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Classification Classification
Q1. What is a Controlled Medical Device?
What does "Controlled Medical Device" or "Class Ⅱ device" mean in physiotherapy device?
It is devided into 3 classifications according to the risk.
Depending on the risk given to the human body, all medical devices are classified into "General Medical Device", "Controlled Medical Device" and "Highly Controlled Medical Device". Most medical devices are classified into "Controlled Meddical Device". The medical devices which Techno Link sells are "Controlled Medical Device (ClassⅡ Device)".
■General Medical Device (ClassⅠ )
Examples: In-vitro diagnostic device, scalpel, tweezers, X-ray film etc. Even if side effects/impariment occur, there is little possibility of affecting human life or health.
■Controlled Medical Device(ClassⅡ)
Examples: Physiotherapy device, electronic endoscope, MRI, gastrointestinal catheter etc. It is needed to be controlled properly because it may affect human life and health.
■Highly Controlled Medical Device(ClassⅢ,Ⅳ)
Examples: Dialyzer, pacamaker, radiotherapy device etc. It may have a serious impact on human life and health. Regardless of the above mentioned classifications, medical devices which require expert knowledge and skills for maintenance inspection, repair and other management are called "Controlled Medical Device requiring special maintenance". In such as catalog, it is written as "Controlled Medical Device (ClassⅡ)・Controlled Medical Device requiring special maintenance". It is a medical device which requires appropriate management because there is a possibility of affecting human life and health and needs expert knowledge and skills for maintenance inspection, repair and other management .
What is the safety standard (classification) of medical electrical device?
Regarding the safety standard of medical electrical device, "Medical equipment-Part 1: General requirements for safety" is specified in JIS T 0601-1:2012. Among them, in order to apply a medical electrical device safely there are 3 classifications for safety means and there are 3 classifications for the way to apply to patients. The medical devices Techo Link sell are different by specifications, but Techtron corresponds to a ClassⅠ.
■Class Ⅰ device
It has a 3P plug for medical use. It is needed that the facility has 3P outlet for medical use.
■ClassⅡ device
The insulation is doubled, and it is OK that the facility has even 2P outlet.
■Internally powered device
It has a power supply internally. In case that it connects a power supply adaptor, It is equivalent to ClassⅠorⅡ.
Q3. What is JMDN code?
In addition to the above classifications, the medical device in Japan has the Japan Medical Device Name JMDN (Japan Medical Device Nomenclature), and all medical devices correspond to either JMDN. In other words, in corresponded to the establishment of this JMDN, the above medical device classifications corresponded by General Medical Device, Controlled Medical Device, High Controlled Medical Device (ClassⅠ～Ⅳ) are notified by Ministry of Health, Labour and Welfare. ※Excerpt 11246000 Ultrashort wave Treatment Device 11248000 Ultrasonic Treatment Device 35372000 Low Frequency Device 70623000 Combination Low Frequency/Ultrasonic Wave Treatment Device for Physical Therapy 70986000 Low Frequency Device for Home Use 70988000 Ultrashort wave Treatment Device for Home Use