ISO 18113-2:2009
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
Reference number
ISO 18113-2:2009
Edición 1
2009-12
Retirada
ISO 18113-2:2009
40985
Retirada (Edición 1, 2009)

Resumen

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.

Informaciones generales

  •  : Retirada
     : 2009-12
    : Retirada de la Norma Internacional [95.99]
  •  : 1
     : 10
  • ISO/TC 212
    11.100.10 
  • RSS actualizaciones

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