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SRPS EN ISO 18113-3:2011

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

Jun 28, 2011
95.99   Withdrawal of Standard   Feb 28, 2013

General information

95.99     Feb 28, 2013

ISS

Z076

European Norm

11.100.10  

English  

From plan 2011

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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 directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

98/79/EC

In vitro diagnostic medical devices

Harmonized
Directive 98/79/EC
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

Directive 2007/47/EC

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN 591:2008

NOW

WITHDRAWN
SRPS EN ISO 18113-3:2011
95.99 Withdrawal of Standard
Feb 28, 2013

REVISED BY

WITHDRAWN
SRPS EN ISO 18113-3:2013

Related project

Adopted from EN ISO 18113-3:2009

Adopted from ISO 18113-3:2009 IDENTICAL