Most recent
BS EN ISO 18113-2:2011
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for professional use (British Standard)
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.
Content Provider
British Standards Institution [bsi]
