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  1. #1
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    To which standards must we conform for our electronics/electrical product?

    Hello
    My company has developed a way of removing body and facial hair for cosmetic reasons. It involves high frequency flashing (~1KHz) of high intensity light into the skin. The skin is flashed with pulses of light, and each light pulse is further divided up into finer light pulses. Nobody else is doing it like this, and it works better.

    The equipment involves an offline 70W Flyback SMPS. This feeds a flash capacitor which is charged up to 400V, and then pulse flashes into a xenon tube which fires the light at the skin....killing hair growth.

    The problem is, we don’t completely know exactly which regulatory approvals we must conform to. How can we find out? (We wish to sell to EU, UK and USA)

    From offline SMPS datasheets we can see that there are standards such as EN55015 etc that we must conform to etc …..but how can we possibly know the complete spectrum of standards to which we must conform?......i mean, we could go into production, sell 100000 products, and then find out that we have not conformed to some vague standard which applies to our use case……we would then be fined all our profits and forced to close down.

    If we cannot find out the full list of standards to which we must conform, then we will have to sell out to a huge corporation who is interested in buying us out. This corporation has warned us that we have no way of knowing every single standard which applies to us, and therefore we must sell out to them. They have told us that if we go it alone, they will scrutinise our product, and find which standard we are falling foul of, and report us to the regulatory bodies and get us closed down.

    The corporation has told us that the standards themselves are brought in by big corporations lobbying politicians to bring the standards in….they warn us that if we go it alone, they will lobby for a standard to be introduced which we do not meet, and make it impossible for us to stay in business.

    How can we find out every single standard to which we must conform?
    Or must we simply sell out and give up?
    Last edited by treez; 14th September 2019 at 17:52.

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  2. #2
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    Re: To which standards must we conform for our electronics/electrical product?

    Start a discussion with a certified EMC lab. They should be able to tell you what EMC-related standards you should follow for different markets.
    Hopefully they can also give information, or at least point to some other company/lab, regarding non-EMC requirements for medical equipment.

    It may also be a good idea to contact some government authority and ask questions. Since the eye vision probably can be destroyed by misuse, there should be some safety-related requirements.


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  3. #3
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    Re: To which standards must we conform for our electronics/electrical product?

    you'll likely need UR (underwriters labs) approval in US
    and CE mark in europe

    no idea what happens in UK after Brexit

    since its cosmetic, there may also be requirements from food & drug or ???


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  4. #4
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    Re: To which standards must we conform for our electronics/electrical product?

    I came across this site on guidelines for laser and intense pulse light hair removal. Not sure if these guidelines apply to your device. But maybe there's some other information you might find helpful. https://onlinelibrary.wiley.com/doi/...3.2011.04406.x

    - - - Updated - - -

    https://www.emergobyul.com/blog/2019...se-firms-ready


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  5. #5
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    Re: To which standards must we conform for our electronics/electrical product?

    look up other IPL machines and whatever standards they say they conform to


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