standardnovice
Registered
Hi, this is my first post here and I'd like to say what a great resource this forum has been for me as i am very new to regulatory work in my firm.
I have the following conundrum:
I have a battery powered (internally powdered) medical device that can connect to
1. A battery charger compliant with IEC 62368 that is connected to mains
2. Other equipments that are connected to mains which are IEC 60601-1 or IEC 62368 compliant, used to transfer signals to my device.
Q: Do I have to consider earth/touch leakage current from the above 2 when my device is connected to them?
Example- current flowing through the medical device to the patient (via other contacts) to the ground? Especially given the compliance of charger/equipment to 62368 or 60601?
Note: If leakage current tests do apply, could you clarify if they follow clause 8.7 or 16.6 (ME equipment or ME system) when these equipment are connected to my device.
Thank you in advance!
I have the following conundrum:
I have a battery powered (internally powdered) medical device that can connect to
1. A battery charger compliant with IEC 62368 that is connected to mains
2. Other equipments that are connected to mains which are IEC 60601-1 or IEC 62368 compliant, used to transfer signals to my device.
Q: Do I have to consider earth/touch leakage current from the above 2 when my device is connected to them?
Example- current flowing through the medical device to the patient (via other contacts) to the ground? Especially given the compliance of charger/equipment to 62368 or 60601?
Note: If leakage current tests do apply, could you clarify if they follow clause 8.7 or 16.6 (ME equipment or ME system) when these equipment are connected to my device.
Thank you in advance!
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