ΕΛΟΤ EN ISO 18113-2 Ε3
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022)
Abstract
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.
Info
Publication Date
2024-06-28
Greek Title
In vitro διαγνωστικά προϊόντα για ιατρική χρήση - Πληροφορίες που παρέχονται από τον κατασκευαστή (επισήμανση) - Μέρος 2: In vitro διαγνωστικά αντιδραστήρια για επαγγελματική χρήση
English Title
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022)
Standard Stage
Techincal Body
YReplaces
ΕΛΟΤ EN ISO 18113-2 E2:2012Related Documents
