One, the enterprise should have with the storage of medical equipment requirements and scale of storage facilities and equipment, warehouse floor smooth, hardened; room temperature library temperature of 0 ℃ ~ 30 ℃, the storage of medical equipment with special temperature and humidity requirements, should also have its storage requirements and scale of constant temperature library (15 ℃ ~ 25 ℃), refrigerated storage (2 ℃ ~ 8 ℃), freezer (-15 ℃ ~ -25 ℃) 15 ℃ ~ -25 ℃).
Second, the enterprise storage of medical devices should meet the following requirements:
1. Storage of implantable interventional medical devices (class code Ⅲ-6821, Ⅲ-6846, Ⅲ-6863, Ⅲ-6877), picking spaces should be not less than 5000.
2. Storage of disposable sterile consumables medical devices (class code for Ⅲ-6815, Ⅲ-6845, Ⅲ-6864, Ⅲ-6865, Ⅲ-6866), the pallet should be not less than 2,000 spaces, the height of the pallet between the shelves is not less than 1.5 meters, the pallet specifications should be consistent with the national standard "intermodal common flat pallet main dimensions and tolerances" (GB/T2934-). 1996).
3. Storage needs to be refrigerated, frozen preservation of medical equipment, refrigerated storage volume of not less than 1,000 cubic meters, freezer volume of not less than 50 cubic meters.
4. Storage of other types of medical devices other than the above categories, not less than 1,000 palletized spaces, not less than 5,000 picking spaces.
Three, warehousing equipment and facilities mainly consists of warehousing management equipment, automatic identification of goods information equipment and other aspects of the specific requirements are as follows:
1. Can be used including but not limited to bar code preparation, printing equipment and computer information management equipment, in the warehousing of medical equipment without effective automatic identification labels for its code, to achieve the warehousing of medical equipment information automatic collection and storage, distribution process traceability.
2. Goods information automatic identification equipment. Medical equipment storage, storage, sorting, inspection, inventory, storage review and other links should use electronic identification system management (for implantable medical devices should be able to identify and record the product serial number), can be used, including but not limited to bar code and radio frequency identification equipment, to achieve the whole process of medical equipment storage, distribution traceability.
Four, enterprises should establish a central control room. Central control room should have warehouse temperature and humidity monitoring, constant temperature warehouse, cold storage, freezer, refrigerated truck temperature and humidity monitoring, general warehousing operations video monitoring, storage equipment control and abnormal conditions alarm function.
The room temperature warehouse should be at least every 30 minutes automatically record a real-time temperature and humidity data; constant temperature warehouse, cold storage, freezer should be at least every 10 minutes automatically record a real-time temperature and humidity data; refrigerated trucks should be at least every 5 minutes automatically record a real-time temperature data; when the monitoring of the value of the temperature and humidity exceeds the prescribed range, it should be at least every 2 minutes to record a real-time temperature and humidity data.
V. Enterprises storing cold chain medical devices should be equipped with standby power supply equipment or dual-channel power supply, with the function of power protection in case of emergencies.