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DIN EN ISO 18113-2:2013
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009); German version EN ISO 18113-2:2011
This part of DIN EN ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for professional use. Furthermore, this part of DIN EN ISO 18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use. This part of DIN EN ISO 18113 can also be applied to accessories, where appropriate. This part of DIN EN ISO 18113 applies to labels for the outer and immediate containers and to the instructions for use.
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Deutsches Institut für Normung [din]
Deutsches Institut für Normung [din]