EN 1639:2009

Dentistry - Medical devices for dentistry - Instruments

Publication date:   Aug 20, 2010

General information

90.60 Close of review   Dec 2, 2019

CEN

CEN/TC 55 Dentistry

European Norm

11.060.25   Dental instruments

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Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

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

Life cycle

PREVIOUSLY

WITHDRAWN
EN 1639:2004

NOW

PUBLISHED
EN 1639:2009
90.60 Close of review
Dec 2, 2019