B
blackrooster
We are working on preparing a battery powered medical device for FDA and I am currently going through 60601-1. It is a 3V primary LiPo battery that has UL 1620 and IEC 60086-4. We have reverse polarity protection and a fuse on our PCB but there is nothing on the battery itself.
Is it typical that I should be looking into having the battery supplier provide some protection at the battery terminals or is this overkill? I have been trying to read about it but everything seems to talk about secondary rechargeable batteries.
I thought the battery was ok due to the approvals but now I am reading about 15.4.3.5 which basically says to assess the risk of a short between the fuse and the terminals. I tested the short circuit of a couple batteries and they both vented after several minutes. It seems that I need to consider the risk of this gas emission. I don’t know how to mitigate it except to make sure it can never happen which leads me back again to the protection on the battery terminals.
I welcome any comments on expected protection of primary lithium batteries or how to manage the risk of toxic gas from the battery.
Is it typical that I should be looking into having the battery supplier provide some protection at the battery terminals or is this overkill? I have been trying to read about it but everything seems to talk about secondary rechargeable batteries.
I thought the battery was ok due to the approvals but now I am reading about 15.4.3.5 which basically says to assess the risk of a short between the fuse and the terminals. I tested the short circuit of a couple batteries and they both vented after several minutes. It seems that I need to consider the risk of this gas emission. I don’t know how to mitigate it except to make sure it can never happen which leads me back again to the protection on the battery terminals.
I welcome any comments on expected protection of primary lithium batteries or how to manage the risk of toxic gas from the battery.