This standard was last reviewed and confirmed in 2015. Therefore this version remains current.
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.
Status : PublishedPublication date : 2009-12
Edition : 1Number of pages : 10
Technical Committee:Clinical laboratory testing and in vitro diagnostic test systems
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