Face Mask Construction and Production

Particle Filtered Face Masks are generally produced in a structure consisting of 3 or more 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. Filtration capacity can be increased with technologies such as electrostatic loading of filter material. 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. It is not recommended to make seams in the joining of the layers and it is recommended to make a welded joint.
There are models with valve (valve mechanism that reduces filtration during exhalation and provides comfortable breathing) and without valve. (The use of vented masks in the fight against Covid19 is not recommended, although the wearer may spread viruses to the environment without filtration. )

 

The design of the masks is as important as the performance of the filter materials. It should be designed to fit the wearer's face properly, preventing air passage from areas such as under the chin, nose edges and cheeks.


This combined with high filtration manufacturer must ensure that the design and production of low breathing resistance

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Product Standard and Performance

Particle Filtered Face Masks, which are subject to the Personal Protective Equipment Regulation, should be produced in accordance with the TS EN 149 + A1: 2009 standard and a CE mark should be placed on it, indicating that it is in compliance with this standard and the Personal Protective Equipment Regulation.​

Performance of Particle Filter Face Masks

TS EN 149 + A1: 2009 standard defines the features and performance requirements of the product. According to these requirements, the products are subjected to experiments after various conditions such as temperature, wearing simulation, mechanics, and their performance levels are determined. The table below shows the important test and performance limits used in the classification of the product. (In the fight against Covid19, healthcare professionals are recommended to use FFP2 or FFP3 protection level masks.)​

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Respiratory Resistance Limits​

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As a result of the experiments, the results obtained outside the limits given above cannot be considered in accordance with this standard.​

Legislation Governing the Product

Particle Filtered Face Masks are defined as Category 3 in the Personal Protective Equipment 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 149 + A1: 2009 standard are also met. In the use of the CE mark, there is an obligation to work with a Notified Body. Our company is a Notified Body authorized by the Ministry of Family, Labor and Social Services and the European Commission in this regard. In order for the manufacturer to put CE mark on its products, it must develop a product that meets the requirements of this standard. The conformity of the products to the standard is determined by the tests given in the TS EN 149 + A1 standard. In order for the manufacturer to place the CE mark on the Particle Filtered Face Mask, after obtaining the EC Type Examination Approval on the product model under the supervision of a Notified Body, it is required to take the necessary technical and quality control measures to be able to produce with the same performance in mass production continuously under the supervision of the Notified Body. It should prepare a technical file showing that these requirements are fulfilled as required by the legislation and issue an EC Declaration of Conformity.​