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Norm

ISO 18113-4:2009

Issue date: 2009 12 17

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...
Withdrawn: 2022 10 06
Publisher:
International Organization for Standardization
Format:
Digital | 10 Pages
Language:
English

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.

ISO 18113-4:2022
2022 10 06
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4:...
Norm
ISO 18113-4:2009
2009 12 17
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4:...
Norm
Norm
ISO 18113-4:2022
Issue date : 2022 10 06
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing