Article XII of the production enterprises should determine the production of products to avoid contamination, in the corresponding level of clean room (area) within the production process. Air clean level of clean room (area) between the static pressure difference should be greater than 5 Pa, clean room (area) and the outdoor atmosphere should be greater than 10 Pa static pressure difference, and there should be an indication of the pressure difference of the device. The gradient of pressure difference between clean rooms of the same level should be reasonable. Sterile medical device production clean room (area) level set the principle of the appendix.
Article XIII of the clean room (area) should be in accordance with the production process of sterile medical devices and the required air cleanliness level for reasonable layout. The same clean room (area) or adjacent clean room (area) production operations shall not cross-contaminate each other.
Clean room (area) of the temperature and relative humidity should be compatible with the requirements of the production process. No special requirements, the temperature should be controlled at 18 ~ 28 ℃, relative humidity control at 45% ~ 65%.
There are no specific regulations!