SRPS EN ISO 18113-4:2013

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)

Scope

ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing.
ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.
ISO 18113-4:2009 can also be applied to accessories, where appropriate.
ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.