According to The People's Republic of China pharmaceutical industry YY 0314-1999 idt ISO 6170:1995 standard provisions, the following five indicators, lack of a failing grade products.
1, suction volume of Experiment: suction volume, that is, blood volume, the error is within ± 10%, otherwise to be ineligible. Blood volume is currently not allowed to major problems. This will not only result in inaccurate test results, but can also cause congestion and damage to testing equipment.
2, the container leakage test: The complex solution containing sodium fluorescein harvesting vessels inverted 60 minutes in deionized water, in the long-wave UV light source, the darkroom in the normal visual acuity observed no fluorescence, in order to pass. Container leaking blood vessels is currently mining the amount of the main reasons for inaccurate.
3, the container strength test: the container with the centrifuge to 3000g the role of centrifugal acceleration for 10 minutes without rupture qualified. Abroad, strict requirements are: 2 meters from the ground, mining vessel vertical landing is not broken, so prevent tube damage due to accidental cause, resulting in sample loss.
4, the minimum free-space experiments: to ensure adequate mixing of blood the smallest space. Blood volume of 0.5ml-5ml,> blood volume +25%; blood volume> 5ml persons, "blood volume by 15%.
5, solvent, solute and solution dosage compared with precision experiments: the error should be planted in the required standard within ± 10%. This is easily overlooked, yet common problem is caused by testing one of the main data is not accurate.