Disposable three-layer non-woven mask

Introduction of disposable three-layer non-woven masks

Product name: disposable three-layer non-woven mask
Material: non-woven fabric, filter cloth
Product characteristics: filtration effect B.F.E is as high as 99.9%, especially suitable for electronics factories,

Made of soft and comfortable P.P. material, it does not irritate the skin and is comfortable to wear. The nose bridge design can be adjusted most comfortably according to different face shapes. With the optional ultrasonic spot welding, the earbands are very strong and will not fall easily. Applicable to electronics manufacturing, dust-free workshops, catering services, food processing, schools, riding motorcycles, spray processing, stamping hardware, hospitals, handicraft industries, hospitals, beauty, pharmaceuticals, factories, environmental cleaning, public places multiple uses.

skills requirement

1 Scope

This standard specifies the basic requirements, test methods, identification and instructions for use of medical protective masks (hereinafter referred to as masks), packaging, transportation and storage.

This standard applies to self-priming filtering dust-proof medical protective masks that can filter particulates in the air and block droplets, blood, body fluids, secretions, etc.

2 Normative references

The clauses in the following documents have become the clauses of this standard after being referenced. For dated references, all subsequent amendments (excluding the content of errata) or revisions are not applicable to this standard. However, all parties who have reached an agreement in accordance with this standard are encouraged to study whether the latest versions of these documents can be used. . For undated references, the latest version applies to this standard.
GB / T191-2000 Packing, storage and transportation icon
GB / T 4745-1997 Textiles-Determination of surface moisture resistance
GB 15980-1995 Hygienic Standard for Disposable Medical Supplies
GB / T 16886.7-2001 Biological evaluation of medical devices Part 7: Residues of ethylene oxide sterilization

GB / T 16886.10-2000 Biological evaluation of medical devices. Part 10: Stimulation and sensitization tests

3 terms and terms

3.1 filtering efficiency
Under specified conditions, the percentage of particulate matter filtered out by the protective product.
3.2 flame retardation
The protective properties prevent itself from being ignited, flame burning and smoldering.
3.3 disinfection
Physical or chemical methods are used to kill or remove pathogenic microorganisms on the transmission medium to make them harmless.
3.4 sterilization
Physically or chemically kill all microorganisms on the vector to make them sterile.
3.5 self-inhalation filter type dust mask
It is a clean air-type respirator for dust-proof, which can overcome the resistance of parts by the wearer's breathing.
3.6 Sealing half-mask
A mask that fits your face and covers your nose and mouth.
3.7 Spray rating

Indicates the degree of moisture resistance of the fabric surface.

4 Technical requirements

4.1 Basic dimensions of masks
a) The size of the central part of the rectangular mask after deployment: the length is not less than 17cm, and the width is not less than 17cm;
b) The size of the close-fitting arch mask: the transverse diameter is not less than 14cm, and the longitudinal diameter is not less than 14cm.
4.2 Appearance
c) There must be no holes or stains on the surface of the mask;
d) Masks should not have exhalation valves.
4.3 Nose Clip
a) The mask must be equipped with a nose clip;
b) The nose clip is made of bendable plastic material, and the length is not less than 8.5cm.
4.4 Mask band
a) Mask straps should be easy to adjust.
b) There should be sufficient strength to fix the position of the mask. The breaking strength of the connection point between each mask belt and the mask body should not be less than 10N.
4.5 Filtration efficiency
The particle filtration efficiency of the mask filter should be not less than 95%.
4.6 Air resistance
When the gas flow rate is 85L / min, the suction resistance of the mask must not exceed 343.2Pa (35mmH2O).
4.7 Synthetic blood penetration barrier properties
Synthetic blood was sprayed onto the mask sample at a pressure of 10.7 kPa (80 mmHg). There should be no infiltration on the inside of the mask.
4.8 Surface moisture resistance
The water level of the mask should not be lower than the GB3 level in GB / T4745.
4.9 Disinfection and sterilization
a) Masks marked as disinfected should meet the requirements of 4.3.2 in GB 15980.
b) Masks marked as sterilized should meet the requirements of 4.3.2 in GB 15980.
4.10 Residual ethylene oxide
For ethylene oxide sterilized masks, the residual ethylene oxide content should not exceed 10 μg / g.
4.11 Flame retardant properties
The materials used should not be flammable. After the flame is removed, the continuous burning shall not exceed 5s.
4.12 Skin irritation
The mask material should be free of skin irritation.
4.13 Logo and instruction manual

Should comply with the provisions of this standard 6.

5 Test method

5.1 Basic dimensions of masks
Measure with a universal gage and comply with Article 4.1.
5.2 Appearance
Visual inspection shall comply with the provisions of Article 4.2.
5.3 Nose Clip
After inspection and measurement with a universal or special measuring tool, it shall meet the requirements of Article 4.3.
5.4 Mask strap
A total of 4 masks should be tested. Two were temperature pretreated and two were not pretreated.
Temperature pretreatment conditions:
a) (70 ± 3) ℃ in air for 24 hours
b) (－30 ± 3) ℃ in the air for 24 hours
After temperature pretreatment, it should be recovered at room temperature for at least 4 hours.
Through visual inspection and tension meter measurement, shall comply with the provisions of 4.4.
5.5 Filtration efficiency and airflow resistance test
Six mask filters should be used for the filtration efficiency test. Three were temperature pretreated and three were not pretreated.
Temperature pretreatment conditions:
a) (70 ± 3) ℃ in air for 24 hours
b) (－30 ± 3) ℃ in the air for 24 hours
After temperature pretreatment, it should be recovered at room temperature for at least 4 hours.
The air flow should be stabilized to (85 ± 2) L / min.
The test should be continued until the filter reaches the minimum filtration efficiency or at least (200 ± 5) mg of aerosol is applied to the filter.
The size distribution of NaCl aerosol particles used in the specified test conditions shall be such that the median diameter of the count is (0.075 ± 0.020) μm, and the geometric standard deviation does not exceed 1.86.
The filtration efficiency measurement result should be greater than or equal to 4.5.
The inhalation resistance of the mask should meet the requirements of Article 4.6 of this standard.
5.6 Synthetic blood penetration barrier properties
Check 5 masks.
The mask was pretreated at (21 ± 5) ℃ and relative humidity (85 ± 5)% for at least 4h. Remove the mask from the environmental box for testing within 1 minute.
The mask is fixed on the protruding jig, and 2 ml of synthetic blood (surface tension (4.0-4.4) × 10-4 N / cm) is sprayed from a cannula with an inner diameter of 0.84 mm in a horizontal direction toward the tested mask at a distance of 305 mm. The test pressure is 10.7kPa (80 mmHg). Remove the mask and check if the inside surface is transparent. The results shall comply with the provisions of Article 4.7 of this standard.
5.7 Surface moisture permeability test
The test shall be performed by the method specified in GB / T 4745, and the results shall meet the requirements of Article 4.8 of this standard.
5.8 Disinfection and sterilization
The test shall be performed by the method specified in GB 15980, and the results shall meet the requirements of Article 4.9 of this standard.
5.9 Residual ethylene oxide
The test is carried out in accordance with the method specified in GB15980-1995, and the results shall meet the requirements of 4.10 of this standard.
5.10 Flame retardant properties:
A total of 4 masks should be tested. Two were temperature pretreated and two were not pretreated.
Temperature pretreatment conditions:
a) (70 ± 3) ℃ in air for 24 hours
b) (－30 ± 3) ℃ in the air for 24 hours
After temperature pretreatment, it should be recovered at room temperature for at least 4 hours.
The single burner test shall be carried out in accordance with the following procedures, and the results shall meet the requirements of 4.11.
Wear a mask on a metal head mold, and the linear speed of the head mold movement measured at the tip of the nose is (60 ± 5) mm / s.
The position of the head mold passing through the propane burner is adjustable. The distance between the top of the burner and the lowest part of the mask (when placed directly on the burner) should be set at (20 ± 2) mm.
Turn the head mold away from the area adjacent to the burner, turn on the propane gas, adjust the pressure to 20,000 to 30,000 Pa (0.2 bar to 0.3 bar) and ignite the gas. Through the needle valve and carefully adjust the air supply pressure, adjust the flame height to (40 ± 4) mm. The temperature of the flame shall be (800 ± 50) ° C, measured with a 1.5mm diameter metal-isolated thermocouple probe (20 ± 2) mm above the tip of the burner.
Set the headform into motion and record the effect of the mask on one pass through the flame.
The test should be repeated so that all materials outside the mask can be evaluated. Any one component should pass through the flame only once.
5.11 Skin irritation
The test shall be conducted 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.
5.12 Identification and instruction manual

Visual inspection shall comply with the provisions of Article 4.13.

6 Identification and instruction manual

6.1 Identification
6.1.1 The minimum packaging of masks should have at least the following clearly identifiable identification. If the packaging is transparent, the identification should be visible through the packaging:
a) product name;
b) the name or trademark of the manufacturer or supplier;
c) product form identification;
d) Filter material grade: N95 / N99;
e) shelf life;
f) a description of "see information provided by the producer";
g) storage conditions recommended by the manufacturer (at least temperature and humidity conditions);
h) the parts to be assembled should be marked with safety symbols;
i) one-time use should have a one-time logo;
j) Repetitive use should indicate the sterilization method.
Note: N95 / N95 is the grade of filter material. The filter efficiency of this grade for non-oily particles is not less than 95% / 99%.
6.1.2 The packing box shall have at least the following contents or signs:
a) manufacturer's name and address, telephone, zip code;
b) product name;
c) product implementation standard number;
d) production batch number;
e) weight;
f) number of specifications;
g) volume;
h) The words and signs such as sun protection and fear of wetness shall be in accordance with GB / T191.
6.2 Instruction Manual
The instruction manual should be in Chinese at least.
The instruction manual should give at least the following:
a) uses and restrictions of use;
b) the meaning of colored codes;
c) inspections required before use;
d) suitability for wearing;
e) method of use;
f) maintenance (eg cleaning, disinfection), if applicable;
g) storage;
h) the meaning of the symbols and / or illustrations used;
i) Possible problems should be given, such as: the suitability of the mask (check before use); if hair enters the mask edge, the leakage prevention requirements may not be met; air quality (pollutants, Oxygen, etc.);
j) equipment used in explosive atmospheres;
k) should include recommendations on when to discard masks;

l) If the mask is not designed for single use, the manufacturer should recommend cleaning and disinfection methods.

7 Packaging, transportation and storage:

7.1 Packaging
7.1.1 Masks should be packaged to prevent mechanical damage and contamination before use.
7.1.2 The masks are packed in boxes, put in the certificate of conformity (packing list), and sealed.
7.2 Transport
According to the conditions stipulated in the contract.

7.3 Storage