Regulatory Open Forum

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  • 1.  Pressure air standard

    Posted 30-May-2018 13:02
    Hello all,

    Can someone assist me by providing information related to any standard that is required to comply with for an accessory that is operated with pressured air.

    Thanks for your Help.

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    Natalia Soto
    QA/RA Superintendent
    Alajuela
    Costa Rica
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  • 2.  RE: Pressure air standard

    Posted 31-May-2018 03:01
    You might try looking into endoscopy guidance documents. Gastroenterology endoscopes all use air pressure for insufflation. That being said, i might be able to help you more if i had more information. What discipline is you device being used in? Does the pressure come in contact with the human body? Internallt? Externally? Standards regarding which aspect?

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    Sharon Goldfarb
    CEO
    sgc.reg.clin@gmail.com
    Giv'atayim
    Israel
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