Historical
ONORM EN ISO 18113-4:2012
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009) (Austrian Standard)
ISO 18113-4 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing.
ISO 18113-4 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.
ISO 18113-4 can also be applied to accessories, where appropriate.
ISO 18113-4 applies to the labels for outer and immediate containers and to the instructions for use.
Austrian Standards Institute [on]