Published
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.
Directives related to this standards.
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
Harmonized
Replaces
SSH EN 1639:2008
PUBLISHED
SSH EN 1639:2009
60.60
Standard published
Oct 28, 2010
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