Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking

Description
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.
It is intended to provide adequate sealing on the face of the wearer against the ambient atmosphere, when the skin is dry or moist and when the head is moved.
Air enters the particle filtering half mask and passes directly to the nose and mouth area of the facepiece or, via an inhalation valve(s) if fitted. The exhaled air flows through the filter material and/or an exhalation valve (if fitted) directly to the ambient atmosphere. These devices are designed to protect against both solid and liquid aerosols.

Classification
Particle filtering half masks are classified according to their filtering efficiency and their maximum total inward leakage. There are three classes of devices:
FFP1, FFP2 and FFP3.
The protection provided by an FFP2 – or FFP3 – device includes that provided by the device of lower class or classes.

Total inward leakage
The laboratory tests shall indicate that the particle filtering half mask can be used by the wearer to protect with high probability against the potential hazard to be expected.
The total inward leakage consists of three components: face seal leakage, exhalation valve leakage (if exhalation valve fitted) and filter penetration.
For particle filtering half masks fitted in accordance with the manufacturer’s information, at least 46 out of the 50 individual exercise results (i.e. 10 subjects x 5 exercises) for total inward leakage shall be not greater than
25 % for FFP1
11 % for FFP2
5 % for FFP3
and, in addition, at least 8 out of the 10 individual wearer arithmetic means for the total inward leakage shall be not greater than
22 % for FFP1
8 % for FFP2
2 % for FFP3

Penetration of filter material

Maximum penetration of test aerosol;

Sodium chloride test 95 l/min % max.: FFP1:20 / FFP2:6 / FFP3:1

Paraffin oil test 95 l/min % max.: FFP1:20 / FFP2:6 / FFP3:1

A total of 9 samples of particle filtering half masks shall be tested for each aerosol.
Testing in accordance with 8.11 using the Penetration test according to EN 13274-7, shall be performed on:
– 3 samples as received;
– 3 samples after the simulated wearing treatment described in 8.3.1.
Testing in accordance with 8.11 using the Exposure test with a specified mass of test aerosol of 120 mg, and for particle filtering devices claimed to be re-usable additionally the Storage test, according to EN 13274-7, shall be performed:
– for non-re-usable devices on:
– 3 samples after the test for mechanical strength in accordance with 8.3.3 followed by temperature conditioning in accordance with 8.3.2.
– for re-usable devices on:
– 3 samples after the test for mechanical strength in accordance with 8.3.3 followed by temperature conditioning in accordance with 8.3.2. and followed by one cleaning and disinfecting cycle according to the manufacturer’s instruction

Carbon dioxide content of the inhalation air
The carbon dioxide content of the inhalation air (dead space) shall not exceed an average of 1,0 % (by volume)

Exhalation valve(s)
A particle filtering half mask may have one or more exhalation valve(s), which shall function correctly in all orientations.
Testing shall be done in accordance with 8.2 and 8.9.1.
If an exhalation valve is provided it shall be protected against or be resistant to dirt and mechanical damage and may be shrouded or may include any other device that may be necessary for the particle filtering half mask to comply with 7.9.
Testing shall be done in accordance with 8.2. Exhalation valve(s), if fitted, shall continue to operate correctly after a continuous exhalation flow of 300 l/min over a period of 30 s.
Testing shall be done in accordance with 8.3.4. When the exhalation valve housing is attached to the faceblank, it shall withstand axially a tensile force of 10 N applied for 10 s. Testing shall be done in accordance with 8.8

Breathing resistance