一次性使用医用口罩适用于覆盖使用者的口、鼻及下颌，用于普通医疗环境中佩戴、阻隔口腔和鼻腔呼出或喷出污染物的一次性使用口罩。口罩的细菌过滤效率应不小于95%。不适用于医用防护口罩，医用外科口罩。根据我国医药行业标准《YY/T 0969-2013 一次性使用医用口罩》 [1] （此标准为器械非采标推荐性行业标准）
迟发型超敏反应：口罩的迟发型超敏反应应不大于1级。
外观
口罩佩戴好后，应能罩住佩戴者的口、鼻至下颌。应符合设计的尺寸，最大偏差应不超过±5%。
鼻夹
口罩上应配有鼻夹，鼻夹有可塑性材料制成。
鼻夹长度应不小于8.0cm。
口罩带
口罩带应戴取方便。
每根口罩带于口罩体连接点处的断裂强力应不小于10N。
细菌过滤效率（BFE）
口罩的细菌过滤效率应不小于95%。（与《YY 0469-2011 医用外科口罩》中的细菌过滤效率相同）
细菌过滤效率试验的气体流速控制在28.3L/min，使用菌种为金黄色葡萄球菌ATCC 6538，其细菌气溶胶的平均颗粒直径（MPS）为（3.0±0.3）μm。
通气阻力
口罩两侧面进行气体交换的通气阻力应不大于49Pa/cm³。
通气阻力试验取口罩中心部位进行测试，试验用气体流量需调整至（8±0.2）L/min，样品测试区直径为25mm，测试样品试验面积为A。用压差计或等效设备测定口罩两侧压差，按公式 ΔP=M/A 计算通气阻力。
ΔP ——试验样品每平方厘米面积的压力差值，单位为帕每平方厘米（Pa/cm³）；
M ——试验样品压差值，单位为帕（Pa）；
A ——试验样品测试面积，单位为平方厘米。
微生物指标
非灭菌口罩应符合下列要求：细菌菌落总数（CFU/g）：≤100；大肠菌群、绿脓杆菌、金黄色葡萄球菌、溶血性链球菌及真菌等：不得检出。
灭菌口罩应无菌。
环氧乙烷残留量
口罩如经环氧乙烷灭菌或消毒，其环氧乙烷残留量应不超过10μg/g。
生物学评价
The disposable medical mask is suitable for covering the user's mouth, nose and jaw. It is used to wear and block the exhalation or ejection of pollutants from the mouth and nose in the general medical environment. The bacterial filtration efficiency of the mask shall not be less than 95%. Not applicable to medical protective masks and medical surgical masks. According to the Chinese pharmaceutical industry standard YY / T 0969-2013 disposable medical mask [1] (this standard is a recommended industry standard for non standard collection of devices)
细胞毒性：口罩的细胞毒性应不大于2级。
皮肤刺激：口罩的原发刺激记分应不大于0.4。
appearance
After wearing the mask, it should cover the wearer's mouth, nose to jaw. It shall conform to the designed dimensions, and the maximum deviation shall not exceed ± 5%.
Nasal clip
The mask shall be equipped with a nose clip made of plastic material.
The length of nose clip shall not be less than 8.0cm.
Mask belt
The mask belt should be easy to wear and take.
The breaking strength of each mask belt at the connection point of the mask body shall not be less than 10N.
Bacterial filtration efficiency (BFE)
The bacterial filtration efficiency of the mask shall not be less than 95%（ (same as the bacterial filtration efficiency in YY 0469-2011 medical surgical mask)
The gas flow rate of bacterial filtration efficiency test is controlled at 28.3l/min. The strain used is Staphylococcus aureus ATCC 6538, and the average particle diameter (MPS) of bacterial aerosol is (3.0 ± 0.3) μ m。
Ventilation resistance
The ventilation resistance of gas exchange on both sides of the mask shall not be greater than 49pa / cm ³。
The ventilation resistance test shall be conducted at the center of the mask. The gas flow for the test shall be adjusted to (8 ± 0.2) l / min, the diameter of the sample test area is 25mm, and the test area of the test sample is a. Measure the differential pressure on both sides of the mask with a differential pressure gauge or equivalent equipment according to the formula Δ P = m / A to calculate ventilation resistance.
Δ P -- pressure difference per square centimeter of test sample, unit: PA / cm ³）；
M -- pressure difference of test sample, unit: Pa;
A - test area of test sample, unit: cm2.
Microbial index
The non sterile mask shall meet the following requirements: total bacterial colony (CFU / g): ≤ 100; Coliform, Pseudomonas aeruginosa, Staphylococcus aureus, hemolytic streptococcus and fungi shall not be detected.
The sterilization mask shall be sterile.
Ethylene oxide residue
If the mask is sterilized or disinfected with ethylene oxide, the residual amount of ethylene oxide shall not exceed 10% μ g/g。
Biological evaluation
Cytotoxicity: the cytotoxicity of the mask shall not be greater than grade 2.
Skin irritation: the primary irritation score of the mask shall not be greater than 0.4.
Delayed type hypersensitivity: the delayed type hypersensitivity of the mask shall not be greater than grade 1.
