One is made of pure cotton absorbent gauze or knitted fabric with various non-woven fabrics in between; the other is directly sewn from non-woven fabrics. The filtration effect is good, and the ventilation is slightly poor.
[Edit this paragraph] The technical requirements for medical protective masks were issued on April 29, 2003. The implementation of the National Quality Supervision, Inspection and Quarantine issued on April 29, 2003. This standard is used to evaluate the quality of medical protective masks.
4.1 of this standard is recommended, and the rest are mandatory.
The production unit organizes production according to this standard from the date of implementation of this standard, and the distribution unit implements from June 15, 2003.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of Beijing Medical Device Testing Institute.
This standard was drafted by: Beijing Medical Device Testing Institute.
The main drafters of this standard: Zhang Zhaoyuan, Bi Chunlei, Liao Xiaoman, Yan Xue, Zeng Ning.
Technical requirements for medical protective masks 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, dust-proof medical protective masks that can filter particles in the air and block droplets, blood, body fluids, secretions, etc.
2 Normative reference documents The clauses in the following documents become the clauses of this standard through the quotation of this standard. For dated reference documents, all subsequent amendments (not including errata content) or revisions are not applicable to this standard. However, parties that have reached an agreement based on this standard are encouraged to study whether the latest versions of these documents . For the cited documents without date, the latest version is applicable to this standard.
GB / T191-2000 Graphical symbols for packaging, storage and transportation GB / T 4745-1997 Determination of moisture resistance of textile fabrics Moisture test GB 15980-1995 Hygienic standard for disposable medical supplies GB / T 16886.7-2001 Biological evaluation of medical devices 7 Part: Residue of ethylene oxide sterilization GB / T 16886.10-2000 Biological evaluation of medical devices Part 10: Irritation and sensitization test 3 Terms and terms 3.1 Filtering efficiency
Under the specified conditions, the percentage of particulate matter in the air filtered by the protector.
3.2 Flame retardation
Protective products prevent itself from being ignited, flame burning and smoldering performance.
3.3 Disinfection
Use physical or chemical methods to kill or remove pathogenic microorganisms on the vector to make it harmless.
3.4 sterilization
Use physical or chemical methods to kill all microorganisms on the vector to make them sterile.
3.5 Self-inhalation filter type dust mask
Clean air breathing protective gear used for dust prevention to overcome the resistance of components by the wearer's breath.
3.6 Sealing half-mask
A mask that covers the nose and mouth in close contact with the face.
3.7 Spray rating
Indicates the degree of moisture resistance of the fabric surface.
4 Technical requirements 4.1 Basic dimensions of the mask a) The size of the central part of the rectangular mask after unfolding: length is not less than 17cm, width is not less than 17cm;
b) The size of the tight-fitting arch mask: the horizontal 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) The mask should not have an exhalation valve.
4.3 Nose clips a) Nose clips must be provided on the mask;
b) The nose clip is made of bendable plastic material with a length of not less than 8.5cm.
4.4 Mask band a) The mask band 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 band and mask body should not be less than 10N.
4.5 Filtration efficiency The particle filtration efficiency of the mask filter material should not be less than 95%.
4.6 Airflow resistance When the gas flow rate is 85L / min, the inhalation resistance of the mask must not exceed 343.2Pa (35mmH2O).
4.7 Synthetic blood penetration barrier performance Synthetic blood is sprayed towards the mask sample at a pressure of 10.7kPa (80 mmHg). No penetration should occur on the inside of the mask.
4.8 The moisture resistance level of the surface moisture-resistant mask should not be lower than the provisions of GB3 in GB / T4745.
4.9 Disinfection and sterilization a) The masks marked as disinfection level shall 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 amount of ethylene oxide. For masks sterilized with ethylene oxide, the residual amount of ethylene oxide should not exceed 10 μg / g.
4.11 Materials used for flame retardancy should not be flammable. After moving away from the flame, burning should not exceed 5s.
4.12 Skin irritation mask materials should be free of skin irritation.
4.13 The mark and instruction manual shall comply with the provisions in 6 of this standard.
5 Test methods 5.1 The basic dimensions of the mask are measured with a universal measuring tool, which shall comply with the provisions of Article 4.1.
5.2 The visual inspection of appearance shall comply with the provisions of Article 4.2.
5.3 The nose clip passes the inspection and is measured with a general or special measuring tool, which shall comply with the provisions of Article 4.3.
5.4 A total of 4 masks should be tested with masks. 2 are pre-treated with temperature, 2 are not pre-treated.
Temperature pretreatment conditions:
a) (70 ± 3) ℃ air for 24 hours b) (-30 ± 3) ℃ air for 24 hours After temperature pretreatment, it should be restored to room temperature for at least 4 hours.
Through visual inspection and tensometer measurement, they shall comply with the provisions of 4.4.
5.5 Filtration efficiency and airflow resistance test The filtration efficiency test should be performed using 6 mask filter materials. Three are temperature pretreated and three are not pretreated.
Temperature pretreatment conditions:
a) (70 ± 3) ℃ air for 24 hours b) (-30 ± 3) ℃ air for 24 hours After temperature pretreatment, it should be restored to room temperature for at least 4 hours.
The air flow should be stable to (85 ± 2) L / min.
The test should be continued until the filter material reaches the minimum filtration efficiency or at least (200 ± 5) mg of aerosol acts on the filter material.
The NaCl aerosol particle size distribution under the specified test conditions should be the median diameter of the count (0.075 ± 0.020) μm, and the geometric standard deviation should not exceed 1.86.
The filtration efficiency measurement result should be greater than or equal to 4.5.
The suction resistance of the mask should meet the requirements of Article 4.6 of this standard.
5.6 Check 5 masks for synthetic blood penetration barrier performance.
Masks are pretreated at (21 ± 5) ° C and relative humidity (85 ± 5)% for at least 4 hours. Take the mask out of the environmental box for testing within 1 minute.
The mask is fixed on a protruding jig, and 2ml of synthetic blood (surface tension (4.0-4.4) × 10-4N / cm) is sprayed horizontally from the cannula with an inner diameter of 0.84mm to the mask under test at a distance of 305mm. The test pressure is 10.7kPa (80 mmHg). Remove the mask and check if the inner side penetrates. The result shall comply with the provisions of Article 4.7 of this standard.
5.7 The surface moisture permeability test shall be conducted by the method specified in GB / T 4745, and the results shall comply with the provisions of Article 4.8 of this standard.
5.8 Disinfection and sterilization shall be tested by the method specified in GB 15980, and the results shall meet the requirements of Article 4.9 of this standard.
5.9 The residual amount of ethylene oxide shall be tested according to the method stipulated in GB15980-1995, and the result shall comply with the provisions of Article 4.10 of this standard.
5.10 Flame retardant performance:
A total of 4 masks should be tested. 2 are pre-treated with temperature, 2 are not pre-treated.
Temperature pretreatment conditions:
a) (70 ± 3) ℃ air for 24 hours b) (-30 ± 3) ℃ air for 24 hours After temperature pretreatment, it should be restored to 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.
Put the mask on the metal head mold, and the linear motion speed 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 is adjustable. 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 (20 ± 2) mm.
Turn the head mold away from the area adjacent to the burner, turn on the propane gas, adjust the pressure to 20000 ~ 30000Pa (0.2bar ~ 0.3bar) and ignite the gas. Through the needle valve and carefully adjust the gas supply pressure, adjust the flame height to (40 ± 4) mm. The temperature of the flame is measured at (20 ± 2) mm above the burner tip with a 1.5 mm diameter metal insulated thermocouple probe, which should be (800 ± 50) ° C.
Set the head mold to the motion state and record the effect of the mask through flames.
The test should be repeated so that all materials outside the mask can be evaluated. Any component should only pass through the flame once.
5.11 Skin irritation is 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.
5.12 The visual inspection of the label and instruction manual shall comply with the provisions of Article 4.13.
6 Marking and User Manual 6.1 Marking 6.1.1 The minimum packaging of the mask should have at least the following clearly identifiable marks. If the packaging is transparent, the mark should be visible through the packaging:
a) Product name;
b) The name and trademark of the manufacturer or supplier;
c) Product form identification;
d) Filter grade: N95;
e) Storage period;
f) "Please refer to the information provided by the producer";
g) The storage conditions recommended by the manufacturer (at least temperature and humidity conditions);
h) The components to be assembled should be marked with safety symbols;
i) One-time use should have a one-time mark;
j) The sterilization method should be indicated for repeated use.
Note: N95 is the grade of filter material. The filtration efficiency of this grade of filter material to non-oily particles is not less than 95%.
6.1.2 The packaging should have at least the following content or logo:
a) Manufacturer's name and address, telephone, postcode;
b) Product name;
c) Product implementation standard number;
d) Production lot number;
e) weight;
f) number of specifications;
g) volume;
h) The words and signs such as sun protection and fear of moisture shall comply with the provisions of GB / T191.
6.2 Operating Instructions The operating instructions should be in Chinese at least.
The instruction manual shall give at least the following contents:
a) Purpose and use restrictions;
b) The meaning of colored codes;
c) Inspections required before use;
d) wearing suitability;
e) Method of use;
f) Maintenance (eg cleaning, disinfection), if applicable;
g) storage;
h) The meaning of the symbols and / or illustrations used;
i) Issues that may arise, such as: suitability of the mask (check before use); if hair enters the edge of the mask, the leakage prevention requirements may not be met; Oxygen, etc.);
j) Equipment used in explosive atmospheres;
k) It should include recommendations on when masks should be discarded;
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 The packaging of the mask should be able to prevent mechanical damage and contamination before use.
7.1.2 Masks are packed in quantity, put in a certificate (packing list), and sealed.
7.2 Transportation is in accordance with the conditions stipulated in the contract.

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