Shenzhen Chuangying Times Technology Co., Ltd. |
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medical doctor surgical face mask disposable medical kids face
masks kn 95 non medical face mask
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The following are extracted from the network, for reference only
The production requirements are different, and the specific
differences are as follows:
Medical devices are divided into three categories. Respirators
belong to Class II medical devices. The production environment of
either medical cup type protective masks or disposable medical
masks must be at or above the level of 100000 (medical name: Class
D clean workshop), which is a national mandatory requirement. The
production environment must be dust-free and sterile. The masks
with special requirements must be produced under the specified
temperature and humidity range.
After production, medical masks are usually sterilized by ethylene
oxide sterilization. After sterilization, there will be ethylene
oxide residues on the masks. Ethylene oxide is a toxic carcinogen.
Long term inhalation of ethylene oxide not only irritates the
respiratory tract, but also has a strong carcinogenic potential.
The post sterilization resolution period is currently generally 14
days. This is a relatively safe ethylene oxide resolution time
verified by the enterprise, which can ensure that the residual
ethylene oxide content in the mask is lower than the safety
standard of 10ug/g