6.1 The configuration of instruments and equipment should be able to meet the needs of blood testing business. The basic instruments and equipment of the laboratory should include centrifuges, incubators, water baths, enzyme markers, plate washers, biochemical analyzers, refrigeration and freezing equipment and other special equipment. Centralized testing laboratory testing instruments, equipment should be equipped with their functions.
6.2 The use of instruments and equipment should be consistent with relevant national standards. Manufacturers and suppliers of instruments and equipment should have the appropriate qualifications prescribed by national laws and regulations. And they should be able to get sufficient consumables required for the instruments and equipment from the market.
6.3 A management system for evaluation, confirmation, maintenance, calibration and continuous monitoring of instruments and equipment must be established and implemented to ensure that the instruments and equipment meet the requirements for their intended use. Measuring instruments shall meet the requirements for calibration, with obvious signs of passing periodic calibration.
6.4 Large and critical instruments and equipment should be marked with unique labels, clear maintenance and calibration cycles, archives should be managed by a person with records of use, maintenance and calibration. Faulty or out-of-service instruments and equipment should be clearly labeled to prevent misuse.
6.5 The key instruments and equipments in the process of blood testing should be set up with uninterrupted power supply (UPS), and formulate the emergency plan in case of failure, and the emergency measures should not affect the quality of blood testing. The management requirements of all emergency backup instruments and equipment are the same as those of conventional instruments and equipment.
6.6 Large and critical instruments and equipment after repair or large-scale maintenance, before re-use, should be checked to ensure that its performance meets the expected requirements. Measuring instruments after repair or large-scale maintenance, need to calibrate the instrument before use.