Superseded Standard
Historical

NBN EN ISO 18113-2:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)

Summary

ISO 18113-2:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for professional use.
ISO 18113-2:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use.
ISO 18113-2:2009 can also be applied to accessories.
ISO 18113-2:2009 applies to the labels for outer and immediate containers and to the instructions for use.

Technical characteristics

Publisher Bureau de Normalisation Belge (NBN)
Publication Date 12/14/2011
Cancellation Date 10/31/2014
Page Count 26
EAN ---
ISBN ---
Weight (in grams) ---
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