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Homepage>CSN Standards>85 HEALTH SERVICE>8570 Diagnostic systems in vitro>CSN EN ISO 18113-2 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
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CSN EN ISO 18113-2 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use

CSN EN ISO 18113-2

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

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LANGUAGE
English
Category:857027
Released:2009
Released:2011
Number of Standard:CSN EN ISO 18113-2
DESCRIPTION

EN ISO 18113-2


EN ISO 18113-2 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use - ISO 18113-2:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for professional use. ISO 18113-2:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use. ISO 18113-2:2009 can also be applied to accessories. ISO 18113-2:2009 applies to the labels for outer and immediate containers and to the instructions for use.

Original English text of CSN EN Standard.
The price of the Standard included all amendments and correcturs.
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