GB 19083-2003 Technical requirements for medical protective masks GB19083-2003 standard download decompression password: www.bzxz.net

National Standard of the People's Republic of China
GB19083—2003
Technical requirements for protective face mask for medical use2003-04-29 Issued
2003-04-29 Implementation
Issued by the General Administration of Quality Supervision, Inspection and Quarantine4
This standard is used to evaluate the quality of medical protective masks. 4.1 of this standard is recommended, and the rest are mandatory. GB19083—2003
Production units shall organize production according to this standard from the date of implementation of this standard, and distribution units shall implement it from June 15, 2003. This standard is proposed by the State Food and Drug Administration. This standard is under the jurisdiction of Beijing Medical Device Testing Institute. Drafting unit of this standard: Beijing Medical Device Testing Institute. Main drafters of this standard: Zhang Zhaoyuan, Bi Chunlei, Liao Xiaoshou, Yan Xue, Zeng Ning. 1
1 Scope
Technical requirements for medical protective masks
GB19083——2003
This standard specifies the basic requirements, test methods, marking and instructions for use, as well as packaging, transportation and storage of medical protective masks (hereinafter referred to as masks).
This standard applies to self-priming filter-type dust-proof medical protective masks that can filter particles in the air and block droplets, blood, body fluids, secretions, etc.
2 Normative references
The clauses in the following documents become the clauses of this standard through reference in this standard. For all dated referenced documents, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, the parties to the agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For all undated referenced documents, the latest versions shall apply to this standard.
GB/T191-2000 Pictorial marking for packaging, storage and transportation GB/T4745-1997 Determination of moisture resistance of textile fabrics Water-soaking test GB15980-1995 Disposable medical supplies. Hygienic standards GB/T16886.7-2001 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residue GB/T16886.10-2000 Biological evaluation of medical devices Part 10: Irritation and sensitization test 3 Terms and terms
3.1 Filtering efficiency filteringefficiency The percentage of particulate matter in the air filtered out by protective products under specified conditions. 3.2 Flame retardation
The performance of protective products to prevent themselves from being ignited, burning with flames and smoldering. 3.3 Disinfection
Kill or remove pathogenic microorganisms on the transmission medium by physical or chemical methods to make them harmless. 3.4 Sterilization
Kill all microorganisms on the transmission medium by physical or chemical methods to make it sterile. 3.5 Self-inhalation filter type dust mask self-inhalation filter type dust mask relies on the wearer's breathing to overcome the resistance of the components, and is used for dust-proof air-purifying breathing equipment. 3.6 Sealing half-mask
A mask that fits tightly with the face and can cover the nose and mouth. 3.7 Spray rating
Indicates the degree of moisture resistance of the fabric surface.
4 Technical requirements
GB19083—2003
4.1 Basic dimensions of masks
a) The central part size of the rectangular mask after unfolding: the length is not less than 17cm, the width is not less than 17cm; b) The size of the close-fitting arched mask: the horizontal diameter is not less than 14cm, and the vertical diameter is not less than 14cm. 4.2 Appearance
c) There should 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 a bendable plastic material and its length should not be less than 8.5cm. 4.4 Mask strap
a) The mask strap should be easy to adjust.
b) It should have sufficient strength to fix the position of the mask. The breaking strength of each mask strap and the connection point of the mask body should not be less than 10N4.5 Filtration efficiency
The particle filtration efficiency of the mask filter material should not be less than 95%. 4.6 Air flow resistance
When the gas flow rate is 85L/min, the inhalation resistance of the mask shall not exceed 343.2Pa (35mmH2O). 4.7 Synthetic blood penetration barrier performance
Synthetic blood is sprayed at a pressure of 10.7kPa (80mmHg) to the mask sample, and no penetration should occur 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 specified in GB/T4745. 4.9 Disinfection and sterilization
a) Masks marked as disinfection grade should meet the requirements of 4.3.2 in GB15980. b) Masks marked as sterilization grade should meet the requirements of 4.3.2 in GB15980. 4.10 Ethylene oxide residue
The ethylene oxide residue of masks sterilized with ethylene oxide should not exceed 10ig/g. 4.11 Flame retardant performance
The materials used should not be flammable. The flame should not continue to burn for more than 5s after being removed from the flame: 4.12 Skin irritation
The mask material should not have skin irritation reaction.
4.13 Marking and instruction manual
Should comply with the provisions of 6 of this standard.
5 Test method
5.1 Basic dimensions of masks
Measured with universal measuring tools, shall comply with the provisions of Article 4.1. 2
5.2 Appearance
Daily force inspection, shall comply with the provisions of Article 4.2. 5.3 Nose clip
By inspection and measurement with universal or special measuring tools, shall comply with the provisions of Article 4.3. 5.4 Mouth band
A total of 4 mouthpieces shall be tested. 2 are temperature pretreated and 2 are not pretreated. Temperature pretreatment conditions:
a) (70±3)℃ in air for 24 hours
b) (-30±3)℃ in air for 24 hours. After temperature pretreatment, it should be restored at room temperature for at least 4 hours. Daily force inspection and tensile test shall comply with the provisions of 4.4. 5.5 Filtration efficiency and airflow resistance test
GB19083—2003
Six mask filter materials should be used for filtration efficiency test. Three are temperature pretreated and three are not pretreated. Temperature pretreatment conditions:
a) (70±3)℃ air for 24 hourswwW.bzxz.Net
b) (-30±3)℃ air for 24 hours
After temperature pretreatment, it should be restored at room temperature for at least 4 hours. The air flow rate should be stable to (85±2)L/min. The test should be carried out until the filter material reaches the minimum filtration efficiency or at least (200±5)mg of aerosol acts on the filter material.
The particle size distribution of NaCI aerosol used under the specified test conditions should be a count median diameter of (0.075±0.020)im, and the geometric standard deviation should not exceed 1.86.
The filtration efficiency measurement result should be greater than or equal to the provisions of 4.5. The inhalation resistance of the mask shall comply with the provisions of Article 4.6 of this standard. 5.6 Synthetic blood penetration barrier performance
Check 5 masks.
The masks are treated at (21 ± 5) °C and relative humidity (85 ± 5)% for at least 4 hours. The masks are tested within 1 minute after being taken out of the environmental chamber.
The mask is fixed on a protruding fixture, and 2 ml of synthetic blood (surface tension (4.0～4.4)×10N/cm) is sprayed horizontally from a sleeve with an inner diameter of 0.84 mm to the tested mask at a distance of 305 mm. The test pressure is 10.7 kPa (80 mmHg). Remove the mask and check whether the inner side is penetrated. The result shall comply with the provisions of Article 4.7 of this standard. 5.7 Surface moisture permeability test
The test is carried out using the method specified in GB/T4745, and the result shall comply with the provisions of Article 4.8 of this standard. 5.8 Disinfection and sterilization
The test shall be conducted according to the method specified in GB15980, and the results shall comply with the provisions of Article 4.9 of this standard. 5.9 Ethylene oxide residue
The test shall be conducted according to the method specified in GB15980-1995, and the results 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 were temperature pretreated and 2 were not pretreated. Temperature pretreatment conditions:
a) (70±3)℃ in air for 24 hours
b) (-30±3)℃ in air for 24 hours
GB19083—2003
After temperature pretreatment, it should be restored at room temperature for at least 4 hours. The single burner test is carried out according to the following procedures, and the results should comply with the provisions of 4.11. The mask is worn on the metal head mold, and the linear 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. Adjust the flame height to (40+4)mm by means of the needle valve and carefully adjust the gas supply pressure. The temperature of the flame is measured with a 1.5mm diameter metal-isolated thermocouple probe at (20±2)mm above the burner tip and should be (800±50)℃. Set the head mold to motion and record the effect of the mask passing through the flame once. The test should be repeated so that all materials on the outside of the mask can be evaluated. Any component should only pass through the flame once. 5.11 Skin irritation
The test shall be carried out in accordance with the method specified in GB/T16886.10, and the results shall comply with the provisions of Article 4.12 of this standard. 5.12 Labeling and instructions for use
Visual inspection shall comply with the provisions of Article 4.13. 6 Labels and Instructions for Use
6.1 Labels
6.1.1 The smallest package of masks should have at least the following clear and recognizable labels. If the package is transparent, the labels should be visible through the package:
Product name:
Name and trademark of the manufacturer or supplier: Product form identification;
Filter material level: N95;
Shelf life;
"Please refer to the information provided by the manufacturer\";f
Storage conditions recommended by the manufacturer (at least temperature and humidity conditions): Parts that need to be assembled should be marked with safety symbols; Disposable masks should have Disposable label; for reusable ones, the sterilization method should be indicated. Note: N95 is the grade of filter material. The filtration efficiency of this grade of filter material for non-oily particles is not less than 95%. 6.1.2 The packaging box should have at least the following content or labeling: Manufacturer's name and address, telephone number, zip code: a)
b) Product name:
c) Product implementation standard number:
d) Production batch number:
e) Weight;
f) Specification quantity:
g) Volume;
h) Words and logos such as sun protection and moisture-proof. The logos should comply with the provisions of GB/T191. 6.2 Instructions for use
The instruction manual should be in Chinese at least.
The instruction manual should at least give the following information: a) Purpose and restrictions on use:
The meaning of the color code;
Inspections to be carried out before use;
Fitness of wearing;
How to use:
Maintenance (e.g. cleaning, disinfection), if applicable: Storage:
The meaning of the symbols and/or diagrams used in GB19083-2003; Possible problems should be given, such as: the suitability of the mask (check before use); Leakage prevention if hair enters the edge of the mask The requirements may not be met: Air quality (pollutants, hypoxia, etc.): Equipment used in explosive gas environments; Recommendations on the time to discard the mask should be included; 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 The masks are packed according to quantity, and the certificate of conformity (packing list) is placed and the box is sealed. 7.2 Transportation
According to the conditions stipulated in the contract.
7.3 Storage
According to the provisions of the instruction manual.
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