Chapter I General Provisions
Article 1 (Purpose) According to the requirements of the "Regulations on the Supervision and Administration of Medical Devices" and other relevant laws and regulations, to strengthen the quality management of transportation and storage processes requiring refrigerated and frozen medical devices (hereinafter referred to as "cold chain management medical devices"), Medical devices are always in compliance with the medical device specifications and labeling temperature requirements in all aspects of production, operation and use.
Article 2 (Scope of Application) The medical device production and operation enterprises and the use of units to transport and store cold chain management medical devices shall follow this guide.
Chapter II Personnel and Facilities
Article 3 (Training of key personnel) The staff of the cold chain management medical equipment receiving, accepting, storing, inspecting, leaving the warehouse, transporting, etc. shall accept relevant laws and regulations, professional knowledge, working systems and standard operating procedures. Training, after passing the examination, can only be employed.
Article 4 (Refrigerated Refrigeration Equipment) Medical device manufacturers and wholesale enterprises shall be equipped with suitable cold storage (refrigerator or freezer), refrigerated truck, refrigerator or incubator according to the variety and scale of production and operation.
Medical device retail enterprises and users should be equipped with suitable cold storage or refrigeration equipment (refrigerators/tanks, etc.) according to the type and scale of operation and use.
Article 5 (cold storage) cold storage shall have the function of automatically regulating the temperature, and shall be equipped with an auxiliary refrigeration unit. The refrigeration capacity of the unit shall be compatible with the volume of the cold storage. In order to ensure continuous power supply to the refrigeration system, the cold storage should be equipped with a standby generator set or a dual-loop power supply system.
The cold storage should be divided into the area to be inspected, the storage area, the return area, the pre-cooling area (package) of the packaging materials, etc., and clearly marked.
Article 6 (Refrigerated vehicles) Refrigerated vehicles shall have automatic temperature regulation function. The compartments shall be waterproof and sealed, and there shall be room for ensuring sufficient circulation of airflow in the compartments.
Article 7 (refrigerator, incubator) refrigerators and incubators should have good insulation function. The refrigerator should be able to automatically adjust the temperature inside the cabinet; the incubator should be equipped with a coolant and a temperature isolation device, and meet the storage and transportation requirements marked in the product labeling instructions.
Article 8 (Temperature Control System) The cold storage and refrigerated trucks shall be equipped with an automatic temperature monitoring system (hereinafter referred to as “temperature control systemâ€) to monitor the ambient temperature and establish equipment operation, inspection, maintenance and maintenance files. The system should have the following features:
(1) The technical parameters such as measurement range, accuracy and resolution of the temperature control system can meet the management needs, and have the functions of continuous monitoring, continuous recording, data storage, display and alarm.
(2) The temperature data of the measuring point is updated at least every 1 minute during the operation of the equipment. The real-time temperature data is automatically recorded at least every 30 minutes during the storage process, and the real-time temperature data is automatically recorded at least every 5 minutes during the transportation process. When the monitored temperature value is outside the specified range, the system should record the real-time temperature data at least every 2 minutes.
(3) When the monitoring temperature reaches the set threshold or exceeds the specified range, the temperature control system can realize the sound and light alarm, and at the same time realize the short message and other communication methods to immediately send alarm information to at least two designated personnel.
The temperature measurement points of cold storage and refrigerated trucks should be set and installed according to the verification conclusion. Each (stand-alone) independent cold storage and refrigerated truck should have at least two temperature measuring point terminals installed. The temperature measuring point terminal and the temperature monitoring device should be calibrated at least once a year.
Refrigerators, incubators or other refrigeration equipment should be equipped with equipment that automatically records and stores the temperature.
Chapter III Verification Management
Article 9 (Device Verification) Cold storage, refrigerated trucks, refrigerators, incubators, and temperature control systems shall be verified under pre-use verification, periodic verification, and deactivation for longer than the specified time limit. Unverified facilities and equipment shall not be used for the transportation and storage of cold chain management medical devices.
(1) Establish and form verification control documents, including verification schemes, standards, reports, evaluations, deviation handling and preventive measures.
(2) Determine the appropriate continuous verification time according to the verification object to ensure the sufficient, effective and continuous verification data.
(3) The temperature sensor and temperature monitoring equipment used for verification shall be calibrated by a qualified metrology institution. The calibration certificate (copy) shall be used as an essential annex to the verification report, and the verification data shall be true, complete, valid and traceable.
(4) Properly and reasonably use the relevant facilities and equipment according to the parameters and conditions determined by the verification.
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