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Hi, all
I am designing a medical device which should be attached to human skin (somehow like a hearing aid), I have two questions about it.
1, Does it belong to "hand-held" ME equipment?
the term "hand-held" referring to electrical equipment intended to be supported by the hand during normal use. ----3.37
2, I am using a high voltage regulator(DC/DC) inside (around 180 volts). I want to make sure if it is illegal?
For ME equipment intended to be connected to supply MAINS, the following rated voltages shall not be exceeded:
- 250 V for hand-held ME equipment (4.10.2)
Thanks in advance
I am designing a medical device which should be attached to human skin (somehow like a hearing aid), I have two questions about it.
1, Does it belong to "hand-held" ME equipment?
the term "hand-held" referring to electrical equipment intended to be supported by the hand during normal use. ----3.37
2, I am using a high voltage regulator(DC/DC) inside (around 180 volts). I want to make sure if it is illegal?
For ME equipment intended to be connected to supply MAINS, the following rated voltages shall not be exceeded:
- 250 V for hand-held ME equipment (4.10.2)
Thanks in advance