The standard management center of the SPDA issued the new national standard draft of medical protective mask and medical disposable protective clothing.

Revision items of GB 19083 medical protective masks
Compared with GB 19083-2010, except for editorial changes, the main technical changes of the draft standard are as follows:
(1) The name of the standard is changed to medical protective mask. The product standard involves both technical requirements and testing methods, so the name of the standard is modified as medical protective mask.
(2) According to the changes of requirements and test methods in the draft, the normative references are modified accordingly.
(3) According to the changes of requirements and test methods in the draft, the term definitions are modified accordingly. The specific changes are as follows: the term definitions of fitness factor are deleted, and the term definitions of dead cavity, total leakage rate, counting median diameter, aerodynamic particle diameter and aerodynamic mass median diameter are added.
(4) Added mask categories (N95, N99 and N100). The classification of masks is more intuitive by distinguishing them according to different filtering efficiency.
(5) The requirement of airflow resistance is deleted and the requirement of respiratory resistance is added. The air flow resistance in the 2009 edition is given when the filtration efficiency is tested by the filter material tester, which is different from the requirements and detection methods of similar product standards at home and abroad. The revision refers to domestic and foreign standards, changes the air flow resistance to ventilation resistance, and tests it according to the method in GB 2626-2019 respiratory protection self-priming filter anti particulate respirator.
(6) Requirements for dead cavity and total leakage rate are added. There is no dead cavity requirement in the 2009 edition. According to the standards of similar products at home and abroad, the dead cavity requirement is added in this revision; The 2009 edition does not require the total leakage rate, but uses to evaluate the tightness. In this revision, the tightness requirement is deleted on the basis of referring to the standards of similar products at home and abroad, and the total leakage rate requirement is added as an important index to evaluate the protective effect of protective masks.
(7) The anti synthetic blood penetration requirement is modified from "10.7 kPa (80 mmHg) pressure" to "16 kPa (120 mmHg) pressure". According to the actual development of the industry, the requirements for resistance to synthetic blood penetration are increased accordingly, which is consistent with the requirements in the approval draft of YY 0469 revised in 2020.
(8) The requirements for microbial limit of non sterilized masks are modified to "total microbial count ≤ 100 cfu / g". For the microbial limit requirements of non sterilized masks, refer to the determination basis in YY 0469 approval draft revised in 2020. Pathogenic bacteria are no longer required, but the total amount of microorganisms is controlled.
(9) The name of "flame retardancy" is modified to "flammability", and the test is carried out with reference to the corresponding methods in GB 2626-2019. According to domestic and foreign standards, flame retardancy and flammability are not the same concept. This standard should investigate flammability rather than flame retardancy.
(10) Added biocompatibility requirements. The requirements for cytotoxicity and delayed type hypersensitivity are added, and the requirements for skin irritation are modified. Due to the large contact area and long contact time between the medical protective mask and the wearer's facial skin, the biocompatibility requirements are added with reference to the determination basis in the approval draft of YY 0469 revised in 2020.
(11) Deleted tightness requirements. The tightness requirement in the 2010 standard shall be the evaluation index for medical personnel in selecting medical protective masks, rather than product type inspection. In order to gradually guide medical personnel to carry out tightness test when selecting medical protective masks, this revision adds "safety warning information should state that 'due to individual face differences, this product cannot guarantee the tightness of all wearers, and tightness evaluation should be carried out before use', or equivalent warning" in the instructions for use of the draft standard.

Revision items of GB 19082 disposable medical protective clothing
Compared with GB 19082-2009, except for editorial changes, the main technical changes of the draft standard are as follows:
(1) The name of the standard is modified to medical disposable protective clothing. The product standard involves both technical requirements and testing methods, so the name of the standard is modified as medical disposable protective clothing.
(2) According to the changes of requirements and test methods in the draft, the normative references are modified accordingly.
(3) According to the changes of requirements and test methods in the draft, the term definitions are modified accordingly. The specific changes are as follows: the term definitions of particulate matter, electrostatic attenuation and attenuation time are deleted, the term definitions of filtration efficiency and synthetic blood are modified, and the term definitions of moisture permeability, thermal resistance, moisture resistance, counting median diameter, aerodynamic particle diameter and aerodynamic quality median diameter are added.
(4) According to the requirements of Article 19 of the measures for the administration of mandatory national standards, all the technical requirements of mandatory national standards shall be mandatory. The size and specification requirements are deleted from the draft standard.
(5) The physical property requirements of protective clothing materials are modified and graded according to the physical properties. According to the domestic and foreign standards and the feedback of manufacturers, the requirements for elongation at break are deleted in the draft standard, and the physical performance requirements for tear strength, puncture resistance and joint strength are added.
(6) Modified water permeability requirements. Refer to the classification and testing method of water permeability in the current effective latest method standard GB / T 4744-2013 hydrostatic method for testing and evaluation of waterproof properties of textiles.
(7) The penetration performance of anti infective factors is added. In addition to retaining the particle filtration efficiency requirements of the 2009 standard, the anti phage penetration requirements are added as the penetration evaluation index of anti infective factors with reference to domestic and foreign standards.
(8) Added comfort index. According to the problems in the practical application of products, especially during the COVID-19 period, combined with the actual development of the industry, the requirements of comfort index were increased, including the requirements of moisture permeability, and the requirements of thermal resistance and moisture resistance were increased.
(9) The name and requirements of flame retardancy are modified to "flammability". According to domestic and foreign standards, flame retardancy and flammability are not the same concept. This standard should investigate flammability rather than flame retardancy.
(10) The requirements for skin irritation and microbial indicators were modified. Skin irritation is formulated with reference to the 2020 YY 0469 draft for approval. Microbial indicators also refer to the determination basis in YY 0469 approval draft revised in 2020. Pathogenic bacteria are no longer required, but the total amount of microorganisms is controlled.
(11)  The electrostatic attenuation performance requirements are deleted. Because the protective clothing materials are different, this index is not applicable to some product materials. According to domestic and foreign standards and opinions of manufacturers, the antistatic requirements are retained and the electrostatic attenuation performance requirements are deleted.

Zhejiang Yanpeng Nonwoven Machinery Co. , Ltd. is a professional manufacturer specializing in the research and development of non-woven production lines. It located in Wenzhou city, Zhejiang. The existing plant is more than 20, 000 square meters and has more than 130 employees. In recent years, we became the leading supplier of non woven production line in domestic and abroad.

Since from the beginning of 2008, we always focused on nonwoven equipment R& D and production. Until today, we serve over 200 customers at home and abroad , and installed over 600 non woven production lines in all over the world.

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