What medical equipment is needed in the medical laboratory?

The medical laboratory is one of the hot topics of grading diagnosis and treatment. From the list of medical institutions newly approved by the provincial and municipal health planning committees this year, the third-party medical laboratory is also the largest, and the production and sales of medical devices are large. market!

So, what are the basic requirements of the state for medical laboratory? Medical equipment companies want to do business in the medical laboratory, and what kind of equipment should they start?

On October 18th, the National Health and Family Planning Commission issued the "Basic Standards for Medical Laboratory (Trial)" and "Management Specifications for Medical Laboratory (Trial)", and put forward specific requirements for the establishment of medical laboratory.

List of medical equipment required for medical laboratory

According to the "Basic Standards for Medical Laboratory (Trial)", the laboratory setting of the medical laboratory should include: clinical blood and body fluid testing, clinical chemistry testing, clinical immunology, clinical microbiology, clinical cell molecular genetics. And clinical pathology majors. There are special departments or full-time personnel such as medical record information, reagents, quality and safety management, as well as auxiliary inspection departments and disinfection supply rooms (you can also set up other medical institutions to undertake corresponding services).

The equipment configuration of the medical laboratory should include three parts: basic equipment, pathological diagnosis equipment, and information equipment.

(1) Basic equipment.

Basic equipment including refrigerators, centrifuges, samplers, pressure steam sterilizers, biological safety cabinets, etc., should be compatible with the inspection items and workloads carried out.

All inspection equipment, such as biochemical analyzers, blood cell analyzers, urine analyzers, microplate readers, luminescence analyzers, bacterial culture and identification instruments, nucleic acid analyzers, mass spectrometry analyzers, etc., should comply with national food and drug regulations. Relevant requirements for medical device management announced by the General Administration of Supervision and Administration.

(2) Pathological diagnosis equipment.

The number of conventional equipment such as centrifuges, samplers, disinfection equipment, biological safety cabinets, specimen cabinets, slicing cabinets, wax block cabinets, general photographic equipment, digital slicing systems, optical microscopes, etc. should be adapted to the volume of business.

There is at least one microscope for more than 5 people.

Configure the corresponding number of molecular pathological diagnosis and technical equipment, such as PCR chamber and corresponding equipment, nucleic acid extraction equipment, molecular hybridization instrument, cryogenic centrifuge, fluorescence microscope, etc.

Professional pathology equipment includes closed automatic dewatering machine, wax block embedding machine, HE automatic dyeing machine, spreader, paraffin slicer, automatic liquid/thin cell production equipment, frozen slicer (optional), Automatic immunohistochemical staining machine, etc., professional pathology equipment needs to have the "National Food and Drug Administration" level of medical device registration number.

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