GB 19083-2023 PDF English
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Protective face mask for medical use
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Technical requirements for protective face mask for medical use
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GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
CCS C 44
Replacing GB 19083-2010
Protective face mask for medical use
Issued on: NOVEMBER 27, 2023
Implemented on: DECEMBER 01, 2025
Issued by. State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword... 4
1 Scope... 5
2 Normative references... 5
3 Terms and definitions... 6
4 Requirements... 7
4.1 Basic requirements... 7
4.2 Mask belt connection strength... 7
4.3 Filtration efficiency... 7
4.4 Respiratory resistance... 7
4.5 Dead space... 8
4.6 Total inward leakage... 8
4.7 Resistance against penetration by synthetic blood... 8
4.8 Microbiological indicators... 8
4.9 Ethylene oxide residue (if applicable)... 8
4.10 Flammability (if applicable)... 8
4.11 Biocompatibility... 8
5 Test methods... 9
5.1 Test conditions... 9
5.2 Basic requirements... 9
5.3 Temperature and humidity pretreatment conditions... 9
5.4 Mask belt connection strength... 9
5.5 Filtration efficiency... 10
5.6 Respiratory resistance... 11
5.7 Dead space... 13
5.8 Total inward leakage... 14
5.9 Resistance against penetration by synthetic blood... 15
5.10 Microbiological indicators... 15
5.11 Residue of ethylene oxide... 15
5.12 Flammability... 15
Protective face mask for medical use
1 Scope
This document specifies the requirements, markings, instructions for use, as well as
packaging and storage of disposable protective face mask for medical use (hereinafter
referred to as “face mask”), and describes the corresponding test methods.
This document is applicable to non-powered air-purifying face masks (half masks) for
filtering particles in the air and blocking droplets, blood, body fluids, secretions, etc. in
medical working environments.
This document does not apply to masks that protect against any chemical gases and
vapors.
2 Normative references
The following documents are referred to in the text in such a way that some or all of
their content constitutes requirements of this document. For dated references, only the
version corresponding to that date is applicable to this document; for undated references,
the latest version (including all amendments) is applicable to this document.
GB 2626-2019, Respiratory protection - Non-powered air-purifying particle
respirator
GB/T 14233.1-2022, Test methods for infusion, transfusion, injection equipment
for medical use - Part 1.Chemical analysis methods
GB/T 16886.5, Biological evaluation of medical devices - Part 5.Tests for in vitro
cytotoxicity
GB/T 16886.10, Biological evaluation of medical devices - Part 10.Tests for
irritation and skin sensitization
GB/T 16886.12, Biological evaluation of medical devices - Part 12.Sample
preparation and reference materials
GB/T 32610-2016, Technical specification of daily protective mask
YY 0469, Surgical mask
YY/T 0691-2008, Clothing for protection against infectious agents - Medical face
masks - Test method for resistance against penetration by synthetic blood (fixed
volume, horizontally projected)
YY/T 0866, Total inward leakage determination method of protective face mask
for medical use
Pharmacopoeia of the People’s Republic of China 2020 Edition Volume IV
ISO 16900-5.2016/Amd.1.2018, Respiratory protective devices - Methods of test
and test equipment - Part 5.Breathing machine, metabolic simulator, RPD
headforms and torso, tools and verification tools/Amendment 1.RPD head forms
front and side view
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
filtering efficiency
The percentage of particulate matter filtered out by the mask under specified test
conditions.
3.2
dead space
The volume of air that is re-inhaled from the previous exhalation.
Note. It is expressed by the volume fraction of CO2 in the inhaled gas.
[Source. GB/T 12903-2008, 5.3.10]
3.3
total inward leakage; TIL
The ratio of the concentration of the simulated agent leaking into the mask from all
parts including the mask when the subject inhales TO the concentration of the simulated
agent in the test environment under the test conditions specified in the laboratory.
[Source. GB/T 12903-2008, 5.3.7, modified]
3.4
fit
The degree of fit between the periphery of the mask and the specific user’s face.
4 Requirements
4.1 Basic requirements
Mask materials and structural design shall meet the following requirements.
a) The appearance of the mask is free from damage and stains;
b) The mask can cover the wearer’s mouth and nose and fit tightly to the face;
c) The mask shall not be equipped with an exhalation valve;
d) The mask is equipped with a nose clip or a design as an alternative of the nose
clip, which can be used for fixing and tightening when worn;
e) The mask belt is made of elastic material or adjustable design, which is easy to
wear and remove, and can firmly fix the mask on the face.
4.2 Mask belt connection strength
4.2.1 The breaking strength of each mask belt shall not be less than 10 N.
4.2.2 The breaking strength at each connection point between the mask belt and the
mask body shall not be less than 10 N.
4.3 Filtration efficiency
Under the specified test flow conditions, the filtering efficiency of the mask for non-
oily particles shall meet the requirements in Table 1.
4.4 Respiratory resistance
The inspiratory resistance and expiratory resistance of the mask shall meet the
requirements in Table 1.
4.5 Dead space
The average volume fraction of CO2 in inhaled air shall not exceed 1%.
4.6 Total inward leakage
The total inward leakage shall meet the requirements in Table 1.
4.7 Resistance against penetration by synthetic blood
Spray 2 mL of synthetic blood onto the mask at a pressure of 16 kPa (120 mmHg), and
there shall be no penetration on the inside of the mask.
4.8 Microbiological indicators
4.8.1 Sterile masks shall be sterile.
4.8.2 The total number of microorganisms in non-sterile masks shall be less than or
equal to 100 CFU/g.
4.9 Ethylene oxide residue (if applicable)
If the mask has been ethylene oxide-sterilized or disinfected, its ethylene oxide residue
shall not exceed 10 μg/g.
4.10 Flammability (if applicable)
If the manufacturer expressly states that the mask material is not flammable, when
testing according to 5.12, the after-flame time shall not exceed 5 seconds.
4.11 Biocompatibility
4.11.1 Skin irritation
The primary stimulation score shall not be greater than 0.4.
4.11.2 Cytotoxicity
The relative cell proliferation rate (survival rate) shall not be less than 70%.
4.11.3 Delayed type hypersensitivity
Delayed type hypersensitivity shall not be greater than grade 1.
5 Test methods
5.1 Test conditions
Except for special requirements, the test shall be carried out in an environment with a
temperature of 16 °C ~ 32 °C and a relative humidity of (50±30)%.
5.2 Basic requirements
Randomly select at least 3 masks from 3 minimum independent packaging units,
visually inspect and actually wear them, and check whether they meet the requirements
of 4.1.
5.3 Temperature and humidity pretreatment conditions
Remove the sample packaging and perform pretreatment in the following order.
a) Place in an environment of (38±2.5) ℃ and (85±5)% relative humidity for (24±1)
h;
b) Place in a dry environment of (70±3) °C for (24±1) h;
c) Place in an environment of (-30±3) °C for (24±1) h.
The pretreatment method used should avoid thermal shock, and allow the sample
temperature to return to room temperature for at least 4 hours before subsequent
pretreatment or testing.
5.4 Mask belt connection strength
5.4.1 Number of samples
Take at least 4 mask samples and perform temperature and humidity pretreatment
according to 5.3.
5.4.2 Testing methods
Fix the main body of the mask with the outer side of the mask facing up; cut the mask
belt from the middle; let the mask belt hang naturally; apply a static pull force of 10 N
at the end for 10 seconds. The mask belt and the connection must not be disconnected.
In case of disconnection, the disconnection part (mask belt or connection point) shall
be reported.
If there is no fixed connection between the mask belt and the mask body, the mask belt
shall be removed, with one end fixed, and the other end loaded with a static tension
force of 10 N for 10 seconds. The mask belt shall not be disconnected.
5.5 Filtration efficiency
5.5.1 Number of samples
Take at least 4 mask samples and perform temperature and humidity pretreatment
according to 5.3.
5.5.2 Testing devices and conditions
The test environment temperature is (25 ± 5) °C; the relative humidity is (30 ± 10)%.
The schematic diagram of the filtering efficiency testing device is shown in Figure 1,
which shall meet the following conditions.
a) Aerosol generation system.
1) Be capable of producing dried and charge-neutralized sodium chloride
particles;
2) The aerosol concentration shall not be greater than 50 mg/m3, and the
concentration change shall not exceed ±10% during the entire test process
after stabilization;
3) Particle size distribution. The count median diameter is (0.075±0.020) μm,
and the geometric standard deviation of particle distribution is ≤1.86.
Note. The count median diameter (CMD) of 0.075 μm is equivalent to the mass
median aerodynamic diameter (MMAD) of approximately 0.3 μm.
b) The detection flow range is 15 L/min ~ 110 L/min, and the accuracy is 2%.
c) The dynamic detection range of particulate matter is 0.001 mg/m3 ~ 50 mg/m3,
and the accuracy is 0.001mg/m3 or 1%.
d) The detection range of filtering efficiency is 0 ~ 99.999%, and the resolution is
at least 0.003%.
5.5.3 Testing methods
When the detection flow rate is (85±4) L/min, carry out the loading test, and the total
loading amount shall be at least (50±5) mg.
Before starting the test, fix and seal the edge of the mask to keep the shape of the mask
consistent with the normal wearing mode; if necessary, use a special clamp. After the
test starts, record the filtering efficiency during the loading process. When the specified
loading capacity is not reached and the filtering efficiency is lower than the grade limit
required in 4.3, the test shall be stopped and the sample shall be judged to be unqualified.
When the specified loading capacity is reached and the filtering efficiency has not been
lower than the required limit of this grade, judge it to be qualified. Record the lowest
value during the test as the filtering efficiency of the mask.
5.6 Respiratory resistance
5.6.1 Number of samples
Take at least 4 mask samples and perform temperature and humidity pretreatment
according to 5.3.
5.6.2 Testing equipment and testing conditions
5.6.2.1 Test head form
The head form specified in Appendix D of GB 2626-2019, Appendix B of GB/T 32610-
2016 or ISO 16900-5.2016/Amd.1.2018 can be used.
5.6.2.2 Testing equipment and conditions
The schematic diagram of the respiratory resistance testing device is shown in Figure
2, which shall meet the following conditions.
a) The flow meter measurement range is 0 L/min ~ 100 L/min, and the accuracy is
not less than 3%;
b) The micromanometer measurement range is -1 000 Pa ~ 1 000 Pa, the accuracy
is not less than 1%, and the resolution is at least 1 Pa.
5.6.3 Testing methods
Wear the mask correctly on the test head form; seal the fitting edges of the mask, but
prevent the mask from deforming and do not reduce the ventilation area.
When testing respiratory resistance, seal the edges of the mask first to minimize the
difference in results caused by using different head forms. When using head forms
specified in different standards in 5.6.2.1, or head forms of the same standard but
different models, on the premise of ensuring edge sealing, select the maximum
respiratory resistance as the final test result.
Detect the inspiratory resistance and expiratory resistance respectively at a flow rate of
(85±1) L/min, and record the maximum value to check whether it meets the
requirements of 4.4.
5.7 Dead space
5.7.1 Number of samples
Take at least 4 mask samples and perform temperature and humidity pretreatment
according to 5.3.
5.7.2 Testing equipment and testing conditions
The requirements for test head form are the same as 5.6.2.1.The schematic diagram of
the dead space testing device is shown in Figure 3, which shall meet the following
conditions.
a) The response time of the solenoid valve shall not be greater than 5 ms;
b) The total volume of the pipeline between the outlet of the breathing simulator
and the inhaled gas sampling inlet at the mouth of the head form shall not exceed
2 L;
c) The range of the exhaled gas carbon dioxide (CO2) analyzer shall not be less
than 10% (volume fraction), and the accuracy shall be 0.01% ~ 0.1% (volume
fraction);
d) The range of the inhaled gas carbon dioxide (CO2) analyzer shall not be less than
5% (volume fraction), and the accuracy shall be 0.01% ~ 0.1% (volume fraction);
e) The CO2 flow meter measurement range shall not be less than 40 L/min, and the
accuracy shall be at least 1 L/min;
f) The CO2 volume fraction in exhaled gas shall be (5±0.1)%;
g) An electric fan shall blow air so that the wind speed at a distance of 5 cm from
the front of the sample is 0.3 m/s ~ 0.7 m/s.
5.7.3 Testing methods
The laboratory shall have good ventilation environment. Continuously monitor the CO2
concentration, in the environment at 1 m in front of the tested sample, which shall not
exceed 0.1% (volume fraction); otherwise, the test is invalid.
Wear the mask correctly on the test head form; seal the fitting edges of the mask, but
prevent the mask from deforming and do not reduce the ventilation area. Turn on the
dead space testing device; set the breathing frequency of the breathing simulator to 20
times/min, the tidal volume to 1.5 L; adjust the CO2 concentration in the exhaled air to
reach a stable state. Continuously monitor the CO2 concentration in the inhaled air until
it reaches a stable value.
Take the arithmetic mean (Ca) of the test results of the mask samples, and the arithmetic
mean (Cb) of the ambient CO2 concentration, and the difference (Ca - Cb) is the final
result. Check whether it meets the requirements of 4.5.
5.8 Total inward leakage
5.8.1 Number of samples
Take at least 10 mask samples and perform temperature and humidity pretreatment
according to 5.3.
5.8.2 Testing methods
Carry out testing in accordance with the method specified in YY/T 0866, and use the
sodium flame photometer method under pulse sampling mode as the arbitration method.
When the testing results meet the total inward leakage requirements at each grade in
4.6 by action and by person, judge it to be qualified, otherwise, judge the item as
unqualified.
5.9 Resistance against penetration by synthetic blood
Take at least 4 masks and carry out the test according to the method specified in YY/T
0691-2008.If all the results meet the requirements of 4.7, judge it as qualified. For the
preparation method of synthetic blood, see YY 0469.
5.10 Microbiological indicators
5.10.1 Sterility
Carry out the test in accordance with the test methods for sterility inspection method
(General Chapter 1101) of the Pharmacopoeia of the People's Republic of China (2020
Edition, Volume IV). Carry out the treatment of the test sample and the inoculation
culture medium in accordance with the provisions of the dressing test sample in the
direct inoculation method.
5.10.2 Microbial limits
Carry out the test in accordance with the membrane-filter procedure stipulated in the
microbial enumeration method (General Chapter 1105) in the microbial limit inspection
of non-sterile products in Pharmacopoeia of the People's Republic of China (2020
edition, volume IV). Obtain the total number of microorganisms by adding the results
of the total number of aerobic bacteria, mold and yeast.
Preparation of test solution. Randomly select at least 2 smallest packages; take no less
than 10 g of the test sample; cut it into pieces and use a diluent containing 0.1% (volume
fraction) polysorbate 80 (or other non-bacterial surfactant) – such as pH 7.0 sterile
sodium chloride-peptone buffer, or pH 7.2 phosphate buffer, or 0.9% sterile sodium
chloride solution – to prepare a 1.50 (g/mL) test solution; mix thoroughly.
5.11 Residue of ethylene oxide
Carry out the test according to the method specified in 9.4 of GB/T 14233.1-2022.
5.12 Flammability
5.12.1 Number of samples
Take at least 4 mask samples and perform temperature and humidity pretreatment
according to 5.3.
5.12.2 Testing methods
Follow the following steps for testing. When all samples meet the requirements of 4.10,
judge them to be qualified.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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