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DIN EN ISO 18113-2:2024
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022); German version EN ISO 18113-2:2024
This part of the DIN EN ISO 18113 series specifies requirements for information provided by the manufacturer of IVD reagents, calibrators and controls for professional use. Where applicable, this draft standard may also be applied to accessories. This part of DIN EN ISO 18113 applies to labels for the outer and primary containers and the instructions for use.
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Deutsches Institut für Normung [din]