EN ISO 18113-2:2009
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
31-12-2012
15-12-2009
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.
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