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SRPS EN 1639:2011

Dentistry - Medical devices for dentistry - Instruments

Aug 29, 2011

General information

90.93     May 22, 2024

90.20    Jan 15, 2025

ISS

Z106

European Norm

11.060.25  

English  

From plan 2011

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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 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.

93/42/EEC

Medical devices

Harmonized
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WITHDRAWN
SRPS EN 1639:2009

NOW

PUBLISHED
SRPS EN 1639:2011
90.93 Standard confirmed
May 22, 2024

Related project

Adopted from EN 1639:2009