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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
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testi...
Valid
Publisher:
International Organization for Standardization
Format:
Digital | 11 Pages
Language:
English
ICS
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.
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
