Subject: Re: Q: EN46000 /Andrews/Meron
Date: Mon, 8 Nov 1999 16:35:12 -0600
From: Emanuel Meron
> Subject: Q: EN46000 /Andrews
> From:
>
> Respected List Members,
> Can anyone direct me to more information on the system requirements
> mandated by EN46000?
>
> Any and all information is most appreciated.
>
> Thanks,
>
> Ethan Andrews
EN46001 and EN46002 are not stand alone standards. They give additional requirements for the application of ISO9001 and ISO9002 to the medical device industry. To really understand the requirements you must read EN46001 together with ISO9001, and EN46002 together with ISO9002. A system in compliance with those standards is a prerequisite for CE marking a medical device in accordance with the European Medical Device Directive 93/34/EEC (MDD). Such a system will be similar, though not identical, to one complying with FDA's QSR (Quality System Regulation) 21 CFR 820.
Emanuel Meron
Date: Mon, 8 Nov 1999 16:35:12 -0600
From: Emanuel Meron
> Subject: Q: EN46000 /Andrews
> From:
>
> Respected List Members,
> Can anyone direct me to more information on the system requirements
> mandated by EN46000?
>
> Any and all information is most appreciated.
>
> Thanks,
>
> Ethan Andrews
EN46001 and EN46002 are not stand alone standards. They give additional requirements for the application of ISO9001 and ISO9002 to the medical device industry. To really understand the requirements you must read EN46001 together with ISO9001, and EN46002 together with ISO9002. A system in compliance with those standards is a prerequisite for CE marking a medical device in accordance with the European Medical Device Directive 93/34/EEC (MDD). Such a system will be similar, though not identical, to one complying with FDA's QSR (Quality System Regulation) 21 CFR 820.
Emanuel Meron