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Battery Powered Disposable Pump - What IEC 60601 testing is required, if any?

D

deviceguy

#1
My company is developing a medical device that uses a battery powered DC (brush) motor to drive a pump to deliver saline to the catheter. There is no electrical patient connection. The entire unit is disposed of after the procedure. the batteries are alkaline and are removable for proper disposal. What IEC 60601 requirements would I be expected to meet?

thanks.
 
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Peter Selvey

Staff member
Moderator
#2
There would be a few applicable requirements such as marking, instruction manual and handling of batteries, but the bulk of the standard would not be applicable (or at least, not applicable in a way that significantly influences the design).

Unfortunately, despite the standard being mostly not applicable, the only way to handle it is to check all items one by one to confirm what is or is not applicable. For the 2nd edition there are about 450-500 discrete items, for the 3rd edition around 1,500.

For an experienced test engineer, it would take around 2-3hrs to scan all the requirements (maybe 4-5 for the 3rd edition).

I suggest to shop around for a test lab that will not charge a huge amount, but keep in mind paperwork takes time no matter how simple the task. Also, ask the test lab how they will handle the 3V battery part. Sometimes they may go into overkill on the electrical isolation part. Look for a lab that applies some common sense.
 
A

AmirBaron

#3
[FONT=Arial,Bold][FONT=Arial,Bold]Don't forget to check if 60601-2-24 is relevent for your device.[/FONT][/FONT]
[FONT=Arial,Bold][FONT=Arial,Bold]It's a particular requirements for the safety of infusion[/FONT]

[FONT=Arial,Bold]pumps and controllers.[/FONT]

[/FONT]
 
E

ejacob3

#5
I have a similar application but instead am applying suction to a catheter (non-venous). I have a AA battery powered pump that is not applying any sort of voltages to the patient nor is even considered an applied part.

Do I have to consider other than the -8 disposal:
EMC, leakage to operator etc?
 
D

deviceguy

#6
You may be surprised by what is considered an applied part. It is often easier to do the testing than justify the exemption from the clause. You will need to consider the entire standard and produce a base document that defines your position on inclusion or exclusion based on the type of device. You will need to do EMC, RFI all the standard stuff as well as risk management for 3rd edition which can be a pain. You new risk documents (FMEA etc) should consider all hazards described in the standard, even if you don't test to them you still need to examine them.

Hope this helps.
 
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