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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.

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Austrian Standards Institute [on]

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