The injection molding process for the classification of medical devices
Dalian injection moldingSummary of the hospital medical equipment can be divided into three categories, namely the diagnostic and therapeutic two categories and the necessary medical equipment classification level of different requirements.
The necessary level of medical equipment, hospital requires three types can be divided into the following categories:
意甲下注The first type refers to its security, effectiveness can be ensured through a routine administration of medical apparatus and instruments;The second category refers to its security, effectiveness of medical devices shall be controlled;The third type of class is refers to the implantation in the human body, to support and sustain life;Potentially dangerous to the human body and to its security, effectiveness must strictly control the medical apparatus and instruments.
意甲下注It is important to note that if a medical device contains a class and second class, then the medical equipment is second class.If the containing class ii and class iii medical devices, the medical equipment belong to three categories.And so on, we can draw the same conclusions.
Household various simple medical instruments, such as thermometer, stethoscope, sphygmomanometer, etc., with the development of electronic technology, automatic, semi-automatic electronic household medical equipment such as blood glucose meter, electronic sphygmomanometer, hit the market in succession, such as electronic thermometers.
意甲下注Second, the diagnostic device class can be divided into the following categories:
Image (X-ray machine, CT scan, mri, B to wait), analysis instrument (various types of counter, biochemical, immune analysis instrument, etc.), the electric physiology class (such as ecg machine, eeg, emg machine, etc.), physical diagnostic kits (thermometer, blood pressure, microscope, audiometer, various physiological recorder, etc.).
Three, treatment device class can be divided into the following categories:
意甲下注Radiotherapy machine (such as deep X-ray apparatus, cobalt 60 therapy apparatus, accelerator, ng dao, various isotopic therapeutic apparatus, etc.);The common surgical instruments, optical instruments (fiber endoscopy, laser therapy apparatus, etc.);Auxiliary surgical instruments (such as a variety of anesthesia machine and breathing machine, extracorporeal circulation, etc.);Other classes (microwave, hyperbaric oxygen, etc.).