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EN ISO 18113-5:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009) EN ISO 18113-5:2011

Publication date:   Feb 17, 2012

General information

99.60 Withdrawal effective   Jun 12, 2024

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 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.
ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.
ISO 18113-5:2009 can also be applied to accessories.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
Legislation 98/79/EC

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 18113-5:2009

NOW

WITHDRAWN
EN ISO 18113-5:2011
99.60 Withdrawal effective
Jun 12, 2024

REVISED BY

PUBLISHED
EN ISO 18113-5:2024

Relations

Adopted from ISO 18113-5:2009 IDENTICAL