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Standards for medical masks

Standards for medical masks

Release date: 2020.09.28

Postscript (2021.6.18): On June 16, 2021, the Japanese Industrial Standards (JIS) for general masks, medical masks, and infection control medical masks were established. With the spread of the new coronavirus (COVID-19), the wearing of masks is strongly recommended and has become indispensable for both daily life and medical workers. Therefore, the performance and test methods of masks have been standardized. , JIS T9001 (performance requirements and test methods for medical and general masks) for medical and general masks, and corona infection countermeasures, so that users can purchase with confidence by standardizing JIS T9002 (Performance requirements and test methods for medical masks for infection control) has been established for masks for medical personnel who wear masks.

There is no performance standard for medical masks in Japan. HoweverIn the medical field, performance such as prevention of droplet infection and infiltration of blood and body fluids is required, so many products are based on the standards set by ASTM International (International Standardization and Standardization Organization) in the United States. There are levels from 1 to 3, and the higher the number, the higher the performance.

ASTM-F2100-19 (US standard for medical masks)

Characteristic Level 1 Level 2 Level 3
Bacterial filtration rate (%) ≧95 ≧98 ≧98
Fine particle filtration rate (%) ≧95 ≧98 ≧98
Expiratory resistance (mmH2O / cm2) <5.0 <6.0 <6.0
Liquid protection (mmHg) 80 120 160
Flammability Class1 Class1 Class1
Bacterial Filtration Efficiency (BFE)
Bacterial collection performance. Shows the rate at which the particles are filtered.
Particle Filtration Efficiency (PFE)
An index of mask filter performance, which indicates the percentage of 0.1 μm particles filtered by the mask.
Expiratory resistance (⊿P: Air Exchange Pressure)
It is an index of the wearer's ease of breathing.
Liquid Resistant (FR)
Assuming a situation where blood is scattered directly from a blood vessel to a mask during surgery, etc.
It tests the permeability of artificial blood under pressures equivalent to blood pressure and shows how well it can withstand.
Flammability
It is an index of the flammability of the mask. The smaller the number, the harder it is to burn, and the surgical mask must be Class 1.

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MEDIUS

ASOURCE NAVI editorial department

MEDIUS Group is developing a business centered on the sale of medical equipment. We (Medical + us) involved in medical care also want to play the role of an information source (Media) that delivers useful information for the medical field and people's healthy tomorrow.

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