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BS EN ISO 18113-2:2011

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for professional use (British Standard)

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.


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British Standards Institution [BSI]


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