This standard specifies the basic requirements for medical protective masks (hereinafter referred to as masks), test methods, marking and instructions for use and packaging, transportation and storage.
This standard applies to the air can be filtered particles, blocking droplets, blood, body fluids, secretions, etc. Self-priming filter dust medical protective masks. The following documents in the provisions of this standard by reference and become the provisions of this standard. All subsequent change orders (excluding errata) or revisions of dated referenced documents do not apply to this standard; however, parties who have reached agreement under this standard are encouraged to investigate whether the latest versions of these documents may be used. Where undated references to the document, its latest version applies to this standard.
GB/T191-2000 Graphic symbols for packaging, storage and transportation
GB/T 4745-1997 Determination of surface moisture resistance of textile fabrics Water-staining test
GB 15980-1995 Hygienic standard for disposable medical products
GB/T 16886.7-2001 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residue
GB/T 16886.10-2000 Biological evaluation of medical devices Part 10: Irritation and sensitization test 兾1 filtering efficiency filtering efficiency
In the specified conditions, the care of the product will be filtered out of the air particulate matter in the percentage.
3232 Flame retardation flame retardation
Shield to prevent itself from ignition, flaming combustion and the performance of negative combustion.
3 disinfection
Physical or chemical methods to kill or remove pathogenic microorganisms on the transmission medium, so that it is harmless.
4 sterilization
Physical or chemical methods to kill all the microorganisms on the medium of communication, so that it is sterile.
325 Self-inhalation filter type dust maskself-inhalation filter type dust mask
Relying on the wearer's respiration to overcome the resistance of the components, used to prevent the dust of the clean air respiratory protective gear.
3636 sealed sealing half-mask
The mask that can cover the nose and mouth with the face.
7 Spray rating
Indicates the degree of moisture resistance of the fabric surface. Singed1 basic size of mask
a) Rectangular mask unfolded center part of the size: length of not less than 17cm, width of not less than 17cm;
b) Close arch mask size: horizontal diameter of not less than 14cm, vertical diameter of not less than 14cm.
sung2 appearance
c) mask surface shall not have holes, stains;
Sung2 Appearance
c) The mask should not have holes or stains on the surface.
⒋3 Nose Clip
a) The mask must be equipped with a nose clip;
b) The nose clip should be made of bendable plastic material, and the length of the nose clip should not be less than 8.5cm.
⒋4 Mask Strap
a) The mask strap should be easy to adjust.
b) It should be strong enough to hold the mask in place. The breaking strength of each strap should be not less than 10N at the point of connection with the mask body.
⒋5 Filtration Efficiency
The particle filtration efficiency of the mask media should be not less than 95%.
sung6 Airflow resistance
In the case of gas flow rate of 85L/min, the suction resistance of the mask shall not exceed 343.2Pa (35mmH2O).
Sung7 Synthetic blood penetration barrier performance
Synthetic blood is sprayed at 10.7kPa (80 mmHg) pressure to the mask sample, and there should be no penetration on the inside of the mask.
S⒋8 surface moisture resistance
The mask water level should not be less than GB/T4745 in GB3 level.
S⒋9 Disinfection and sterilization
a) Masks labeled as disinfection grade should meet the requirements of 4.3.2 of GB 15980.
b) Masks labeled as sterilized should meet the requirements of 4.3.2 of GB 15980.
⒋10 Ethylene Oxide Residue
Ethylene Oxide Residue of masks sterilized by Ethylene Oxide should be no more than 10μg/g.
⒋11 Flame Retardant Properties
The materials used should not be flammable. It should not burn for more than 5 seconds after being removed from the flame.
S⒋12 Skin irritation
The mask material should be free from skin irritation.
Sung 13 signs and instructions
Should comply with the provisions of this standard 6. Be careful 1 mask basic size
Measured with a common gauge, should be consistent with the provisions of Article 4.1.
Be careful2 Appearance
Visual inspection, shall comply with the provisions of Article 4.2.
Be careful3 Nose Clamps
These shall conform to the provisions of Article 4.3 by inspection and measurement with a general or special gauge.
Be careful with 4 mask straps
Total*** 4 masks shall be tested. 2 with temperature pretreatment and 2 without.
Temperature preconditioning conditions:
a) (70±3) °C in air for 24 hours
b) (-30±3) °C in air for 24 hours
Recovery at room temperature should be made for a minimum of 4 hours after temperature preconditioning.
Both by visual inspection and tensiometer measurement shall comply with 4.4.
Careful 5 Filtration Efficiency and Airflow Resistance Tests
Six mask filter media should be used for the filtration efficiency test. three with temperature pretreatment and three without pretreatment.
Temperature pretreatment conditions:
a) (70±3) °C in air for 24 hours
b) (-30±3) °C in air for 24 hours
The temperature pretreatment should be followed by a minimum of 4 hours recovery at room temperature.
Air flow should be stabilized to (85±2) L/min.
The test should be continued until the filter media reaches its minimum filtration efficiency or until at least (200±5) mg of aerosol has been applied to the filter media.
In the specified test conditions with NaCl aerosol particle size distribution should be counted median diameter in (0.075 ± 0.020) μm, geometric standard deviation does not exceed 1.86.
Filtration efficiency measurements should be greater than or equal to the provisions of 4.5.
The suction resistance of the mask should be consistent with the provisions of this standard 4.6.
Be careful 6 synthetic blood penetration barrier performance
Check five masks.
The masks shall be pre-treated at (21±5)°C and (85±5)% relative humidity for at least 4 h. The masks shall be tested within 1 minute of removal from the environmental chamber.
The mask was fixed on a protruding fixture, and 2 ml of synthetic blood (surface tension (4.0-4.4) × 10-4N/cm) was sprayed horizontally from a cannula with an inner diameter of 0.84 mm at a distance of 305 mm into the mask under test. The test pressure was 10.7 kPa (80 mmHg). Remove the mask and check whether the inner side is permeable. The results should be consistent with the provisions of Article 4.7 of this standard.
Be careful 7 surface moisture permeability test
The test is carried out using the method specified in GB/T 4745, and the results should be consistent with the provisions of article 4.8 of this standard.
Be careful to 8 disinfection and sterilization
The test is carried out using the methods specified in GB 15980, and the results shall comply with the provisions of Article 4.9 of this standard.
Be careful 9 ethylene oxide residue
Tested in accordance with the methods specified in GB 15980-1995, the results should be consistent with the provisions of Article 4.10 of this standard.
Be careful 10 flame retardant properties:
Total **** should be tested 4 masks. 2 after temperature pretreatment, 2 without pretreatment.
Temperature pretreatment conditions:
a) (70±3) °C in air for 24 hours
b) (-30±3) °C in air for 24 hours
There shall be a minimum of 4 hours of recovery at room temperature after temperature pretreatment.
The single burner test is performed according to the following procedure and the results shall comply with 4.11.
The mask is placed over a metal head mold with a linear velocity of head motion of (60±5) mm/s measured at the tip of the nose.
The position of the head mold through the propane burner is adjustable. The distance between the tip of the burner and the lowest portion of the mouthpiece (when placed directly across the burner) should be set at (20±2) mm.
Turning the head mold away from the area adjacent to the burner, propane gas is turned on, the pressure is adjusted to 20,000 to 30,000 Pa (0.2 bar to 0.3 bar) and the gas is ignited. Adjust the flame height at (40±4) mm by means of a needle valve and careful adjustment of the gas supply pressure.The temperature of the flame should be (800±50)°C measured at (20±2) mm above the burner tip with a 1.5 mm diameter metal isolated thermocouple probe.
Set the head mold to motion and record the effect of one pass of the mouthpiece through the flame.
The test shall be repeated so that all materials on the exterior of the mask can be evaluated. Any one component should pass through the flame only once.
Be careful 11 skin irritation
Tested in accordance with the method specified in GB/T 16886.10, and the results shall comply with the provisions of article 4.12 of this standard.
Be careful 12 signs and instructions for use
Visual inspection, should be consistent with the provisions of Article 4.13. Selection1 Labeling
Selection1.1 The minimum packaging of the mask shall bear at least the following clearly recognizable labeling, which, if the packaging is transparent, shall be visible through the packaging:
a) Product name;
b) Name of the manufacturer or supplier, and trademark;
c) Product form labeling;
d) Filter material grade: N95/ N99;
e) Storage period;
f) "See information from producer" statement;
g) Storage conditions (at least temperature and humidity) recommended by the producer;
h) Safety symbols for parts to be assembled;
i) Disposable parts;
i) Name of the manufacturer or supplier;
c) Product form labeling;
d) Filter media grade: N95/ N99;
e) Storage period;
f) "Refer to information provided by the manufacturer.
i) Single-use should be marked as single-use;
j) Repeated-use should be marked with the sterilization method.
Note: N95/N95 is the grade of filter media, which has a filtration efficiency of not less than 95%/99% for non-oily particles.
Choice 1.2 At least the following contents or markings should be on the packing box:
a) Manufacturer's name and address, telephone number, zip code;
b) Product name;
c) Product implementation standard number;
d) Production lot number;
e) Weight;
f) Specification quantity;
g ) Volume;
h) sun protection, fear of moisture and other words and signs, signs should be consistent with the provisions of GB/T191.
Optional 2 instruction manual
Instruction manual should be at least in Chinese.
The instruction manual shall give at least the following:
a) Use and use restrictions;
b) The meaning of the color code;
c) Checks to be carried out prior to use;
d) Suitability for wear;
e) Methods of use;
f) Maintenance (e.g., cleaning, disinfecting), if applicable;<
g) Storage;
h) Meaning of symbols and/or illustrations used;
i) Possible problems should be given, e.g.: mask fit (check before use); leakage protection may not be achieved if hair gets within the mask seal; air quality (contaminants, oxygen deficiency, etc.);
j) Use of the equipment in environments with explosive gas environments;
k) Recommendations for mask discard time should be included;
l) If the mask is not designed for single use, the manufacturer should recommend cleaning and sanitizing methods.
7 Packaging, transportation and storage
Borrow 1 Packaging
Borrow 1.1 Masks should be packaged in such a way as to prevent mechanical damage and contamination prior to use.
Borrow1.2 Masks are boxed according to the quantity, put in the certificate of conformity (packing list) and sealed.
Borrow2 Transportation
According to the conditions of the contract.
3 Borrow3 Storage