The less non-interfering elements that can be measured by the biochemistry analyzer when analyzing the content of chemical elements, the better, and the need to wash the test article with ultrapure water for more effective calibration. The water purifier for biochemical analysis is an ultrapure water preparation instrument designed specifically for fully automatic biochemical analyzers. Biochemical analysis water purifier according to the biochemical instrument needs ultrapure water consumption characteristics, generally designed for 10L / hour to 60 liters per hour.
Biochemical analytical water purifier for ultrapure water requirements generally require ultrapure water resistivity & gt; 10 MΩ-cm.
Biochemical analytical ultrapure water purifier is designed with certain characteristics:
* Water storage tanks using closed non-pressure water tanks, automatic biochemical analyzers can be directly sucked into the machine
* Equipped with a large tanks, 120-500 liters of volume. 500 liters.
* Equipped with reverse osmosis membranes, purification packages are larger than ordinary ultrapure water specifications.
* Biochemical analytical ultrapure water purifiers are often designed to conserve consumables due to the rapid replacement of consumables associated with high water production.
* Biochemical analyzers are more commonly used in hospital testing departments, and the working hours of the medical sector are somewhat unique, requiring easy and quick replacement of consumables and timely after-sales service for biochemical analyzers. These requirements make the biochemical analyzer type ultrapure water machine in the user maintenance and consumables replacement easier.
* Bioanalytical ultrapure water dispensers are usually floor standing, increasing the space inside the dispenser to fill more consumables and reducing the frequency of consumable replacement.
Biochemical analyzer water purifier is not managed as a medical device:
In order to meet the needs of supervision and management of medical devices, the State Food and Drug Administration issued a circular on February 7, 2007, to clarify the definition of the classification of the extracorporeal shockwave cardiovascular therapy system and other 68 products.
As the management of Class III medical devices are: extracorporeal shock wave cardiovascular therapy system; iris instrument; bamboo charcoal far-infrared heating belt, bamboo charcoal heating massage pillow; brain function test system; non-invasive focused ultrasound body shaping instrument; electrode catheter; beauty and slimming instrument; rare earth silver elimination spray (does not contain drugs); calcium hydroxide suspension; uterine tubal diagnostic device; calcium hydroxide isotonic solution; desensitization paste. Body cavity mucosal labeling solution; dimethyl sulfoxide cryopreservation solution; peripheral blood chromosome culture medium kit; electroconvulsive therapy instrument; field-conducted shrinkage stick; ionic introduction cosmetic instrument (for eliminating scars).
As Class II medical device management are: genetic analysis system; ventilator humidifier; dental desensitizer; polishing paste; total carnitine determination reagent and free carnitine determination reagent; 5'nucleotidase determination kit; glucose 6 phosphate dehydrogenase determination kit; umbilical cord clamps; surgical knot tying device; bracket, buccal tubes; saline therapy tubes; physiological sea water nasal Mucosal Cleaning Products; Multifunctional Counting Trays; Fumigation Chairs (without drugs); Electronic Turbidimeter Turbidity Quality Control Tubes (Standard Tubes); Oxygen Concentration Monitor for Neonatal Ventilators; Liquid Bandaids; Fully Automated Urine Constituent Analyzers Calibrators; Non-invasive Glaucoma Treatment Systems; Dentinometers; Rehabilitation Devices; Pain and Sensory Analyzers; PACS Workstations.
As Class I medical devices management are: temporary positioning crown and bridge; hematopoietic pipette; radiotherapy positioning thermoplastic material; antipyretic patches; negative pressure adjustable balanced breast suction; knee surgical tools; elbow multi-purpose pressurized internal fixation bracket mounting tools; pressurized screw surgical mounting tools; orthopedic intramedullary surgical mounting tools; surgical toolkit for external fixator; spinal adjustable fixation bracket surgical mounting tools Micro blood sample cup (tube).
Not to be managed as medical devices are: carbonate spring processing machine; thermal cutting knife; disposable fecal concentrate egg collection and latent blood reaction container; medical cara boots; single-use shoe covers; foot wraps; blood sedimentation frame; new sanitary pads; arm resting table; suspension sterilization aerosol machine; biochemical analyzer water purifier; orthopedic surgical navigation system with infrared reflective sphere; bio-magnetic massager; dental colorimetry. Lipid perfluoropropane microbubbles.