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INMETRO certfication - medical monitors

Discussion in 'Other Medical Device Regulations World-Wide' started by Shanks, Nov 21, 2016.

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  1. Shanks

    Shanks New Member

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    Hello *,

    I am seeking your advise regarding medical monitors for endoscopy system within the INMETRO certfication.

    I do not have a question regiding the filing process!
    I want to know if medical monitors require INMETRO certification or not?
    My opinion is NO, cause the monitors do not change any parameters or the picture. They are just displaying the view of the camera/endoscope.

    Thanks for your opinion and experience!

    Best regards

    Shanks
     
    Shanks, Nov 21, 2016
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  2. Atul Khandekar

    Atul Khandekar Administrator Staff Member

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    Can someone help with this question? Thanks.
     
    Atul Khandekar, Nov 28, 2016
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  3. Vintage Goose

    Vintage Goose Active Member

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    Hi, I am a long way from being an expert, but..... I believe all electrical Medical Devices require certification by Inmetro. I would assume (although I can't confirm) that this applies to the accessories of medical devices as well. In which case medical monitors almost certainly do require Inmetro certification.

    I would recommend discussing the product with one of the certification bodies to get a more definitive answer.
     
    Vintage Goose, Nov 28, 2016
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    Atul Khandekar likes this.