M
Hi There,
My company has not yet purchased 60601-1-8, as we're not sure yet if it applies. (...so forgive me here, I'm going off what I know of the standard through related articles, and other posts on this forum..).
My question is this: Does a battery-meter constitute an alarm?
I realize that both the definition & implementation of an alarm (either visual or auditory), are tied to the Risk Management assessment results done by the manufacturer.
So, the relevant question in this case would be : "Does the battery depletion represent a potential hazardous situation to the User?", correct?
...however, even this is open to interpretation....
For example, consider a hearing-aid that is battery powered.
- If the battery fails, there is no immediate danger to the user. (low risk)
- However, the fact that their hearing-aid has stopped working might mean they fail to hear, for example, an on-coming car. (high risk)
- BUT, the failing of the battery should be highly detectable by the user (they'd notice if they suddenly can't hear as well), which would mitigate the risk above. (medium risk?)
So, in the end, would the device require a "low-battery" alarm as per 60601-1-8?
Any thoughts/advice much appreciated!
MM.
My company has not yet purchased 60601-1-8, as we're not sure yet if it applies. (...so forgive me here, I'm going off what I know of the standard through related articles, and other posts on this forum..).
My question is this: Does a battery-meter constitute an alarm?
I realize that both the definition & implementation of an alarm (either visual or auditory), are tied to the Risk Management assessment results done by the manufacturer.
So, the relevant question in this case would be : "Does the battery depletion represent a potential hazardous situation to the User?", correct?
...however, even this is open to interpretation....
For example, consider a hearing-aid that is battery powered.
- If the battery fails, there is no immediate danger to the user. (low risk)
- However, the fact that their hearing-aid has stopped working might mean they fail to hear, for example, an on-coming car. (high risk)
- BUT, the failing of the battery should be highly detectable by the user (they'd notice if they suddenly can't hear as well), which would mitigate the risk above. (medium risk?)
So, in the end, would the device require a "low-battery" alarm as per 60601-1-8?
Any thoughts/advice much appreciated!
MM.