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  • 1.  IEC 60601-1-2 (4th Edition) and CISPR11 versions

    Posted 15-Nov-2018 02:41
    Hi 

    Can anyone help me understand which version of CISPR 11,  FDA will require for compliance to IEC 60601-1-2 - 4th Edition.

    IEC 60601-1-2 is an FDA recognized consensus standard and references CISPR 11 throughout,  but CISPR 11 is not listed in the the recognized consensus standard database. 

    I believe the most recent edition is CISPR 11:2015+AMD1:2016 CSV


    Grateful for any help with this.

    regards
    Mike


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    Mike Kilkelly
    Quality Manager
    Galway
    Ireland
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  • 2.  RE: IEC 60601-1-2 (4th Edition) and CISPR11 versions

    Posted 16-Nov-2018 02:40
    The CISPR edition that is referenced in IEC 60601-1-2:2014 is "edition 5.1, including CISPR 11:2009 and its Amendment 1:2010".  The CISPR referenced is a consolidated version of that standard. 
    This information about the CISPR 11 standard is located in the normative references - Clause 2 of the IEC 60601-1-2:2014 standard.
    Hope this helps,

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    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
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