Standard Document
Second Edition
ISO
ISO18113-1
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements
This document establishes key principles and essential requirements for information provided by manufacturers of in vitro diagnostic (IVD) medical devices. It ensures clarity and completeness in device documentation while excluding language requirements, performance evaluation devices, shipping documents, safety data sheets, and marketing materials.
October 01, 2022
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Product Details
ISO18113-1Ed2E
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