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> From: rlanz <rl...@concentric.net>
> To: Farnsworth, Heber <hfarn...@physio-control.com>
> Subject: Re: CE Technical Documentation
> Date: Wednesday, March 25, 1998 9:09 AM
>
> I recommend, for clarity, you state which CE directives you are referring
> to. For example a Technical File is used differently in the EMC and Low
> Voltage Directive. The Medical Directive makes reference to a Design or
> Technical Dossier, and could be subject to Notified Body inspection.
This
> would depend on the type of product. Summarily, all of these terms
> describe documented evidence of compliance with the intended
> specification(safety, emc, performance). You can add Device Record or
> Device Master Record to the list; referred to in FDA regulations.
>
> Regards,
> Richard Lanzillotto
> Regulatory Consultant
> rl...@concentric.net
> > From: Farnsworth, Heber <hfarn...@physio-control.com>
> > To: pstc Post Message (E-mail) <emc-p...@ieee.org>
> > Subject: CE Technical Documentation
> > Date: Tuesday, March 24, 1998 10:20 AM
> >
> >
> > Could someone point me toward definitions for the following terms (with
> > regard to CE marking documentation)
> >
> > -Technical Documentation
> > -Technical Documentation File
> > -Technical Dossier
> > -(other related terms)
> >
> > I'm having trouble explaining the difference.
> >
> >
> >
> >
> >
