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ISO 18113-4:2009

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

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Abstract

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.

 

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