Surgical masks Walid Negla .pdf

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QC Procedure
Surgical Mask

Quality Support


Prepared By: Walid Negla
Date Prepared: April 01, 2020

Medical mask
Medical mask is suitable for covering the user's mouth, nose and jaw, and is used for wearing
and blocking the exhalation or exhalation of pollutants in the oral and nasal cavity in the
general medical environment.

There are 3 types of masks:

1- Single use masks (normally one layer, very thin) are typically only effective at capturing
larger dust particles, but can do so fairly well.
2- Surgical mask standards have higher requirements for capturing virus-sized (0.1 micron)
particles, however they vary by region.
the product is made of three layers of non-woven fabric, mask belt and nose clip

3-Pollution masks (respirators) typically capture >90% of virus-sized particles.
Use for non-harmful dusts from sanding, grinding, and sawing 95% filter efficiency against
solid particles. Provides a comfortable fit
These masks are intended to be used for protection against solids, such as those from
minerals, coal, iron ore, flour and certain other substances. They are extremely durable with a
soft and comfortable inner surface also have an adjustable nosepiece and secured head straps
to provide proper fit.

Type of masks and respirator

Is it a medical device?


Face mask
(cloth or paper

Surgical mask

N95 respirator

Surgical N95





Prevents large particles
Reduces your exposure to Provides the protection of both
expelled by you, the wearer very small airborne particles
a surgical mask and N95
Prevents large particles
expelled by you, the wearer, reaching the environment.
May not protect against s To be used as a physical barrier
from reaching the
To be used as a physical
from large droplets of blood or
barrier to protect you from
prays and direct liquid body fluids as well as very small


Does not fit tightly

Filtration efficiency

Does not fit tightly

Fluid resistance
(i.e., resistance to
penetration of
bodily fluids)

Not fluid resistant

large droplets of blood or body


Does not fit tightly

Tight fit#

Minimum 95%** against
Bacterial filtration efficiency particulate aerosols (of 0.3
above 95%*
micron in size) free of oil


Not tested for fluid

* As recommended in European Standard for Surgical masks - Requirements and test methods (EN 14683:2005)
** As certified by National Institute for Occupational Safety and Health (NIOSH)
# Proper fit of respirators is verified by respiratory fit testing as per Singapore Standard 548:2009

particles (e.g. fine aerosolised
droplets), such as those
produced by coughing.
Tight fit#
Minimum 95%** against
particulate aerosols (of 0.3
micron in size) free of oil.

Tested to be fluid-resistant


Common factors for masks quality control inspection
-Storage condition check : The relative humidity of no more than 80%, no corrosive gas and good
ventilation indoor, no high temperature.
- Carton drop testing
- Packaging & Labels Check
- printing check : the manufacturer’s name printed on its packaging and in the product
- Expiry date check
- Fitting check : provide a good fit to the face
- Appearance and internal check : the number of layers, the number of filter; the noise wire, the
elastic band
- Pull test on ear loop/seam
- Measurement of product
- Basic function check
- Smell test
- Rub test for logo/fabric
- flammability test : the masks should be fireproof, flame goes out quickly when the igniting flame
is with-drawn.
- Particle filtration efficiency (PFE) test : aim to evaluates the nonviable particle retention or
filtration efficiency of filter media and other filtration devices at sub-micron levels
- bacterial filtration efficiency (BFE) & viral filtration efficiency (VFE) tests: BVE sould be more
than 95%
- Synthetic blood penetration for liquid barriers test: this test aim to determine a product’s ability
to act as a barrier to blood-borne pathogens or other liquid.
- Differential pressure test : it indicates the easiness of breathing.

Surgical face mask details : internal check
Disposable surgical face mask is the most widely used face mask in the world now, it
prevents the bacteria from outside world, also helps catch the bacteria shed in liquid
droplets and aerosols from the wearer's mouth and nose.
It’s usually made up of three or four layers, often with two filters
1.Blue Non-woven Fabric: PP Spunbond
Cut into 170 to 175 MM for adult size
Density from 18 GSM to 25 GSM
Regular standard or SS standard
2.Filtering Material: Melt-blown Fabric
Usually 25 GSM for normal, use one layer or two layers.
Can choose different filtration rate: FFP1/FFP2/FFP3
or N95/N99,
Sometimes, to filter gas, active carbon will be added.
Cut into 170 to 175 MM for adult size
3.White Non-woven Fabric
Cut into 190 to 195 MM for adult size
Density from 18 GSM to 25 GSM
Regular standard or SS standard
4.Plastic nose wire
100% PE, width in 3MM


5.Round Elastic Band

Surgical face mask details (aluminum nose wire)
The 2nd type, the fabric is the same as the 1st type, only nose wire and elastic band different. As it’s wider
than round elastic, so more comfort.
- Aluminum nose wire :100% Aluminum, Width 3mm, thickness from 0.4 mm to 0.6MM, 0.5 mm is the
most common type.
- Flat elastic brand: Made from Spandex and Polyester, Width 3.5mm to 4mm, Flat and hollow, like a flat

Model 2

Steps for Fitting check : Surgical mask
- Wash your hands with soap and water.
- Put on the mask to cover your nose and mouth, then stretch it gently over your
- Press the thin metal wire along the upper edge gently against the bridge of your
nose so that the mask fits nicely on your face.
-Wash your hands after removing your mask.


Steps for Fitting check :N95

- Wash your hands with soap and water.
- Select a fit tested respirator.
. - Place the respirator over nose, mouth and chin.
- Fit flexible nose piece over nose bridge.
- Secure on head with ties and/or elastic and adjust to fit.
- Perform a fit check by inhaling and exhaling. During inhalation, the respirator
should collapse. During exhalation, check for leakage around face. There should
be a good fit.


Medical Mask Specification
There is no standard specification for medical masks function in Japan. However, the prevention
function against fluid such as moist body substance is required in medical front.
As medical mask function, Bacterial Filtration Efficiency (BFE) and Pressure Drop (⊿P) are main
required specification. In addition to these specification, Particle Filtration Efficiency (PFE) and Fluid
Resistant (FR) are required depending on mask grade.
The following indicates U.S. medical mask specification ASTM (Americn Society for Testing and
Materials) F2100.


Low level

Middle Level

High Level

















TEST 1 : Bacterial & Viral Filtration Efficiency (BFE/VFE):

It indicates filtration efficiency when particles, including
bacterium, which average size is 3μm are filtered.
Staphylococcus (approximately 3μm) is used to test the function
of a mask. The function of a mask is better when the number is
high. In case of medical masks, it should be more than 95 %.
The Bacterial Filtration Efficiency (BFE) test is performed on
filtration materials and devices that are designed to provide
protection against biological aerosols, such as face masks,
surgical gowns, caps, and air filters.
This test is used for FDA 510(k) submissions for surgical masks, is
required by ASTM F2100 and EN 14683, and complies with
ASTM F2101 and EN14683.
The Viral Filtration Efficiency (VFE) test follows the same
procedure as BFE, except the challenge organism used is the
bacteriophase phiX174.


Filtration effectiveness
Each country has their own certification standard for each mask type. For example, Europe
uses the EN 14683 standard for surgical masks, whereas China uses the YY 0469 standard. Each
standard varies a little by country, however they are broadly similar.


TEST 2: Flamability test

The Flammability test determines the time of flame
spread for the given material. All fabrics of natural or
regenerated cellulose, as well as certain types of
finished and unfinished fabrics made from other
natural or synthetic fibers, are combustible. Some
combustible fabrics are potentially dangerous to the
wearer because of the speed and intensity of flame
with which these fabrics burn and their ease of ignition.
The Flammability test procedure evaluates the
flammability of medical textiles including face masks,
surgical gowns, and drapes. The test method is
designed to comply with 16 CFR Part 1610. This test is
required by the ASTM F2100 (Standard Specification for
Performance of Materials Used in Medical Face Masks)
to ensure that all face masks meet the requirements for
Class 1 flammability. Testing is also required for 510(k)
submissions to the FDA.


TEST 3: Particle Filtration Efficiency (PFE)

The Particle Filtration Efficiency (PFE) test evaluates the
nonviable particle retention or filtration efficiency of filter
media and other filtration devices at sub-micron levels.
This test is performed on face masks and all filter material
that allows 1 cubic foot per minute (CFM) flow to pass
through it.
It indicates filtration efficacy when fine particles, which
average count median diameter isapproximately 0.1μm are
Fine particles (0.1μm) is used to test the function of a
mask. The function of a mask is better when the number is
This test is required for ASTM F2100 and is performed
according to the ASTM F2100 and follows the basic
principle of ASTM F2299.


TEST 4 : Fluid Resistant /Synthetic Blood Penetration
for Liquid Barriers

The Synthetic Blood Penetration – Splash Resistance test
is made to determine a product’s ability to act as a barrier
to blood-borne/liquid pathogens.
The Splash Resistance test method challenges medical face
masks with a fixed volume of synthetic blood directed at
high velocity at the center of the mask.
2 mL of synthetic blood is sprayed through a small cannula
onto the surface of the face mask. At the conclusion of the
test, the back side of the medical face mask is observed for
synthetic blood penetration. Face masks can be evaluated
at three different velocities corresponding to a human
blood pressure of 80, 120, and 160 mm Hg. If the mask
passes at the highest pressure, there is no need to test the
mask at a lower pressure
This test is required by ASTM F2100 and is tested in
compliance with ASTM F1862, ASTM F2100, EN 14683, and
ISO 26609.

TEST 5 : Respirator Precertification Test (N95) – NIOSH

Masks intended for respirator precertification may require
NaCl, DOP, valve leak, and inhalation/exhalation tests to verify
conformity to NIOSH standards.

The Sodium Chloride Aerosol Challenge (NaCl) – NIOSH
Respirator Prequalification test uses a widely accepted
method for evaluating particle penetration and air flow
resistance properties of a variety of filtration materials.
Respirators must be prequalified before submitting to NIOSH
for certification; other materials, such as breathing system
filters and face masks, are tested to determine filtration
efficiency for marketing. These tests are performed for masks
seeking N95 respirator precertification.
The Dioctyl Phthalate (DOP) test is used to evaluate particle
penetration and air flow resistance properties for a variety of
filtration materials, including HEPA filters, NIOSH respirators,
and filter media. The test is performed in compliance with 42
CFR Part 84 and NIOSH Procedure No. RCT-APR-STP-00510056, 0058 and 0059. 2005 and is necessary for
prequalification for NIOSH certification of respirators.

TEST 6: Differential Pressure

The Delta P test is performed to determine the breathability of masks by measuring the
differential air pressure on either side of the test article using a manometer, at a constant flow
rate of 8 L/min.
Certain amount of air is passed through masks, and the difference of pressure between both
sides are measured.
When the difference is small, it indicates the resistance is small, so that it is easy to breath.
The important point for high function mask is the balance between high level of filtration
efficacy and low level of pressure drop.


International Standards for Mask

EN Specification CE EN149
EN specification is European standards which were build due to the integration of the EU.
EN149FFP is for dust respirators which is satisfied of EN specification.
NIOSH Specification
National Institute for Occupational Safety and Health (NIOSH) in Department of Health and Human
Services established this specification for dust respirators.
With regard to N95, N means not resistant to oil. In addition, 95 indicates that a mask can catch test
particle more than 95%. According to tuberculosis infection prevention guideline in U.S. Centers for
Disease Control and Prevention, the specification is established for prevention of aerial infection.
Japan National Assay Specification
Health, Labour and Welfare Ministry in Japan established this specification for dust respirators.
In case of work in dusty environment, it must use masks satisfied with national assay, that doesn't
need for virus prevention and disaster sites.


International Standards for Mask

• Single use mask
Chinese standards (GB;YY) : YY/ T0969
EU standard (EN) : EN149
United States Standard : NIOSH specification
British standards (BS):
Japanese standards : Japan National Assay Specification
• Surgical mask
Chinese standards (GB;YY) : YY0469
EU standard (EN) :EN 14683,
United States Standard (ASTM):ASTM F2100
British standards (BS): BS EN 14683:2019
Japanese standards (JST):No standards
• N95 Mask
Chinese standards (GB;YY) GB 2626
EU standard (EN)EN 149/2001
United States Standard : NIOSH 42 CFR 84


Thank you


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