Historical
ONORM EN ISO 18113-5:2012
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009) (Austrian Standard)
ISO 18113-5 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.
ISO 18113-5 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.
ISO 18113-5 can also be applied to accessories.
Austrian Standards Institute [on]