Diagnostické zdravotnické prostředky in vitro - Informace poskytované výrobcem (označování štítky) - Část 2: Diagnostická činidla in vitro pro profesionální použití (Norma k přímému použití jako ČSN).

The information about the standard:

Designation standards: ČSN EN ISO 18113-2-ed.2
Classification mark: 857027
Catalog number: 519960
Publication date standards: 1.11.2024
The number of pages: 28
Approximate weight : 84 g (0.19 lbs)
Country: Czech technical standard
Kategorie: Technické normy ČSN

Annotation of standard text ČSN EN ISO 18113-2-ed.2 (857027):

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