ISO 18113-4:2009
ISO 18113-4:2009


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.

General information 

  •  :  Withdrawn
     : 2009-12
  •  : 1
     : 10
  •  : ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
  •  :
    11.100.10 In vitro diagnostic test systems

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