ALL about face masks , respirators

1. Face Mask’s
Respirators
F.F.P’s
Dr.Johny B

2. Q1) What is FFP ?
A) Filtering Face Piece.
Q2) Types of FFP?
A2) The EN 149 standard defines three classes of
filter efficiency for these masks,
namely FFP1, FFP2 and FFP3.
- It is an example of a mechanical filter respirator.

3. FFP : 1
• It is the least filtering mask of the three.
• Aerosol filtration percentage: 80% minimum.
• Internal leak rate: Maximum 22%.
• It is mainly used as a dust mask (for example for DIY jobs).
• Dust can cause lung diseases, such as
- silicosis, - anthracose, - asbestosis and
- siderose (in particular dust from coal, silica, iron
ore, zinc, aluminum or even cement).

4. F.F.P : 2
• Aerosol filtration percentage: Not less than 94%.
• Internal leak rate: Maximum 8%.
• This mask offers protection in various areas such as
the glass industry, foundry, construction, pharmaceutical industry
and agriculture.
• It effectively stops powdered chemicals.
• This mask can also serve as protection against influenza
viruses such as avian influenza or severe acute respiratory
syndrome associated with the coronavirus (SARS), as well as against
the bacteria of pneumonic plague and tuberculosis.
• It is similar to the N95 mask

5. F.F.P : 3
• Aerosol filtration percentage: Not less than 99%.
• Internal leak rate: Maximum 2%
• The FFP3 mask is the most filtering of the FFP masks.
• It protects against very fine particles such
as asbestos and ceramic.
• It does not protect against gases and
in particular nitrogen oxide.

6. Class
Filter penetration
limit (at 95 L/min
air flow)
Inward leakage Typical Elastic Band
FFP1
Filters at least 80%
of airborne
particles
<22% Yellow
FFP2
Filters at least 94%
of airborne
particles
<8% Blue or White
FFP3
Filters at least 99%
of airborne
particles
<2% Red

7. • What is Exhalation valve ?
• Wearing a respirator for an extended period of time can
become uncomfortable due to breathing resistance and
buildup of heat and humidity inside the mask.
- To alleviate these issues and improve comfort, some
masks are equipped with an exhalation valve.
- This valve allows the exhaled air to escape freely from
the mask, avoiding condensation and preventing the filter
from becoming less permeable and unpleasant to wear.

8. - FFP3 masks generally have very thick filter layers and a higher
resistance, which makes breathing more difficult. For this reason,
most of these FFP3 masks are offered with an exhalation valve.
- A mask with an exhalation valve protects the wearer just as well
as a mask without a valve.
- However, it is important to note that an exhalation valve allows
unfiltered air to freely exit the mask. Therefore, in the case of
diseases with airborne or respiratory droplet transmission
(like COVID-19) a mask with a valve will not protect other people
and the environment from the pathogens potentially exhaled by the
person wearing such a mask.
- In these situations, masks without exhalation valves are
preferable in order to protect others.
- Additionally, the exhalation valve might malfunction, which could
increase the risk of infiltration of contaminants or toxic dust.

9. • How to Use FFP ?
• The mask should be as close to the face as possible; a metal tab
makes it possible to adjust the mask to the bridge of the nose.
• A beard is not recommended
• The elastics should be shortened by a button for young children.
• As a protection against infectious diseases, it is only effective in
combination with frequent and effective hand washing.

10. • Hands should be washed thoroughly before putting on the
mask.
• The mask should not be touched during use (or hands
should be washed immediately).
• The mask should be replaced when wet.
• It should be removed by taking it from the back without
touching the front of the mask and then placing it into a
suitable closed container before washing hands again.
• To protect other people (and not only the wearer) the mask
should not have an exhalation valve.

11. • Are they RE-usable?
• In March 2020, at the time of the coronavirus
pandemic in the Netherlands, due to the scarcity
of mouth masks the Netherlands National
Institute for Public Health and the Environment
(RIVM) published a (brief) advice on how
to sterilize and reuse FFP masks that were
originally certified for single use

12. • What are Standards for FFP ?
• FFP masks must meet certain standards. To
qualify as FFP, the masks must meet
the EN 149 standard.

13. What is EN 149 standard?
• This European standard, the first version of which dates
from 2001, establishes the minimum characteristics of
respiratory protection equipment. It includes laboratory
tests, field tests and certain requirements to ensure the
conformity of the masks.
The following points are analyzed:-
• Packaging
• Materials: resistance to manipulation
• Practical performance test
• Leakage: total leakage inwards and penetration of the filter
material

14. 2009 version of EN149:-
• With the publication of the 2009 version of the standard,
the designation of the respiratory protection mask is now
"particulate filtering half mask". The abbreviation NR or R is
added after FFP1, FFP2, FFP3:
• NR (not reusable): if the use of the filtering half-face mask
is limited to one working day. It is not reusable.
• R (reusable): if the filtering half-face mask can be used for
more than one working day, so it is reusable.

15. Additional suffixes include:-
• Anti-clogging NR masks (D). When the half mask has passed
the dolomite dust test, a letter D can be added to indicate
that the service life may exceed 8 h. Example: FFP3 NR D.
• Valve :-
The presence of a valve can be indicated by the letter V.
• Particulate type. The letters S or L respectively specify the
filtration of solid dust (NaCl-only) or liquid mist (paraffin
oil). Example: FFP3 SLV.

16. • What is Dolomite test?
• This test checks whether the mask maintains a good level of
breathing resistance after being subjected to high levels
of dolomite dust.
• This means the "D" symbol is a quality indicator for the filter
material used and ensures that a mask can be worn over a
long period even at high levels of dust concentration.

17. Legal notes:-
• FFP respirators are considered Personal Protective Equipment (PPE).
Here is the notice that should appear on every mask :-
• Manufacturer's name
• Mask
• CE number of the certification body + EN 149: 2009 + the mask
class (FFP1, FFP2 or FFP3) + acronym (NR or R)
• The marking must comply with Directive 89/686 / EECon PPE.
• If any of these entries are missing, the mask will be considered non-
compliant.

18. • There are some European organizations that issue an
examination certificate confirming conformity and specifying
the characteristics of the products:
• INRS then APAVE in France
• INSPEC in Great Britain
• FACHAUSSCHUSS in Germany

19. • A few other jurisdictions use FFP-like standards to govern their masks as
well. They include:-
• Russia (GOST R 12.4.191-2011): identical.
• South Korea (KMOEL - 2017-64): considered identical to pre-2009 version.
FFP1 is called "2nd grade" or KF80, FFP2 "1st grade" or KF94, and FFP3
"special grade" or KF99.
• Australia and New Zealand (AS/NZ 1716:2012): similar grades with a
different test agent. Grades are written simply "P".
• Brazil (ABNT/NBR 13698:2011): identical to pre-2009 version. Grades are
written as "PFF".
• Japan (JMHLW-Notification 214, 2018): similar grades with a different
coding scheme for NR/R and S/L types. Written with a two-letter prefix
D/R and S/L that maps to NR/R and S/L respectively. Leakage requirement
not present.
• Taiwan (CNS 14755): D1/D2/D3 grades for 80/95/99 efficiency.
No requirements for inward leakage.

20. • What is EN#14683:2005?
• This European Standard specifies construction and
performance requirements, and test methods for surgical
masks intended to limit the transmission of infective agents
from staff to patients and (in certain situations vice
versa) during surgical procedures in operating theatres
and other medical settings with similar requirements.
• This European Standard is not applicable to masks intended
exclusively for the personal protection of staff.
• This standard is intended to help facilitate the choice of
surgical face masks in the European Market by
standardizing the information and performance data
required for the masks.

21. • There are three test methods used to classify
surgical masks:-
1) Bacterial Filtration Efficiency in vitro (BFE)
2) Breathing Resistance (Delta P)
3) Splash Resistance (ASTM F1862-‐07)

22. 1) Bacterial Filtration Efficiency in vitro (BFE)
(ASTM F2101-‐07)
• This test is used to determine the amount of infective agent
that is retained by the surgical facemask, which is directly
related to the amount of bacteria released through the mask
into the air of the surgical theatre.
• Classification:
BFE => 95% TYPE I
BFE => 98% TYPE II

23. 2) Breathing Resistance (Delta P)
• This test is used to determine the resistance airflow of the
facemask.
Classification:
• TYPE I & II (non splash resistant) = < 29.4 Pa/cm2
• TYPE IR & IIR (splash resistant) = < 49.0 Pa/cm2
• ‘R’ splash resistant.

24. 3) Splash Resistance (ASTM F1862-07):-
• This test is used to determine the resistance penetration of
potentially contaminated fluid splashes.
Classification:-
• TYPE I & TYPE II not applicable TYPE IR & TYPE IIR >120 mmHg,
• 120 mmHg is a minimum value. It corresponds to the average
systolic arterial blood pressure, and intends to protect against
ruptures in small arteries causing small sprays of blood.
• Some products off protection even in excess of the 120 mmHg.

25. ThankYou…