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Norm
ISO 18113-2:2022
Ausgabedatum: 2022 10 06
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators and controls intended for professiona...
Gültig
Herausgeber:
International Organization for Standardization
Format:
Digital | 11 Seiten
Sprache:
Englisch
ICS
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators and controls intended for professional use.
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 self-testing.
ISO 18113-2:2022
2022 10 06
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2:...
Norm
↖
ISO 18113-2:2009
2009 12 09
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2:...
Norm
