Pharmaceutical & Health Technology

Industry Standards

  • 1.  Industry Standards

    Posted 04-04-2019 11:20
    Hello!  This is my first time posting.  I have a question regarding accessing foreign industry standards.  I have a request for DSTU EN ISO 13485.  I supplied the BS EN ISO 13485 version but they are insistent that it be the Ukrainian version.  I am not having much success in locating it.  Any insight on how to acquire this would be most appreciated!


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    Jamie Hullinger
    Research Librarian
    Zimmer Biomet
    5743733130
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  • 2.  RE: Industry Standards

    Posted 04-04-2019 11:39
    Hello, Jamie

    Welcome to the PHT discussions and thank you for posting your first message!

    Apologies if you already looked at the ISO site, but from the site you can find the information of the Ukranian (DSTU) member site, including a link out to the Ukranian site.

    I quickly looked at the Ukranian site and even though I don't speak or read Ukranian, a quick & simple search on the standard revealed the following: Навчання за темою: Підготовка кандидатів в аудитори та внутрішніх аудиторів з сертифікації систем управління якістю відповідно до вимог ISO 13485:2016 та ДСТУ EN ISO 13485:2018 | ДП "УкрНДНЦ"

    Without knowing the language, I couldn't confirm if this indeed was the Ukranian version you would need. With the contact information from the ISO member site page for Ukrania, you might be able to reach out to someone.

    Hope that helps!

    Cheers,

    Chrissy


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    Christine (Chrissy) Geluk, M.S.L.I.S.
    Principal & Founder
    Librarian At Your Service LLC
    support@librarianatyourservice.com | Chrissy@librarianatyourservice.com | Twitter @cmgeluk | Instagram @cgeluk
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  • 3.  RE: Industry Standards

    Posted 04-04-2019 13:20
    I also do not speak/read it but Google Translate confirmed that it is indeed in Ukrainian, so there's that.  If you trust "the Google," the translation of the URL Chrissy shared is a training session on the standard, unfortunately.  But you can also use Google Translate as a frame over a page to view the contents in a more familiar language like so: Google Translate over the DSTU page (pages will load slowly)

    I used this frame to locate a price list for Standards but did not see 13485 among them.  However, there are two email addresses for ordering individual standards so maybe they can help: ushop@uas.org.ua or assistant@uas.org.ua

    There's also a posted Communication on the development of this standard with an email address for requests (Link to translated announcement): info@acclmu.org.ua

    And should you fancy a vacation, per a Google translation, "You have the opportunity to get free access to the texts of any standards, catalogs and classifiers available in the National Fund of normative documents in the reading room of the Fund at the following address: Kyiv street. Svyatoshinskaya, 2, room 307." (Google Translate: Info on ordering standards)

    This is a tough question - wishing you the best of luck in locating what you need!

    All the best,
    Tyler


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    Tyler Phelps
    Clinical Research Librarian
    Intuitive Surgical, Inc.
    tyler.phelps@intusurg.com
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