Product description: The nose bridge is made of environmentally friendly full plastic strip, does not contain any metal, with vapor permeability, comfortable. Filtering effect B.F.E up to 99.9%, especially suitable for electronic factories, using soft and comfortable P.P. material, does not irritate the skin comfortable to wear. Nose clip design can be adjusted according to different face shapes. The earbands are made of soft and comfortable P.P. material, which does not irritate the skin and is comfortable to wear. Can be applied to electronic manufacturing, clean room, food service, food processing, schools, riding a motorcycle, spray processing, stamping hardware, health hospitals, hand processing industry, hospitals, beauty, pharmaceuticals, factories, environmental cleanliness, public **** occasions and other purposes Note: 1.Size: 9CMx17.5 2.Products can be sent free sample delivery.
The most famous manufacturers in China are; Xiantao Likai Protective Products Co.
2003-04-29 issued 2003-04-29 implementation
A General Administration of Quality Supervision, Inspection and Quarantine issued
Preface
This standard is used for the evaluation of the quality of medical protective masks.
This standard 4.1 is recommended, the rest is mandatory.
Production units since the date of implementation of this standard according to this standard organization, distribution units since June 15, 2003 onwards.
This standard is proposed by the State Food and Drug Administration.
This standard by the Beijing medical equipment testing institute.
This standard drafting unit: Beijing medical equipment testing.
The main drafter 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 for medical protective masks (hereinafter referred to as masks), test methods, labeling 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.
2 normative references
The following documents in the provisions of this standard through the reference and become the provisions of this standard. Where the cited document is dated, all of its subsequent change orders (excluding the contents of the errata) or revised versions are not applicable to this standard, however, the parties to the agreement under this standard are encouraged to study whether the latest version of these documents can 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
3 Nouns and terminology
3.1 Filtering efficiency filtering efficiency
In the stipulated conditions, the care of the product will be filtered out of the particulate matter in the air. percent.
3.2 Flame retardation
The performance of the product to prevent itself from ignition, flaming and deflagration.
3.3 disinfection
Physical or chemical methods to kill or remove pathogenic microorganisms on the vector, so that it is harmless.
3.4 sterilization
Physical or chemical methods to kill all the microorganisms on the medium of transmission to make it sterile.
3.5 self-inhalation filter type dust mask self-inhalation filter type dust mask
Relying on the wearer's breathing to overcome the resistance of the components, used for dust clean air respiratory protective gear.
3.6 sealing half-mask
The mask that can cover the nose and mouth by sealing with the face.
3.7 Spray rating
Indicates the degree of resistance to moisture on the fabric surface.
4 Technical Requirements
4.1 Basic dimensions of the mask
a) The size of the center part of the rectangular mask after unfolding: the length is not less than 17cm, the width is not less than 17cm;
b) The dimensions of the closed arch mask: the horizontal diameter is not less than 14cm, and the longitudinal diameter is not less than 14cm.
4.2 Appearance
4.2 Appearance
d) There shall be no exhalation valve on the mask.
4.3 Nose clip
a) The mask must be equipped with a nose clip;
b) The nose clip is made of bendable and malleable material, and the length is not less than 8.5cm.
4.4 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 mask strap at the connection point with the mask body should be not less than 10N.
4.5 Filtration efficiency
The particle filtration efficiency of the mask filter media should be not less than 95%.
4.6 Airflow resistance
At a gas flow rate of 85L/min, the suction resistance of the mask shall not exceed 343.2Pa (35mmH2O).
4.7 Synthetic blood penetration barrier performance
Synthetic blood is sprayed into the mask sample at a pressure of 10.7kPa (80 mmHg), and there should be no penetration on the inside of the mask.
4.8 Surface moisture resistance
The mask water staining level should not be less than GB/T4745 in GB3 level.
4.9 Disinfection and sterilization
a) Masks labeled as disinfection grade should meet the requirements of 4.3.2 of GB 15980.
b) Masks labeled as sterilization grade shall meet the requirements of 4.3.2 of GB 15980.
4.10 Ethylene oxide residue
Ethylene oxide residue of masks sterilized by ethylene oxide should be no more than 10 μg/g.
4.11 Flame retardant properties
The materials used should not be flammable. Continued burning after removal from the flame should not exceed 5s.
4.12 Skin irritation
The mask material should be free of skin irritation reaction.
4.13 Signs and instructions for use
Should comply with the provisions of this standard 6.
5 Test Methods
5.1 The basic dimensions of the mask
Measured with a common gauge, shall comply with the provisions of Article 4.1.
5.2 Appearance
Visual inspection, shall comply with the provisions of Article 4.2.
5.3 Nose clips
These shall conform to the provisions of clause 4.3 by inspection and measurement with a common or specialized gauge.
5.4 Mouthpiece Strips
Total*** 4 mouthpieces 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 shall be made for a minimum of 4 hours after temperature preconditioning.
Both by visual inspection and tensiometer measurement shall comply with 4.4.
5.5 Filtration efficiency and airflow resistance test
Six mask filter media should be used for 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 the NaCl aerosol particle size distribution should be counted for the median diameter in (0.075 ± 0.020) μm, the geometric standard deviation does not exceed 1.86.
Filtering efficiency measurements should be greater than or equal to the provisions of the 4.5.
The suction resistance of the mask should be consistent with the provisions of this standard 4.6.
5.6 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.
5.7 Surface moisture permeability test
The test is conducted by the method specified in GB/T 4745, and the results shall conform to the provisions of Article 4.8 of this standard.
5.8 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.
5.9 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.
5.10 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
After the temperature pretreatment should be recovered at room temperature for at least 4 hours.
The single burner test is performed according to the following procedure and the results shall comply with 4.11.
The mask is placed on 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 was turned on with the pressure adjusted to 20,000 to 30,000 Pa (0.2 bar to 0.3 bar) and the gas 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, measured at (20±2) mm above the tip of the burner with a 1.5 mm diameter metal-isolated thermocouple probe, should be (800±50) C. The flame should be at (800±50) C when measured by 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.
5.11 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.
5.12 Marking and instructions for use
Visual inspection, shall comply with the provisions of Article 4.13.
6 Marking and instructions for use
6.1 Marking
6.1.1 The minimum package of masks should have at least the following clear and easy to recognize the marking, and if the package is transparent, the marking should be able to be seen through the package:
a) the product name;
b) the name of the manufacturer or supplier, the trademark;
c) the product form labeling;
d) Filter media grade: N95/N99;
e) Storage period;
f) "See producer's information" statement;
g) Producer's recommended storage conditions (at least temperature and humidity conditions);
h) Components to be assembled should be marked with a safety symbol;
i) Single-use should be marked as single-use;
j) Repeated-use should be marked with the method of sterilization.
Note: N95/N95 is the grade of filter media, which has a filtration efficiency of not less than 95%/99% for non-oily particles.
6.1.2 The box should have at least the following contents or markings:
a) Manufacturer's name and address, telephone number, zip code;
b) Product name;
c) Product implementation standard number;
d) Production batch number;
e) Weight;
f) Specification quantity;
g) Volume;
h) Sun protection, humidity and other words and signs, signs should be consistent with the provisions of GB/T191.
6.2 Instruction manual
Instruction manual should be used at least in Chinese.
The instruction manual shall give at least the following contents:
a) the use and use restrictions;
b) the meaning of the color code;
c) the inspection to be carried out prior to the use;
d) the suitability of wear;
e) the method of use;
f) the maintenance (e.g., cleaning, disinfection), if applicable;< /p>
f) the maintenance (such as cleaning, disinfection), if applicable;< /p>
f) the use of the product.
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 disposal times 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:
7.1 Packaging
7.1.1 The mask should be packaged in such a way as to prevent mechanical damage and contamination prior to use.
7.1.2 Masks are boxed according to the quantity, put in the certificate of conformity (packing list) and sealed.
7.2 Transportation
According to the conditions of the contract.
7.3 Storage
According to the provisions of the instruction manual.