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prEN ISO 18113-2

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/DIS 18113-2:2021)

General information
Draft
Base Documents
ISO/DIS 18113-2; prEN ISO 18113-2
Directives or regulations
None

Standard history

Status
Date
Type
Name
Main
prEN ISO 18113-2
02.11.2011
Main
This document specifies requirements for information supplied by the manufacturer of IVD reagents, calibrators and controls intended for professional use. This document can also be applied to accessories. This document applies 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.
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