Description of the connection between GB/T 38880-2020 Technical Specification for Children's Masks and Medical Mask Standards

Release time:

2021-11-08

Children's masks are an important product to protect children's health and safety during epidemics or in air pollution environments. The Technical Specification for Children's Masks was officially released on May 6, 2020, and technical forces in the field of medical devices have actively participated in the development of this standard, and the technical content of the standard has been well connected with the medical mask standard.

1. on bacterial filtration efficiency

Article 5.3 of GB/T 38880-2020 "Technical Specification for Children's Masks" requires,Children's hygiene masksThe requirement for bacterial filtration efficiency is ≥ 95%.

This technical index comes from the provisions of the current mandatory pharmaceutical industry standard YY 0459 "Medical Surgical Mask" on bacterial filtration efficiency. This index is also the index adopted by the European Union standard EN 14683 Type I and the American standard ASTM F2100. From the perspective of ensuring the safety of children wearing in daily scenes, the same index as that of medical masks is adopted in the formulation of bacterial filtration efficiency index in civil children's health masks.

The test method of this project is carried out according to the test method in Appendix B of YY 0459. The test method verifies the filtering effect of the mask on bacteria by examining the barrier ability of the mask to the aerosol of Staphylococcus aureus with a particle size of about 3 microns. This method can effectively verify the barrier ability of children's hygiene masks to pollutants such as saliva and droplets from the oral cavity and nasal cavity, as well as large particles such as pollen in nature, so as to ensure the basic safety of children's daily wearing process and reduce the infection of common pathogenic bacteria.

2. ethylene oxide residue

In the production process of enterprises in order to meet the indicators of hygiene, often using disinfection and sterilization process, including ethylene oxide is more economical, the typical way of disinfection and sterilization. China's current mandatory national standards GB 19083 "Technical Requirements for Medical Protective Masks", YY 0469 "Medical Surgical Masks" and other medical mask standards have put forward sterilization requirements for masks, and require ethylene oxide residues not to exceed 10 μg/g. From the perspective of foreign standards, Japan is also no more than 10 μg/g, and the United States has different regulations based on the use of medical devices.

From the perspective of children's health and safety, children's masks need to be sterilized according to medical masks, so as to avoid the hidden danger of bacterial contamination caused by insufficient cleanliness in the production process. GB/T 38880-2020, on the one hand, connects the requirements of medical mask standards for sterilization, on the other hand, greatly improves the requirements of the limit of ethylene oxide residue, and the specified limit is not more than 2 μg/g.

The test method of this project clearly stipulates that it shall be carried out in accordance with the provisions of Chapter 9 of GB /T 14233.1-2008, that is, gas chromatography shall be used for determination. The method has high sensitivity, good repeatability and low detection limit.

3. microbial indicators

During the use of the mask, the product is attached to the mouth, nose and face, and the filtered air enters the respiratory tract directly through the mask. The face and mask area belong to a humid and closed environment. Therefore, if there are too many pathogenic microorganisms on the inner surface of the product, it may cause facial skin infections, respiratory infections, etc., and must be controlled. The GB/T 38880-2020 standard refers to the provisions of GB 15979-2001 "Hygienic Standard for Disposable Sanitary Products" and clearly requires that pathogenic bacteria (coliform, Pseudomonas aeruginosa, Staphylococcus aureus and hemolytic streptococcus) in children's masks shall not be detected, and bacteria and fungi shall not exceed the standard (the total number of bacterial colonies ≤ 200cfu/g, the total number of fungal colonies ≤ 100cfu/g). The specific test method is Annex B of GB 15979-2001.

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