The most important criterion at the stage of Conformity Assessment for surgical masks is the determination of what conditions the mask will be used under and what performance value it meets according to the area of use. En 149 mask testing is also performed according to many special test standards according to the areas of use applied in surgical masks and according to the test criteria depending on these standards. Surgical masks for medical purposes, which are evaluated in two groups as Type 1 and Type 2 according to the level of bacterial permeability, are also evaluated as Type 2 or type iir in terms of splash resistance. There are separate basic requirements for each type.
EN 149 is the standard to be referenced
Medical surgical face masks, also known as medical masks, are designed to protect the entire working environment in operating rooms, in medical institutions, in environments where health activities are carried out. The standard to be considered and referenced in designs is the en 149 standard. This standard, which defines two types of medical-purpose surgical masks with protection levels, is also used for patients. En 149 mask test, a mask called Type 1, is used in pandemic or epidemic situations to reduce the risk of infection and viruses spreading in society. Face masks for surgical purposes, known as Type 2, are designed for use by medical personnel in the operating room or in similar situations and medical settings.
Tests Are Done To The Finished Product
All performance tests applied in surgical masks are applied to the fully finished product or to the part taken from the fully finished product. Tests on the raw material do not necessarily mean that the finally purchased mask meets the standard requirements and does not guarantee the mask of any kind. At the stage of En 149 mask testing, evaluation of the effectiveness of bacterial filtration of masks, bio-compatibility with, microbial cleanliness level, air permeability pressure difference and splash resistance resistance pressure tests are performed in accordance with ISO 22609:2004 standard. En 149 mask testing is also performed based on certain factors such as the level of efficiency provided by the medical mask, the quality of the material, the filtration efficiency, and the fit of the mask on the user's face.
Must Be Produced In Controlled Environments
Almost all surgical masks designed for medical purposes should be produced in appropriate and controlled environments. During the production phase, the biological charge must be controlled. Medical masks should not be broken, divided or torn during normal use. For this, the production stage must be produced with careful care and control. En 149 mask Test, special care should also be shown in cleaning special filters to be used for surgical masks. The harmony of the mask with the face is also extremely important. Attention should also be paid to the fact that it is designed to fully cover the nose, jaw and mouth.
FFP used in masks
En 149 European standard for masks used in operating rooms or similar medical environments covers experimental methods, manufacturing and performance characteristics for medical masks designed to prevent infection factors from being transmitted from patient to staff or from staff to patient. FFP, used in masks, means a filter for breathing, a single-use and maintenance-free dust mask. The classification as FFP1 or FFP2 and FFP3 also classifies filtration performance by being defined in EN 149:2001 and AI:2009 standards in accordance with the European Union Personal Protective Equipment Directive.
Produced For Single-Use
Medical surgical masks used to prevent airborne infection and avoid exposure to particles are manufactured to be disposable. The ability of masks to resist depends on their effectiveness in excluding pathogens and pollutants. Medical surgical face masks, which protect against both small and large pathogens, are highly effective in the fine particles found in erosols.