This standard was last reviewed and confirmed in 2015. Therefore this version remains current.
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.
Status : PublishedPublication date : 2009-12
Edition : 1Number of pages : 8
Technical Committee:Clinical laboratory testing and in vitro diagnostic test systems
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