The most famous domestic manufacturers are: Xiantao Li Kai Protective Products Co., Ltd., Xiantao Xiongyanqiang Protective Products Co., Ltd. and other enterprises.
Promulgated on April 29th, 2003 and implemented on April 29th, 2003.
Issued by the General Administration of Quality Supervision, Inspection and Quarantine.
order
This standard is used to evaluate the quality of medical protective masks.
In this standard, 4. 1 is the recommended value, and the rest are mandatory values.
The production unit shall organize production according to this standard from the date of implementation of this standard, and the distribution unit shall implement it from June 6, 2003.
This standard is proposed by the US Food and Drug Administration.
This standard is under the jurisdiction of Beijing Medical Device Inspection Institute.
Drafting unit of this standard: Beijing Medical Device Inspection Institute.
Main drafters of this standard: Zhang Zhaoyuan, Bi Chunlei, Liao Xiaoman, Xue Yan and Zeng Ning.
Technical requirements for medical protective masks
1 range
This standard specifies the basic requirements, test methods, identification and instructions for use, packaging, transportation and storage of medical protective masks.
This standard is applicable to self-priming filtering dust-proof medical protective masks, which can filter particles in the air and block droplets, blood, body fluids and secretions.
2 normative reference documents
The clauses in the following documents become the clauses of this standard by reference. All subsequent modifications (excluding errata) or revisions of dated reference documents are not applicable to this standard. However, parties who have reached 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/T 19 1-2000 graphic signs for packaging, storage and transportation
Textile fabrics. determination of surface moisture resistance. immersion test.
GB 15980- 1995 Hygienic standard for disposable medical supplies.
GB/T 16886.7-200 1 biological evaluation of medical devices part 7: ethylene oxide sterilization residues.
Gb/t16886. 10-2000 biological evaluation of medical devices part10: stimulation and sensitization test.
3 nouns and terms
3. 1 filtration efficiency
The percentage of particulate matter in the air filtered by protective products under certain conditions.
3.2 Flame Retardancy of Flame Retardancy
The performance of protective products to prevent themselves from being ignited, burned and smoldering.
3.3 disinfection
Kill or remove pathogenic microorganisms on the medium by physical or chemical methods to make them harmless.
3.4 sterilization and disinfection
Kill all microorganisms in the culture medium by physical or chemical methods to make it sterile.
3.5 Self-priming filter dust mask
The wearer's breathing overcomes the resistance of parts, which is a dust-proof breathing protection device.
3.6 seal half mask
A mask that is close to the face and can cover the nose and mouth.
3.7 Humidity grade
Indicates the moisture-proof degree of the fabric surface.
4 technical requirements
4. 1 basic dimensions of mask
A) Dimensions of the central part of the unfolded rectangular mask: the length is not less than 17cm, and the width is not less than17cm;
B) Dimensions of the closed arched mask: the transverse diameter shall not be less than 14cm, and the longitudinal diameter shall not be less than 14cm.
4.2 Appearance
C) There shall be no holes or stains on the surface of the mask;
D) The mask should not have an exhalation valve.
4.3 nose clip
A) The mask must be equipped with a nose clip;
B) The nose clip is made of flexible plastic material with a length of not less than 8.5cm
4.4 Mask Belt
A) The mask strap should be easy to adjust.
B) It should be strong enough to fix the position of the mask. The breaking strength of the connection point between each mask strap and the mask body shall not be less than 10N.
4.5 filtration efficiency
The particle filtration efficiency of mask filter material should be not less than 95%.
4.6 airflow resistance
When the gas flow rate is 85L/min, the inspiratory resistance of the mask shall not exceed 343.2Pa(35mmH2O).
4.7 Synthetic Blood Permeability Barrier Performance
Synthetic blood is sprayed on the mask sample at a pressure of 10.7kPa (80 mmHg), and there should be no infiltration inside the mask.
4.8 Surface moisture resistance
The humidity level of the mask shall not be lower than the GB3 level in GB/T4745.
4.9 Disinfection and sterilization
A) Masks marked with disinfection grade shall meet the requirements of 4.3.2 in GB 15980.
B) Masks marked with sterilization grade shall meet the requirements of 4.3.2 in GB 15980.
4. 10 ethylene oxide residue
For masks sterilized with ethylene oxide, the ethylene oxide residue shall not exceed10 μ g/g/g.
4. 1 1 flame retardancy
The materials used should not be flammable. Continue to burn after leaving the flame should not exceed 5 s.
4. 12 skin irritation
The mask material should have no skin irritation.
4. 13 logo and instructions for use
Should comply with the provisions of this standard 6.
5 test method
5. 1 basic dimensions of mask
Measurement with universal measuring tools shall comply with the provisions of Article 4. 1.
5.2 appearance
Visual inspection shall comply with Article 4.2.
5.3 nose clip
Inspection and measurement with general or special measuring tools shall comply with the provisions of Article 4.3.
5.4 Mask Belt
A total of 4 masks should be tested. Two were pretreated by temperature, and two were not pretreated.
Temperature pretreatment conditions:
A) at (70 3)℃
b)(-30±3)℃
After temperature pretreatment, it should be restored at room temperature for at least 4 hours.
Through visual inspection and tensiometer measurement, it shall comply with the provisions of 4.4.
5.5 filtration efficiency and airflow resistance test
Six kinds of mask filter materials should be used in the filtration efficiency test. Three were pretreated by temperature, and three were not pretreated.
Temperature pretreatment conditions:
A) at (70 3)℃
b)(-30±3)℃
After temperature pretreatment, it should be restored at room temperature for at least 4 hours.
The air flow rate should be stabilized at (85 2) L/min.
The test shall be conducted until the filter material reaches the lowest filtration efficiency or at least (200 5) mg aerosol acts on the filter material.
Under the specified test conditions, the particle size distribution of sodium chloride aerosol should be (0.075 0.020) micron, and the geometric standard deviation should not exceed 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.
5.6 Synthetic blood permeability barrier performance
Check 5 masks.
The mask was taken out of the environmental box for testing at (265 438 0 5)℃ and (85 5)% relative humidity within 1 min.
Fix the mask on the protruding fixture, and horizontally spray 2ml of synthetic blood (surface tension (4.0 ~ 4.4) × 10-4n/cm) to the mask to be tested from the sleeve with the inner diameter of 0.84mm. The test pressure is 10.7 kPa (80 mm Hg). Take off the mask and check whether the inside is penetrated. The results shall conform to the provisions of Article 4.7 of this standard.
5.7 Surface Moisture Permeability Test
The test shall be conducted according to the method specified in GB/T 4745, and the results shall conform to the provisions in Article 4.8 of this standard.
5.8 Disinfection and sterilization
The test shall be carried out according to the method specified in GB 15980, and the results shall meet the provisions in Article 4.9 of this standard.
5.9 Residual ethylene oxide
The test shall be conducted according to the method specified in GB 15980- 1995, and the results shall meet the provisions in Article 4. 10 of this standard.
5. 10 flame retardancy:
A total of 4 masks should be tested. Two were pretreated by temperature, and two were not pretreated.
Temperature pretreatment conditions:
A) at (70 3)℃
b)(-30±3)℃
After temperature pretreatment, it should be restored 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 of 4. 1 1.
Put the mask on the metal head mold, and the linear velocity of the head mold measured at the tip of the nose is (60 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) shall be set to (20 2) mm..
Move the head mold away from the area near the burner, turn on propane gas, adjust the pressure to 20000 ~ 30000 Pa (0.2 bar ~ 0.3 bar), and ignite the gas. Adjust the flame height to (40 4) mm through the needle valve, and carefully adjust the air supply pressure. Use a thermocouple probe with a diameter of 65438 0.5mm to measure the flame temperature at (20 2) mm above the top of the burner, which should be (800 50)℃.
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 can only pass through the flame once.
5. 1 1 skin irritation
The test shall be carried out according to the method specified in GB/T 16886. 10, and the results shall conform to Article 4. 12 of this standard.
5. 12 Identification and Instruction Manual
Visual inspection shall comply with the requirements of Article 4. 13.
6 Identification and Instruction Manual
6. 1 logo
6. 1. 1 The minimum package of the mask should have at least the following clear and legible marks. If the package is transparent, the mark shall be visible through the package:
A) product name;
B) Name and trademark of the manufacturer or supplier;
C) product form identification;
D) Filter material grade: N95/N99；; ;
E) storage period;
F) State "Please refer to the information provided by the manufacturer";
G) storage conditions recommended by the manufacturer (at least temperature and humidity conditions);
H) Components to be assembled shall be marked with safety symbols;
I) One-time use should have one-time identification;
J) If it is reused, 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 have at least the following contents or signs:
A) Name and address, telephone number and postal code of the manufacturer;
B) product name;
C) Product execution standard number;
D) production batch number;
E) weight;
F) Specification and 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/T 19 1.
6.2 instruction manual
The instructions must be at least in Chinese.
The instructions shall at least give the following contents:
A) use and use restrictions;
B) the meaning of color code;
C) Inspection before use;
D) Suitability to wear;
E) method of use;
F) Maintenance (such as cleaning and disinfection) when applicable;
G) storage;
H) Meaning of symbols and/or charts used;
I) Possible problems should be given, such as the suitability of masks (check before use); If the hair enters the edge of the mask, it may not meet the requirements of leakage prevention; Air quality (pollutants, lack of oxygen, etc. );
J) Equipment used in explosive gas environment;
K) Suggestions on the time to discard masks should be included;
L) If the mask is not designed for one-time use, the manufacturer should recommend cleaning and disinfection methods.
7 Packaging, transportation and storage:
7. 1 packaging
7. 1. 1 The packaging of the mask should be able to prevent mechanical damage and pollution before use.
7. 1.2 masks should be packed according to the quantity, put into the certificate (packing list) and sealed.
7.2 transportation
According to the conditions stipulated in the contract.
7.3 storage
According to the provisions of the instruction manual.