Medical device goods storage environment temperature, humidity range?

The warehouse temperature and humidity should be in line with the requirements of the operating medical device manual or labeling. For medical devices with special temperature and humidity storage requirements, should be equipped with effective control and monitoring of temperature and humidity equipment or instruments.

Retail display of medical devices should meet the following requirements:

(a) according to the classification as well as storage requirements partition display, and set up conspicuous signs, category labels in clear handwriting, placed accurately;

(b) medical devices should be arranged in a neat and orderly manner, to avoid direct sunlight;

(c) the need for refrigeration, freezing of medical equipment is placed in the cold storage, Refrigeration equipment, the temperature should be monitored and recorded;

(d) medical devices and non-medical devices should be displayed separately, there is a clear separation, and conspicuous labeling.

businesses operating Class III medical devices, should have a computer information management system that meets the requirements of quality management of medical equipment business, to ensure that the operation of the product can be traced. Computer information management system shall have the following functions:

(a) with the realization of interdepartmental, between the post of information transfer and data **** enjoy the function;

(b) with the medical device business ticket generation, printing and management functions;

(c) with a record of medical device product information (name, registration certificate number or filing voucher number, Specification model, production lot number or serial number, production date or expiration date) and production company information and to achieve quality traceability tracking function;

(d) including purchasing, receiving, inspection, storage, inspection, sales, warehousing, review and other aspects of the business process of the quality control function, can be judged, control the business process, to ensure that all the quality control function of real-time and effective;

(E) with suppliers, purchasers and the purchase and sale of medical devices, the legitimacy and validity of the audit and control functions;

(F) with the expiration date of the inventory of medical devices for automatic tracking and control functions, near-expiration date warning and more than the expiration date of the automatic locking and other functions, to prevent the expiration of the sale of medical devices.

Baidu Encyclopedia - Code for Quality Management of Medical Device Business