EN ISO 18113-1:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) EN ISO 18113-1:2011

Publication date:   Feb 17, 2012

General information

60.60 Standard published   Oct 19, 2011

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

11.100.10   In vitro diagnostic test systems

Buying

Published

Language in which you want to receive the document.

Scope

ISO 18113-1:2009 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 18113-1:2009

NOW

PUBLISHED
EN ISO 18113-1:2011
60.60 Standard published
Oct 19, 2011

REVISED BY

IN_DEVELOPMENT
FprEN ISO 18113-1

Relations

Adopted from ISO 18113-1:2009 IDENTICAL