Added paraffin oil test to KF80 mask...Strengthen Health Mask Performance Evaluation Criteria
Aug 11, 2025
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Health masks are classified into KF80, KF94, and KF99 grades depending on the degree to which fine particles are filtered. KF80 can filter out more than 80% of fine particles with an average size of 0.6 μm, and KF94 and KF99 can filter out more than 94% and 99% of fine particles with an average size of 0.4 μm, respectively. The larger the number behind KF, the greater the effect of blocking fine particles, but it may be difficult or uncomfortable to breathe, so an appropriate product should be selected in consideration of the level of generation of particulate harmful substances and the amount of respiration for each individual.
The Ministry of Food and Drug Safety announced the administration on August 11th and will receive opinions by September 1st to reorganize regulations on the approval and reporting of non-drug products, including the addition of test standards for evaluating the performance of non-drug health masks.
The main revisions include ▲ additional setting of dust collection efficiency test standards for health masks (KF80) ▲ establishing grounds for submission of non-clinical trial data using animal replacement tests ▲ maintenance of difficult terms.
First of all, the performance evaluation criteria are strengthened by adding 'paraffin oil test', which evaluates the blocking performance of liquid particles, to the dust collection efficiency test criteria to evaluate the respiratory protection performance of health masks (KF80). As a test to evaluate the blocking efficiency of the filter, 's sodium chloride test' should be set to evaluate the blocking performance of solid particles, and 'paraffin oil test' should be set to evaluate the blocking performance of liquid particles. Both sodium chloride and paraffin oil tests are already applied to KF94, KF99 masks and European FFP1-grade masks.
In addition, reflecting the trend of reducing animal testing to expand animal welfare internationally, non-animal or human biology-based test data can be submitted as non-clinical test data on toxicity and pharmacological action when approving non-drug products.
The Ministry of Food and Drug Safety said it expects the revision of the notice to strengthen mask safety management to contribute to improving public health and to actively utilize animal replacement tests when applying for non-drug product approval.
This article was translated by Naver AI translator.
