Hi,
I have a problem with LVD and standard 62368-1, I'm not sure if our device should comply with them. We are designing a medical device with WiFi, so: our device has to comply with MDR and RED. According to article 3.1 of RED, any radio device has to comply with safety requirements set out in 2014/35/EE but with no voltage limits. It means that our device has to comply with RED, MDR and LVD. Essential requirements form LVD are covered by standard IEC 62368-1. Does it mean that our medical device shall comply with requirements from IEC 62368-1 or any other LVD harmonized standard? Are medical devices excluded from this standard because IEC 62368-1 is for "audio/video, information and communication technology equipment"?
I wasn't able to find any information about it. I would be very grateful for your help.
I have a problem with LVD and standard 62368-1, I'm not sure if our device should comply with them. We are designing a medical device with WiFi, so: our device has to comply with MDR and RED. According to article 3.1 of RED, any radio device has to comply with safety requirements set out in 2014/35/EE but with no voltage limits. It means that our device has to comply with RED, MDR and LVD. Essential requirements form LVD are covered by standard IEC 62368-1. Does it mean that our medical device shall comply with requirements from IEC 62368-1 or any other LVD harmonized standard? Are medical devices excluded from this standard because IEC 62368-1 is for "audio/video, information and communication technology equipment"?
I wasn't able to find any information about it. I would be very grateful for your help.