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PусскийAccording to the provisions of the People's Republic of China Pharmaceutical Industry Standard YY 0314-1999 idt ISO 6170:1995, the following five indicators, if one is missing, is a substandard product.
1. Aspiration volume experiment: the aspiration volume, that is, the amount of blood drawn, the error is within ±10%, otherwise it is unqualified. Inaccurate blood draw is the main problem currently. This not only causes inaccurate inspection results, but also causes blockage and damage to the inspection equipment.
2. Container leakage experiment: The vacuum blood collection tube containing the sodium fluorescein composite solution was placed upside down in deionized water for 60 minutes, and under long-wave ultraviolet light source, there was no fluorescence under normal vision in a dark room, which was qualified. Leakage of the container is the main reason for the inaccurate blood volume of the current vacuum blood collection tube.
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3. Container strength test: the container is subjected to a centrifuge at 3000g centrifugal acceleration for 10 minutes, and it is qualified if it does not break. Strict requirements abroad are: 2 meters above the ground, the vacuum blood collection tube does not rupture when falling vertically, which can prevent the test tube from being damaged due to carelessness and causing the loss of specimens.
4. The minimum free space experiment: the minimum space to ensure that the blood is fully mixed. The amount of blood drawn is 0.5ml-5ml,>+25% of the amount of blood drawn; if the amount of blood drawn>5ml,>15% of the amount of blood drawn.
5. Solvent, dissolved mass ratio and solution addition accuracy experiment: the error should be within ±10% of the specified standard plant. This is a common and easily overlooked problem, and it is one of the main reasons for the inaccuracy of the test data.
