PCB Board class 3 or Class 2 for Class 2 medical device

qualitynewbie

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Hi, The PCB vendor wants to know if IPC 6012 Class 2 or Class 3 standard needs to be followed for class 2 medical device which is not of high risk and not used as life sustaining device. Please advice. My thinking is IPC 6012 Class 2 standard is okay.
 

outdoorsNW

Quite Involved in Discussions
Please tell us more about the nature of the medical device. Most importantly, what happens to the patient if the PCB fails.
Also, what actions would a medical professional need to take if the device fails?

To meet IPC class 3, the PCB usually needs to be designed to meet the more demanding requirements of Class 3.
 

qualitynewbie

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The PCB controls how the joystick moves. If it breaks, the joystick will get stuck and part of the image will not be focused correctly. A Class 1 laser hits the eye, but when it is not in use, a shutter keeps it from hurting the eye. This shutter is not controlled by the PCB board.
 

outdoorsNW

Quite Involved in Discussions
Based on your description that the device partially stops working (partial loss of focus) and that there is no harm to the patient because safety functions are controlled by a different PCB, class 2 is most likely appropriate. If a patient could become trapped in the machine (as opposed to having difficulty getting out of the machine) because the focus mechanism also retracts part of the device, then you need to consider if class 3 is a better choice.
 
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