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CSN EN ISO 18113-4
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
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| Category: | 857027 |
| Released: | 2009 |
| Released: | 2011 |
| Number of Standard: | CSN EN ISO 18113-4 |
DESCRIPTION
EN ISO 18113-4
EN ISO 18113-4 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing - ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing. ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing. ISO 18113-4:2009 can also be applied to accessories, where appropriate. ISO 18113-4:2009 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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