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GB 2626-2019: [N95/KN95 face mask] Respiratory protection -- Non-powered air-purifying particle respirator
GB 2626-2019
NATIONAL STANDARD OF THE
PEOPLE?€?S REPUBLIC OF CHINA
ICS 13.340.30
C 73
Replacing GB 2626-2006
Respiratory protection - Non-powered air-purifying
particle respirator
ISSUED ON: DECEMBER 31, 2019
IMPLEMENTED ON: JULY 01, 2020
Issued by: State Administration for Market Regulation;
Standardization Administration of PRC.
Table of Contents
Foreword ... 4??
1 Scope ... 6??
2 Normative references ... 6??
3 Terms and definitions ... 7??
4 Classification and marking ... 11??
4.1 Classification of facepiece ... 11??
4.2 Classification of filter element ... 11??
4.3 Grades of filter element ... 12??
4.4 Marking ... 12??
5 Technical requirements ... 12??
5.1 Basic requirements ... 12??
5.2 Visual inspection ... 13??
5.3 Filter efficiency ... 14??
5.4 Leakage ... 14??
5.5 Breathing resistance ... 15??
5.6 Exhalation valve ... 15??
5.7 Dead space ... 16??
5.8 View field ... 16??
5.9 Head harness ... 16??
5.10 Connections and connecting parts ... 17??
5.11 Lens ... 17??
5.12 Air tightness ... 17??
5.13 Flammability ... 17??
5.14 Cleaning and disinfection ... 18??
5.15 Practical performance ... 18??
5.16 Information to be provided by the manufacturer ... 18??
5.17 Packaging ... 20??
6 Testing methods ... 20??
6.1 Visual inspection ... 20??
6.2 Pretreatment ... 20??
6.3 Filter efficiency ... 22??
6.4 Leakage ... 26??
6.5 Inhalation resistance ... 31??
6.6 Exhalation resistance ... 34??
6.7 Air tightness of exhalation valve ... 34??
6.8 Protection device of exhalation valve ... 36??
6.9 Dead space ... 36??
6.10 View field ... 38??
6.11 Head harness ... 38??
6.12 Connections and connecting parts ... 39??
6.13 Lens ... 40??
6.14 Air tightness ... 40??
6.15 Flammability ... 41??
6.16 Practical performance ... 42??
7 Product marking ... 43??
7.1 Markings on the product ... 43??
7.2 Marking on the packaging ... 43??
Appendix A (Informative) Summary of testing requirements ... 45??
Appendix B (Informative) CMD and MMAD conversion method ... 48??
Appendix C (Normative) Method for judging whether KP filter element?€?s loading
filter efficiency continues to decrease ... 51??
Appendix D (Normative) Main dimensions of test head mold ... 53??
Appendix E (Informative) Main differences between this standard and the 2006
edition ... 54??
References ... 57??
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces GB 2626-2006 "Respiratory protection equipment -
Non-powered air-purifying particle respirator".
Compared with GB 2626-2006, the main changes in this standard are as follows:
- CHANGE the standard name from "Respiratory protection equipment -
Non-powered air-purifying particle respirator" to "Respiratory protection -
Non-powered air-purifying particle respirator";
- DELETE three terms "smoke", "fog" and "microorganism"; ADD seven
terms "penetration", "user face-seal check", "assigned protection factor",
"count median diameter", "mass median diameter", "aerodynamic
diameter", "mass median aerodynamic diameter" (see 3.14 and 3.19 ~
3.24);
- MODIFY the requirements for inspiratory resistance and expiratory
resistance of various types of respirators (see 5.5);
- MODIFY the requirements and test methods for air tightness of exhalation
valves (see 5.6.1 and 6.7);
- MODIFY the name of the exhalation valve cover to an exhalation valve
protection device (see 5.6.2 and 6.8);
- MODIFY the vision requirements for various types of respirators (see 5.8);
- ADD the requirements and test methods for products that the manufacturer
claims filter elements can be reused after cleaning and / or disinfection [see
5.14.1, 5.16d), 6.2.3];
- ADD the practical performance requirements and testing methods (see 5.15
and 6.16);
- ADD a description of the method of judging the service life of filter elements
in the information part to be provided by the manufacturer; ADD the
application restrictions on non-flame-retardant products (see 5.16);
- In the testing method of filter efficiency, ADD the conversion method of
particle size used for testing of filter efficiency (see Appendix B),
requirements for accuracy and resolution of particle detector for the filter
efficiency testing equipment (see 6.3.2) and judgment of loading end point
(see 6.3.4.4, 6.3.4.5, 6.3.4.6, Appendix C); ADD the requirements for load
(see 6.3.3);
- In the testing method of leakage, ADD requirements for sample inspection
(see 6.4.1.4); ADD the accuracy requirements for particle detectors (see
6.4.2.4); ADD a formula for calculating the inward leakage by subject [see
formula (5)];
- ADD the schematic diagram of the structure of the built-in breathing hose
for the test head mold for breathing resistance testing and dead space
testing (see Figure 4);
- In the test method of breathing resistance, MODIFY the requirements for
the micromanometer parameters (see 6.5.2.3); ADD the requirements for
airtightness between the respirator facepiece and the test head mold (see
6.5.4 and 6.6.4);
- MODIFY the schematic diagram of the testing device for dead space (see
Figure 6);
- In the test method of head harness, ADD the requirement to apply the test
tensile force in the direction in which the head harness is stretched during
normal use (see 6.11.3).
Note: See Appendix E for the main differences between this standard and the
2006 edition.
This standard was proposed by and shall be under the jurisdiction of the
Ministry of Emergency Management of the People's Republic of China.
Drafting organizations of this standard: China Iron and Steel Group Wuhan
Safety and Environmental Protection Research Institute Co., Ltd., Academy of
Military Science and Chemical Research Institute, 3M China Co., Ltd.
The main drafters of this standard: Cheng Jun, Ding Songtao, Yang Xiaobing,
Yao Hong, Zhou Xiaoping, Cai Xialin, Zhang Shouxin, Yu Jingjing.
This standard was first issued in 1981, revised to GB/T 2626-1992 in 1992, then
revised to GB 2626-2006 in 2006.
Respiratory protection - Non-powered air-purifying
particle respirator
1 Scope
This standard specifies the classification and marking, technical requirements,
testing methods, identification of non-powered air-purifying particle respirator.
This standard applies to non-powered air-purifying respirator that protects
against particle.
This standard does not apply to respirators that protect against harmful gases
and vapors. It does not apply to the respirators for hypoxic environments,
underwater operations, escape, fire-fighting.
2 Normative references
The following documents are essential to the application of this document. For
the dated documents, only the versions with the dates indicated are applicable
to this document; for the undated documents, only the latest version (including
all the amendments) are applicable to this standard.
GB 2890-2009 Respiratory protection - Non-powered air-purifying
respirators
GB/T 5703 Basic human body measurements for technological design
GB/T 10586 Specifications for damp heat chambers
GB/T 10589 Specifications for low temperature test chambers
GB/T 11158 Specifications for high temperature test chambers
GB/T 18664-2002 Selection, use and maintenance of respiratory protective
equipment
GB/T 23465-2009 Respiratory protective equipment - Practical performance
evaluation methods
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Particle
Solid, liquid or particle mixed with solid and liquid suspended in air, such as
dust, smoke, mist and microorganisms.
[GB/T 18664-2002, definition 3.1.15]
3.2
Dust
The tiny solid particles suspended in the air, which are generally produced
by the solid materials being broken by mechanical forces.
[GB/T 18664-2002, definition 3.1.16]
3.3
Non-powered air-purifying respirator
Filtered respirator that relies on the wearer?€?s breathing to overcome the
airflow resistance of the component.
[GB/T 18664-2002, definition 3.1.3]
3.4
Tight-fitting facepiece
A facepiece that can cover the mouth and nose and fit tightly to the face, or
a facepiece that can cover the eyes, mouth, and nose and fit tightly to the
head and face.
Note 1: The close-fitting facepiece is divided into a half facepiece and a full
facepiece.
Note 2: Rewrite GB/T 18664-2002, definition 3.1.5.
3.5
Half facepiece
A tight-fitting facepiece that covers the mouth and nose, or covers the mouth,
nose, and jaw.
Note: Half facepieces are divided into disposable facepieces and
replaceable half facepieces.
3.6
Full facepiece
Tight-fitting facepiece that covers eyes, mouth, nose and jaw.
3.7
Disposable facepiece
A half facepiece mainly composed of a filter material, which can be provided
with an exhalation valve.
3.8
Replaceable facepiece
Closed half-facepieces and full facepieces with single or multiple
replaceable filter elements, which can be provided with breathing valves and
/ or breathing hose.
3.9
Inhalation valve
A one-way valve that only allows inhaled air to enter the facepiece and
prevents exhaled air from exiting the facepiece through it.
[GB 2890-2009, definition 3.6]
3.10
Exhalation valve
A one-way valve that only allows exhaled air to exit the facepiece and
prevents inhaled air from entering the facepiece through it.
[GB 2890-2009, definition 3.7]
3.11
Breathing hose
A flexible, air-tight air hose for connecting a facepiece to a filter element.
3.12
Filter element
Filter materials or filter components used in filtered respirators to filter out
harmful substances in the inhaled air.
Examples: canisters (filter cartridges), dust canisters, filter media, etc.
[GB/T 18664-2002, definition 3.1.22]
3.13
Filter efficiency
Under the specified testing conditions, the level of particle is filtered out by
the filter element.
3.14
Penetration
The level of particle penetrating the filter element under specified testing
conditions.
Note: Penetration = 100% - filter efficiency.
3.15
Total inward leakage; TIL
Under the specified laboratory test environment, the ratio of the
concentration of the simulant leaked into the facepiece from all the facepiece
components including the filter element when the subject inhaled to the
concentration of the simulant in the test environment outside the respirator
facepiece.
Total inward leakage = Ci / C0 ?? 100% ?€??€??€??€??€??€??€??€??€??€? (1)
Where:
Ci - The concentration of the simulant in the respirator facepiece;
C0 - Concentration of the simulant in the test environment outside the
respirator facepiece.
3.16
Inward leakage; IL
Under the specified laboratory testing environment, the ratio of the
concentration of the simulant leaked into the facepiece from all other parts
of the facepiece except the filter element when the subject inhaled to the
concentration of the simulant in the test environment outside the respirator
facepiece.
Inward leakage = Ci/C0 ?? 100% ?€??€??€??€??€??€??€??€??€??€? (2)
Where:
Ci - The concentration of the simulant in the respirator facepiece;
C0 - Concentration of the simulant in the test environment outside the
respirator facepiece.
3.17
Dead space
Volume fraction of carbon dioxide gas as re-inhaled from a previous
exhalation.
3.18
Head harness
A part for fixing the facepiece on the head.
3.19
User face-seal check
A simple tightness check method performed by the respirator wearer, to
ensure that the tight-fitting facepiece is worn correctly.
Note: Rewrite GB/T 18664-2002, definition 3.1.24.
3.20
Assigned protection factor
One type or category of respiratory protective equipment with suitable
functions, which is expected to reduce the concentration of air pollutants on
the premise that it is suitable for users to wear and use correctly.
Note: Rewrite GB/T 18664-2002, definition 3.1.29.
3.21
Count median diameter; CMD
When the particles are sorted according to the particle size, the particle size
at which the number of particles larger than the particle size and smaller than
the particle size each accounts for 50% of the total particle size.
3.22
Mass median diameter; MMD
When the particles are sorted according to the particle size, the particle size
at which the mass of particles larger than the particle size and smaller than
the particle size each accounts for 50% of the total particle mass.
3.23
Aerodynamic diameter
The diameter of a unit density spherical particle that has the same settling
velocity as the particle in question.
3.24
Mass median aerodynamic diameter, MMAD
When the particle is sorted according to the size of the aerodynamic particle
size, the particle size at which the mass of particles larger than the particle
size and smaller than the particle size each accounts for 50% of the total
particle mass.
4 Classification and marking
4.1 Classification of facepiece
According to the structure, the facepiece is divided into three types: disposable
facepiece, replaceable half facepiece, full facepiece.
4.2 Classification of filter element
Filter elements are divided into two categories: KN and KP. Category KN is only
suitable for filtering non-oily particles; category KP is suitable for filtering oily
and non-oily particles.
4.3 Grades of filter element
According to the level of filter efficiency, the grades of filter elements is classified
according to Table 1.
Table 1 -- Grades of filter element
Type of filter element Type of facepiece Disposable facepiece Replaceable half facepiece Full facepiece
Category KN
KN90
KN95
KN100
KN90
KN95
KN100
KN95
KN100
Category KP
KP90
KP95
KP100
KP90
KP95
KP100
KP95
KP100
4.4 Marking
The filter elements of disposable facepieces and replaceable facepieces shall
be marked ...