Standard Document
Second Edition
ISO
ISO18113-2
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
This document defines requirements for information provided by manufacturers of in vitro diagnostic (IVD) reagents, calibrators, and controls for professional use, including labeling and instructions for use. It also applies to certain accessories but excludes IVD instruments, equipment, and self-testing reagents.
October 01, 2022
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ISO18113-2Ed2E
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