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BSI BS EN ISO 18113-2:2024

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) -- In vitro diagnostic reagents for professional use
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BSI BS EN ISO 18113-2:2024

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) -- In vitro diagnostic reagents for professional use

PUBLISH DATE 2024
PAGES 26
BSI BS EN ISO 18113-2:2024
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.
SDO BSI: British Standards Institution
Document Number ISO 18113-2
Publication Date June 12, 2024
Language en - English
Page Count 26
Revision Level
Supercedes
Committee CH/212
Publish Date Document Id Type View
June 12, 2024 BS EN ISO 18113-2:2024 Revision
Feb. 28, 2010 BS EN ISO 18113-2:2009 Revision
Dec. 7, 2006 BS ISO 18113-2:2006 Revision
Jan. 31, 2012 BS EN ISO 18113-2:2011 Consolidated