Pro, specific other information: 1. The production environment that the enterprise has should be good sanitary conditions, fresh air, dusty atmosphere, low concentration of bacteria, no harmful gases, and good natural environment. Production plant should be around the four no (no stagnant water, no weeds, no garbage, no mosquitoes and flies breeding grounds), it is desirable that there is no bare land. The area around the plant should be green, and should not plant plants that are easy to disperse pollen.2. Enterprises should determine the process of production in the corresponding level of clean room (area) according to the quality requirements of the sterile medical devices produced to avoid contamination in the production. Air clean level of different neighboring rooms between the static pressure difference should be greater than 5 Pa, clean room (area) and non-clean room (area) of the static pressure difference should be greater than 10 Pa, the positive room and the surrounding area should maintain a relatively negative pressure.