EN ISO 18113-3:2009

Name: EN ISO 18113-3:2009
Brand: CEN
SKU: EN ISO 18113-3:2009
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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009) EN ISO 18113-3:2009

Publication date: Mar 22, 2010

General information

Current stage: 99.60 Withdrawal effective Oct 19, 2011

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Status: Withdrawn

Scope

ISO 18113-3:2009 specifies requirements for information supplied by the manufacturer of in vitro dignostic (IVD) instruments for professional use.
ISO 18113-3:2009 also applies to apparatus and equipment intended to be used with IVD instruments for professional use.
ISO 18113-3:2009 can also be applied to accessories, where appropriate.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting

2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

PREVIOUSLY

WITHDRAWN
EN 591:2001

NOW

WITHDRAWN
EN ISO 18113-3:2009
99.60 Withdrawal effective
Oct 19, 2011

REVISED BY

PUBLISHED
EN ISO 18113-3:2011