Test requirements for marketing in US when RATED values are not of US

akp060

Involved In Discussions
#1
Hi All,

If my device is not rated at a voltage and/or frequency than the ones for utility supply in the US, would the test reports still be good for the FDA purpose? In the US could I use a voltage converter inside a hospital for connecting my device? If yes, would I have to include the converter as an off the shelf component in my regulatory submission and would I need to test with the converter included in the test sample?

If I have missed anything please let me know
 
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Peter Selvey

Staff member
Super Moderator
#2
It doesn't sound like a practical approach for a few reasons and probably not legal either. Might be OK for extremely low volumes e.g. clinical trial, where the installation is checked out by a qualified professional.
 

akp060

Involved In Discussions
#3
It doesn't sound like a practical approach for a few reasons and probably not legal either. Might be OK for extremely low volumes e.g. clinical trial, where the installation is checked out by a qualified professional.
Is this with reference to the use of a voltage converter?
 

Peter Selvey

Staff member
Super Moderator
#4
Selling a device that is rated for say 230V in the USA sounds like it could be in breach of a law somewhere. This includes basic national or state laws for connection to the electrical supply (i.e. laws outside of the FDA's scope). Not sure but worth to check.

Next would be the practicality and safe use with a converter. The size might be an issue if the device's power is more than 100W. Need also to check the plugs to make sure mistakes are not possible. If the device is earthed (Class I) need to check if the earthing is followed through. Then consider any impacts to the EMC profile. For general safety need to confirm the converter is in compliance with it's relevant safety standards and if it gets used inside the patient environment it may need additional measures. Instructions for use need to be clear as well.

There could be more (or less) issues that come up depending on the actual converter supplied. Reliability as well - my experience with converters is they are designed for occasional use (e.g. while travelling) not for continuous use.

It's not a situation I've seen before so this is more gut feeling than specific references. You would probably need to actually assemble a "system" together (specific converter + device) and run it by some professionals to get a good feel for all the potential issues.
 

akp060

Involved In Discussions
#5
Selling a device that is rated for say 230V in the USA sounds like it could be in breach of a law somewhere. This includes basic national or state laws for connection to the electrical supply (i.e. laws outside of the FDA's scope). Not sure but worth to check.

Next would be the practicality and safe use with a converter. The size might be an issue if the device's power is more than 100W. Need also to check the plugs to make sure mistakes are not possible. If the device is earthed (Class I) need to check if the earthing is followed through. Then consider any impacts to the EMC profile. For general safety need to confirm the converter is in compliance with it's relevant safety standards and if it gets used inside the patient environment it may need additional measures. Instructions for use need to be clear as well.

There could be more (or less) issues that come up depending on the actual converter supplied. Reliability as well - my experience with converters is they are designed for occasional use (e.g. while travelling) not for continuous use.

It's not a situation I've seen before so this is more gut feeling than specific references. You would probably need to actually assemble a "system" together (specific converter + device) and run it by some professionals to get a good feel for all the potential issues.

Thank You for the thoughts, Peter! I had similar questions in mind.
 

Tidge

Trusted Information Resource
#6
FWIW: US hospitals can accept devices with different line voltages, without the need of a converter. This depends on the electrical infrastructure of the hospital.
 
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