According to Article 20 of the "Code for the Quality Management of Medical Device Business", the conditions of the warehouse should meet the following requirements:
(1) The environment inside and outside the warehouse is clean and tidy, with no source of contamination;
(2) The internal walls of the warehouse are clean and smooth, the ground is flat, and the housing structure is tight;
(3) There are measures to prevent the operation of outdoor loading and unloading, handling, receiving and shipping from being affected by abnormal weather;
(4) The warehouse has reliable safety protection measures to control and manage the entry of unrelated personnel. Measures;
(D) the warehouse has a reliable security measures, the ability of unrelated personnel to enter the implementation of controllable management.
Expanded Information:
Medical Device Quality Management System (MDQMS) is a system for the management of medical devices. p>According to Article 21 of the "Code for Quality Management of Medical Device Operation", the warehouse should be equipped with facilities and equipment appropriate to the scope of business and scale of operation, including:
(a) effective isolation of medical devices and the ground between the equipment, including shelves, trays, etc.;
(b) avoidance of light, ventilation, moisture, insect and rodent facilities;
(c) meet the safety and security requirements of lighting equipment. Electricity requirements of the lighting equipment;
(D) the storage of packaging materials;
(E) special requirements of medical devices should be equipped with the appropriate facilities and equipment.
Baidu Encyclopedia - Medical Device Business Quality Management Code