Medical devices
refer to instruments, equipment, utensils, in vitro diagnostic reagents and calibrators, materials and other similar or related articles directly or indirectly used in the human body, including required computer software.
The effect is obtained by physical means, not by pharmacological, immunological, or metabolic means, or although these means are involved but only play an auxiliary role.
Objective: Diagnosis, prevention, monitoring, treatment or remission of disease; Diagnosis, monitoring, treatment, mitigation or functional compensation of injury; The examination, replacement, regulation or support of physiological structures or processes; Life support or maintenance; Pregnancy control; Examination of samples from the human body to provide information for medical or diagnostic purposes.
Includes: medical equipment and medical consumables;
Unified medical devices are divided into active and passive devices by the CFDA (China Food and Drug Administration), how do we distinguish these two devices?
- Active medical devices:
Devices that require the use of electricity, gas, etc., rather than energy generated directly by the human body or gravity, to play their functions.
For example: all kinds of medical electrical equipment X-ray machine, ECG monitor, ventilator, anesthesia machine, implantable cardiac pacemaker defibrillator, electrocardiogram machine,medical monitor, ultrasonic diagnostic instrument, hemodialysis device, high-frequency surgical equipment, etc.
- According to the Rules for the Classification of Medical Devices (Order No. 15 of the State Food and Drug Administration) :
- Article 5 According to the factors affecting the risk degree of medical devices, medical devices can be divided into the following situations:
- (三) According to different structural characteristics and whether contact with the human body, the use of medical devices includes:
- Active contact human instruments: energy therapy instruments, diagnostic monitoring instruments, liquid delivery instruments, ionizing radiation instruments, implant instruments, other active contact human instruments.
- Active non-contact human instruments: clinical testing equipment, independent software, medical device disinfection and sterilization equipment, other active non-contact human instruments.
- (D) According to the possibility of injury to the human body during use, the use of medical devices includes the following conditions:
- Active contact with human instruments: according to the degree of damage that may be caused by loss of control, it is divided into minor damage, moderate damage, and serious damage. "
- Passive medical devices:
Medical devices that do not rely on any electricity or other energy sources, but are directly generated by the human body or gravity to perform their functions.
For example: endoscope clamp, scissors supporting equipment, medical infusion, blood transfusion, injection equipment detection, blood pressure meter, blood pressure meter detection, medical equipment in the detection of insoluble particles, ethylene oxide residue detection, artificial heart valve detection, surgical implant device detection, vascular stent detection, hollow fiber dialyzer detection, intraocular lens detection.
- Safety: No harmful side effects after use on the human body, and can play a role in the design and use of passive medical devices, including three aspects:
- Safety for patients. There can be short-term or long-term security in terms of time;
- Safety for medical personnel and operators;
- Safety to the surrounding environment
- Effectiveness: The safety and effectiveness of medical device products should involve product design, materials, production, sterilization, packaging, storage, transportation, use other links - in order to achieve the intended use and ensure product safety, it is necessary to ensure that all aspects of the above are fully and strictly controlled.
Active and passive medical devices are differentiated according to product characteristics. In addition to active medical devices and passive medical devices, in vitro diagnostic reagents are also included in a broad range of medical devices.
Aboutmedical consumables
- - Shenzhen Sinelink Electronics Co., Ltd. is a manufacturer and exporter of medical electronic accessories and medical consumables, which integrates design, development, production and sales.
- Our products include monitoring accessories, electroencephalogram accessories, radio frequency accessories, high-frequency surgery and others. We support the OEM/ODM customization of related products, now provide services for major hospitals and medical equipment manufacturers.
- Welcome to contact me if have need, hope to have the opportunity to serve you.