EN ISO 18113-1:2011

Name: EN ISO 18113-1:2011
Brand: CEN
SKU: EN ISO 18113-1:2011
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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

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 18113-1:2009 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

Legislation 98/79/EC

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 18113-1:2009

NOW

WITHDRAWN
EN ISO 18113-1:2011
99.60 Withdrawal effective
Jun 12, 2024

REVISED BY

PUBLISHED
EN ISO 18113-1:2024