Standards and Marking

STANDARDS

EN 140 STANDARD - Half and quarter mask

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

Dust filters are devices conceived to protect the users against:

  • dusts
  • fumes
  • mists

They fully meet all requirements provided by the standard including breathing resistance, filter penetration, obstruction and mechanical resistance.
Dust filters are classified also according to their re-usability during time and have the following markings:

  • NR which means not reusable: filters suitable to be used for a single work shift
  • R which means reusable: filters suitable to be used for more than one work shift.

EN 14387 STANDARD - Gas filters and combined filters

Gas filters are devices conceived to grant to the user the protection against:

  • gases
  • vapours

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.
To each type of contaminant is associated a colour code as follows:

A
ORGANIC GASES AND VAPOURS
B INORGANIC GASES AND VAPOURS
E GAS AND ACID VAPOURS
K AMMONIA AND ITS DERIVATIVES
P TOXIC, SOLID AND LIQUID AEROSOLS

PROTECTION CATEGORIES OF GAS AND DUST FILTERS

  • Gas filters are identified according to their protection ability against gases. Therefore they are divided into three protection classes defined by numbers 1, 2 and 3. Gas filter has to be immediately replaced when contaminant odour is perceived. The filter will be saturated and it will be no longer able to filter and/or absorb any substance.
  • Dust filters are divided in three protective classes defined by acronym P1, P2 and P3. To each protective class corresponds a filtering efficiency value expressed as a percentage %. Filtering efficiency of P3 class includes the efficiency of P1 and P2 classes. Dust filter has to be replaced when you meet breathing difficulty.
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

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

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:

  • dusts
  • fumes
  • mists

DOLOMITE DUST CLOGGING TEST

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

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


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

The dust filtering half masks are classified according to their reusability over time and have the following markings:
NR which means not reusable: masks to be used during only one work shift
R which means reusable: masks to be used during more work shifts.

 

REACH

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

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

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.

 

ELASTICI-AURICOLARI

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.

NASELLO-INV

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.

3-STRATI

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.

RESISTENZA-SPRUZZI

 

SPLASH/FLUID RESISTANCE

 

The device has an outer layer that protects the user from the exposure to splashes, blood and contaminated fluids.



MARKING

This site uses cookies, including third-party profiling. By continuing to browse the site you agree to our use of cookies.