This standard specifies the basic requirements, test methods, labels and instructions for use, packaging, transportation and storage of medical protective masks (hereinafter referred to as masks).
This standard is applicable to self-priming and filtering dust-proof medical protective masks that can filter particles in the air and block droplets, blood, body fluids and secretions. The clauses in the following documents become the clauses of this standard through the reference of this standard. For dated reference documents, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, all parties who reach an agreement according to this standard are encouraged to study whether the latest versions of these documents can be used. For undated reference documents, the latest edition is applicable to this standard.
GB/T191-2 Graphical signs for packaging, storage and transportation
GB/T 4745-1997 Surface moisture resistance test of textile fabrics
GB 1598-1995 Hygienic standard for disposable medical supplies
GB/T 16886.7-21 Biological evaluation of medical devices Part 7: Sterilization residue of ethylene oxide < p T 16886.1-2 Biological evaluation of medical devices Part 1: Stimulation and sensitization test 13. filtering efficiency
The percentage of particulate matter in the air filtered by protective products under specified conditions.
13. 2 flame retardation
the performance of protective products to prevent themselves from being ignited, flaming and smoldering.
3. disinfection
To kill or remove pathogenic microorganisms in the media by physical or chemical methods, so as to make them harmless.
13.4 sterilization
kill all microorganisms in the media by physical or chemical methods to make them sterile.
13. 5 self-priming filter dust mask self-absorption filter type dust mask
a clean air breathing protective device for dust prevention, which overcomes the resistance of parts by the wearer's breathing.
3. 6 sealing half-mask
A mask that can cover the nose and mouth by being close to the face.
[13] 7 The wet rating
indicates the degree of moisture resistance of the fabric surface. 1. Basic dimensions of the mask
a) Dimensions 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) dimensions of the closed arch mask: the transverse diameter is not less than 14cm, and the longitudinal diameter is not less than 14cm.
2. Appearance
c) There shall be no holes or stains on the surface of the mask;
d) The mask should not have an exhalation valve.
3. Nose clips
a) The mask must be equipped with nose clips;
b) The nose clip is made of bendable plastic material, and the length is not less than 8.5cm.
4 mask strap
a) the mask strap should be easily adjusted.
b) there should be enough strength to fix the position of the mask. The breaking strength of the connection point between each mask belt and the mask body shall be not less than 1N.
2. 5 filtration efficiency
The particle filtration efficiency of mask filter material should be not less than 95%.
6. airflow resistance
when the airflow is 85L/min, the inspiratory resistance of the mask shall not exceed 343.2Pa(35mmH2O).
1. 7 Penetration barrier performance of synthetic blood
Synthetic blood is sprayed on the mask sample at a pressure of 1.7kPa (8 mmHg), and there should be no infiltration inside the mask.
2. 8 Surface moisture resistance
The wet level of the mask should not be lower than that specified in GB/T4745.
2. 9 Disinfection and sterilization
a) Masks marked as disinfection level shall meet the requirements of 4.3.2 in GB 1598.
b) masks marked as sterilization grade shall meet the requirements of 4.3.2 in GB 1598.
1. 1 Residual amount of ethylene oxide
The residual amount of ethylene oxide in masks sterilized with ethylene oxide should not exceed 1μg/g/g..
1. 11 Flame retardancy
The materials used should not be flammable. Continue to burn after moving away from the flame should not exceed 5 s.
2. skin irritation
the mask material should have no skin irritation.
2. 13 signs and instructions for use
should comply with the provisions in this standard 6. ⒌1 The basic size of the mask
measured with general measuring tools shall comply with the provisions of Article 4.1.
⒌2 Appearance
Visual inspection shall comply with Article 4.2.
⒌3 Nose clip
After inspection and measurement with general or special measuring tools, it shall comply with the provisions of Article 4.3.
⒌4 masks
4 masks should be tested in total. Two were pretreated by temperature, and two were not pretreated.
temperature pretreatment conditions:
a) (7 3)℃ for 24 hours
b) (-3 3)℃ for 24 hours
after temperature pretreatment, it should be recovered at room temperature for at least 4 hours.
visual inspection and tensiometer measurement shall comply with the provisions in 4.4.
⒌5 filtration efficiency and airflow resistance test
Six filter materials for masks should be used for filtration efficiency test. Three were pretreated by temperature, and three were not pretreated.
temperature pretreatment conditions:
a) (7 3)℃ for 24 hours
b) (-3 3)℃ 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 carried out until the filter material reaches the lowest filtration efficiency or at least (2 5) mg of aerosol acts on the filter material.
The particle size distribution of NaCl aerosol used under the specified test conditions should be (.75 .2) μ m with geometric standard deviation less than 1.86.
the measurement result of filtration efficiency should be greater than or equal to the regulation of 4.5.
the inspiratory resistance of the mask shall comply with the provisions of article 4.6 of this standard.
⒌6 Penetration barrier performance of synthetic blood
Check 5 masks.
the mask was pretreated at (21 5)℃ and (85 5)% relative humidity for at least 4h. Take the mask out of the environmental box for testing within 1 minute.
the mask is fixed on the protruding fixture, and 2ml of synthetic blood (surface tension (4. ~ 4.4) × 1-4n/cm) is sprayed horizontally from the sleeve with an inner diameter of .84mm to the mask to be tested at a distance of 35mm. The test pressure is 1.7kPa (8 mmHg). Take off the mask and check whether the inner side is penetrated. The results shall conform to the provisions of Article 4.7 of this standard.
⒌7 surface moisture permeability test
The test shall be conducted by the method specified in GB/T 4745, and the results shall conform to the provisions in Article 4.8 of this standard.
⒌8 Disinfection and sterilization
The test shall be conducted by the method specified in GB 1598, and the results shall conform to the provisions in Article 4.9 of this standard.
⒌9 ethylene oxide residue
The test shall be carried out according to the method specified in GB1598-1995, and the results shall meet the provisions in Article 4.1 of this standard.
⒌1 Flame retardancy:
Four masks should be tested in total. Two were pretreated by temperature, and two were not pretreated.
temperature pretreatment conditions:
a) (7 3)℃ for 24 hours
b) (-3 3)℃ for 24 hours
after temperature pretreatment, it should be recovered at room temperature for at least 4 hours.
the single burner test shall be conducted according to the following procedures, and the results shall meet the requirements in 4.11.
put the mask on the metal head mold, and the linear velocity of the head mold measured at the tip of the nose is (6 5) mm/s.
the position of the head mold passing through the propane burner can be adjusted. The distance between the top of the burner and the lowest part of the mask (when placed directly against the burner) should be set at (2 2) mm.
turn the head mold away from the area adjacent to the burner, turn on propane gas, adjust the pressure to 2 ~ 3 pa (.2 bar ~ .3 bar) and ignite the gas. Adjust the flame height to (4 4) mm by needle valve and carefully adjusting the air supply pressure. The flame temperature shall be (8 5)℃ when measured at (2 2) mm above the burner tip with a thermocouple probe with a diameter of 1.5mm metal isolation.
set the head mold to the moving state and record the effect of the mask passing through the flame once.
the test should be repeated so that all materials outside the mask can be evaluated. Any component should pass through the flame only once.
⒌11 Skin irritation
The test shall be conducted according to the method specified in GB/T 16886.1, and the results shall conform to the provisions in Article 4.12 of this standard.
⒌12 Marking and instruction manual
Visual inspection shall comply with Article 4.13. [6] 1 logo
[6] 1.1 The minimum package of the mask should have at least the following clear and easily recognizable logo. If the package is transparent, the logo should be visible through the package:
a) product name;
b) the name and trademark of the manufacturer or supplier;
c) product form identification;
d) filter material grade: N95/N99；;
e) storage period;
f) Description of "Please refer to the information provided by the producer";
g) storage conditions recommended by the manufacturer (at least temperature and humidity conditions);
h) The components to be assembled shall be marked with safety symbols;
i) disposable labels shall be provided for disposable use;
j) If it is used repeatedly, the sterilization method shall be indicated.
note: N95/N95 is the grade of filter media, and the filtering efficiency of this grade of filter media for non-oily particles is not less than 95%/99%.
[6] 1.2 The packing box shall contain at least the following contents or marks:
a) the name and address, telephone number and zip code of the manufacturer;
b) product name;
c) product execution standard number;
d) production batch number;
e) weight;
f) specification quantity;
g) volume;
h) words and signs such as sun protection and fear of humidity, and the signs shall comply with the provisions of GB/T191.
2 instruction manual
The instruction manual should be at least in Chinese.
The instruction manual shall at least give the following contents:
a) Purpose and use restrictions;
b) the meaning of colored codes;
c) check before use;
d) wearing suitability;
e) method of use;
f) maintenance (such as cleaning and disinfection), if applicable;
g) storage;
h) the meaning of the symbols and/or diagrams used;
i) possible problems should be given, such as the suitability of the mask (check before use); If hair enters the edge of the mask, the requirement of leakage prevention may not be met; Air quality (pollutants, lack of oxygen, etc.);
j) equipment used in the environment with explosive gas;
k) It should include suggestions on the disposal time of masks;
l) if the mask is not designed for disposable use, the manufacturer should recommend cleaning and disinfection methods.
7 packaging, transportation and storage
1 packaging
1.1 The packaging of the mask should be able to prevent mechanical damage and pollution before use.
⒎1.2 The masks shall be packed according to the quantity, put into the certificate (packing list) and sealed.
2 transportation
according to the conditions stipulated in the contract.
⒎3 storage