Why is the pipetting workstation a medical device?

Why the pipetting workstation is a medical device is mainly because when it is used in medical treatment, biological experiments, clinical diagnosis and other application scenarios, its professionalism and indispensability are highlighted in these application scenarios, which profoundly defines its role as a medical device. core attributes. The following is a detailed introduction to why pipetting workstations are medical devices:

1. Definition of medical devices

Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related items that are used directly or indirectly on the human body, including the required computer software. The main purpose of these equipment or items is to obtain physiological, pathological and anatomical information of the human body through physical and other means or to assist in diagnosis, treatment, monitoring, relief or compensation of the human body's condition; or to examine samples derived from the human body for medical or Provide information for diagnostic purposes.

2. Definition and classification of pipetting workstations

The pipetting workstation is an efficient and reliable experimental tool. Its main function is to carry out liquid movement, separation and drug screening in the fields of biochemistry, medicine, pharmacy and other fields. According to the "Regulations on the Supervision and Administration of Medical Devices" and its implementation rules, pipetting workstations are classified as medical devices because they are used directly or indirectly in medical experiments, diagnosis, treatment and other processes.

3. Legal and regulatory requirements

1. Regulatory requirements: According to my country's "Regulations on the Supervision and Administration of Medical Devices" and related laws and regulations, pipetting workstations, as medical devices, need to be filed or registered before production and sales. At the same time, its production, operation and use must comply with the requirements of relevant regulations and standards for medical devices.

2. Test report: During the filing or registration process for a pipetting workstation, documents such as safety regulations and EMC (electromagnetic compatibility) test reports are usually required to prove that the product meets relevant safety and quality standards. The issuing agencies of these test reports are usually third-party testing agencies with corresponding qualifications.

4. Functions and uses of pipetting workstation

1. Main functions: The pipetting workstation can accurately transfer a specific volume of liquid from one container to another to meet the specific needs of experiments or diagnosis. It usually has the characteristics of programmability, high precision, and high efficiency, which can greatly improve the accuracy and repeatability of experiments.

2. Application fields: Pipetting workstations are widely used in biochemistry, medicine, pharmacy and other fields. In medical experiments, it can be used for operations such as blood separation, cell separation, washing and transfection; in clinical diagnosis, it can assist in sample processing, reagent addition and other steps; in pharmaceutical research, it can be used for drug screening, drug preparation, etc. experiment.

5. Conclusion

Pipetting workstations clearly fall into the category of medical devices because of their wide application and precise operation functions in medical, biological experiments and other fields, as well as the relevant regulations and certification requirements for medical devices that need to be followed. Whether in terms of definition, function, use or regulation, pipetting workstations have the typical characteristics of medical devices.