C
cwokeeffe
I understand EN 375 and EN 591 will be replaced by EN ISO 18113-2 and EN ISO 18113-3.
Does anyone know the timeline for this?
Thanks!
Does anyone know the timeline for this?
Thanks!
In Vitro Diagnostic Medical Devices - Labeling Standards EN 375 and EN 591
Re: Labeling Standards EN 375, EN 591
There's an xls file in this link (I think it is in German) that shows some estimated time. Look at lines 695 & 696 - not sure if it's the information you are after. Anexa4CEN_2009-01-20
There's an xls file in this link (I think it is in German) that shows some estimated time. Look at lines 695 & 696 - not sure if it's the information you are after. Anexa4CEN_2009-01-20
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Re: In vitro diagnostic medical devices - Labeling Standards EN 375, EN 591
Welcome to the Cove, cwokeeffe
All the subparts of ISO 18113 are still under FDIS stage - refer ISO website.
Its is under Stage 50.00 - FDIS registered for formal approval
Welcome to the Cove, cwokeeffe
All the subparts of ISO 18113 are still under FDIS stage - refer ISO website.
Its is under Stage 50.00 - FDIS registered for formal approval
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Y
yana prus
Re: In vitro diagnostic medical devices - Labeling Standards EN 375, EN 591
Hi cwokeeffe!
Once EN 18113-2 and EN 18113-3 would be harmonized, it would appear in the list of the harmonized standards for in vitro diagnostic medical devices in the EC website.
In the last 2 columns you would see the reference to the superseded standards and the date of cessation.
Regards,
Yana
Hi cwokeeffe!
Once EN 18113-2 and EN 18113-3 would be harmonized, it would appear in the list of the harmonized standards for in vitro diagnostic medical devices in the EC website.
In the last 2 columns you would see the reference to the superseded standards and the date of cessation.
Regards,
Yana
Re: In vitro diagnostic medical devices - Labeling Standards EN 375, EN 591
I think you are referring to THIS table, right ?
Yeah, once the ISO standards that I mentioned earlier are finalized, these would get obsolete
I think you are referring to THIS table, right ?
Yeah, once the ISO standards that I mentioned earlier are finalized, these would get obsolete
C
cwokeeffe
Re: In vitro diagnostic medical devices - Labeling Standards EN 375, EN 591
Thanks everyone! Yes I knew it was under approval. I was interested in knowing how long it typically takes to move throught the approval process.
Thanks everyone! Yes I knew it was under approval. I was interested in knowing how long it typically takes to move throught the approval process.
Michael Malis
Quite Involved in Discussions
Hi Marc,
The present status for the EN ISO 18113 (I,II and III) is 2009 and it was published in February of 2010.
Regards,
Mike
The present status for the EN ISO 18113 (I,II and III) is 2009 and it was published in February of 2010.
Regards,
Mike
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