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Standard [CURRENT]
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The standards DIN EN ISO 18113-2 and DIN EN ISO 18113-4 specify requirements for information supplied by the manufacturer of in vitro diagnostic reagents for professional use (Part 2) or for self-testing (Part 4). Furthermore the standards also apply for information supplied by the manufacturer of calibrators and control materials intended for use with IVD medical devices for professional use or self-testing. The standards can also be applied to accessories. They apply to labels for outer and immediate containers and to the instructions for use.
This document replaces DIN EN ISO 18113-2:2010-05 .