Larry,
In the medical side of things which IVD falls under there is an EU Commission
lawyer that has slowed down the Harmonization of many standards on the medical
side the reason is he believes certain of the standards don't meet the
Essential Requirements of the Applicable Directive and so the older version of
the standard is being used. This is happening for a lot of the EN 60601 series
of standards that I deal with all the time. I am not saying for sure this is
the case but if the same issue you would be able to check in the following way.
First go to the CENELEC website and confirm the applicable standard has been
updated to the current version and check the notes about the IVD Directive in
the notes for this applicable standard it may give you a clue or not. After
which check the list of Harmonized Standards to confirm only the older version
has been approved. That as much as I can tell you without spending time
digging thru things which IVD is not my area of expertise but if you have a
Medical Device question under 60601 please let me know.,
Cheerip
Leonard (Leo) Eisner, P.E.
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
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On May 13, 2016, at 12:01 PM, Larry K. Stillings
<la...@complianceworldwide.com> wrote:
> All,
>
> On another note, does anyone know why in the In-Vitro diagnostic directive EN
> 61326-2-6, is still referencing the 2006 edition, and not the 2013 edition?
>
>
> Larry K. Stillings
> Compliance Worldwide, Inc.
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> From: Ronald Pickard [mailto:ronald.pick...@compoundphotonics.com]
> Sent: Friday, May 13, 2016 1:15 PM
> To: EMC-PSTC@LISTSERV.IEEE.ORG
> Subject: [PSES] EU OJ today
>
> To all, FYI.
>
> In the EU OJ today (see link below), there were five (5) harmonized standards
> lists published + 1 corrigendum. This includes a new list for the new EMCD,
> 2014/30/EU. The corrigendum is to replace the latest harmonized standards
> list for the LVD previously published on April 8th. I’m still wondering why
> they are still working with a repealed directive in this case instead of the
> one that has effectively replaced it on April 20th.
> http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C:2016:173:TOC
>
> Best regards,
>
> Ron Pickard
> Regulatory Compliance Engineer
> Compound Photonics
> D | +1 (602) 883-8039
>
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