EN ISO 18113-4:2011

Name: EN ISO 18113-4:2011
Brand: CEN
SKU: EN ISO 18113-4:2011
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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009) EN ISO 18113-4:2011

Publication date: Feb 17, 2012

General information

Current stage: 99.60 Withdrawal effective Jun 12, 2024

Originator: CEN

Owner: CEN/TC 140 In vitro diagnostic medical devices

Type: European Norm

ICS: 11.100.10 In vitro diagnostic test systems

Buying

Status: Published

Scope

ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing.
ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.
ISO 18113-4:2009 can also be applied to accessories, where appropriate.
ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.

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WITHDRAWN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 18113-4:2009

NOW

WITHDRAWN
EN ISO 18113-4:2011
99.60 Withdrawal effective
Jun 12, 2024

REVISED BY

PUBLISHED
EN ISO 18113-4:2024