ISO 18113-2:2022 PDF

Scope: This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators and controls intended for professional use. This document can also be applicable to accessories. This document is applicable to the labels for outer and immediate containers and to the instructions for use. This document does not apply to: a) IVD instruments or equipment; b) IVD reagents for self-testing.

ISO 18113-2:2022 Referenced Document

ISO 14971 Medical devices - Application of risk management to medical devices
ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
ISO 18113-1 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements
ISO 8601-1 Date and time — Representations for information interchange — Part 1: Basic rules — Amendment 1: Technical corrections*， 2022-10-25 Update

2022 ISO 18113-2:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
2009 ISO 18113-2:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use