Pajisje mjekësore për diagnostikimin in vitro - Informacioni i dorëzuar nga prodhuesi (etiketimi) - Pjesa 5: Instrumentet e diagnostikimit in vitro për vetë - testim (ISO 18113-5:2009)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.
ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.
ISO 18113-5:2009 can also be applied to accessories.
English