IEC 62133 Test Report for Lithium Battery Certification

  • Thread starter karthika subramaniam
  • Start date
K

karthika subramaniam

One of our product is under IEC 60601-1 testing, in which we are using android device (Mobile).

We have developed android app which is installed on android device for controlling medical devices motions.

We have provided the Android device certification for IEC 60950-1 for IT equipment.

Regulatory Board, Test Lab is asking for IEC 62133 test report for Lithium battery and also USB charging cable certification that comes along with android device.

We have completed EMC/I testing. If we change MSO, there will be impact on EMC/I testing as well.


Please help
 

Mark Meer

Trusted Information Resource
What is "MSO"?

I presume that you've asked the supplier of your android device what kinds of documentation they can provide?

The USB cable will likely have a UL-listing (nothing to do with IEC 62133).

As for the battery, it might be a problem, as older consumer batteries may not have been tested IEC 62133 (instead, more likely something like UL1642).

If they DON'T have IEC 62133 testing done, there's a few options I can think of:

1. Negotiate with them (e.g. pay them) to get their batteries tested.
2. Find a battery supplier that can provide a battery with the same specification that you can have tested yourself. This is onerous, but has the advantage that you are in control of the battery.
3. Justify in your risk management documentation that whatever battery standards your current supplier uses is sufficient to ensure risk is acceptable. You can then justify not meeting that requirement of IEC 60601-1. In this case you wouldn't be claiming full compliance to the standard, but the tests can still be used as evidence for safety.

Best of luck!
MM
 
K

karthika subramaniam

Hi Mark

MSO - Multiple Socket Outlet

Regarding 3) How can we address in RMF, can you throw some light?

Thank you
 

Pads38

Moderator
I would suggest that the Android device is an accessory to the medical device and is NOT itself a medical device.

The 'app' should be considered a medical device so should satisfy the requirements of 60601-1 Clause 14 and 62304 (lifecycle).

There should be no requirement for the battery in the Android device.
 
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