Notice on "Medical Device Standard Catalog (2022 Edition)"

  Author:MeCan Medical–ultrasound machine manufacturers

Recently, the Medical Device Standard Management Center of the my country Pharmaceutical Supervision Bureau released the "Medical Device Standard Catalog (2022)" (hereinafter referred to as "Catalog Compilation"). The "Catalog" is formed for the current 1851 medical devices and industry standards in accordance with the technical field to better apply medical device standards.

The "Catalog Compilation" is divided into two categories: general technology and professional technology fields. Among them, the field of general technology includes the quality management of medical equipment, the unique logo of the medical equipment, the packaging of medical equipment, the biological evaluation of medical equipment, the general requirements of medical electrical equipment, the general technology of disinfection and sterilization, and the other 7 parts; the professional technology fields include surgery Equipment, medical biological protection, medical X -ray equipment and utensils, medical laboratories and in vitro diagnostic equipment and reagents.

The basic principles of the "Catalog Journal" are the standards of the pioneer home and the post -industry standards; the same level standards are the order in accordance with the standard number; the standards for professional and technical fields are generally common, and the post -product standards and method standards are side by side. Each standard indicates the standard number, standard name, release date, implementation date, alternative relationship (applicable to the standards that have not been implemented) and the port unit.

Medical equipment standards have played an important basic guarantee role in service science supervision and promoting industrial development. According to statistics, in 2021, my country issued a total of 35 medical equipment standards and 146 industry standards. As of February 18, 2022, a total of 1,851 current medical device standards were organized and revised by the my country Drug Administration based on responsibilities, including 235 standards (91 compulsory standards, 144 recommendation standards), and 1616 industry standards (industry standards (industry standards (industry standards (1616 industry standards (industry standards (1616 industry standards ( 298 compulsory standards and 1318 recommendation standards). There are 26 medical device standardization technical committees, sub -technical committees, and 9 medical device standardized technical batch units.

"Prank Medical Device Network" will regularly release information about medical device information on a regular basis. At the same time, as a manufacturer of medical equipment, it is rich in product types, including: clinical testing equipment, breathing anesthesia equipment, and various reagents. If you treat us to us If you are interested, please call the consultation hotline: 400-6656-888.

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Is the Operation of Pesticide Residue Fast Detectors Simple? How to Reduce Agricultural Residues in
Is the Operation of Pesticide Residue Fast Detectors Simple? How to Reduce Agricultural Residues in
  Author:MeCan Medical–ultrasound machine manufacturersSummer is the season for the production of vegetables and fruits, and it is also a period of high incidence of gastrointestinal infectious diseases. Remaining pesticides in fruits and vegetables can cause chronic poisoning in the human body for a long time, bringing potential threats to human health, and even inducing many chronic diseases. In order to solve this problem, many cities now have large vegetable wholesale markets and large fresh supermarkets equipped with pesticide residues fast detectors, which can quickly detect vegetables and fruits. It only takes a few minutes to get results.Many people will worry about a problem when buying pesticide residues, that is, the use of pesticide residues fast detector is inconvenient. Let me introduce the operation steps of pesticide residue fast detector.1. Prepare the sample solution according to the steps of the reagent manual, take 100 microchemical reagents, and inject the control solution test tube and sample liquid test tube. Then pour the control solution and sample liquid into the container.2. Put the sample solutionocyrus in the corresponding channel, close the shading plate, and click the sample name button to select [Sample name], click to detect, pay attention to the detection time and the control solution consistent.3. Click the reaction time to set the corresponding sample reaction time.4. After the progress bar is completed, the test results are displayed. If you need to print, click the [Print] button, and click to print it. The data is automatically saved.5. Continuously measure other samples and repeat 2--5 steps.To solve the problem of pesticide residues of agricultural products, on the one hand, non -standard production, disable high -toxic pesticides, and guide scientific medication; on the other hand, it is necessary to rely on fast inspection instruments such as pesticide residues to strengthen pesticide residues in all aspects of agricultural products, and create no pesticide residues without pesticide residues Agricultural products. In addition to these two aspects, how can we reduce the harm caused by pesticide residues quickly in daily life?Among many vegetables and fresh fruits, pesticide residues contain high melon and fresh fruits and vegetables, such as loofah and four -season beans. The content of pesticide residues in such foods is high, and peel and take as much as possible. Cleaning and bubbles have certain effects on reducing pesticide residues in vegetables and fresh fruits. The residual pesticides on vegetables can be removed according to cold water cleaning, consumption base cleaning, dishwashing, and clean rice water cleaning. Select the use of sunlight dryness method to dissolve and destroy some pesticides in vegetables. Using the characteristics of some organic chemical pesticides, acceleration of dissolution, etc., the full thermal steam method is used to reduce pesticide residues in vegetables.
What Is Sleeping and Breathing, Why Should I Use Non -invasive Ventilator for Treatment?
What Is Sleeping and Breathing, Why Should I Use Non -invasive Ventilator for Treatment?
  Author:MeCan Medical–ultrasound machine manufacturersMarch 21st is International Sleep Day. Successive sleep is one of the three major health standards recognized by the international community. Good sleep quality allows us to live and work more efficiently during the day. However, there is a sleep -related disease, although it will affect our sleep state, but we always don't care much, and even take its symptoms as a symbol of sleeping. It is the obstructive sleep apytic (OSA).Obstructive sleep apnea is mainly due to the closure of the pharynxual tract closure, which leads to the obstruction of the air flow. The areas that are prone to blocking are in the oropiphalm and throat, and these two parts often collapse or block at the same time.The airway of patients with sleep apnea is generally narrower than normal people. The muscles are relaxed during night sleep. The soft tissue (soft palate, tongue, hanging Yonglin, etc.) blocking the airway and causing breathing to stop. Obesity, taking stable drugs, drinking, family inheritance, endocrine hormone, age, etc. are all causes of obstructive sleep and respiratory suspension syndrome. After the diagnosis of obstructive sleep respiratory suspension syndrome is clear, the main treatment method is non -invasive ventilator therapy.The role of non -invasive ventilator is to avoid falling or collapse of soft tissue in the airway. The ventilator blows away the blocked place with a stressful airflow, which is like a stent that supports the breath that is easy to fall off. This bracket is air with pressure, because this pressure is greater than external air pressure, so so Also called "Positive Ventilation".Therefore, non -invasive ventilator can eliminate respiratory suspension, increase oxygen voltage pressure, decrease carbon dioxide pressure, improve sleep structure, and at the same time can alleviate complications caused by sleep respiratory suspension. EssenceHowever, before starting family non -invasive ventilation treatment, it is not possible to buy the treatment machine at will. After the professional sleep center multi -guidance of the diagnosis and pressure of the sleep monitoring instrument, the professional sleep doctor determines the mode of use and the corresponding treatment parameters of the non -invasive ventilator. After determining the treatment plan, we must adhere to the opportunity to treat and review regularly to understand and further evaluate the time for the treatment.
What Is a Coagulation Analyzer? Introduction to the Application and Advantages of Coagulation Analyz
What Is a Coagulation Analyzer? Introduction to the Application and Advantages of Coagulation Analyz
  Author:MeCan Medical–ultrasound machine manufacturersThe coagulation analyzer can also be called a coagulator, a blood condensate analyzer, a blood coagulation analyzer, etc., which measures various component content in human blood in clinical clinical clinical. Regarding regular detection medical equipment. The technical principles used in different types of coagulation analyzers are also different. The main detection methods currently adopted include coagulation method, substrate color rendering method, immune method, and latex condensation method.Field application field of coagulation analyzer:Four conventional coagulation: PT (coagulinase time), APTT (activated partial coagulation activation time), FIB (fibrinogen), TT (coagulant time).Special coagulation items: D-Dimer (D-di agent), FDP (fibrin/fibrin degradation product), AT- (anticoagulantase III).The coagulation analyzer mainly includes automatic coagulation and semi -automatic coagulation. In the context of modernization of medical technology, the market for automation coagulation is more demand. In terms of applications, the current automated coagulation instrument is mainly used in the three major scenarios of research and academic institutions, biotechnology and pharmaceutical companies, hospitals, and diagnostic laboratories.my country's population is huge. As the aging rate continues to rise, the number of patients with thrombotic cardiovascular and cerebrovascular diseases in my country has continued to increase, and the potential for thrombosis and exterior diagnostic market has huge potential. The demand for coagulation analysis instruments has continued to rise, and the industry has developed rapidly. In terms of production, the production technology of coagulation analyzers is low, there are many companies in the market, and the market competition is relatively fierce. The domestic market has not yet formed a leading pattern, and the industry still has development potential.The advantages of Proven Pun-20148A coagulation analyzer: real-time detection of dosage, automatic alarm system; with sample preheating and timing function and automatic detection addition agent signal function; suitable for solidification method, hair color substrate method, immune turbidity method method Testing items, etc. If you want to know more technical parameters, please call 400-6656-888.
Why Do You Need to Detect Specific Proteins and What Are the Instruments for Specific Proteins? -Pra
Why Do You Need to Detect Specific Proteins and What Are the Instruments for Specific Proteins? -Pra
  Author:MeCan Medical–ultrasound machine manufacturersWhen it comes to medical examination or in vitro diagnosis, many people know about blood routine, biochemical, immune, molecules .. What is specific protein? Protein is a substance with more human content and types of ZUI, accounting for 45%of the human body weight, with more than 100,000 types. Enzymes, peptide hormones, cytokines, antibodies, transport proteins, contracted proteins, etc. are protein, so protein is called the material basis of life activity.Specific protein, usually special protein, is a protein containing specific functions in the serum that is widely existed in serum, which performs various important biological functions. Many diseases can cause changes in serum protein, and specific proteins have become important clinical test indicators. Protein has good antigenicity and can use antigen -antibody reactions to determine proteins with a certain antigenicity, so it is also called specific protein detection.The changes in protein are closely related to the physiological and pathological changes of many diseases, including infectious diseases. Infectious diseases refer to a major type of diseases caused by the human body infected with various pathogens (such as viruses, bacteria, fungi, and parasites). After the pathogen and the human body interaction, a series of specific proteins can be produced. These proteins can be produced by bacteria active or bacterial infection. These proteins can be used for assisting diagnosis, severity assessment, and prognosis judgment of infectious diseases.For example, in a specific protein detection, C -reactive protein, when tissue is damaged, inflamed, or infected, C reactive protein can rise sharply within a few hours, and gradually decrease when the disease is improved. Back to normal. C reactive protein is widely used in the diagnosis and identification diagnosis of infection. It is an important indicator of differential bacteria or virus infections. It is used to evaluate the severity of the infection, the curative monitoring of antibiotics, and the C -reactive protein related to multiple pediatric infection diseases. And clinically, it is often applied to disease diagnosis with other indicators such as PCT.Outstanding testing of specific proteins can provide important basis for clinical diagnosis, judgment, and analysis of prognosis. The dedicated to determining a specific protein instrument is called a specific protein analyzer. Specific protein analyzer detection items generally include: ultravisive C reactive protein (HS-CRP), C reactive protein (CRP), anti-link bacteria-soluble hemoride "O" (ASO), rheumatoid factors (RF), immunoglobulin ( IgA, IgG, IGM), tonic C3 (C3), tonic C4 (C4), Fiber Protein (FIB), anthrine -anticipinine peptide antibody (CCP), urine trace white protein (MALB), etc.
Brief Analysis of the Importance of Preventive Maintenance Management on Medical Equipment
Brief Analysis of the Importance of Preventive Maintenance Management on Medical Equipment
  Author:MeCan Medical–ultrasound machine manufacturersThe hospital's modernization is inseparable from various advanced medical equipment, and the use of advanced medical equipment helps doctors to better judge the patient's condition. However, for medical equipment, high precision, high -priced, complex maintenance, shorter update cycle, the installation and use environment of equipment also requires relatively high requirements.In some large hospitals, medical equipment, as a fixed assets of the hospital, occupies more than half of the total asset value, and it is undoubtedly of great significance for the management of medical equipment. Preventive maintenance of medical equipment is the basis for managing medical equipment, extending the service life of medical equipment, and improving the accuracy of medical equipment diagnosis of diseases.Therefore, it is of great significance to improve the attention of medical equipment maintenance and establish and improve the management system of medical equipment in the hospital.Preventive maintenance concept: Preventive maintenance means that within a certain cycle, the device can systematically check, detect, maintain, and replace the wear parts, so that the equipment can work normally. Through preventive maintenance, the fault rate of the equipment is reduced, the maintenance time of maintenance is reduced, and the work of various tasks will be carried out smoothly.The necessity of implementation of anti -maintenance: The maintenance of medical equipment after use is essential. The implementation of preventive maintenance is to regularly maintain medical equipment. By maintaining the equipment to familiarize the structure of the device, understand the current equipment. During the maintenance process, the maintenance personnel accurately record the important conditions such as the equipment indicator and the work parameters, and then can make a rapid judgment of the fault position after recording the contrast after the medical equipment fails.Through preventive maintenance, the situation of the easy -to -wear parts of medical equipment, timely purchase parts and replace it, thereby reducing the incidence of medical equipment failure, avoiding normal examination and treatment of patients due to medical equipment failure or medical accidents. Implementation of preventive maintenance will allow medical equipment to run for a long time in a healthy state, and the service life will be extended. If you want to know more, please pay attention to the "Prun Medical Device Network", we will regularly update some new content for everyone to browse and read.
Brief Analysis of the Current Development Status and Trend of Chinese Medical Device
Brief Analysis of the Current Development Status and Trend of Chinese Medical Device
  Author:MeCan Medical–ultrasound machine manufacturersAt present, the epidemic is still spreading globally, and international trade and economic growth have stalled. Although the exports of Chinese medical equipment remain stable as a whole, they need to be alert to relevant risks and challenges. The relevant person in charge of the Medical Institution Department of the Medical Insurance Chamber of Commerce pointed out that in the short term, due to the needs of epidemic prevention and immunity, the global market has increased its dependence on the supply chain of Chinese medical device.In the long run, the epidemic has become a catalyst for reshaping the global industrial structure. With the introduction of policies in various countries, international competition will intensify, and the competition between Chinese medical devices in the global market will be more intense.In terms of market risks, the global economic recovery will lower the ability of the international market to procure ordinary medical supplies. The surge in demand for epidemic prevention materials, coupled with the decline in the efficiency of the port work, has caused serious lag in the circulation of containers, bringing a sharp increase in international logistics costs, especially shipping. The rise in raw materials and labor costs, and the strengthening of the supervision of merchants by cross -border e -commerce platforms will further squeeze the export profits of the enterprise.In addition, due to international travel restrictions, it is difficult for engineers and sales staff to conduct promotion activities in overseas markets and after -sales service for some large -scale equipment exported equipment, and it is not conducive to market sales.Overseas market expansion also needs to focus on the impact of changes in international market regulations. For example, the European Union has implemented new medical device regulations (MDR) and in vitro diagnostic medical device regulations (IVDR), pay more attention to the clinical performance of the product, strengthen the traceability of medical device products, and pay attention to improving the transparency of patients.These will improve the management and restrictions on medical device products entering the European market accordingly, and put forward higher requirements for the industry's employees, which will bring about increased costs to Chinese export companies, extending certification cycle, and increasing compliance risks, etc. challenge.
Let's Briefly Introduce the Application of Enzymes Immune Detector in Pesticides and Food
Let's Briefly Introduce the Application of Enzymes Immune Detector in Pesticides and Food
  Author:MeCan Medical–ultrasound machine manufacturersThe enzyme missionary instrument is commonly known as the enzyme -linked immunohistic detection instrument. It can be simply divided into two categories: semi -automatic and fully automatic, but its working principles are basically the same. The core of its core is a color meter, that is, the color method is used to analyze the content of the antigen or antibody. Clinical examination, biology research, agricultural science, food and environmental science. Let me introduce the application of enzyme -linked immune detector in pesticides and food.1. Fast diagnosis of animal epidemic.The enzyme -linked immune analyzer adopts the enzyme -linked immune adsorption measurement method and the corresponding reagent with a qualitative or quantitative animal disease diagnosis. Such as: pork blue ear virus, swine fever virus, pig pseudo -rabies virus, pig pseudo -rabies virus GE protein, pig ring virus, pork type encephalitis virus, pig mouth hoof disease 3ABC protein, pig mouth hoof disease virus IgG, pork fine virus, chicken chicken, chicken Bird flu, blue tongue disease, white spot syndrome, cattle infectious pleural pneumonia, cattle plague, cotton acne, and sheep acne detection.Second, pesticide residues.Organic phosphorus pesticides are commonly used in agricultural production in my country. Common types include methylmine, dichlorvos, oxygen fruit, phosphorus, and enemies. Most of them are highly toxic pesticides. By reducing the activity of cholthyne enzymes in the body, delayed neurotoxicity is caused, thereby achieving the purpose of eliminating pests. The enzyme -linked immune detector can be used to detect the methamidine content contained in fruits and vegetables.Third, food safetyThe enzyme -linked immune analysis method uses the special nature of the antibody and the corresponding antigen to detect the antibody contained in the food based on this. The immune enzyme method is to use specific enzymes as detection tags and reaction catalysts. The use of this method can be used to effectively avoid using radioactive elements during the detection process, or to conduct orientation and quantitative analysis of the detected objects. , Chemical residue, edible oil testing, water and wine beverage analysis, condiments, edible pigment, etc.At present, more automatic enzyme -linked immune detectors can be used for qualitative detection and quantitative detection. The detection only takes a few hours. It not only reduces the labor intensity of laboratory personnel, but also greatly improves the accuracy and repeatability of the determination. This is conducive to the further commercialization of ELISA technology in detection and analysis.
How Does the Magnetic Pearl Nucleic Acid Extraction Extract Nucleic Acid and Where Is the Advantage?
How Does the Magnetic Pearl Nucleic Acid Extraction Extract Nucleic Acid and Where Is the Advantage?
  Author:MeCan Medical–ultrasound machine manufacturersAs one of the current effective epidemic prevention and control methods, nucleic acid extraction and testing are no stranger to everyone. Prior to this, the method of extracting the traditional nucleic acid was chemical cracking and cylindrical method. However, with the rapid development of gene diagnosis, genetically modified food detection, and personalized medical care, traditional nucleic acid extraction technology can no longer meet the needs of today's biotechnology. As a result, magnetic pearl nucleic acid extraction came into being.No. A commercialized reagent that used the magnetic bead method to extract DNA and successfully applied for patents in the United States appeared in 1998. The magnetic bead method first absorbs the free nucleic acid molecule to the surface of the magnetic particles by cracking the cells, while the protein and polysaccharides are left in the solution. Under the influence of the magnetic field, the magnetic particles are separated from the liquid to discard the liquid to eliminate the liquid Later, the purified nucleic acid molecules were obtained after being eluted.The magnetic bead method uses the principle of combining and dissipating the magnetic acid activity group with a magnetic granular activity group under certain conditions to avoid the loss of nucleic acid during the extraction process as much as possible, and it can also remove the interference substances in the specimen (such as hemoglobin The effects of bilirubin and lipid blood), obtain high -quality nucleic acid templates. With the development of magnetic bead method extraction technology, DNA extraction has really begun to achieve standardization, rapidness and automation.The kits based on the magnetic acid extractor of the Magnetic Pearl Method are also widely used. Nucleic acid extraction kit does not require any organic solvent and no need to repeat centrifugation. At present, it can extract high -quality DNA and RNA from full blood, serum, plasma, saliva, urine, feces, cerebrospinal fluid, tissue and cells, and shorter time. The recovery rate is higher. And it can be automated and uninvited through mechanical equipment.In addition, the principle of magnetic pearl method is safe and non -toxic, and does not use toxic reagents such as benzene and chloroform in traditional methods. Mainstream nucleic acid extraction methods at home and abroad.
What Is the Extraction Step of the Magnetic Pearl Nucleic Acid Extract Instrument and What Are the C
What Is the Extraction Step of the Magnetic Pearl Nucleic Acid Extract Instrument and What Are the C
  Author:MeCan Medical–ultrasound machine manufacturersThe nucleic acid extract instrument is a supporting nucleic acid extract reagent from the motion to complete the sample nucleic acid extraction work. In the detection of the new crown, nucleic acid extraction is a very important step. At present, the extraction principle of nucleic acid extract instruments on the market is mainly divided into two types: magnetic bead method and membrane adsorption method, of which magnetic bead method occupies the mainstream market. So, what is the extraction step of the magnetic pearl nucleic acid extract instrument?Step 1: Add samples to the cracking solution.Step 2: In the cracking solution, the rupture cells release the nucleic acid to the cracking solution to transfer the magnetic beads to the cracking solution step 3: Fully mix the nucleic acid to adsorb the specific package on the surface of the magnetic beads.Step 4: Repeat the surface of the magnetic beads to remove impurities such as the unnecessary nucleic acid, protein or salt that are not needed.Step 5: Move the magnetic beads into the eluing solution and mix it fully. The nucleic acid is falling off from the surface of the magnetic bead and dissolved into the elution buffer.The magnetic pearl nucleic acid extract instrument is matched with different types of magnetic pearl nucleic acid extract reagents, and multiple samples are operated at the same time, which automatically separate the extraction and purification DNA/RNA from multiple samples such as blood, cells, tissues, viruses. The instrument uses a special magnetic stick adsorption, transfer, and releases magnetic beads to achieve the transfer of sample/magnetic bead/nucleic acid, avoiding liquid treatment, and increasing the degree of automation.Nucleic acid detection, as an important means of screening of new crown virus screening, is expected to maintain a high position for a period of time at home and abroad. The corresponding nucleic acid extract will be very strong in a considerable period of time. The operation is automated, fast, and simple, which provides a strong guarantee for the detection of new crown nucleic acid.
What Is the Working Principle of Magnetic Pearl Nucleic Acid Extract Instrument? What Are the Charac
What Is the Working Principle of Magnetic Pearl Nucleic Acid Extract Instrument? What Are the Charac
  Author:MeCan Medical–ultrasound machine manufacturersNucleic acid extraction instrument is an instrument that uses a supporting nucleic acid extract reagent from the motion to complete the sample nucleic acid extraction work. It is widely used in various fields such as disease control centers, clinical disease diagnosis, blood transfusion safety, forensic identification, environmental microbial testing, food safety testing, animal husbandry and molecular biology research. In fact, with the normalized management of the epidemic, the nucleic acid extract instrument, as one of the commonly used equipment tested by various hospitals, has a higher frequency and the number of purchases has continued to rise. In fact, although everyone is familiar with the term of the nucleic acid extract instrument now, but it is very familiar with the term, but it is very familiar with the term of the nucleic acid extract instrument, but it is very familiar with the term, but it is very familiar with the term. I do nt know how to work and test the method of working principles. Let s take a closer look at the editor of Prank Medical Equipment.There are many classifications of nucleic acid extract instruments. In fact, the most commonly used is magnetic bead method. How does this method work? Magnetic pearl nucleic acid extract instrument is generally divided into two types: suction method and magnetic stick method. The specific operation process is as follows:First, suction method. The extraction of nucleic acids is achieved by fixed magnetic beads and metastasis liquids. Generally, the transfer of the robotic arm is generally controlled by the operating system.1. Crack. Add a cracking solution to the sample to achieve mixing and adequate reactions of the reaction solution through mechanical exercise and heating, cell cracks, and release nucleic acids.2. Adsorption. Add magnetic beads to the sample cracking solution and mix it in full. Use magnetic beads to adsorb nucleic acid under high salt and low pH value. Under the action of magnetic fields, the magnetic beads are separated from the solution. Mo the liquid out of the waste liquid tank and abandon the head.3. Washing. Remove the external magnetic field, add the new suction head to add the washing buffer, mix it fully, remove the impurities, and remove the liquid out of the magnetic field.4. Requesting. Withdrawing the magnetic field and adding the new suction head to add the elution buffer, fully mixed, the combined nucleic acid is separated from the magnetic bead, so as to obtain a purified nucleic acid.Second, magnetic stick method. By fixed liquids, the magnetic acid is separated to achieve the separation of nucleic acids. The principle and process are the same as the pumping method. The difference is the method of separation of magnetic beads and liquids. The magnetic stick method is to separate the magnetic beads from the waste liquid through the adsorption of the magnetic rod to the next step to achieve the extraction of nucleic acid.In fact, the characteristics of this magnetic pearl nucleic acid extract instrument is that it can achieve automation, high -throughput operations, safe and reliable operations, high efficiency, and pollution -free. Therefore, it is recognized by many buyers. When choosing a nucleic acid extraction instrument equipment, no matter which type of device is selected, you must have a basic understanding of it. You cannot judge the quality of the product from the price alone. For more product details, you can consult: 400-6656 -888.
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