H
Hi all,
I'm new here and already appreciating the wealth of experience and knowledge being shared. I come from a consumer product design background, but have recently made the switch to designing medical devices at quite a young company, and could use a steer in the right direction!
I'm in the early stages of designing a class II medical device, which has an internal Li Ion battery (already approved for use in this context). The product will always remain below the 100VA threshold discussed in clause 13.1 (by means of a fuse), which as I understand it, suggests that the risk of 'ignition' is acceptably low, and I therefore do not have to meet the flammability requirements of Sub Clause 11.3, as the enclosure is not considered a fire enclosure.
I expected there to be a section specifically regarding the risks surrounding batteries and the requirements of a battery enclosure (from a flammability perspective) but I appear to be wrong in that assumption. The battery itself has 3 means of protection in its circuitry. Am I correct in my understanding that the requirements placed on the parts that form an enclosure for the battery, should be determined by a risk analysis? I.e, if through the risk analysis, it is deemed that the 3 means of protection on the battery circuitry, plus the 100VA limit, plus the mechanical strength of the battery enclosure are sufficient to minimize any risk, that's acceptable?
Or, have I missed some section that specifically relates to battery enclosures or misunderstood 60601 entirely?
My initial reaction was that anything enclosing the battery should be UL 94 V0 rated, but I can't seem to see that in the standard. (If it was an option, we'd go for this anyway but for specific reasons, its not that straightforward).
Thanks for any advice!
I'm new here and already appreciating the wealth of experience and knowledge being shared. I come from a consumer product design background, but have recently made the switch to designing medical devices at quite a young company, and could use a steer in the right direction!
I'm in the early stages of designing a class II medical device, which has an internal Li Ion battery (already approved for use in this context). The product will always remain below the 100VA threshold discussed in clause 13.1 (by means of a fuse), which as I understand it, suggests that the risk of 'ignition' is acceptably low, and I therefore do not have to meet the flammability requirements of Sub Clause 11.3, as the enclosure is not considered a fire enclosure.
I expected there to be a section specifically regarding the risks surrounding batteries and the requirements of a battery enclosure (from a flammability perspective) but I appear to be wrong in that assumption. The battery itself has 3 means of protection in its circuitry. Am I correct in my understanding that the requirements placed on the parts that form an enclosure for the battery, should be determined by a risk analysis? I.e, if through the risk analysis, it is deemed that the 3 means of protection on the battery circuitry, plus the 100VA limit, plus the mechanical strength of the battery enclosure are sufficient to minimize any risk, that's acceptable?
Or, have I missed some section that specifically relates to battery enclosures or misunderstood 60601 entirely?
My initial reaction was that anything enclosing the battery should be UL 94 V0 rated, but I can't seem to see that in the standard. (If it was an option, we'd go for this anyway but for specific reasons, its not that straightforward).
Thanks for any advice!