Particle Filtering Half Masks
Scope: A particle filtering half mask covers the nose and mouth and the chin and may have inhalation and/or exhalation valve(s). The half mask consists entirely or substantially of filter material or comprises a facepiece in which the main filter(s) form an inseparable part of the device. These devices are designed to protect against both solid and liquid aerosols. (During the Covid19 pandemic, World Health Organisation recommends the use of these types of masks, especially for health workers with a minimum FFP2 protection level)
Product structure and manufacturing: Particle Filtering Half Face Masks are typically manufactured in a three layer structure. 1st and 3rd layers are nonwoven (Spunlaid – Nonwoven), and designed to protect the filtering (meltblown) layer in the middle from mechanical damage or humidity and getting wet. There are some technologies to increase the filtering capability of the filter like electrostatic charging of the filter. The performance of the mask is dependent on the performance of the layer products, the connection of the layers, design of the mask.
There are models with and without valves and for repeated use.
The manufacturers are expected to design a mask with high filtering capability and low inhalation / exhalation resistance.
Ürün Standardı ve Performansı: Kişisel Koruyucu Donanımlar Yönetmeliğine tabi olan Partikül Filtreli Yüz Maskeleri TS EN 149+A1:2009 standardına göre üretilmeli ve üzerine bu standarda ve Kişisel Koruyucu Donanımlar Yönetmeliğine uygun olduğunu gösteren CE işareti konulmalıdır.
Performance of the Particle Filtering Half Masks: The standard EN 149+A1:2009, explains the product specifications and performance requirements. Masks are tested after conditioning according to the tests explained in this standard and the protection levels of the masks are determined. Iportant tests and performance requirements used in classification of te masks are shown iin the table.
Penetration of filter material (%) (Max Allowed)
|Total Inwards Leakage (%) (Max Allowed)||22||8||2|
|Carbon dioxide content of the inhalation air (%)||1||1||1|
Breathing resistance limits
|Class||Maximum permitted resistance (mbar)|
|30 L/min||95 L/min||160 L/min|
Regulation: Particle Filtering Half Masks are classified as category three products in the Personal Protective Equipments Regulation (EU) 2016/425. The products needs a CE certification that ensures the product fulfils the essential health and safety requirements according to EN 149+A1:2009 standard. It is mandatory to work with a Notified Body and fix the CE mark with the number of the Notified Body. The manufacturer needs first a EU Type Examination Certificate for each model and establish a conformity assessment mechanism which is audited by a Notified Body by one of the methods given in the regulation, Module C2 or Module D. In addition the manufacturer is expected to have a technical file and a EU declaration of conformity.
CE Certification Process: UNIVERSAL CERTIFICATION will provide a certification proposal according to the information provided in the application form above including all necessary testing and certification services.
Tha manufacturers who accepts the certification service conditions are expected to send the approved certification proposal with the samples in the number stated in the proposalby mail. Other technical file or official necesaary documentation can be provided during the test period but before the certification. The service duritaion for testing and certification may vary from 10 days to 15 days after receipt of the samples.
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