Diagnostické zdravotnické prostředky in vitro - Informace poskytované výrobcem (označování štítky) - Část 5: Diagnostické přístroje in vitro pro sebetestování (Norma k přímému použití jako ČSN).

The information about the standard:

Designation standards: ČSN EN ISO 18113-5-ed.2
Classification mark: 857027
Catalog number: 519958
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 18113-5-ed.2 (857027):

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.
This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.
This document can also be applicable to accessories.
This document does not apply to:
a) instructions for instrument servicing or repair;
b) IVD reagents, including calibrators and control materials for use in control of the reagent;
c) IVD instruments for professional use