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BSI BS EN ISO 18113-4:2024

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) -- In vitro diagnostic reagents for self-testing
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BSI BS EN ISO 18113-4:2024

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

PUBLISH DATE 2024
PAGES 26
BSI BS EN ISO 18113-4:2024
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing. 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 professional use.
SDO BSI: British Standards Institution
Document Number ISO 18113-4
Publication Date June 12, 2024
Language en - English
Page Count 26
Revision Level
Supercedes
Committee CH/212
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