STANDARDS
EN 140 STANDARD - Half and quarter mask |
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Gas half masks marked EN 140 are devices designed to provide the user with protection if used together with gas filters, dust filters and combined filters; they are in compliance with all the requirements of the standard, such as respiratory resistance, adherence loss and carbon dioxide content of the inhaled air. |
EN 143 STANDARD - Dust filters |
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Dust filters are devices conceived to protect the users against:
They fully meet all requirements provided by the standard including breathing resistance, filter penetration, obstruction and mechanical resistance.
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EN 14387 STANDARD - Gas filters and combined filters | |||||||||||
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Gas filters are devices conceived to grant to the user the protection against:
If air in work environment is contaminated not only by gases and vapours, but also by dusts with concentrations superior to TLV, it is necessary to use combined filters, made of filtering elements both gas and dust resistant, that in this way provide efficient protection also against dusts, fumes and mists. Filters marked EN 14387 fully meet all requirements provided by standard including breathing resistance, ability to protect against gases, filter penetration, obstruction and mechanical resistance.
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PROTECTION CATEGORIES OF GAS AND DUST FILTERS |
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PROTECTION CLASS | MAXIMUM CONCENTRATION OF TEST GAS | |
Class 1 | LOW FILTERING EFFICIENCY | 1000 ppm or 0,1% in volume |
Class 2 | MEDIUM FILTERING EFFICIENCY | 5000 ppm or 0,5% in volume |
Class 3 | HIGH FILTERING EFFICIENCY | 10000 ppm or 1,0 % in volume |
PROTECTION CLASS | NPF | MAXIMUM CONCENTRATION OF TEST AEROSOL |
P1 | 4 | 4 x TLV |
P2 | 12 | 12 x TLV |
P3 | 50 | 50 x TLV |
To define maximum contaminant concentration (theoretical) allowed in the workplace it is necessary to multiply the Nominal Protection Factor (NPF) by TLV. NPF is a value indicating the theoretical level of respirator protection and which indirectly expresses the value of filter efficiency to retain or not of airborne contaminants; TLV is a value indicating the threshold limit concentration of dangerous substances to which a worker can be exposed without suffering damage to health (prolonged exposure up to a work shift). For example, "12xTLV means that the mask P2 is suitable to protect the user in environments with a concentration of contaminant substance up to 12 times the allowed maximum.
REACH |
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In order to safeguard the consumers’ health, the European Union issued the REACH regulation (come into force on 1st June 2007) which forbids the use of certain chemicals. COFRA guarantees the compliance of all its products with the REACH regulation; they do not contain carcinogen substances or mentioned in the European list of forbidden substances and, in order to grant it, all raw materials used during production are subjected to controls. |
EN 149 STANDARD |
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The dust filtering half masks are devices suitable to protect the user against all the external agents which, if inhalated, can be a risk for health or safety. The respirators in compliance with EN 149 standard have been conceived to grant protection against aerosol both liquid and solid, that are:
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DOLOMITE DUST CLOGGING TEST |
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Optional test provided by the standard EN 149 measuring the performances of clogging resistance of a mask. The conformity to this test (which can be noticed with the “D” marking on the mask) guarantees a good level of breathability even in extreme cases of highly concentrated dust. |
FILTERING EFFICIENCY OF THE MASK |
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LEVEL OF PROTECTION |
FILTERING EFFICIENCY OF THE MASK |
FFP1 |
78 % |
FFP2 |
92 % |
FFP3 |
98 % |
The standard EN 149 provides for a test for determination of filtering efficiency which expresses the quantity of contaminant filtered by the masks in laboratory conditions.
MAXIMUM CONCENTRATION OF CONTAMINANT ALLOWED IN THE WORK ENVIRONMENT ACCORDING TO LEVELS OF PROTECTION |
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LEVEL OF PROTECTION | NPF | MAXIMUM CONCENTRATION OF TEST GAS |
FFP1 | 4 | 4 x TLV |
FFP2 | 12 | 12 x TLV |
FFP3 | 50 | 50 x TLV |
To define maximum contaminant concentration (theoretical) allowed in the workplace it is necessary to multiply the Nominal Protection Factor (NPF) by TLV. NPF is a value indicating the theoretical level of respirator protection and which indirectly expresses the value of filter efficiency to retain or not of airborne contaminants; TLV is a value indicating the threshold limit concentration of dangerous substances to which a worker can be exposed without suffering damage to health (prolonged exposure up to a work shift). For example, "12xTLV means that the mask FFP2 is suitable to protect the user in environments with a concentration of contaminant substance up to 12 times the allowed maximum.
REUSABILITY |
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The dust filtering half masks are classified according to their reusability over time and have the following markings:
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REACH |
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In order to safeguard the consumers’ health, the European Union issued the REACH regulation (come into force on 1st June 2007) which forbids the use of certain chemicals. COFRA guarantees the compliance of all its products with the REACH regulation; they do not contain carcinogen substances or mentioned in the European list of forbidden substances and, in order to grant it, all raw materials used during production are subjected to controls. |
EN 14683:2019+AC:2019 STANDARD |
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Medical face masks are intended to limit the transmission of infectious agents from medical staff to patients during surgical procedures and other medical activities with similar requirements. The medical face mask is also effective to reduce the emission of infectious agents from the nose and mouth of an asymptomatic subject or a patient with clinical symptoms.Type IIR medical face masks are essential to protect the wearer from splashes of potentially contaminated liquids.Medical face masks may also be intended to be worn by patients and other people to reduce the risk of spreading infections, particularly in epidemic or pandemic situations.This European Standard does not apply to masks intended exclusively to the individual protection of medical staff. |
PERFORMANCE REQUIREMENTS |
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TEST |
TYPE I |
TYPE II |
TYPE IIR |
Bacterial filtration efficiency (BFE), (%) |
≥ 95 | ≥ 98 | ≥ 98 |
Differential pressure (Pa/cm2) |
< 40 |
< 40 |
< 60 |
Splash resistance pressure (kPa) |
NOT REQUIRED |
NOT REQUIRED |
≥ 16,0 |
Microbial cleanliness (ufc/g) |
≤ 30 | ≤ 30 |
≤ 30 |
TYPE I: Type I medical face masks are used for patients and other people in order to reduce the risk of spreading infections, particularly in epidemic or pandemic situations.Type I masks are not intended to be used by healthcare professionals in the operating room or other medical activities with similar requirements.
TYPE II: Type II medical face masks, besides incorporating all possible applications for type I masks, are also intended to be used by healthcare professionals in the operating room or other medical activities with similar requirements.
TYPE IIR: Type IIR medical face masks, besides incorporating all possible applications for type I and II masks, are intended to be used to protect the wearer from splashes of potentially contaminated liquids.
Facial masks for medical use are officially classified as class I MEDICAL DEVICES which include all non-invasive medical devices, in compliance with European legislation on medical devices.
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EAR LOOPS |
The elasticated ear loops can be easily worn thanks to their comfortable, cylindrical and ultrasonically welded section and they are suitable to be used for long time. |
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INVISIBLE NOSEPIECE |
The invisible nosepiece made of aluminum and flexible plastic material is inserted between the layers of the mask that, in this way, has not exposed metals. The nose piece is very light and allows a prompt adjustment of the mask on the nose. |
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THREE-LAYER PROTECTION |
The device is made of three layers of hypoallergenic and naturally hydrophobic polypropylene, suitable for the composition of a light mask with excellent breathability. The intermediate layer is made of MELT BLOWN material with high filtering performances against bacteria and infectious agents. |
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SPLASH/FLUID RESISTANCE |
The device has an outer layer that protects the user from the exposure to splashes, blood and contaminated fluids. |
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DISPENSER BOX |
Thanks to the special perforated opening, the box can be used as a very useful dispenser to regulate the distribution of masks in single pieces, thus avoiding to contaminate the remaining ones. |