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The state of medical devices according to the degree of risk of the implementation of classified management, the main classification is as follows:
The first category is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices.
The second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.
The third category is a high risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices. Different types of medical devices, rental warehouse demand is different, in the rental warehouse focus is different. However, in some aspects are more or less the same, mainly including the following points.
I. Warehouse qualification
Medical devices belong to the special instrument class, the warehouse qualification requirements are higher. Therefore, medical equipment in the rental warehouse, it is best to choose the warehouse with C two fire qualifications.
Two, the warehouse partition
Medical device manufacturers need to be equipped with at least two warehouses, medical supplies warehouse and finished medical equipment warehouse. The medical consumables warehouse is used to store raw materials, raw materials, packaging materials, etc. required for production; finished medical equipment warehouse is used to store the finished product. The medical equipment warehouse space is color-coded, with the green area being the qualified area, the yellow area being the returned area, and the red area being the unqualified medical equipment warehouse area.
When renting a warehouse, see whether the warehouse partition is reasonable, whether it is conducive to the later partition transformation, in order to achieve the role of partition management, partition storage.
Three, the warehouse temperature and humidity
Based on the performance and requirements of medical devices, general instruments are stored at room temperature, temperature and humidity should be below 30 degrees, humidity is 35-75. Therefore, the warehouse temperature should be controlled at 1-30 degrees, humidity between 45-75%.
Therefore, the warehouse temperature and humidity is up to standard is an important assessment basis.
Four, the warehouse location and the surrounding environment
Medical equipment in general on the warehouse distance requirements are not high, but not far from the hospital and the pharmacy is best. On the environmental requirements around the warehouse should be no source of pollution, environmental cleanliness. The warehouse and business premises should be isolated facilities, area and scale of operation is appropriate. At the same time should be configured to avoid light and ventilation facilities, configure lighting facilities to meet the requirements, configure fire, security, rodent, insect and dust facilities.
Fifth, the type of warehouse
Warehouse whether the canopy area, making loading and unloading, handling, receiving, shipping, etc. are not affected by the weather. Whether there is a high platform area, conducive to the loading and unloading of equipment.
The ground material is which type, epoxy, tile, cement, concrete or emery. According to the characteristics of medical equipment, you should choose a relatively flat ground.
Sixth, security
Whether there are relevant security measures, can be unrelated personnel into the controllable management, etc.. Such as monitoring. In addition, you should also look at the relevant fire, theft and pest control measures are perfect.
In short, medical equipment rental warehouse and other items rental warehouse requirements are more stringent, in the rental warehouse must be on the warehouse type, environment, security, warehouse zoning, etc. to consider, and ultimately find the right warehouse.