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.
Document identifier
ISO 18113-4:2009
Title
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
ISO Category
TC 212: Clinical laboratory testing and in vitro diagnostic test systems
Publication date
2009-12-15
International Relationship
BS EN ISO 18113-4:2011 * DIN EN ISO 18113-4 * DIN EN ISO 18113-4
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