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Regulatory Affairs Medtech
CEN to approve IVD standard on 20 July
14 July 2011
Amanda Maxwell

The European standardisation committee, CEN, is on the point of ratifying pr EN ISO 23640, a standard relating to stability testing of in vitro diagnostics1.

This standard, the only IVD standard on which CEN is currently working, has been drafted by Technical Committee (TC) 140, Working Group 2 – Quality systems for IVD MDs; the date for ratification is set for 20 July...

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