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ILNAS-EN 1639:2009 Edition 10/2009
Dentistry - Medical devices for dentistry - Instruments
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  • 23.9 / copy
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Abstract

This European Standard specifies general requirements for instruments used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, reprocessing, packaging, marking, labelling, and information supplied by the manufacturer. This European Standard does not apply to any necessary energy source to which an instrument needs to be connected. These energy sources are covered by EN 1640. Tests for demonstrating compliance with this European Standard are contained in the level 3 standards, if appropriate.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 55 : Dentistry

Directives

93/42/EEC : Medical devices
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

Implementation

start of the vote on the project    28/08/2008   date of ratification (dor)    19/09/2009
end of the vote on the project    28/01/2009   date of anouncement (doa)    31/01/2010
start of the vote on the final project    18/06/2009   date of publication (dop)    30/04/2010
end of the vote on the final project    18/08/2009   date of withdrawal (dow)    30/04/2010


Publication Official Journal
of the Grand-Duchy of Luxembourg
14/03/2011
Reference Mémorial A N° 47

Relations

Evolutions

Relations to older standards
ILNAS-EN 1639:2004

International Classification for Standards (ICS codes) :

11.060.25 : Dental instruments

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