BAS EN ISO 18113-2:2025
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
General Information
Status: Published
No. of pages: 19
Language: English
Edition: 3.
Adoption method: Endorsment
Publication date: 18.06.2025
Technical committee:
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Abstract
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.
Lifecycle
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Original document and degree of correspondence
- EN ISO 18113-2:2024, identical
- ISO 18113-2:2022, identical