EN 13640:2002 or EN23640:2013 For stability testing of in vitro diagnostic reagents

[esh14]

[FONT=&quot]I understand that the new version of Official Journal of the European Union (OJEU) has been published, please advise if EN 13640:2002 ? For stability testing of in vitro diagnostic reagents is still valid as I couldn?t find either the EN 13640:2002 or EN23640:2013 in the OJEU. Anyone that can help? [/FONT][FONT=&quot]Your help would be appreciated. [/FONT]

 

[Ronen E]

Re: EN 13640:2002 or EN23640:2013 For stability testing of in vitro diagnostic reagen

[FONT=&quot]I understand that the new version of Official Journal of the European Union (OJEU) has been published, please advise if EN 13640:2002 ? For stability testing of in vitro diagnostic reagents is still valid as I couldn?t find either the EN 13640:2002 or EN23640:2013 in the OJEU. Anyone that can help? [/FONT][FONT=&quot]Your help would be appreciated. [/FONT]

Hi,

You can use any published standard to support your compliance; the only difference is that you won't benefit an "automatic" presumption of conformity as with a standard that is on the current harmonized standards list (OJEU).

Cheers,
Ronen.

 

[Rocke]

Re: EN 13640:2002 or EN23640:2013 For stability testing of in vitro diagnostic reagen

There has been a lot of back and forth with these standards and the list.
A gap is created by removing EN 13640:2002 from the harmonised standards? list for IVDs since its successor, EN ISO 23640:2011 is still not harmonised.
I have heard (but not seen evidence) that the Commission and CEN/Cenelec have confirmed the removal as an administrative error which will be reinstated in the next publication.

I am using 23640:2011 for Europe.

Best
Camilla