ΕΛΟΤ EN ISO 18113.02
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
Abstract
ISO 18113-2:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for professional use. ISO 18113-2:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use. ISO 18113-2:2009 can also be applied to accessories. ISO 18113-2:2009 applies to the labels for outer and immediate containers and to the instructions for use.
Info
The standard has been withdrawn
Publication Date
2010-07-20
Withdrawal Date
2012-03-12
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 18113-2:2009)
Standard Stage
Techincal Body
YReplaced by
ΕΛΟΤ EN ISO 18113-2 E2:2012Replaces
ΕΛΟΤ EN 375 Ε2:2001Related Documents
