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  • 1.  EN ISO 15223-1:2021

    Posted 31-Aug-2021 10:31
    The CEN website is now listing EN ISO 15223-1:2021 as approved. EU Member States now have six months to implement the ratified text as their own national standard. The EN version may be purchased from any CEN member body, when available (by 2022-03-31).

    The standard will be considered harmonized once it is cited in the OJEU.

    CEN



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    Lena Cordie-Bancroft
    Leicester
    UK
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  • 2.  RE: EN ISO 15223-1:2021

    Posted 31-Aug-2021 12:23
    Thanks Lena!

    ...I'll start checking EVS soon for a cheaper copy

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    Chris Barkway
    Petersfield
    United Kingdom
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    Original Message


  • 3.  RE: EN ISO 15223-1:2021

    Posted 01-Sep-2021 01:49
    Great news!  And for those that don't know what EVS (Chris's post) stands for it is the Estonian Centre for Standardisation and Accreditation.  Make sure when buying for the EVS eshop you buy 2 copies, purchase an Estonian adopted EN version not the ISO version to save money.  Once it is Harmonized then I would purchase the EVS-EN (Harmonized one) as you will also get the Harmonized Annexes included but that is not happening immediately as Lena indicated.

    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------

    Original Message


  • 4.  RE: EN ISO 15223-1:2021

    Posted 01-Sep-2021 04:56
    I guess the key question is - has there been any deviations made in the EN version or is it the same?  Meaning, there is some references to the Regulations and such, but there is no additional symbols or information specific to the EU.  The EN ISO version is applicable for European compliance, but just wanted to understand if there was any significant differences between the versions.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 5.  RE: EN ISO 15223-1:2021

    Posted 01-Sep-2021 10:05
    The EN versions will have the European Foreword and Annexes Z included. There are no deviations in the EN vs ISO versions other than inclusion the the ef and annexes. There is not another 'harmonized' version available after the OJEU citation, so the EN version is the one you need for the EU.

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    Lena Cordie-Bancroft
    Victoria MN
    United States
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    Original Message


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