ISO 18113-2:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for professional use.
ISO 18113-2:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use.
ISO 18113-2:2009 can also be applied to accessories.
ISO 18113-2:2009 applies to the labels for outer and immediate containers and to the instructions for use.
Status: WithdrawnPublication date: 2009-12
Edition: 1Number of pages: 10
Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems