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Non-woven mask
One type of mask is made from pure cotton gauze or knit fabric, with various non-woven fabrics layered in between, while the other is directly sewn from non-woven fabric. The filtration efficiency is quite good, but the ventilation could be better.
Technical Protective Mask Technical Requirements were released and implemented on April 29, 2003, by the State Administration of Quality Supervision, Inspection and Quarantine. This standard serves to evaluate the quality of medical protective masks. While Section 4.1 of this standard is recommended, the rest are mandatory. Manufacturers must adhere to this standard starting from its implementation date, while distributors will begin compliance from June 15, 2003. The standard was proposed by the State Food and Drug Administration and is under the jurisdiction of the Beijing Medical Device Testing Institute. It was drafted by the Beijing Medical Device Testing Institute, with key contributors including Zhang Zhaoyuan, Bi Chunlei, Liao Xiaoman, Yan Xue, and Zeng Ning.
This standard outlines the fundamental requirements, testing methods, labeling, instructions for use, and packaging, transportation, and storage guidelines for medical protective masks (referred to as masks). It applies to self-inhalation filter-type dust-proof medical protective masks that can filter airborne particles and block droplets, blood, bodily fluids, and secretions.
The standard references several documents, including GB/T191-2000 for packaging and storage pictorial marks, GB/T 4745-1997 for textile fabric surface moisture resistance tests, GB 15980-1995 for disposable medical supplies hygiene standards, and Others related to biological evaluations and sterilization residues. Key terms like filtration efficiency, flame retardancy, disinfection, sterilization, and self-inhalation filter type dust masks are defined.
Technical requirements cover dimensions, appearance, nose clips, adjustability, filtration efficiency, airflow resistance, synthetic blood penetration barriers, surface moisture resistance, disinfection/sterilization, ethylene oxide residuals, flame retardant properties, skin irritation, and labeling. Testing methods include dimension measurement, visual inspections, nose clip assessments, filtration efficiency and airflow resistance tests, synthetic blood penetration checks, surface moisture permeability tests, disinfection/sterilization evaluations, ethylene oxide residue analysis, flame retardant property tests, skin irritation assessments, and visual inspections of markings and instructions.
Packaging and transportation must ensure the masks are protected from damage and contamination. The standard also requires clear labeling on the minimum packaging, including product name, manufacturer details, filter material grade, shelf life, storage conditions, and usage instructions. The instruction manual should at least be in Chinese and provide detailed guidance on use, maintenance, storage, potential issues, and disposal recommendations.
Overall, this standard ensures medical protective masks meet essential safety and performance criteria, providing users with reliable protection.