ISO 18113-3:2022

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ISO 18113-3:2022 is an international standard focusing on the information supplied by the manufacturer for in vitro diagnostic (IVD) instruments intended for professional use. It outlines the requirements for labeling and instructions for use related to these instruments. The standard applies to instruments themselves, as well as associated apparatus, equipment, and accessories used with them. It does not cover instructions for servicing or repair, IVD reagents, or instruments intended for self-testing.