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Homepage>CSN Standards>85 HEALTH SERVICE>8570 Diagnostic systems in vitro>CSN EN ISO 18113-4 ed. 2 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
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Released: 01.11.2024
CSN EN ISO 18113-4 ed. 2 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing

CSN EN ISO 18113-4 ed. 2

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing

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Number of Standard:CSN EN ISO 18113-4 ed. 2
Category:857027
Pages:28
Released:01.11.2024
Catalog number:519964
DESCRIPTION

CSN EN ISO 18113-4 ed. 2

CSN EN ISO 18113-4 ed. 2 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.
Original English text of CSN EN Standard.
The price of the Standard included all amendments and correcturs.
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