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Classification and standard of respirator _ protectio
Original title Classification and standard of masks
Classification of masks According to the shape of the
mask it can be divided into three types flat folding and
cup-shaped The flat mask is easy to carry but the
tightness is poor; the folding mask is easy to carry; the
cup-shaped breathing space is large but it is not
convenient to carry Classified according to the wearing
style It is suitable for workshop workers who wear it for
Full Body Disposable
Coverall a long time and it is troublesome to wear
it Ear wearing type easy to wear suitable for frequent
wearing and taking off Neck wearing type use S hook and
some soft material connectors to connect the ear belt and
convert it into a neck belt type which is suitable for
long-term wearing and more convenient for workshop
workers wearing safety helmets or protective suit Gauze
masks are classified according to the materials used some
workshops still use gauze masks but they follow the
GB19084-2003 standard with low requirements which does
not meet the GB2626-2019 standard and can only protect
against large particles of dust Non-woven masks Most of
the disposable protective masks are non-woven masks which
are mainly based on physical filtration supplemented by
electrostatic adsorption Cloth mask Cloth mask only has
the effect of keeping warm without the effect of
filtering very small particles such as PM Paper mask It
is suitable for food beauty and other industries It has
the characteristics of good air permeability convenient
and comfortable use The paper used follows the GB/T22927-
2008 standard Masks made of other materials such as new
biological protective filter materials Classified by the
scope of application of medical masks domestic divided
into three categories medical ordinary masks surgical
mask medical protective masks Particulate matter
protective mask industrial use conforms to GB2626-2019
standard special labor protection articles safety mark
certification (LA certification) and changed from
compulsory certification to voluntary certification in
2015 If it is used to prevent haze it is necessary to use
a plug-in type which shall comply with the GB/T32610-2016
standard Civil use conforms to GB/T32610-2016 standard
Thermal cloth mask thermal mask suitable for winter wear
only need to meet the relevant standards of fabrics Other
special industries such as chemical industry Different
standards are formulated according to different countries
and industries
Medical Disposable
Coverall with different protection levels and
different particle filtration efficiencies are divided
into different protection levels which will be introduced
in detail in the standard part Other respirators can be
divided into filter type and isolation type
Filter type can be divided into air supply filter type
and self-priming filter type The latter can be divided as
half mask and full mask Isolation type can be classified
as air supply type and portable type which include
positive pressure type and negative pressure type
respectively Technical standards for masks China GB2626-
2019 The first edition of the standard was issued in 1981
(GB2626-1981) which was updated three times in 1992 2006
and 2019 respectively The 2019 edition was changed to
"respiratory protection self-priming filter particulate
respirator" without the word "supplies" The GB2626-2019
edition was issued on December 31 2019 and implemented on
July 1 2020 The standard specifies the classification and
marking technical requirements testing methods and
identification of
Medical Full Body
Coverall self-priming filter particulate
respirators The standard was proposed by the State
Administration of Work Safety and is under the
jurisdiction of the National Technical Committee for
Standardization of Personal Protective Equipment
(SAC/TC112) Compared with the 2006 edition on the basis
of following the basic principles of scientificity
standardization coordination and timeliness according to
the trend of scientific progress and product development
the respiratory resistance index is adjusted without
reducing the protective ability the detection method is
improved the lower vision of the half-mask is optimized
and the comfort of the product is improved See Figure 6
for the scope of application The standard filter elements
are divided into two categories (KN and KP) according to
the filtering performance The KN category is only
applicable to the filtration of non-oily particles
including KN90 (≥ 90%) KN95 (≥ 95%) and KN100 (≥
9997%) KP is suitable for filtering oily and non-oily
particles including KP90 (≥ 90%) KP95 (≥ 95%) and KP100
(≥ 9997%) The number after KN and KP refers to the
filtration efficiency level and the higher the number the
better the filtration effect
KN respirators are not tested for synthetic blood
penetration and surface moisture resistance so they can
be used to block viruses for a short time but they should
not be used to contact patients who may spray or contact
patients for a long time Expand the full text GB/T32610-
2016 The technical specification for daily protective
masks is a standard for civil masks which is proposed by
China Textile Industry Federation and under the
jurisdiction of the National Textile Standardization
Technical Committee (SAC/TC209) See Figure 6 for the
scope of application According to the filtration
efficiency it is divided into Grade I Grade II and Grade
III and the corresponding filtration efficiency is ≥ 99%
≥ 95% and ≥ 90% for saline medium and ≥ 99% ≥ 95% and
≥ 80% for oily medium The protective effect of masks is
divided into A B C and D grades from high to low The
environmental air quality suitable for each grade of
masks is serious pollution serious and below pollution
severe and below pollution moderate and below pollution
All levels of masks should be able to reduce the
concentration of inhaled particulate matter (PM) to ≤ 75
μg/m (air quality index category good and above) in the
corresponding air pollution environment When the
protective effect of the mask is Grade A the filtration
efficiency shall reach Grade II and above; when the
protective effect of the mask is Grade B C and D the
filtration efficiency shall reach Grade III and above
YY/T0969-2013 This standard is an industry standard for
disposable medical masks which was issued on October 21
2013 and implemented on October 1 2014 Ordinary medical
masks meet this standard are suitable for general
protection of medical staff and are only used in general
medical environment (see Figure 6) There are many names
of ordinary medical masks including medical nursing and
disposable medical masks Medical masks without the words
"protection" and "surgery" in their names are all
ordinary medical masks The core indicators of this level
of mask include bacterial filtration efficiency and
ventilation resistance which are not required to have a
barrier effect on blood nor are there any sealing
requirements as shown in Figure 3 YY0469-2011 Medical
surgical mask (YY0469-2011) is the industry standard of
medical surgical mask which was issued on
December 31 2011 and implemented on June 1 2013 The first
edition of the surgical mask industry standard (YY0469-
2004) has been replaced by the 2011 edition It is
applicable to the disposable mask worn in the invasive
operation of clinical medical staff (see Figure 6) It is
a medical mask commonly used in the operating room and
other environments with the risk of body fluid and blood
splashing The outer package must be clearly marked as
surgical mask The core indicators of this type of mask
include bacterial filtration efficiency particle
filtration efficiency synthetic blood penetration
resistance and ventilation resistance (see Table 3) There
is no strict requirement for facial fit like the standard
of medical protective mask The filtration efficiency for
bacteria is ≥ 95% and the filtration efficiency for
particles is limited (≥ 30%) GB19083-2010 GB 19083-2010
Technical Requirements for Protective Masks for Medical
Use was issued on September 2 2010 and implemented on
August 1 2011 The first edition was GB19083-2003 which
was formulated under the situation of fighting against
SARS in the whole country It was issued and implemented
on April 29 2003 There were no protective masks for
medical use before SARS This standard is applicable to
the medical working environment filtering particles in
the air blocking droplets blood
KN95 Face Mask
body fluids secretions including various infectious
viruses (see Figure 6) The core indicators of this type
of mask include particle filtration efficiency synthetic
blood penetration resistance ventilation resistance
surface moisture resistance good fit and total fit factor
(see Table 3) According to the filtration efficiency of
non-oily particles medical protective masks were divided
into grade 1 (≥ 95%) grade 2 (≥ 99%) and grade 3 (≥
9997%) Medical protective masks require that the
filtering efficiency of the mask to non-oily particles is
≥ 95% which meets the N95 or FFP2 or above grade The
protective ability of medical masks in China is medical
protective masks surgical mask and ordinary medical masks
from high to low
Main Standards and Applicable Scope of Masks in China
Cited from Chinese Journal of Infection Control America
The NIOSH standard in the United States classifies the
filter material and filtration efficiency of masks which
is highly recognized all over the world According to the
filter material of the middle layer of the mask it can be
divided into three types N R and P series and each type
can be divided into three levels according to the
filtering efficiency (see Table 4) N is used to protect
non-oily suspended particles Usually non-oily particles
refer to coal dust cement dust acid mist microorganisms
etc Droplets produced by speaking or coughing are not
oily In the current haze pollution suspended particles
are mostly non-oily Oily particulate matter refers to oil
smoke oil mist asphalt smoke etc For example the oil
smoke produced by cooking is oily particulate matter R
and P are used to protect non-oily and oily suspended
particles Compared with R series P series can be used for
a relatively long time The specific use time depends on
the label of different manufacturers N95 mask is a type
of mask with a filtering efficiency of ≥ 95% in the N
series When the tightness of the wearer's face is tested
to ensure that air can pass through the mask under the
condition of close contact with the edge of the face the
N95 certification number will be issued only if it meets
this test During the special period of preventing "Severe
Acute Respiratory Syndrome (SARS)" WHO temporarily
recommends medical staff to use the N95 mask certified by
NIOSH N95 mask is not equal to medical protective masks
which stipulate that the filtering effect of masks should
meet the requirements of N95 and have the ability of
surface moisture resistance and blood barrier ASTM F2100
is a medical standard that classifies masks into three
levels low protection (Level 1) medium protection (Level
2) and high protection (Level 3) The higher the level the
better the protection performance Level 1 and Level 2
masks are commonly referred to as procedure masks; Level
3 masks can be used in the operating room and are also
referred to as surgical masks When the chance of exposure
to viruses is particularly high a higher level of
protection should be selected ASTM certification requires
the mask to meet the relevant standards in bacterial
filtration efficiency particle filtration efficiency
synthetic blood penetration resistance and pressure
difference as shown in Table 3 Level 1 can block 95% of
bacterial particles which is enough to protect the
general community users even if it only meets the low
protection standard; Level 2 and Level 3 (medium to high
protection standards) require masks to block at least 98%
of bacteria and particles while the pressure difference
is only less than 490 Pa/cm Lower protection standards
are more relaxed because it is more difficult to achieve
better protection while maintaining breathability The
main difference between the medium and high protection
standards is that the high protection (Level 3) standard
requires a higher ability to block liquids Medical N95
mask need to meet not only the FDA Surgical Masks-
Premarket Notification Submissions Guidance forIndustry
and FDA Staff standards At the same time in order to meet
the requirements of NIOSH for N95 mask the penetration
and surface moisture resistance of synthetic blood were
tested while the FDA standard basically followed the ASTM
F2100 standard Europe The European Union's standards for
Conformite Europeenne (CE) certification of masks include
BSEN140 BSEN14387 BSEN143 BSEN 149 and BSEN 136 among
which BSEN 149 is mostly used as a filter half-mask that
can protect against particles According to the particle
penetration rate tested it is divided into three grades
P1 (FFP1) P2 (FFP2) and P3 (FFP3) The low filtration
effect of FFP1 is ≥ 80% that of FFP2 is ≥ 94% and that
of FFP3 is ≥ 97% The filtration efficiency of FFP2 mask
is very close to that of the medical protective mask KN95
mask and N95 mask mentioned above
Medical face masks must follow the BSEN14683 standard
(Medical face masks-Requirement sand test methods) which
can be divided into three levels low standard Type I then
Type II and Type II R See Table 3 The previous version
was BSEN14683 2014 which has been replaced by the new
version BSEN14683 2019 One of the main changes in the
2019 edition is the pressure difference The pressure
difference of Type I Type II and Type II R increased from
294 294 and 490 Pa/cm in the 2014 edition to 40 40 and 60
Pa/cm Australia AS/NZS 17162012 is the Australian and New
Zealand standard for respiratory protective devices which
specifies the procedures and materials that must be used
in the manufacture of particle masks as well as the test
and performance results that must be determined to ensure
their safe use The standard is divided into three
categories P1 low filtration effect ≥ 80%; P2 low
filtration effect ≥ 94%; P3 low filtration efficiency ≥
99% Australia's medical mask standard is AS4381 2015
which is divided into Level 1 Level 2 and Level 3
according to the core indicators as shown in Figure 3
Chart 3 Core indicators of medical masks in China the
United States Europe and Australia Cited from Chinese
Journal of Infection Control Figure 4 Classification of
Particulate Matter Protective Masks in NIOSH Standard
Cited from Chinese Journal of Infection Control Japan
Japanese JIST8151 2018 standard is the standard for
respiratory protection devices and is also the
verification standard of the Ministry of Health Labor and
Welfare (MHLW) of Japan The common disposable salt
particle filtration specifications are as follows DS1 low
filtration effect ≥ 80%; DS2 low filtration effect ≥
99%; DS3 low filter effect ≥ 999% The grade of the mask
is shown in Figure 7 Figure 4 Classification of mask
grades in Japan Cited from Chinese Journal of Infection
Control Korea The Korean mask standard KF (Korean filter)
series is issued by the Ministry of Food and Drug Safety
of Korea MFDS) issued the mainstream mask standard in
Korea (Regulations on the Approval Notification and
Evaluation of Quasi-Drugs) KF series is divided into KF80
KF94 and KF99 KF80 ≥ 80% (saline media only); KF94 ≥
94% (oily and saline media); KF99 ≥ 99% (oily and saline
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Topic: Classification and standard of respirator
