The requirements of pure water machine for biochemical analysis generally require ultra-pure water resistivity >: 10mω-cm.
The design of ultra-pure water machine for biochemical analysis has certain characteristics:
* The water storage barrel adopts closed pressure-free barrel, and the automatic biochemical analyzer can directly suck water into the machine.
* All equipped water tanks are large, with a volume of 120-500 liters.
* Equipped with reverse osmosis membrane, the purification package is larger than ordinary ultra-pure water.
* Due to the large water production, the consumables can be replaced quickly. The design of ultra-pure water machine for biochemical analysis usually considers saving consumables.
* Biochemical analyzers are widely used in the clinical laboratory of hospitals, and the working hours of medical departments have certain particularity, which requires convenient and quick replacement of biochemical analyzer consumables and timely after-sales service. These requirements make it easier for biochemical analysis ultra-pure water machine to maintain users and replace consumables.
* Biochemical analysis ultra-pure water machine is usually floor-standing, which increases the space inside the machine, can load more consumables, and reduces the frequency of replacement of consumables.
The pure water machine for biochemical analyzer is not managed as a medical device;
In order to meet the needs of medical device supervision and management, the State Food and Drug Administration of the United States issued a notice on February 7, 2007, clarifying the classification and definition of 68 products such as extracorporeal shock wave cardiovascular treatment system.
As three types of medical devices, it is managed by: extracorporeal shock wave cardiovascular treatment system; Iris instrument; Bamboo charcoal far-infrared electric belt, bamboo charcoal electric massage pillow; Brain function detection system; Non-invasive focused ultrasonic body shaping instrument; Electrode catheter; Beauty slimming instrument; Rare earth silver spray (excluding drugs); Calcium hydroxide suspension; Uterus and fallopian tube diagnosis and treatment device; Isotonic solution of calcium hydroxide; Desensitization cream; Body cavity mucosa labeling solution; Dimethyl sulfoxide frozen preservation solution; Peripheral blood chromosome culture medium kit; Electric shock therapeutic instrument; Field guide contraction rod; Iontophoresis beauty instrument (for scar removal).
As a class II medical device management, there are: gene analysis system; Humidifier for ventilator; Tooth desensitizer; Polishing paste; Total carnitine determination reagent and free carnitine determination reagent; 5' nucleotidase analysis kit; Glucose 6 phosphate dehydrogenase assay kit; Umbilical cord clamp; Surgical knotter; Bracket, buccal tube; Salt therapy tube; Physiological seawater nasal mucosa cleaning products; Multifunctional counting disk; Fumigation chair (excluding drugs); Turbidity quality control tube (standard tube) of electronic turbidimeter; Neonatal ventilator oxygen concentration monitor: liquid band-aid; Calibrator of automatic urine visible component analyzer: non-invasive glaucoma treatment system; Dentin measuring instrument; Rehabilitation treatment equipment; Pain and sensation analyzer; PACS workstation.
As a class I medical device management, it is: temporary positioning of crown and bridge; ESR pipette; Thermoplastic materials for radiotherapy positioning: antipyretic stickers; Negative pressure adjustable balanced breast pump; Knee joint surgical tools; Elbow is a multi-purpose installation tool for pressurized internal fixator; Installation tool for compression screw surgery; Installation tools for orthopedic intramedullary surgery; External fixator surgical kit; Installation tool for spinal adjustable fixator operation; Micro blood sample cup (tube).
Those that are not managed as medical devices are: carbonated spring processing machine; Hot knife; Disposable fecal concentrated egg collection and occult blood reaction container; Medical Kara boots; Disposable shoe cover; Foot-binding; ESR framework; New sanitary napkins; Armrest table; Suspension sterilization aerosol machine; Pure water machine for biochemical analyzer; Infrared reflection ball for orthopedic surgery navigation system: biological magnetic massager; Dental colorimeter; Lipid perfluoropropane microbubbles.