Battery Powered Medical Device Battery Requirements

D

D_A_V_E

#1
We are building a small battey powered medical devices
power is supplied by a 3.7 volt lithium battery and the circuit draws 100mA max

I am planning to buy batteries from China do these need CE marking for use within my device?

I would like to thank you in advance for your time and effort in this matter

Yours,

Dave
 
Elsmar Forum Sponsor
#2
The relevant clause of IEC 60601-1 Ed. 3.1:-
15.4.3.4 Lithium batteries

Lithium batteries used in ME EQUIPMENT that could result in an unacceptable RISK.

Primary lithium batteries shall comply with the requirements of IEC 60086-4.

Secondary lithium batteries shall comply with the requirements of IEC 62133.
Note that this applies to those batteries that could cause unacceptable risk. So if you were able to show that the total energy stored in the cell is incapable of starting a fire then that is sufficient (for that risk - other risks should be considered as well).
 

Eamon

Involved In Discussions
#3
Hello Pads38,

I am perplexed. My understanding is that version 3.1 means 3.0 consolidated with Amendment 1. While we have not paid out $800 for the consolidated edition, my copy of Amendment 1 reads as follows:
15.4.3.4 Lithium batteries

Replace the existing text of the subclause with the following:
Primary lithium batteries shall comply with the requirements of IEC 60086-4. Secondary
lithium batteries shall comply with the requirements of IEC 62133. See also 7.3.3.
Neither my copy of 3.0 nor my Amendment 1 contains any language about unacceptable risk.

Can you help shed light on the source of this discrepancy?

Best regards,

Eamon
 
#5
Thanks Roland for clarifying this.

I think the mistake here was that I quoted from a draft of Edition 3.1.
Apologies for any confusion caused.
 
Q

quaddoc

#6
Hei Cove,

due to some search in this forum I have not found a specific answer for my below given question:

Have compliance to IEC 60068-4 needs to be shown for ordinary lithium coin cells (e.g. CR2032 for memory backup) with respect to fulfillment of cl. 15.4.3.4 of IEC 60601-1:2012?

Can anybody help me with this topic as IEC 60601-1:2012 does not allow the term unacceptable risk with these kind of batteries like IEC 60601-1:2005 do.

Thx in advance
 
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